Leading Health and Life Sciences in Nova Scotia

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

See original release here

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]

ENTREVESTOR: DGI brings patients, data together

See original article here Halifax-based DGI Clinical takes a two-pronged approach to boosting health care: the group gives patients a voice and allows pharmaceutical companies to better understand their clinical trial data. DGI Clinical has developed systems that allow patients to state and communicate their health care priorities. Established in 2001 by Dalhousie-based Alzheimer’s expert Dr. Kenneth Rockwood, DGI has created patient-focused SymptomGuides. The Alzheimer’s and dementia SymptomGuide is available online. It allows sufferers to name the symptoms that most concern them. This information can be shared with family and health professionals. Both patients and caregivers can enter data and track symptoms. It’s important that patients state the symptoms that trouble them, said Chère Chapman, the company’s CEO. “Gone are the days when patients say, ‘Tell me what to do and I’ll do it,’” Chapman said. “The SymptomGuide allows patients to set goals for their treatment  One patient with dementia, for example, may wish to increase their social activity. Another may wish to decrease repetition of asking the same questions.” Chapman said between 4,000 and 5,000 people and their caregivers use the Alzheimer’s and dementia SymptomGuide. Other Symptom Guides have been created for clinical trials and clinic settings, including a recently developed hemophilia Symptom Guide. The company has also built bespoke Alzheimer’s and dementia tools for clinical trials and clinic use. “A company may want to develop a compound to reduce agitation. SymptomGuide will reveal how many of our users are concerned about agitation,” Chapman said. SymptomGuide can reveal details such as the disease stage or stages where agitation bothers patients, whether respondents are already diagnosed, and what therapies they may be on. DGI Clinical is now looking at working in the areas of HIV, cardiovascular disease and renal failure. “Our tools are applicable to chronic diseases, and our scientific team has already done a lot of research in these areas,” said Chapman. She said DGI Clinical’s tools allow pharmaceutical clients to fully understand their data. “The typical phase two drug trial looks at primary and secondary outcomes, including quality of life measures, but these are typically analyzed as if they are unrelated,” she said. “We allow pharmaceutical companies to see how the outcomes interact with each other to produce treatment effects.” She said that drug companies usually try to exclude frail people from drug trials, but people of different levels of frailty do get onto the trials. DGI offers a Frailty Index, which was developed at Dalhousie by Ken Rockwood and Arnold Mitnitski, both DGI scientists. It has been adapted for clinical trial data and provides pharmaceutical companies with greater information about the frailty of their clinical trial subjects. “The Frailty Index reveals the impact of the drug on frail people, resulting in more clinically meaningful information,” Chapman said. She said that deep analysis of data is especially useful when drug trial results are unclear. “It could be a $100-million decision to take a drug to the next level, so digging deeper into the data is worthwhile.” Chapman, a New Brunswick native with a background in health research and business management, had worked around the world before joining DGI a year ago, becoming CEO in December. She said the company is growing steadily, funding its own growth, and focusing on R&D and hiring staff. Halifax is an excellent base as the city’s universities produce great scientists. She said she is not aware of any direct competitors. “Our biggest issue is the education of potential clients,” she said. “We have to get people to change the ways they do things.” So far, the company has no Canadian clients. All clients are U.S. or European pharmaceutical companies or other groups with a health intervention to test. “We are not in a huge rush to grow,” Chapman said. “Science is complicated. It takes time for staff to understand all the science behind what we do, however bright they are.”]]>

Dalhousie University brings innovative ideas from the lab into the real world

See original article in LINK Magazine
Every year brilliant discoveries are made in Dalhousie University’s research labs but without commercialization support many of those discoveries may never lead to potential social or economic benefits. The Industry Liaison and Innovation (ILI) Office, which is the business development arm of the university, is working to get those discoveries out of the labs and into the real world.
“We work to unite talented researchers with local and international companies to help them grow their business and become more competitive,” says Stephen Hartlen, assistant Vice-President of industry relations at Dalhousie and Executive Director of Industry Liaison and Innovation.
One of those unions was made when the ILI office began to work with Diagnostic Radiology Professor, Dr. Daniel Boyd and Dr. Bob Abraham an Interventional Radiologist. The office saw commercial potential in their research ideas and encouraged them to launch the company known today as ABK BioMedical.
Another success story came from Agada Biosciences, who reached out to the ILI office to investigate the prospects of transplanting their company from Washington, DC to Nova Scotia. ILI was pivotal in demonstrating the tremendous support programs for Nova Scotia life sciences companies to help ensure their success, Agada moved to Nova Scotia in 2013. Agada now employs numerous Dalhousie graduates and has extensive partnerships within the Faculty of Medicine.
The commercialization of research discoveries in Nova Scotia is an important financial boost to the region’s economy. With Dalhousie poised as the largest research enterprise in Atlantic Canada and the ILI office facilitating meaningful industry collaborations, more companies like ABK are being launched. The economic and social benefits are far reaching and include the attraction of big industry, investment, start-up formation, job creation and further contributions to research and development in the region.
The office is also a valuable asset to the business community through the transfer of knowledge and technology from the university into the hands of industry. Companies not only benefit from the collaborative facilitation and guidance of the ILI office but can also access various funding initiatives as well.
“We’re proud to be part of the innovation ecosystem in Atlantic Canada and will continue to foster meaningful collaborations with industry,” says Hartlen.