Leading Health and Life Sciences in Nova Scotia

IMV Inc. provides clinical and operational update and announces first quarter 2020 financial results

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IMV Inc., a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, today announced financial results for the first quarter ended March 31, 2020 and provided an update on its clinical and operational progress.

“Despite the current pandemic, we have continued to validate our platform and advance our clinical pipeline targeting various cancers and other serious diseases, including COVID-19,” said Frederic Ors, Chief Executive Officer at IMV. “Today, we are especially pleased to announce that SPiReL, a Phase 2 study of a DPX-Survivac combination regimen in patients with r/r DLBCL, has met its primary efficacy endpoint. This represents a significant milestone for DPX-Survivac, which has so far demonstrated the ability to shrink both solid and hematological tumors with long-lasting clinical responses and a differentiated safety profile. We believe these results in r/r DLBCL, taken together with emerging data from our DeCidE1 study in advanced ovarian cancer, support our plan to accelerate development in both of these indications.”

Mr. Ors continued, “Our recent financing fortifies our corporate position, with cash to fund operations for more than 12 months and several milestones anticipated across our portfolio in the interim. We look forward to presenting translational and updated clinical response data from DeCidE1 at the ASCO20 Virtual Scientific Program, and to further updates from each of our Phase 2 studies of DPX-Survivac later this year. Additionally, we are preparing to advance a DPX-based vaccine candidate for COVID-19, which is on track to enter into clinical trials later this summer.”

IMV Inc. Announces Closing of $25.1 Million Private Placement

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IMV Inc. a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines to fight against infectious diseases including COVID-19, today announced that it has completed its previously announced non-brokered private placement (the “Private Placement”) of 8,770,005 units of the Company (each, a “Unit”) at Cdn$2.86 per Unit for gross proceeds of approximately Cdn$25.1 million. The size of the Private Placement has increased by approximately Cdn$2.8 million following our earlier announcement on April 30, 2020.

The Company intends to use the net proceeds from the Private Placement for the clinical development of its lead candidate, DPX-Survivac, currently being assessed in advanced ovarian cancer, as well as in multiple clinical studies in combination with Merck’s Keytruda®. The balance of the net proceeds will be used for general corporate purposes, including funding research and development, preclinical and clinical expenses, and corporate costs.

NSBI : A spotlight on how some Nova Scotian companies are pivoting operations to help the fight against COVID-19

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From producing protective equipment and hand sanitizer, to innovating medical technology, here’s how some Nova Scotia companies are changing the way they do business.

In response to COVID-19, IMV initiated the development of a vaccine. The company is currently in the preclinical development stage.

As innovation companies and health partners step up to collaborate on new products with Spring Loaded, current projects include the development of a face shield and transport hood.

 

 

 

News Release: IMV Inc. Launches Plans to Advance Clinical Development of a Vaccine Candidate Against COVID-19

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FOR IMMEDIATE RELEASE

Dartmouth, Nova Scotia, March 18, 2020 – IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company (the “Company” or “IMV”), today announced that it is advancing the clinical development of a DPX-based vaccine candidate against COVID-19. Vaccines against infectious disease have been a core part of IMV’s heritage across its DPX platform technology.

The goal of this development program will be to establish the clinical safety and immunogenicity of a vaccine candidate based on the Company’s DPX delivery technology and incorporating peptides targeting novel epitopes from the coronavirus strain. The Company believes that this peptide-based approach, combined with the portability of the DPX platform, offers the potential for accelerated development and rapid, large-scale production of a vaccine.

The Company intends to develop its vaccine candidate DPX-COVID-19 in collaboration with lead investigators for the phase 1 clinical study: Joanne Langley, M.D. and Scott Halperin, M.D., of the Canadian Center for Vaccinology (CCfV) at Dalhousie University, the Izaak Walton Killam Health Center and the Nova Scotia Health Authority and the Canadian Immunization Research Network (CIRN); along with Dr. Gary Kobinger, Ph.D., Director of the Research Centre on Infectious Diseases at the University Laval in Quebec City and Global Urgent and Advanced Research and Development (GUARD) in Canada. The investigators will assist with preclinical and clinical evaluation and with further development strategy in collaboration with the Canadian government and others.

“As lead investigator on the Phase 1 study of DPX-RSV (Respiratory Syncytial Virus), I witnessed the unique potential of IMV’s epitope-based vaccine approach. I was particularly impressed by the persistence of immunogenicity at one year in an older adult population, suggesting that it is possible with this type of approach, to create an immune response that lasts for an extended period of time” said Dr. Langley. “I believe this collaboration creates the possibility of an accelerated path to clinical development of a vaccine to prevent COVID-19, and underscores the importance of public-private partnerships to tackle this epidemic.”

“We appreciate the urgent need to find solutions to the growing pandemic. Across our many clinical studies, we have observed DPX technology to elicit a robust immune response with a sustained effect, including in sensitive populations. We believe this technology offers a meaningful solution as a potential vaccine, especially in older adults and those with pre-existing conditions who are most at risk to this virus and generally more difficult to vaccinate effectively,” said Frederic Ors, Chief Executive Officer of the Company. “Additionally, we are pleased to be collaborating on this project with Dr. Langley, Dr. Halperin and Dr. Kobinger, who are leading voices in
immunization and infectious disease and share our commitment to public health.”

Third-party research in related coronaviruses has identified the benefit of humoral and cellular (B and T cell) immune responses for protection and resolution of infection, and the Company believes the body of data it has produced to date supports its DPX platform for peptide-based induction of B cells and T cells. The Company is now designing a vaccine candidate against COVID-19 based on third-party immunological studies of SARS-CoV and third-party sequencing data available for SARS-CoV-2 with the goal of selecting potentially immunogenic epitopes within the virus that induce neutralizing antibody responses and protective T cell responses.

Through the Company’s other clinical studies, the Company believes its DPX technology has demonstrated a favorable safety profile and immunogenicity in both cancer and infectious disease settings, with sustained effect and potential for single-dose effectiveness as a prophylactic vaccine. Over 200 patients have been dosed with DPX-based immunotherapies and data from these studies suggest treatment is well-tolerated, including in heavily pre-treated cancer patients with advanced-stage disease. The Company has also applied this technology for the prevention of respiratory syncytial virus (RSV), the second-leading cause of respiratory illness in infants, the elderly and the immunosuppressed. The Company reported its Phase 1 data1 from its clinical candidate, DPX-RSV, which demonstrated a favorable safety profile and immunogenicity in older adults (age 50-64), as well as preclinical data from research-stage candidates aimed at other infectious diseases, including malaria and anthrax.

About the DPX Platform

DPX is the Company’s proprietary lipid-based delivery platform with no aqueous component in the final formulation. The DPX platform can be formulated with peptide antigens. Its unique “no release” mechanism of action allows antigen presenting cells (APCs) to be attracted to the injection site, facilitating a robust and sustained immune response within lymph nodes. Fully synthetic, easy to manufacture; each product is stored in dry form and reconstituted in lipids for injection, providing an extended shelf life and simple handling and administration in the clinic. More details about the DPX mechanism of action here: https://imv-inc.com/platform.

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 (DPX). 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 cellactivating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac in advanced ovarian cancer, as well as in a combination therapy in multiple clinical studies with Merck’s Keytruda®. Connect at www.imv-inc.com.

Cautionary Language Regarding 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 forwardlooking statements include, but are not limited to, statements regarding the Company’s intention to develop a DPX-based vaccine candidate against COVID-19, the Company’s belief that the DPX-based platform creates the opportunity for accelerated development and rapid, large-scale production of a COVID-19 vaccine, the Company’s belief in the potential efficacy of its DPXbased vaccine against COVID-19, the Company’s belief in the benefits of the third-party research and studies in related coronavirus and SARS studies and third-party sequencing data and their applicability to the Company’s DPX platform and a DPX platform related vaccine and the Company’s anticipated results from its DPX cancer and infectious disease studies. Such statements 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 and uncertainties affecting the Company and its products. The Company 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, the Company’s ability to develop a DPX-based vaccine candidate against the COVID-19 through the successful and timely completion of clinical trials and studies, the receipt of all regulatory approvals by the Company to commence and then continue clinical studies, and, if successful, the commercialization of its proposed vaccine candidate related to COVID-19, the Company’s ability to raise sufficient capital to fund such clinical trials and studies and the production of any COVID-19 vaccine, the ultimate applicability of any third-party research and studies in related coronavirus and SARS studies and sequencing, the Company’s ability to enter into agreements with the proposed lead investigators to assist in the clinical development on its vaccine candidate related to COVID-19, the Company’s ability to collaborate with governmental authorities with respect to such clinical development, the coverage and applicability of the Company’s intellectual property rights to any vaccine candidate related to COVID-19, the ability of the Company to manufacture any vaccine candidate related to COVID19 rapidly and at scale and other risks detailed from time to time in the Company’s ongoing filings and in its annual information form filed with the Canadian regulatory authorities on SEDAR as www.sedar.com and with the United States Securities and Exchange Commission on EDGAR at www.sec/edgar. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Company’s continuous disclosure documents which are available on SEDAR and on EDGAR.

1: Langley et Al, 2019, Journal of Infectious Diseases

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Source: IMV Inc.

Investor Relations

Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819 ext: 1042
M: (514) 617-9481
E: [email protected]

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: [email protected]

Media

Delphine Davan, Director, Communications, IMV
M: (514) 968-1046
E: [email protected]

News Release: IMV Inc. Announces Breakthrough Data from DeCidE1, its Ongoing Phase 2 Study of DPX-Survivac in Patients with Advanced Recurrent Ovarian Cancer

February 25, 2020 at 3:05 AM EST

First in-vivo T cell therapy to demonstrate clinical activity in hard-to-treat solid tumor

79% of evaluable patients achieved disease control on target lesions; 53% experienced tumor regressions

37% achieved durable clinical benefit lasting ≥ 6 months; including four partial regressions so far, overall response rate not yet reached as six patients remain on treatment

Treatment well-tolerated with limited side effects observed

IMV to host a conference call and webcast today, February 25, 2020 at 8:00 a.m. EST; data also to be featured at KOL symposium on Thursday, February 27, 2020

DARTMOUTH, Nova Scotia–(BUSINESS WIRE)–Feb. 25, 2020– IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, today reported updated results from DeCidE1, an ongoing Phase 2 study of its lead candidate, DPX-Survivac, in patients with advanced recurrent ovarian cancer. The new results show that DPX-Survivac immunotherapy is active and well-tolerated in patients with advanced ovarian cancer.

“Today’s update marks a pivotal milestone for IMV and, we believe, is a breakthrough for targeted T cell immunotherapies, as these results demonstrate for the first time activity in a solid tumor which is among the hardest to treat” said Frederic Ors, President and Chief Executive Officer at IMV. “We were pleased to achieve the primary objectives of our DeCidE1 study, showing DPX-Survivac was active, durable and well-tolerated in advanced ovarian cancer. With these results in hand, we plan to engage with the US Food and Drug Administration (FDA) on the design of a potential pivotal trial in ovarian cancer that might support an accelerated pathway.”

Mr. Ors continued, “Notably, these results also continue to validate the unique mechanism of our DPX platform and the relevance of survivin as a cancer target, as we await updated Phase 2 data from two additional studies of DPX-Survivac in the first half of this year.”

“We are highly encouraged by the data from DeCidE1, which shows that DPX-Survivac immunotherapy was well-tolerated and achieved sustained clinical activity in advanced and recurrent ovarian cancer. This is a particularly significant observation in heavily pre-treated patients, for whom remain tremendous unmet need and limited options beyond single-agent chemotherapy, which generates responses in just 12% of patients with short duration and severe adverse effects,” said Joanne Schindler, M.D., D.V.M., Chief Medical Officer at IMV. “These results demonstrate DPX-Survivac’s clinical potential as a well-tolerated and, possibly, more effective treatment than currently available therapies. We believe this outcome places DPX-Survivac at the forefront of a new paradigm in the treatment of ovarian cancer and other solid tumors, as a targeted T cell therapy that can achieve durable responses while maintaining quality of life.”

Updated Results from DeCidE1

All 22 patients with advanced recurrent ovarian cancer enrolled in this arm of the study were heavily pre-treated, with the median number of prior therapies greater than three.

As of February 24, 2020, 19 patients were evaluable for efficacy with six patients (31%) still receiving treatment. Key preliminary findings are outlined below:

  • 15 patients (79%) achieved disease control, defined as Stable Disease (SD) or Partial Response (PR) on target lesions
    • Tumor shrinkage of target lesions was observed in 10 patients (53%)
  • Durable clinical benefits lasting ≥6 months were observed in seven patients (37%) so far:
    • Four of these seven patients (21% of evaluable patients) achieved PR with tumor regression >30% on target lesions
    • Three stable diseases were ongoing for > 6 months (range 7-9) including -29.5% and -12% tumor regressions
    • Median duration not reached yet, with five of these seven (71%) patients still on treatment at > 6 months (range 7-10)
  • Analysis of Baseline Tumor Burden (BTB) showed durable clinical benefits across a broad range of BTB (1.5-7.7 cm) with a higher number of patients achieving benefits in BTB < 5 cm as previously observed in other arms of the study:
    • Six out 11 with BTB < 5 cm (55%) achieved clinical benefits lasting > 6 months
  • Durable clinical benefits include platinum resistant and refractory patients who previously received PARP inhibitors and bevacizumab
  • Treatment was well-tolerated, with most adverse events being Grade 1-2 reactions at the injection site

Clinical Development Plans for DPX-Survivac in Advanced Recurrent Ovarian Cancer and other cancer indications

IMV plans to take these results to the U.S. Food and Drug Administration (FDA) for a Type B meeting, to align on the design of a Phase 2b study with potential to support registration under accelerated approval in this indication.

In parallel, the Company will continue to evaluate DPX-Survivac in other tumor types. Currently, there are two actively accruing Phase 2 studies of DPX-Survivac in combination with Merck’s Keytruda®: SPiReL, an investigator-sponsored study in recurrent/refractory diffuse large B-cell lymphoma (r/r DLBCL) and a basket study across five solid tumor indications. Updated data are expected from both studies in the first half of 2020.

Conference Call and Webcast Information

IMV will host a conference call and webcast on Tuesday, February 25, 2020 at 8:00 a.m. EST to discuss the DPX-Survivac clinical results.

Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (International). Other interested parties will be able to access the live audio webcast at this link.

The Company also plans to review portions of the data at its upcoming Key Opinion Leader Symposium on Thursday, February 27, 2020 at 8:30 a.m. EST.

Both webcasts will be recorded and available on IMV website for 30 days following under “Events, Webcasts & Presentations.”

About the DeCidE1 Study

“DeCidE1” is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac with intermittent low dose cyclophosphamide (CPA). This phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and –resistant ovarian cancer. Patients received 2 subcutaneous injections of DPX-Survivac 3 weeks apart and every eight weeks thereafter, and intermittent low dose CPA one week on and one week off for up to 1 year. Paired tumor biopsies were performed prior to treatment and on treatment.

Primary endpoints of this study are overall response rate, disease control rate and safety. Secondary endpoints include cell mediated immunity, immune cell infiltration in paired biopsy samples, duration of response, time to progression, overall survival and biomarker analyses.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of targeted immunotherapies designed to elicit antigen-specific functional, robust and sustained de novo T cell response. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of five unique HLA-restricted survivin peptides formulated in IMV’s proprietary DPX drug delivery platform and known to induce a cytotoxic CD8+ T cell response against survivin expressing cancer cells.

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 in advanced ovarian cancer, as well as in a combination therapy in multiple clinical studies with Merck’s Keytruda®. 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 and the timing of expected results from other DPX-Survivac’s studies with other tumor types. 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 and studies, 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: [email protected]

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: [email protected]

Media

Delphine Davan, Director, Communications, IMV
M: (514) 968-1046
E: [email protected]

Source: IMV Inc.

Investor Relations

Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819 ext: 1042
M: (514) 617-9481 E: [email protected]

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: [email protected]

Media

Delphine Davan, Director, Communications, IMV
M: (514) 968-1046
E: [email protected]