22 May 2020 - - Canada-based biopharmaceutical company IMV Inc. (NASDAQ: IMV) (TSX: IMV) has seen positive preclinical results demonstrating robust immunogenic and antibody responses from the majority of peptide epitopes, the company said.

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.

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 neutralising 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, 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 meeting with Health Canada and is finalizing a design for a Phase 1 clinical study of DPX-COVID-19.

The randomised, 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.

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.

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 developing 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 www.imv-inc.com and connect with us on Twitter and LinkedIn.