IMV Inc. , a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, today announced positive preclinical results demonstrating robust immunogenic and antibody responses from the majority of peptide epitopes. Based on these data, the Company has selected multiple peptide epitopes to be formulated within its DPX platform to form a vaccine candidate against the novel coronavirus, DPX-COVID-19.

“These preclinical data are highly encouraging, showing that peptides formulated within the DPX platform have induced early and strong immunogenic response in an animal model. Notably, the antibody responses observed were equivalent or superior to levels achieved with DPX-RSV, which delivered a robust and sustained immune response in a Phase 1 study,” said Marianne Stanford, Ph.D., Vice President Research and Development at IMV. “Based on these results, our team has down selected a combination of peptides that have demonstrated immunogenicity and target several areas of the virus mechanism of entry in a non-overlapping fashion. DPX-COVID-19 is designed to focus the immune response on the weaknesses for the virus, to potentially increase its efficacy at preventing the infection and to efficiently inhibit virus entry into cells, thereby reducing the potential for immune escape, even in case of a mutation.”

“These results reflect the promise and versatility of our DPX platform technology, which has enabled our team to develop a new targeted vaccine candidate just two months after launching into development. Moreover, as we have shown across our clinical studies to date, our unique, targeted approach has elicited favorable results in sensitive populations, including older adult and immunocompromised patients who are most susceptible to this virus,” said Frederic Ors, President and CEO at IMV. “We are working closely with our collaborators to advance DPX-COVID-19 with urgency and remain on track to launch a Phase 1 clinical study in summer 2020.”

IMV and its collaborators have rapidly advanced a DPX-based vaccine for COVID-19, since announcing plans in March. The Company used sequences of the virus and immunoinformatics to predict and identify several hundred epitopes, of which 23 were selected for validation in preclinical studies based on their biological relevance to the virus and potential to generate neutralizing antibodies against SARS-CoV-2. Preclinical studies have been ongoing since the beginning of April, with the goal to validate and down select the most promising peptide candidates targeting weaknesses of the virus.

In preclinical animal models, IMV evaluated all 23 peptides formulated within the DPX platform. The majority of peptide epitopes tested generated targeted antibody responses after the first and second dose, without requiring an adjuvant. Based on these results, IMV has selected an optimal combination of peptides based on the best antibody responses for each of the key mechanisms for attachment, fusion and entry of SARS-CoV-2 into human cells. The antibody responses observed were equivalent or superior to a DPX-based peptide epitope vaccine (DPX-RSV) used as a reference to evaluate the level of immunogenicity in these preclinical studies. DPX-RSV is a vaccine candidate against respiratory syncytial virus (RSV), another RNA respiratory virus, and has demonstrated high functional antibody titers (up to 100-fold increase over placebo maintained for at least 421 days1) in a Phase 1 clinical study in older adults (age 50-64).

Further vaccination-challenge preclinical assays in animal models are currently performed and IMV intends to publish results of preclinical studies in a peer-reviewed scientific journal in the coming weeks.

In April, IMV conducted a pre-Clinical Trial Application (CTA) meeting with Health Canada and is finalizing a design for a Phase 1 clinical study of DPX-COVID-19. The randomized, placebo-controlled study is expected to enroll approximately 84 healthy subjects in two age strata and to assess two different doses of DPX-COVID-19. The Company is on track to initiate this study in the summer of 2020.

About DPX-COVID-19

DPX-COVID-19 is IMV’s vaccine candidate against the novel strain of coronavirus that is causing the current pandemic. It is a DPX-based formulation of multiple peptides of the SARS-CoV-2 that generated early and strong immune responses during the 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