On October 8, Canada-based biotech company, IMV, which is soon to publish pre-clinical data on DPX-COVID-19, its immunotherapy-based vaccine candidate for the prevention of SARS-COV-2, announced that to increase its current manufacturing capacity, the company had entered a collaboration with a global manufacturing partner and initiated the 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 the capacity to produce several hundred million doses of DPX-COVID-19.
DPX-COVID-19 could be a game-changer for countries like India because it is fully synthetic, which allows it to be lyophilised, stored and transported at 2°C to 8°C, which can then use existing cold chain infrastructure.
While IMV is not yet revealing more on the manufacturing collaboration, Frederic Ors, CEO, IMV explained why the company believes that DPX-COVID-19 has the potential to improve the duration of the immune response and protect older adults and more vulnerable individuals from SARS-COV-2 infection, in an interaction with Viveka Roychowdhury
What is the mode of action of IMV’s COVID-19 vaccine candidate based on the company’s proprietary delivery platform (DPX)?
The DPX delivery platform offers a unique way to “program” immune cells in vivo and generate a targeted, robust and durable immune response against the elements (antigens) that are formulated with the platform. DPX-COVID-19 is a formulation of the DPX delivery platform with four complementary and non-overlapping areas on the virus spike that were selected for their high immunogenicity and potential to block the ability of the virus to infect human cells in preclinical studies.
DPX-COVID-19 would keep its potential efficacy independently from current/future mutations of the virus at this site. This is as a result of having four separate targets and peptides, which makes the chances of a mutation affecting this vaccine mathematically unlikely. In the event there is a mutation within one of the peptide sequences comprising the vaccine, DPX-COVID-19 can be readily reformulated, given the innovative delivery platform and synthetic nature of the vaccine.
The company has received further funding from the Government of Canada, could you give us the latest update and what this means for the next steps in the clinical development of DPX-COVID-19?
The total of 10 million non-dilutive funding we received from the Government of Canada will fully-fund phase 1 and we will apply for additional grants to fund phase 2. We will look to partner with other companies to run a phase 3 in target countries for its distribution.
On what basis was the clinical plan updated to run a larger Phase 1/2 study? What is the timeline to starting these studies, how many volunteers will the trial include, countries etc.?
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. 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 2 studies. We plan on enrolling more than 600 volunteers in the Phase 1/2 study.
The design of this larger Phase 1/2 study will incorporate the same two-age strata cohorts (18-55 years old and over 55 years old) as originally designed, according to the release. Are the results from the preclinical studies which have been ongoing since mid-August showing evidence of a sufficient duration of immune reaction? Will it be a single or two-shot vaccine?
In addition to our preclinical data, which will be published soon, IMV’s DPX-RSV Phase 1 trial was successfully completed for the potential treatment of the respiratory syncytial virus (RSV) strain A, and this research has helped provide insights for the development of DPX-COVID-19. Based on this clinical data in infectious diseases, as well as our insights in oncology immunotherapies, 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.
The DPX-RSV research has provided proof of concept for the DPX platform in a context of vaccine development, as well as a reference to evaluate the level of immunogenicity in preclinical studies for DPX-COVID-19. The clinical efficacy and safety findings of DPX-RSV include:
- Safety and long-term efficacy in aged adults. Our Phase 1 clinical trial in 50–64 years old healthy adults demonstrated DPX-RSV to be safe and well-tolerated and induced robust antigen-specific serum IgG responses that were sustained for more than a year. We saw a 100x increase of target antibody titres in all the subjects who receive a 0.025 mg dose of the vaccine.
- Generates robust cellular and humoral immune response. Our phase 1 clinical study demonstrated a favourable isotype profile of SHe-specific antibodies, including IgG1, IgG3 and IgA, and cellular immune response that includes CD4+ T cell responses.
- Validation of DPX as a useful platform for vaccination. Phase 1 clinical data also validate the application of the DPX technology in the infectious disease setting.
A major advantage is that IMV’s vaccine candidate, DPX-COVID-19, is fully synthetic which allows it to be lyophilised, stored and transported at 2°C to 8°C, which is a huge benefit in countries like India, which can then use existing cold chain infrastructure. Can you give us more details of the collaboration with a global manufacturing partner and India’s potential role? Any timeline to production, clinical trial partnerships etc.?
Further details are forthcoming