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IMV Provides Updates On COVID-19 Vaccine Program; Co. Selected For Additional Canadian Government Funding, Phase 1/2 Study Updated, Collaboration Initiated With A Global Manufacturing Partner

Selected for additional funding by Canadian Government bringing total support to $10M for clinical development and manufacturing of DPX-COVID-19 Clinical plan updated to run a larger Phase 1/2 study with the

· 10/08/2020 07:13

Selected for additional funding by Canadian Government bringing total support to $10M for clinical development and manufacturing of DPX-COVID-19

Clinical plan updated to run a larger Phase 1/2 study with the goal to expedite later-stage development

Collaboration initiated with a global manufacturing partner to develop and expand manufacturing capacity up to several hundred million of doses

IMV Inc. (NASDAQ:IMV, TSX:IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, today provides updates on its vaccine candidate, DPX-COVID-19, for the prevention of infection caused by the novel coronavirus SARS-COV-2.

"We are advancing DPX-COVID-19 on the strength of its novel mechanism of action and potential for rapid scale-up manufacturing. We greatly appreciate the recognition, financial support, and guidance from the Government of Canada. We believe it will provide the opportunity to potentially accelerate the late-stage clinical development of DPX-COVID-19 while ensuring the highest level of safety and likelihood of success," said Frederic Ors, Chief Executive Officer of IMV.

"Based on our previous clinical data in oncology and infectious diseases, DPX-COVID-19 has the potential to improve the duration of the immune response and protect older adults and more vulnerable individuals. We are delighted that the Government of Canada sees promise in our approach which, we believe, represents a unique and complementary value proposition in the current landscape of vaccines in clinical development."

"Expanding our manufacturing capabilities with global partners is also an important step in our strategy for the global deployment of DPX-COVID-19. We believe this partnership will enable rapid expansion of manufacturing capacity to eventually distribute our vaccine in countries in need."

Selection and Additional Funding for Clinical Development and Manufacturing

IMV received notification from the Government of Canada indicating that it had reviewed IMV's proposal and its DPX-COVID-19 vaccine candidate had met the required scientific and technical thresholds for funding. As part of the Government of Canada's continuing support for the development of domestic COVID-19 vaccines, the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) is providing advisory services and up to $5.4 million in funding to support the continuation of clinical trials for IMV's DPX-COVID-19 vaccine candidate.

The total DPX-COVID19 funding secured by IMV from different governmental sources to date is approximately $10M. The current funding secured, and further potential funding are milestone based and dependent on the achievement of certain objectives.

Expedited Phase 1/2 Clinical Study

In consultation with Health Canada, IMV decided to combine its original Phase 1 and 2 studies into a single trial with the potential to accelerate the clinical development and the timeline of the overall project. In collaboration with its lead investigators for the Phase 1/2 clinical study, Joanne Langley, MD, and Scott Halperin, MD, of the Canadian Center for Vaccinology, the design of this larger study will incorporate the same two-age strata cohorts (18-55 years old and over 55 years old) as originally designed.

The Phase 1/2 trial is expected to be initiated before the end of 2020 after the completion of the preclinical safety, GLP toxicology and challenge studies that are required to advance into Phase 1/2 studies. These preclinical studies have been ongoing since mid-August.

Increased Manufacturing Capacity for DPX-COVID-19

To increase its current manufacturing capacity, IMV has entered a collaboration with a global manufacturing partner and initiated transfer and scale-up activities of DPX-COVID-19. This collaboration has the potential to bring two additional production sites in India and Europe with capacity to produce several hundred million doses of DPX-COVID-19.

In parallel, the Company continues its efforts to:

  • Secure additional non-dilutive funding and agreements with commercial partners to conduct its clinical trials; and
  • Publish preclinical study results on the selection of the peptides composing DPX-COVID-19 and the data supporting the Phase 1/2 clinical trial in a peer-reviewed scientific journal which are expected before the end of 2020.