Received agreement with Health Canada on Phase 1 clinical study design protocol which also includes older patients of 56 years and above

Completed cGMP formulation and manufacturing process development for clinical trials

Ready and prepared for Clinical Trial Application submission for regulatory approval

DARTMOUTH, Canada I July 14, 2020 I IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, provides further details today on the Company’s rapid progress in developing its candidate vaccine to prevent COVID-19 infection in response to the global health threat posed by the novel coronavirus. “We are working closely with regulatory agencies and our collaborators to initiate clinical studies as quickly as possible. The design of the phase 1 clinical study, agreed with Health Canada, is a randomized controlled study, assessing the safety and immunogenicity of DPX-COVID-19, in 84 healthy adults across two age cohorts: (1) adults between 18-55 years old inclusive and (2) 56 and above. Two dose levels of DPX-COVID-19 will be tested (25μg or 50μg). We are pleased that Health Canada has welcomed the design of a phase 1 trial that includes this vulnerable population.” The rapid progress in target selection, the vaccine formulation, manufacturing and preclinical results so far not only demonstrate the potential of our delivery platform, but also build on our previously reported clinical data from a similarly designed vaccine against RSV, the respiratory syncytial virus,” says Frederic Ors, Chief Executive Officer at IMV. “Clinical results1 have shown our DPX-based vaccine against RSV demonstrated a unique ability to generate safe and long-lasting immune responses in older adults.” IMV’s candidate vaccine, DPX-COVID-19, is based on IMV’s first-in-class delivery platform that generates targeted and sustained immune response in vivo. Fully synthetic, the vaccine candidate is designed to focus the immune response on the weaknesses of the virus with the goal to optimize safety and efficacy:

  • DPX-COVID-19 is a formulation of the DPX delivery platform with four complementary peptide antigens that were selected for their high immunogenicity and ability to bind non-overlapping areas on the virus spike and impact its infective function in preclinical studies,
  • Importantly, our selected targets are located outside of the 614 mutation which, according to recent research2,3has been demonstrated to increase the virus’ ability to infect cells in vitro and suggested to potentially reduce vaccine-induced immunity. We believe our vaccine candidate would retain its potential efficacy independently from current/future mutations of the virus at this site,

Areas on the virus spike identified as potentially responsible for vaccine-enhanced disease4 have been excluded from our target selection to minimize safety risk.

Since the Company announced the selection of its candidate vaccine on May 21st, the Company has made significant progress.

  • Preclinical studies have demonstrated the capacity of DPX-COVID-19 to induce strong immunogenicity including the binding on target to the spike protein and viral neutralization,
  • The Company has completed the current good manufacturing practice (“cGMP”) formulation and manufacturing process development for DPX-COVID-19, and
  • Multiple batches have been successfully produced at IMV.

Next milestones are anticipated as we commence phase 1 clinical trials this summer with results in the Fall of 2020. Once results are published, we plan to initiate phase 2 clinical trials in the second half of the year.

About DPX-COVID-19

DPX-COVID-19 is IMV’s vaccine candidate against the novel strain of coronavirus that is responsible for the current pandemic. It is a DPX-based formulation of multiple peptides of the SARS-CoV-2 that generated early and strong immune responses in preclinical assays in animal models. A first-in-human Phase 1 clinical study is scheduled to initiate during summer 2020. Fully synthetic, DPX-COVID-19 has the potential for fast and large-scale manufacturing to supply a significant number of doses rapidly compared to more conventional vaccines. For more information, visit our dedicated webpage to the development of DPX-COVID-19.

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 cancer-targeted immunotherapies and vaccines 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. IMV is also developing a DPX-based vaccine to fight against COVID-19. Visit and connect with us on Twitter and LinkedIn.