Canadian biotech company IMV has made impressively rapid, solid progress on the development of a vaccine candidate against the novel coronavirus, using its lipid-based vaccine delivery platform, DPX. New developments in just two weeks include, include: initiation of peptide candidate manufacturing (based on 23 selected biologically relevant epitopes), with plans for cGMP scale-up already being made; preclinical models developed; Phase I clinical trial design completed and sites identified; with regulatory discussions with Health Canada already underway.
PRESS RELEASE
IMV Inc, a clinical-stage biopharmaceutical company, today provided updates on the development of DPX-COVID-19, a vaccine candidate against the novel coronavirus, and on the company’s business and clinical operations amid the COVID-19 pandemic.
“As the COVID-19 pandemic continues to spread, we have taken all necessary measures to prioritise the health and safety of our employees, patients, investigators and each of their families. In parallel, we remain committed to serving the unmet needs of patients, both through our efforts to potentially develop a prophylactic vaccine to curb this novel coronavirus and across our ongoing clinical studies with DPX-Survivac in advanced-stage cancer patients,” said Frederic Ors, Chief Executive Officer of IMV. “We are committed to progressing the development of our DPX-COVID-19 vaccine candidate working expeditiously with our partners to advance human clinical studies as fast as possible.”
Update on IMV’s Development of DPX-COVID-19
On Wednesday, March 18, 2020, IMV announced in a press release plans to develop of a DPX-based vaccine for COVID-19 in collaboration with well-respected experts. Since the genomic and proteomic sequences of the novel coronavirus (SARS-Cov2) were made available, the company has made significant progress as follows:
- 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 neutralising 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.
- In collaboration with Gary Kobinger, PhD, Director of the Research Centre on Infectious Diseases at the University Laval (Quebec City, Canada) 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.
- In collaboration with Joanne Langley, MD at the Canadian Center for Vaccinology (CCfV) and the Canadian Immunization Research Network (CIRN) the design of a Phase I clinical study in 48 healthy subjects has been completed and clinical sites identified in both Nova Scotia and Québec.
- IMV has initiated discussions with Health Canada in preparation for a Clinical Trial Application (CTA). A meeting is being scheduled in the week of April 20, 2020, with the goal to initiate the clinical study in the summer of 2020.
- The company has submitted several grant applications in Canada in an effort to help support its clinical program.
IMV will continue to provide updates on the development of DPX-COVID-19, and is working on a dedicated DPX-COVID-19 page on its website.
Update on IMV’s Business and Clinical Operations
IMV prioritises the health and safety of its employees and their families, and of the patients, investigators and healthcare professionals involved in clinical studies of DPX candidates.
Business Operations:
In line with public health interventions recommended to impede the spread of COVID-19, IMV has implemented policies to protect its team: Health Canada hygiene measures were enforced on premises; the company suspended all corporate travel outside Canada and between corporate offices in Québec and Dartmouth; and the company’s IT infrastructure has been revised to support employees working from home.
With its COVID-19 development activities and its ongoing clinical trials, IMV is considered as an essential health and community service provider and is making all efforts to comply with the classification requirements of Nova Scotia and Quebec.
The company has taken additional action to maximise social distancing, including reviewing individual lab schedules on a weekly basis to ensure the continuity of activities in the lab and assessing activities to require the minimum number of people who can perform the activity safely and with appropriate quality.
Clinical Operations:
It is anticipated that the COVID-19 pandemic crisis will impact ongoing trial activities across the industry due to the pressure placed on the healthcare system as well as governmental and institutional restrictions.
IMV’s clinical team is working closely with each clinical site and our CRO on a contingency plan to ensure that patient safety and the integrity of data is maintained.
IMV is following the FDA guidance issued for the COVID-19 pandemic: “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards”.
Additionally, the team continues to monitor updated institutional, regional and national guidance to fully comply with applicable guidelines as they are issued. It is noted that some clinical sites have paused or slowed enrolment in clinical trials, while other sites, less impacted, are continuing activities as planned. The overall enrolment rate may decrease, but clinical activities are continuing, and patients are encouraged to attend visits as planned or to discuss alternatives with their physician.
The current activities performed at central labs to assess the eligibility of patients and the management of clinical samples is not impacted, and IMV is working with the vendors to ensure continuity of activities.
Drug supply is not expected to be impacted at this time. As added precaution, IMV is working on a contingency plan to ensure proper provisioning of drugs to all clinical sites in the event of future transportation or other constraints.
About the DPX Platform
DPX is the company’s proprietary lipid-based delivery platform with no aqueous component in the final formulation. The DPX platform can be formulated with peptide antigens. Its unique “no release” mechanism of action allows antigen presenting cells (APCs) to be attracted to the injection site, facilitating a robust and sustained immune response within lymph nodes. Fully synthetic, easy to manufacture; each product is stored in dry form and reconstituted in lipids for injection, providing an extended shelf life and simple handling and administration in the clinic. More details about the DPX mechanism of action here: https://imv-inc.com/platform.
Link to Press Release.