IMV Inc.

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IMV is a clinical-stage immuno-oncology company that wants to transform the way we engage human immunity to address some of the most complex, devastating diseases in today’s medical landscape.

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IMV Inc.

lockPrivateGroup

IMV is a clinical-stage immuno-oncology company that wants to transform the way we engage human immunity to address s......

people4 Members       (0)

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8020 Admin

2 hours ago

8020 Admin posted a press release IMV Inc. Announces Third Quarter 2019 Financial Results and Provides Corporate Update in IMV INC.

DARTMOUTH, Nova Scotia





  • Reported preliminary data from Phase 2 basket study of DPX-Survivac in multiple solid tumors at the ESMO annual meeting, showing treatment was well-tolerated and showed signs of clinical activity





  • Entered into research collaboration with The Wistar Institute, leveraging DPX technology to develop targeted T cell therapy against BRAF mutation





  • Multiple near-term readouts from Phase 2 studies of DPX-Survivac, including updated data from SPiReL in recurrent/refractory  DLBCL to be presented at ASH 2019 on December 8, 2019 and topline interim results from DeCidE1 in advanced ovarian cancer expected during Q1 2020





  • Management to host conference call and webcast this morning at 8:00 am ET




IMV Inc. (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, today announced its financial and operational results for the third quarter ended September 30, 2019.


“In the third quarter and more recently, we have continued to advance our pipeline forward. In particular, we were pleased to report preliminary data at ESMO that highlighted DPX-Survivac’s potential to treat numerous solid tumors beyond our lead indications. Additionally, we launched a collaboration with The Wistar Institute, which applies our DPX-based targeted T cell therapy to the common BRAF mutation – another prevalent target across a range of tumor types,” said Frederic Ors, President and Chief Executive Officer of IMV. “Importantly, these recent achievements reinforce our belief in the breadth of our platform and its ability to produce cancer-targeted T cells that elicit a more rapid, robust and sustained immune response. Looking ahead, we await key readouts from DPX-Survivac, including updated data from the Phase 2 study in r/r DLBCL at ASH on December 8, 2019 and topline interim data from our Phase 1b/2 study in advanced ovarian cancer during the first quarter of next year. As we close in on proof-of-concept in these indications of high unmet medical need, we continue to believe both represent fast-to-market opportunities and are therefore preparing to launch potential pivotal studies in 2020.”


DPX-Survivac Clinical Program Updates


Phase 1b/2 DeCidE1 Study in Advanced Recurrent Ovarian Cancer


DeCidE1, the Company’s Phase 1b/2 open-label study evaluating the safety and efficacy of DPX-Survivac and intermittent low-dose cyclophosphamide (CPA), with and without Epacadostat, in advanced recurrent ovarian cancer, is ongoing without Epacadostat.


Enrollment is complete in this study and the Company intends to report topline interim data during Q1 2020.


Phase 2 SPiReL Study in Recurrent/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)


SPiReL, an investigator-sponsored Phase 2 study evaluating DPX-Survivac and ildCPA in combination with Keytruda® (pembrolizumab) in recurrent/refractory DLBCL is ongoing.


Neil Berinstein, M.D. FRCPC, ABIM, Hematologist at the Sunnybrook Health Science Centre will deliver a poster presentation at the American Society of Hematology (ASH) Annual Meeting on December 8, 2019, including updated data from the study.


As of November 7, 2019, 17 patients have been enrolled across five different clinical sites in Canada. The non-randomized, open label study is expected to enroll 25 evaluable participants in Canada. Additional patients are being screened and topline data are expected from this study in the first half of 2020.


Phase 2 Basket Trial in Multiple Advanced and Metastatic Solid Tumors


In September 2019, at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, IMV presented preliminary results from its ongoing Phase 2 basket trial, evaluating DPX-Survivac and intermittent low-dose CPA in combination with pembrolizumab in patients with advanced and metastatic solid tumors.


As of the data cut-off, 23 patients had been treated across all five patient cohorts with bladder, hepatocellular carcinoma (liver), ovarian, and non-small cell lung (NSCLC) cancers, as well as tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker. Preliminary results from the first on-study scan showed signs of clinical activity with tumor regressions observed in patients with ovarian, non-small cell lung and bladder cancers, including two partial responses, and a consistent safety profile including no grade 3-4 immune-related adverse events. The preliminary data are available here.


As of November 7, 2019, 13 clinical sites have been activated, 64 patients are screened, and 31 patients have been enrolled. The study continues to enroll patients towards a total enrollment target of 184 patients across all five cohorts. The Company expects to report topline data in the first half of 2020.


Operational Highlights:


Appointment of Joanne Schindler, M.D., D.V.M. as Chief Medical Officer. Dr. Schindler joined IMV in November 2019 with over 15 years of experience in the biopharmaceutical industry, primarily in early-stage oncology drug development. Most recently, she served as Vice President, Clinical Development and Executive Medical Director at H3 Biomedicine, where she oversaw clinical development strategy and execution.


Research collaboration with Meenhard Herlyn, D.V.M., D.Sc. and The Wistar Institute to develop a targeted T cell therapy against the BRAF mutation. Under this collaboration, IMV will optimize the DPX formulation with Wistar-identified peptides targeting BRAF, one of the most frequently identified cancer-causing mutations in melanoma and various other cancers, including non-Hodgkin’s lymphoma, colorectal cancer, thyroid cancer, and non-small cell lung and ovarian carcinomas. IMV holds an exclusive option to in-license intellectual property related to the program.


Upcoming Milestones:


Over the course of upcoming quarters, the Company expects to deliver the following milestones:



  • Updated results from Phase 2 SPiReL trial (DLBCL) at ASH 2019 on December 8, 2019

  • Topline results from Phase 1b/2 DeCidE1 trial (ovarian) during Q1 2020

  • Topline results from Phase 2 SPiReL trial (DLBCL) in 1H 2020

  • Topline results from Phase 2 basket trial (multiple tumors) of DPX-Survivac in 1H 2020.


Overview of Q3 2019 Financial Results (In Canadian dollars)


At September 30, 2019, the Corporation had cash and cash equivalents of $21.4 million and working capital of $21.2 million, compared with $14.9 million and $12.2 million, respectively at December 31, 2018. Management believes that the Corporation’s cash resources of $21.4 million and its additional potential cash resources of $2.3 million will be sufficient to fund operations for the next twelve months.


For the nine-month period ended September 30, 2019, IMV's cash burn rate (defined as net loss and comprehensive loss adjusted for charges to operations not involving cash as described in the statement of cash flows) was $17.4 million. Based on the current business plan, the Corporation forecasts the quarterly cash burn rate to be between $5 million and $6 million for the fourth quarter of 2019.


The net loss and comprehensive loss of $7.9 million ($0.16 per share) for the three-month period ended September 30, 2019, was $1.9M higher than the net loss and comprehensive loss for three-month period ended September 30, 2018. This relates mainly to an increase in R&D expenses of $1.8M related to the basket trial and pre-clinical preparation for a phase I trial with DPX-SurMAGE.


For the nine-month period ended September 30 2019, the net loss and comprehensive loss of $18.9M ($0.38 per share) was $4.6M higher than the net loss and comprehensive loss for the nine-month period ended September 30 2018. This relates mainly to an increase in R&D expenses of $5.1M related to the basket trial and the preparation for a phase I trial with DPX-SurMAGE.


As of November 7, 2019, the number of issued and outstanding common shares was 50,630,875 and a total of 1,932,080 stock options, warrants, and deferred share units were outstanding.


The Corporation's unaudited interim condensed consolidated results of operations, financial condition and cash flows for the three and nine-months ended September 30, 2019 and the related management's discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.


Conference Call and Webcast Information


Management will host conference call and webcast this morning, November 8, 2019 at 8:00 am ET. Financial analysts are invited to join the conference call by dialing (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (international) using the conference ID# 6590953. Other interested parties will be able to access the live audio webcast at this link: https://ir.imv-inc.com/events-and-presentations.


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-targeted immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac targeted therapy in advanced ovarian cancer, and as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.



Read more here: https://www.quotemedia.com/portal/quote/?qm_symbol=IMV%3ACA&qmodStoryID=7245759475744792 

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8020 Admin

2 days ago

8020 Admin posted a press release Updated Results from Phase 2 SPiReL Study Evaluating IMV's DPX-Survivac as Combination Therapy in Patients with r/r DLBCL to be Presented at 61st American Society of Hematology (ASH) Annual Meeting in IMV INC.

DARTMOUTH, Nova Scotia



87.5% of evaluable subjects exhibited clinical benefit, including 2 complete responses and 3 partial responses

All patients tested were positive for survivin and blood analysis shows strong survivin-specific T cell responses correlated with clinical responses

The final conference poster presentation will include additional data collected between the abstract submission and the presentation itself


IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, today announced that updated results from SPiRel, a Phase 2 study of the Company’s lead program, DPX-Survivac, as a combination therapy in patients with recurrent/refractory diffuse large B-cell lymphoma (DLBCL), will be featured in a poster session at the 61st American Society of Hematology (ASH) Annual Meeting, being held December 7-10, 2019 in Orlando, FL.


Poster Presentation Details:


Poster Title: Combination of DPX-Survivac, Low Dose Cyclophosphamide, and Pembrolizumab in Recurrent/Refractory DLBCL: The SPiReL Study


Presenter: Neil Berinstein, MD, FRCPC, ABIM, Haematologist at the Sunnybrook Health Sciences Centre, Toronto, ON.


Publication Number: 3236


Session Name: 704. Immunotherapies: poster II


Date and Time: December 8, 2019, 6:00 p.m. – 8:00 p.m. EDT


Location: Orange County Convention Center, Hall B


The American Society of Hematology has published the official abstracts on its meeting website in advance of the ASH Annual Meeting.


The final conference poster presentation will include additional data collected between the abstract submission on June 27, 2019 and the presentation itself. The poster will be available under Events, Webcasts and Presentations in the investors section of IMV’s website on the day of presentation.


About the SPiReL study


“SPiReL” is a Phase 2 non-randomized, open label, efficacy and safety study. Eligible subjects have recurrent/refractory DLBCL, confirmed expression of survivin are eligible for curative therapy. Study treatment includes administering two doses of 0.5 mL of DPX-Survivac 3 weeks apart followed by up to six 0.1 mL doses every 8 weeks. Intermittent low dose cyclophosphamide is administered orally at 50 mg twice daily for 7 days followed by 7 days off. Pembrolizumab 200 mg is administered every 3 weeks. Study participants continue active therapy for up to one year or until disease progression, whichever occurs first.


The primary objective of this study is to document the response rate to this treatment combination using modified Cheson criteria. Secondary objectives include duration of response and safety. Exploratory endpoints include T cell response, tumor immune cell infiltration, and gene expression analysis. Enrollment is ongoing with a goal of up to 25 subjects in this multi-center study.


At the time of data cut-off for the abstract on June 27, 2019, 23 subjects have been screened and 12 have been enrolled.


About DPX-Survivac


DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that programs targeted T cells in vivo. It has demonstrated the potential for industry-leading targeted, persistent, and durable CD8+ T cell generation. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a cytotoxic T cell immune response against cancer cells presenting survivin peptides on their surface.


Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.


DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements regarding the FDA potentially granting accelerated regulatory approval of DPX-Survivac. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful design and completion of clinical trials and the receipt and timely receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.




Investor Relations

Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819 ext : 1042
M: (514) 617-9481 E: mjasmin@imv-inc.com

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: josh.rappaport@sternir.com

Media

Delphine Davan, Director, Communications, IMV
M: (514) 968-1046
E: ddavan@imv-inc.com



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8020 Admin

3 days ago

8020 Admin posted a press release IMV to Present Clinical Translational Data from DeCidE1 Study of DPX-Survivac at SITC 2019 Annual Meeting in IMV INC.


Robust survivin-specific T cell responses observed in recurrent late-stage ovarian cancer in nearly all evaluable subjects

Survivin-specific T cells remain active and proliferative over time, leading to T cell infiltration and the repopulation of up to 90% of the tumor microenvironment


IMV Inc. (Nasdaq:IMV)(TSX:IMV), a clinical stage biopharmaceutical company pioneering a novel class of immunotherapies, today announced that translational data, including comprehensive immune profiling of clinical samples from subjects treated with IMV’s lead compound, DPX-Survivac, will be presented during the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held on November 6 – 10, 2019 in National Harbor, MD.


In connection with DeCidE1, IMV’s ongoing Phase 1b/2 study of DPX-Survivac in advanced recurrent ovarian cancer, the Company conducted immune-profiling of peripheral blood mononuclear cell (PBMC) and tumor samples to evaluate the program’s underlying mechanism of action. The data suggest that the treatment regimen per the study protocol induced robust and sustained survivin-specific T cell responses from nearly all evaluable subjects and T cell infiltration into tumors without loss of functionality. Specifically, a comparison of T cell receptor β-chain repertoire analyses between pre- and on-treatment tumor biopsies shows new clonotypes can represent up to 90% of the intratumoral T cell population.


“We are very pleased to present these translational clinical data in advanced recurrent ovarian cancer at this important scientific venue. Taken together with earlier data, this comprehensive analysis continues to validate our new T cell therapy mechanism,” said Frederic Ors, President and Chief Executive Officer at IMV. “We find these data highly encouraging, as they highlight some of the key distinctive features of our promising new treatment for patients with this hard-to-reach cancer, as well as for patients with one of the numerous other tumor types that express survivin. We look forward to demonstrating how this effect translates into patient benefits with upcoming topline data from this study.”


Poster Presentation Details:


Poster Title: Comprehensive immune profiling of clinical samples from subjects with advanced recurrent epithelial ovarian cancer treated with a novel T cell activating therapy, DPX-Survivac


Presenter: Brennan S. Dirk, PhD – IMV Inc, Dartmouth, Nova Scotia


Abstract Number: P586


Date and Time: Poster will be displayed all day on Nov. 9, 2019, 7:00 am - 8:30 pm EST


Location: Poster Hall (Prince George AB)


SITC has published the official abstracts on its meeting website in advance of the SITC Annual Meeting. The poster will be available under Events, Webcasts and Presentations in the investors section of IMV’s website on the day of presentation.


About DPX-Survivac


DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that program targeted T cells in vivo. It has demonstrated the potential for targeted, persistent, and durable T cell generation. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a CD8+ T cell immune response against cancer cells presenting survivin peptides on their surface.


Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.


DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements regarding the FDA potentially granting accelerated regulatory approval of DPX-Survivac. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful design and completion of clinical trials and the receipt and timely receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.


View source version on businesswire.com: https://www.businesswire.com/news/home/20191105005656/en/



Investor Relations


Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819 ext : 1042
M: (514) 617-9481 E: mjasmin@imv-inc.com


Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: josh.rappaport@sternir.com


Media


Delphine Davan, Director, Communications, IMV
M: (514) 698 1046
E: ddavan@imv-inc.com


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8020 Admin

9 days ago

8020 Admin posted a press release IMV Appoints Joanne Schindler, M.D., D.V.M. as Chief Medical Officer in IMV INC.

IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, today announced the appointment of Joanne Schindler, M.D., D.V.M. as its new Chief Medical Officer, effective November 4, 2019. Dr. Schindler will succeed Gabriela Rosu, M.D., who is leaving the company to pursue other opportunities.


“We are very excited to welcome Dr. Joanne Schindler, who brings a wealth of experience in oncology-focused drug development and clinical trial execution to IMV,” said Fred Ors, Chief Executive Officer of IMV. “Over the last few years, our clinical efforts have sought to leverage the potential of our DPX technology to deliver a novel class of immunotherapies for the treatment of patients with hard-to-treat cancers. We expect to benefit greatly from Joanne’s leadership as we near key proof-of-concept readouts from our lead program and as we continue to explore the breadth of our platform across other targets of interest.”


Mr. Ors continued, “We also want to take this opportunity to thank Dr. Gabriela Rosu for her many contributions to IMV’s clinical program and wish her the best in her future pursuits.”


Dr. Schindler brings over 15 years of experience in the biopharmaceutical industry, primarily in early-stage oncology drug development. Most recently, she served as Vice President, Clinical Development and Executive Medical Director at H3 Biomedicine, overseeing the company’s clinical development efforts. Previously, she worked as Vice President, Clinical Development at Constellation Pharmaceuticals, and earlier held various clinical development leadership roles at SynDevRx, ImmunoGen, Novartis, Fresenius Biotech and GlycoGenesys. Over the course of her career, Dr. Schindler has played an instrumental role in advancing novel programs into the clinic, as well as the development and execution of clinical strategy. She holds an M.D. from the University of Connecticut School of Medicine, a D.V.M. from Tufts University School of Veterinary Medicine and a B.A. in biology from Brandeis University.


“I am delighted to join IMV at this critical stage in the company’s growth,” said Dr. Schindler. “Immunotherapy is at the forefront of novel treatments for cancer and I have been deeply impressed with IMV’s sophisticated science and data produced to date. Targeted T-cells born out of IMV’s DPX platform have exhibited the potential to elicit a more rapid, robust and sustained immune response over other therapies, particularly when paired with a highly prevalent tumor-associated target like survivin. I look forward to working with the team to advance its clinical portfolio, to unlock the promise of this technology and to bring these important benefits to cancer patients in need.”


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements regarding the FDA potentially granting accelerated regulatory approval of DPX-Survivac. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful design and completion of clinical trials and the receipt and timely receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.





Investor Relations


Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819, ext: 1042
M: (514) 617-9481
E: mjasmin@imv-inc.com


Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: josh.rappaport@sternir.com


Media


Mrs. Delphine Davan, Director of Communications, IMV
M: (514) 968-1046
E: ddavan@imv-inc.com


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8020 Admin

10 days ago

8020 Admin posted a press release IMV Inc. to Announce Third Quarter 2019 Results and Host a Conference Call and Webcast on November 8, 2019 in IMV INC.

IMV Inc. (“IMV” or the “Corporation”) (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, announced today that it will hold a conference call and webcast on Friday, November 8, 2019 at 8:00 a.m. ET to discuss the company’s third quarter 2019 financial and operational results.


Financial analysts are invited to join the conference call by dialing (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (international) using the conference ID# 6590953


Other interested parties will be able to access the live audio webcast at this link: https://ir.imv-inc.com/events-and-presentations. The webcast will be recorded and available on the IMV website for 30 days following the call.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.


View source version on businesswire.com: https://www.businesswire.com/news/home/20191029005212/en/



Investor Relations
Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819, ext: 1042
M: (514) 617-9481 E: mjasmin@imv-inc.com
Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: josh.rappaport@sternir.com
Media
Mrs. Delphine Davan, Director of Communications, IMV
M: (514) 968-1046
E: ddavan@imv-inc.com


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8020 Admin

23 days ago

8020 Admin posted a press release / C O R R E C T I O N From Source - IMV Inc / in IMV INC.

DARTMOUTH, Nova Scotia


In the news release issued on October 11, IMV announced that company management presentation at the BIO Investor Forum is scheduled on October 23 at 5:00 PM PST (8:00 PM EST).


Please, note that the presentation and webcast are scheduled on October 23 at 2:00 PM PST (5:00 PM EST).


The corrected release follows:


IMV Inc. to Present at Upcoming Investor Conference


IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, today announced that company management will be attending the BIO Investor Forum to be held on October 22-23 at the Westin St. Francis, San Francisco.


BIO Investor Forum Oct. 23 2:00 PM PST / 5:00 PM EST


A live webcast of this presentation will be available under “Events, Webcasts and Presentations” in the investors section of IMV’s website and a replay will be available approximately one hour after the presentation. Afterwards, it will be available for approximately 30 days.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements regarding the FDA potentially granting accelerated regulatory approval of DPX-Survivac. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful design and completion of clinical trials and the receipt and timely receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.





Investor Relations


Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819 ext : 1042
M: (514) 617-9481 E: mjasmin@imv-inc.com


Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: josh.rappaport@sternir.com


Media


Mrs. Delphine Davan, Director of Communications, IMV
M: (514) 968-1046 E: ddavan@imv-inc.com



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Media Relations posted an update in IMV INC.

3 months ago

MI3 Technical Note

IMV Inc. (IMV – TSX) $3.74
‘’ Transforming the way, we harness Human Immunity’’


insert_drive_fileTechnical-Note-July-29-2019-1.pdf
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Media Relations

7 months ago

Media Relations posted an update Mr. Marc Jasmin, Director of Investor Relations IMV Inc. IMV-TSX in IMV INC.

Mr. Marc Jasmin, Director of Investor Relations IMV Inc. IMV-TSX presenting to a packed audience hosted by MI3 Communications in St George de Beauce. 


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7 months ago

luc@mi3.ca has joined IMV Inc.

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8020 Admin

2 hours ago

8020 Admin posted a press release IMV Inc. Announces Third Quarter 2019 Financial Results and Provides Corporate Update in IMV INC.

DARTMOUTH, Nova Scotia





  • Reported preliminary data from Phase 2 basket study of DPX-Survivac in multiple solid tumors at the ESMO annual meeting, showing treatment was well-tolerated and showed signs of clinical activity





  • Entered into research collaboration with The Wistar Institute, leveraging DPX technology to develop targeted T cell therapy against BRAF mutation





  • Multiple near-term readouts from Phase 2 studies of DPX-Survivac, including updated data from SPiReL in recurrent/refractory  DLBCL to be presented at ASH 2019 on December 8, 2019 and topline interim results from DeCidE1 in advanced ovarian cancer expected during Q1 2020





  • Management to host conference call and webcast this morning at 8:00 am ET




IMV Inc. (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, today announced its financial and operational results for the third quarter ended September 30, 2019.


“In the third quarter and more recently, we have continued to advance our pipeline forward. In particular, we were pleased to report preliminary data at ESMO that highlighted DPX-Survivac’s potential to treat numerous solid tumors beyond our lead indications. Additionally, we launched a collaboration with The Wistar Institute, which applies our DPX-based targeted T cell therapy to the common BRAF mutation – another prevalent target across a range of tumor types,” said Frederic Ors, President and Chief Executive Officer of IMV. “Importantly, these recent achievements reinforce our belief in the breadth of our platform and its ability to produce cancer-targeted T cells that elicit a more rapid, robust and sustained immune response. Looking ahead, we await key readouts from DPX-Survivac, including updated data from the Phase 2 study in r/r DLBCL at ASH on December 8, 2019 and topline interim data from our Phase 1b/2 study in advanced ovarian cancer during the first quarter of next year. As we close in on proof-of-concept in these indications of high unmet medical need, we continue to believe both represent fast-to-market opportunities and are therefore preparing to launch potential pivotal studies in 2020.”


DPX-Survivac Clinical Program Updates


Phase 1b/2 DeCidE1 Study in Advanced Recurrent Ovarian Cancer


DeCidE1, the Company’s Phase 1b/2 open-label study evaluating the safety and efficacy of DPX-Survivac and intermittent low-dose cyclophosphamide (CPA), with and without Epacadostat, in advanced recurrent ovarian cancer, is ongoing without Epacadostat.


Enrollment is complete in this study and the Company intends to report topline interim data during Q1 2020.


Phase 2 SPiReL Study in Recurrent/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)


SPiReL, an investigator-sponsored Phase 2 study evaluating DPX-Survivac and ildCPA in combination with Keytruda® (pembrolizumab) in recurrent/refractory DLBCL is ongoing.


Neil Berinstein, M.D. FRCPC, ABIM, Hematologist at the Sunnybrook Health Science Centre will deliver a poster presentation at the American Society of Hematology (ASH) Annual Meeting on December 8, 2019, including updated data from the study.


As of November 7, 2019, 17 patients have been enrolled across five different clinical sites in Canada. The non-randomized, open label study is expected to enroll 25 evaluable participants in Canada. Additional patients are being screened and topline data are expected from this study in the first half of 2020.


Phase 2 Basket Trial in Multiple Advanced and Metastatic Solid Tumors


In September 2019, at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, IMV presented preliminary results from its ongoing Phase 2 basket trial, evaluating DPX-Survivac and intermittent low-dose CPA in combination with pembrolizumab in patients with advanced and metastatic solid tumors.


As of the data cut-off, 23 patients had been treated across all five patient cohorts with bladder, hepatocellular carcinoma (liver), ovarian, and non-small cell lung (NSCLC) cancers, as well as tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker. Preliminary results from the first on-study scan showed signs of clinical activity with tumor regressions observed in patients with ovarian, non-small cell lung and bladder cancers, including two partial responses, and a consistent safety profile including no grade 3-4 immune-related adverse events. The preliminary data are available here.


As of November 7, 2019, 13 clinical sites have been activated, 64 patients are screened, and 31 patients have been enrolled. The study continues to enroll patients towards a total enrollment target of 184 patients across all five cohorts. The Company expects to report topline data in the first half of 2020.


Operational Highlights:


Appointment of Joanne Schindler, M.D., D.V.M. as Chief Medical Officer. Dr. Schindler joined IMV in November 2019 with over 15 years of experience in the biopharmaceutical industry, primarily in early-stage oncology drug development. Most recently, she served as Vice President, Clinical Development and Executive Medical Director at H3 Biomedicine, where she oversaw clinical development strategy and execution.


Research collaboration with Meenhard Herlyn, D.V.M., D.Sc. and The Wistar Institute to develop a targeted T cell therapy against the BRAF mutation. Under this collaboration, IMV will optimize the DPX formulation with Wistar-identified peptides targeting BRAF, one of the most frequently identified cancer-causing mutations in melanoma and various other cancers, including non-Hodgkin’s lymphoma, colorectal cancer, thyroid cancer, and non-small cell lung and ovarian carcinomas. IMV holds an exclusive option to in-license intellectual property related to the program.


Upcoming Milestones:


Over the course of upcoming quarters, the Company expects to deliver the following milestones:



  • Updated results from Phase 2 SPiReL trial (DLBCL) at ASH 2019 on December 8, 2019

  • Topline results from Phase 1b/2 DeCidE1 trial (ovarian) during Q1 2020

  • Topline results from Phase 2 SPiReL trial (DLBCL) in 1H 2020

  • Topline results from Phase 2 basket trial (multiple tumors) of DPX-Survivac in 1H 2020.


Overview of Q3 2019 Financial Results (In Canadian dollars)


At September 30, 2019, the Corporation had cash and cash equivalents of $21.4 million and working capital of $21.2 million, compared with $14.9 million and $12.2 million, respectively at December 31, 2018. Management believes that the Corporation’s cash resources of $21.4 million and its additional potential cash resources of $2.3 million will be sufficient to fund operations for the next twelve months.


For the nine-month period ended September 30, 2019, IMV's cash burn rate (defined as net loss and comprehensive loss adjusted for charges to operations not involving cash as described in the statement of cash flows) was $17.4 million. Based on the current business plan, the Corporation forecasts the quarterly cash burn rate to be between $5 million and $6 million for the fourth quarter of 2019.


The net loss and comprehensive loss of $7.9 million ($0.16 per share) for the three-month period ended September 30, 2019, was $1.9M higher than the net loss and comprehensive loss for three-month period ended September 30, 2018. This relates mainly to an increase in R&D expenses of $1.8M related to the basket trial and pre-clinical preparation for a phase I trial with DPX-SurMAGE.


For the nine-month period ended September 30 2019, the net loss and comprehensive loss of $18.9M ($0.38 per share) was $4.6M higher than the net loss and comprehensive loss for the nine-month period ended September 30 2018. This relates mainly to an increase in R&D expenses of $5.1M related to the basket trial and the preparation for a phase I trial with DPX-SurMAGE.


As of November 7, 2019, the number of issued and outstanding common shares was 50,630,875 and a total of 1,932,080 stock options, warrants, and deferred share units were outstanding.


The Corporation's unaudited interim condensed consolidated results of operations, financial condition and cash flows for the three and nine-months ended September 30, 2019 and the related management's discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.


Conference Call and Webcast Information


Management will host conference call and webcast this morning, November 8, 2019 at 8:00 am ET. Financial analysts are invited to join the conference call by dialing (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (international) using the conference ID# 6590953. Other interested parties will be able to access the live audio webcast at this link: https://ir.imv-inc.com/events-and-presentations.


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-targeted immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac targeted therapy in advanced ovarian cancer, and as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.



Read more here: https://www.quotemedia.com/portal/quote/?qm_symbol=IMV%3ACA&qmodStoryID=7245759475744792 

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8020 Admin

2 days ago

8020 Admin posted a press release Updated Results from Phase 2 SPiReL Study Evaluating IMV's DPX-Survivac as Combination Therapy in Patients with r/r DLBCL to be Presented at 61st American Society of Hematology (ASH) Annual Meeting in IMV INC.

DARTMOUTH, Nova Scotia



87.5% of evaluable subjects exhibited clinical benefit, including 2 complete responses and 3 partial responses

All patients tested were positive for survivin and blood analysis shows strong survivin-specific T cell responses correlated with clinical responses

The final conference poster presentation will include additional data collected between the abstract submission and the presentation itself


IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, today announced that updated results from SPiRel, a Phase 2 study of the Company’s lead program, DPX-Survivac, as a combination therapy in patients with recurrent/refractory diffuse large B-cell lymphoma (DLBCL), will be featured in a poster session at the 61st American Society of Hematology (ASH) Annual Meeting, being held December 7-10, 2019 in Orlando, FL.


Poster Presentation Details:


Poster Title: Combination of DPX-Survivac, Low Dose Cyclophosphamide, and Pembrolizumab in Recurrent/Refractory DLBCL: The SPiReL Study


Presenter: Neil Berinstein, MD, FRCPC, ABIM, Haematologist at the Sunnybrook Health Sciences Centre, Toronto, ON.


Publication Number: 3236


Session Name: 704. Immunotherapies: poster II


Date and Time: December 8, 2019, 6:00 p.m. – 8:00 p.m. EDT


Location: Orange County Convention Center, Hall B


The American Society of Hematology has published the official abstracts on its meeting website in advance of the ASH Annual Meeting.


The final conference poster presentation will include additional data collected between the abstract submission on June 27, 2019 and the presentation itself. The poster will be available under Events, Webcasts and Presentations in the investors section of IMV’s website on the day of presentation.


About the SPiReL study


“SPiReL” is a Phase 2 non-randomized, open label, efficacy and safety study. Eligible subjects have recurrent/refractory DLBCL, confirmed expression of survivin are eligible for curative therapy. Study treatment includes administering two doses of 0.5 mL of DPX-Survivac 3 weeks apart followed by up to six 0.1 mL doses every 8 weeks. Intermittent low dose cyclophosphamide is administered orally at 50 mg twice daily for 7 days followed by 7 days off. Pembrolizumab 200 mg is administered every 3 weeks. Study participants continue active therapy for up to one year or until disease progression, whichever occurs first.


The primary objective of this study is to document the response rate to this treatment combination using modified Cheson criteria. Secondary objectives include duration of response and safety. Exploratory endpoints include T cell response, tumor immune cell infiltration, and gene expression analysis. Enrollment is ongoing with a goal of up to 25 subjects in this multi-center study.


At the time of data cut-off for the abstract on June 27, 2019, 23 subjects have been screened and 12 have been enrolled.


About DPX-Survivac


DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that programs targeted T cells in vivo. It has demonstrated the potential for industry-leading targeted, persistent, and durable CD8+ T cell generation. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a cytotoxic T cell immune response against cancer cells presenting survivin peptides on their surface.


Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.


DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements regarding the FDA potentially granting accelerated regulatory approval of DPX-Survivac. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful design and completion of clinical trials and the receipt and timely receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.




Investor Relations

Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819 ext : 1042
M: (514) 617-9481 E: mjasmin@imv-inc.com

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: josh.rappaport@sternir.com

Media

Delphine Davan, Director, Communications, IMV
M: (514) 968-1046
E: ddavan@imv-inc.com



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8020 Admin

3 days ago

8020 Admin posted a press release IMV to Present Clinical Translational Data from DeCidE1 Study of DPX-Survivac at SITC 2019 Annual Meeting in IMV INC.


Robust survivin-specific T cell responses observed in recurrent late-stage ovarian cancer in nearly all evaluable subjects

Survivin-specific T cells remain active and proliferative over time, leading to T cell infiltration and the repopulation of up to 90% of the tumor microenvironment


IMV Inc. (Nasdaq:IMV)(TSX:IMV), a clinical stage biopharmaceutical company pioneering a novel class of immunotherapies, today announced that translational data, including comprehensive immune profiling of clinical samples from subjects treated with IMV’s lead compound, DPX-Survivac, will be presented during the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held on November 6 – 10, 2019 in National Harbor, MD.


In connection with DeCidE1, IMV’s ongoing Phase 1b/2 study of DPX-Survivac in advanced recurrent ovarian cancer, the Company conducted immune-profiling of peripheral blood mononuclear cell (PBMC) and tumor samples to evaluate the program’s underlying mechanism of action. The data suggest that the treatment regimen per the study protocol induced robust and sustained survivin-specific T cell responses from nearly all evaluable subjects and T cell infiltration into tumors without loss of functionality. Specifically, a comparison of T cell receptor β-chain repertoire analyses between pre- and on-treatment tumor biopsies shows new clonotypes can represent up to 90% of the intratumoral T cell population.


“We are very pleased to present these translational clinical data in advanced recurrent ovarian cancer at this important scientific venue. Taken together with earlier data, this comprehensive analysis continues to validate our new T cell therapy mechanism,” said Frederic Ors, President and Chief Executive Officer at IMV. “We find these data highly encouraging, as they highlight some of the key distinctive features of our promising new treatment for patients with this hard-to-reach cancer, as well as for patients with one of the numerous other tumor types that express survivin. We look forward to demonstrating how this effect translates into patient benefits with upcoming topline data from this study.”


Poster Presentation Details:


Poster Title: Comprehensive immune profiling of clinical samples from subjects with advanced recurrent epithelial ovarian cancer treated with a novel T cell activating therapy, DPX-Survivac


Presenter: Brennan S. Dirk, PhD – IMV Inc, Dartmouth, Nova Scotia


Abstract Number: P586


Date and Time: Poster will be displayed all day on Nov. 9, 2019, 7:00 am - 8:30 pm EST


Location: Poster Hall (Prince George AB)


SITC has published the official abstracts on its meeting website in advance of the SITC Annual Meeting. The poster will be available under Events, Webcasts and Presentations in the investors section of IMV’s website on the day of presentation.


About DPX-Survivac


DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that program targeted T cells in vivo. It has demonstrated the potential for targeted, persistent, and durable T cell generation. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a CD8+ T cell immune response against cancer cells presenting survivin peptides on their surface.


Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.


DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements regarding the FDA potentially granting accelerated regulatory approval of DPX-Survivac. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful design and completion of clinical trials and the receipt and timely receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.


View source version on businesswire.com: https://www.businesswire.com/news/home/20191105005656/en/



Investor Relations


Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819 ext : 1042
M: (514) 617-9481 E: mjasmin@imv-inc.com


Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: josh.rappaport@sternir.com


Media


Delphine Davan, Director, Communications, IMV
M: (514) 698 1046
E: ddavan@imv-inc.com


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8020 Admin

9 days ago

8020 Admin posted a press release IMV Appoints Joanne Schindler, M.D., D.V.M. as Chief Medical Officer in IMV INC.

IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, today announced the appointment of Joanne Schindler, M.D., D.V.M. as its new Chief Medical Officer, effective November 4, 2019. Dr. Schindler will succeed Gabriela Rosu, M.D., who is leaving the company to pursue other opportunities.


“We are very excited to welcome Dr. Joanne Schindler, who brings a wealth of experience in oncology-focused drug development and clinical trial execution to IMV,” said Fred Ors, Chief Executive Officer of IMV. “Over the last few years, our clinical efforts have sought to leverage the potential of our DPX technology to deliver a novel class of immunotherapies for the treatment of patients with hard-to-treat cancers. We expect to benefit greatly from Joanne’s leadership as we near key proof-of-concept readouts from our lead program and as we continue to explore the breadth of our platform across other targets of interest.”


Mr. Ors continued, “We also want to take this opportunity to thank Dr. Gabriela Rosu for her many contributions to IMV’s clinical program and wish her the best in her future pursuits.”


Dr. Schindler brings over 15 years of experience in the biopharmaceutical industry, primarily in early-stage oncology drug development. Most recently, she served as Vice President, Clinical Development and Executive Medical Director at H3 Biomedicine, overseeing the company’s clinical development efforts. Previously, she worked as Vice President, Clinical Development at Constellation Pharmaceuticals, and earlier held various clinical development leadership roles at SynDevRx, ImmunoGen, Novartis, Fresenius Biotech and GlycoGenesys. Over the course of her career, Dr. Schindler has played an instrumental role in advancing novel programs into the clinic, as well as the development and execution of clinical strategy. She holds an M.D. from the University of Connecticut School of Medicine, a D.V.M. from Tufts University School of Veterinary Medicine and a B.A. in biology from Brandeis University.


“I am delighted to join IMV at this critical stage in the company’s growth,” said Dr. Schindler. “Immunotherapy is at the forefront of novel treatments for cancer and I have been deeply impressed with IMV’s sophisticated science and data produced to date. Targeted T-cells born out of IMV’s DPX platform have exhibited the potential to elicit a more rapid, robust and sustained immune response over other therapies, particularly when paired with a highly prevalent tumor-associated target like survivin. I look forward to working with the team to advance its clinical portfolio, to unlock the promise of this technology and to bring these important benefits to cancer patients in need.”


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements regarding the FDA potentially granting accelerated regulatory approval of DPX-Survivac. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful design and completion of clinical trials and the receipt and timely receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.





Investor Relations


Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819, ext: 1042
M: (514) 617-9481
E: mjasmin@imv-inc.com


Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: josh.rappaport@sternir.com


Media


Mrs. Delphine Davan, Director of Communications, IMV
M: (514) 968-1046
E: ddavan@imv-inc.com


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8020 Admin

10 days ago

8020 Admin posted a press release IMV Inc. to Announce Third Quarter 2019 Results and Host a Conference Call and Webcast on November 8, 2019 in IMV INC.

IMV Inc. (“IMV” or the “Corporation”) (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, announced today that it will hold a conference call and webcast on Friday, November 8, 2019 at 8:00 a.m. ET to discuss the company’s third quarter 2019 financial and operational results.


Financial analysts are invited to join the conference call by dialing (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (international) using the conference ID# 6590953


Other interested parties will be able to access the live audio webcast at this link: https://ir.imv-inc.com/events-and-presentations. The webcast will be recorded and available on the IMV website for 30 days following the call.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.


View source version on businesswire.com: https://www.businesswire.com/news/home/20191029005212/en/



Investor Relations
Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819, ext: 1042
M: (514) 617-9481 E: mjasmin@imv-inc.com
Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: josh.rappaport@sternir.com
Media
Mrs. Delphine Davan, Director of Communications, IMV
M: (514) 968-1046
E: ddavan@imv-inc.com


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8020 Admin

23 days ago

8020 Admin posted a press release / C O R R E C T I O N From Source - IMV Inc / in IMV INC.

DARTMOUTH, Nova Scotia


In the news release issued on October 11, IMV announced that company management presentation at the BIO Investor Forum is scheduled on October 23 at 5:00 PM PST (8:00 PM EST).


Please, note that the presentation and webcast are scheduled on October 23 at 2:00 PM PST (5:00 PM EST).


The corrected release follows:


IMV Inc. to Present at Upcoming Investor Conference


IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, today announced that company management will be attending the BIO Investor Forum to be held on October 22-23 at the Westin St. Francis, San Francisco.


BIO Investor Forum Oct. 23 2:00 PM PST / 5:00 PM EST


A live webcast of this presentation will be available under “Events, Webcasts and Presentations” in the investors section of IMV’s website and a replay will be available approximately one hour after the presentation. Afterwards, it will be available for approximately 30 days.


IMV Forward-Looking Statements


This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements regarding the FDA potentially granting accelerated regulatory approval of DPX-Survivac. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful design and completion of clinical trials and the receipt and timely receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.


About IMV


IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com.





Investor Relations


Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819 ext : 1042
M: (514) 617-9481 E: mjasmin@imv-inc.com


Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: josh.rappaport@sternir.com


Media


Mrs. Delphine Davan, Director of Communications, IMV
M: (514) 968-1046 E: ddavan@imv-inc.com



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Thumb 8020 media relations

Media Relations posted an update in IMV INC.

3 months ago

MI3 Technical Note

IMV Inc. (IMV – TSX) $3.74
‘’ Transforming the way, we harness Human Immunity’’


insert_drive_fileTechnical-Note-July-29-2019-1.pdf
Thumb technical note july 29 2019 1

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Media Relations

7 months ago

Media Relations posted an update Mr. Marc Jasmin, Director of Investor Relations IMV Inc. IMV-TSX in IMV INC.

Mr. Marc Jasmin, Director of Investor Relations IMV Inc. IMV-TSX presenting to a packed audience hosted by MI3 Communications in St George de Beauce. 


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luc@mi3.ca

7 months ago

luc@mi3.ca has joined IMV Inc.

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