In response to the global crisis, IMV has initiated the development of a vaccine to protect against the COVID-19 pandemic. IMV believes its targeted peptide epitope* approach has the potential to optimize and exceed the safety and efficacy profile of more conventional vaccines.
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Dr. Marianne Stanford, VP Research & Development holding vials of the vaccine candidate - April 29, 2020
Dr. Marianne Stanford, May 21, 2020
DPX-COVID-19 at a glance
- DPX-COVID-19 is a formulation of the DPX platform with peptides epitopes* from the spike proteins of the novel coronavirus (SARS-CoV-2)
- The DPX platform provides a new and unique mechanism of action, enabling peptide epitopes* to generate a strong and sustained target-specific immune response over an extended period.
- In previous studies conducted by IMV, a peptide epitope vaccine (DPX-RSV) against another respiratory virus; the Respiratory Syncytial Virus (RSV), demonstrated a 100X increase of target antibody titers in all the subjects who receive a 0.025mg dose of the vaccine.i
- All DPX-based products have demonstrated a good safety profile across clinical studies
- DPX-COVID-19 utilizes a multi-target approach, to optimize immune response against virus’ weaknesses, enhance efficacy at preventing infection and reduce potential for immune escape, even in case of a virus mutation
- 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
- Phase 1 clinical study of DPX-COVID-19 is scheduled during summer 2020
*Peptide epitopes are information molecules that can very precisely direct immune responses toward specific areas exposed on the surface of the virus
A multi-target approach based on our DPX platform’s unique mechanism of action
IMV allied with renowned experts
- The Research Centre on Infectious Diseases at the University Laval in Quebec City. Some of our pre-clinical studies in animal models are run in collaboration with Dr. Gary Kobinger.
- The Canadian Immunization Research Network (CIRN) will perform Phase 1 Clinical studies
Development plan of the vaccine candidate
As illustrated above, IMV has made significant progress since the genomic and proteomic sequences of the novel coronavirus (SARS-Cov2) were made available: The Company has used sequences of the virus and immunoinformatics to predict and identify several hundred epitopes, of which 23 were selected for their biological relevance to the virus and potential to generate neutralizing antibodies against SARS-CoV-2. Based on this analysis, IMV has begun manufacturing peptide candidates targeting these epitopes as well as planning with IMV’s suppliers and contract manufacturers to prepare for the cGMP batch required to support a clinical study in humans. Preclinical assays in animal models are also planned in April through May of this year to validate the safety and potency of the vaccine candidate before initiating the human clinical study. The design of a Phase 1 clinical study has been completed and clinical sites identified in both Nova Scotia and Quebec. IMV has initiated discussions with Health Canada in preparation for a Clinical Trial Application (CTA) with the goal to initiate the clinical study in the summer of 2020.
Questions & Answers
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When did IMV start working on the development of a vaccine against COVID-19?
As soon as the detailed genomic and proteomic sequences of the novel coronavirus (SARS-CoV-2) were made available at the end of February 2020.
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When did IMV announce the development of a vaccine against COVID-19?
IMV made an official announcement on March 18 in a press release when the top peptide epitopes were successfully identified and selected for development, and has provided updates in a second press release issued on March 30. On May 21, 2020, the Company has announced the selection of its vaccine candidate in a press release.
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What is IMV’s strategy for the development of the vaccine against COVID-19?
The Company has used sequences of the virus and immunoinformatics to predict and identify several hundred epitopes, of which 23 were selected for their biological relevance to the virus and potential to generate neutralizing antibodies against SARS-CoV-2.
Peptide epitopes are information molecules that can direct our immune system against targeted areas exposed on the surface of a virus. There are typically thousands of epitopes on viruses, but few have the potential to effectively neutralize and prevent the infection. IMV’s researchers utilized predicted epitopes from the literature and selected peptide epitopes representing the most promising immunological “Achilles heel” of the coronavirus.
IMV has formulated selected peptide epitopes with its DPX platform which has a unique “no release” mechanism of action and allows a specific, robust, and sustained immune response. The benefit of this targeted and prolonged delivery is a potential increase in safety and efficacy by exclusively focusing the attack of the immune system onto the spike proteins of the virus.
IMV’s selected vaccine candidate is designed to target non-overlapping neutralizing epitopes with the potential to act synergistically on 3 different key mechanisms of infection of the virus (see the picture above).
DPX-COVID-19 utilizes a multi-target approach, to optimize immune response against virus’ weaknesses, enhance efficacy at preventing infection, and reduce the potential for immune escape, even in case of a virus mutation.
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What is the difference between IMV’s DPX-based vaccine and traditional vaccines?
The DPX platform is formulated with small peptides that are present at the surface of the virus. DPX-COVID-19 has the potential to generate a targeted immune response against these peptides and eliminate the virus with expected limited side effectsii. It has the potential to be used widely, including aged adults and people with weakened immune systems and long-term health problems.
Conventional vaccines typically use the whole virus (live-attenuated or inactivated) to trigger an immune response. Since viruses have a complex structure, it is difficult to know which elements generate the immune response. Conventional vaccines have some limitations and may induce unwanted immune-related side effects, especially in people with weakened immune systems, long-term health problems, or people who’ve had an organ transplant.ii
The benefit of a targeted and prolonged approach is a potential increase in safety and efficacy by exclusively focusing the attack of the immune system onto the weaknesses of the virus.
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Why is it easy and fast to produce DPX-COVID-19?
All DPX-based therapies are fully synthetic, which means that there are no biologic components in the formulation and does not require any biologic manufacturing processes.
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When are pre-clinical studies planned?
Pre-clinical assays in animal models have been performed to select the best candidates and validate the safety and potency. Other preclinical assays are ongoing to characterize the vaccine candidate and its mechanism of action.
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Has IMV started the manufacturing of the vaccine against COVID-19?
IMV has completed preclinical manufacturing batches and formulations for animal testing. IMV is now preparing for GMP batch to be ready for the start of clinical trials this summer.
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When will the clinical studies start?
In collaboration with Joanne Langley, M.D. at the Canadian Center for Vaccinology (CCfV), the McGill Health Center and the Canadian Immunization Research Network (CIRN), a Phase 1 clinical study in 48 healthy subjects is being planned at two clinical sites in Nova Scotia and Quebec.
IMV has initiated discussions with Health Canada in preparation for a Clinical Trial Application (CTA). End of April, IMV has met with Health Canada in preparation for its clinical trial application (CTA) and is in the process of finalizing its Phase 1 design. The randomized, placebo-controlled study will enroll approximately 84 healthy subjects in two age strata and will assess two different doses of DPX-COVID-19.
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How will these studies be funded?
The Company has submitted several grant applications in Canada to get support for its clinical program.
Information updated on May 25, 2020
i https://pubmed.ncbi.nlm.nih.gov/29617814/
ii https://www.vaccines.gov/basics/types