GSK and Medicago Launch Phase 2/3 Clinical Trials of Adjuvanted Plant-Derived COVID-19 Vaccine Candidate Amid Global Surge in Cases

November 15, 2020 /BioonBIOON/ -- At present, the COVID-19 epidemic is still spreading rapidly worldwide. According to Baidu's "Real-time Data on the Novel Coronavirus Pneumonia Epidemic"Big DataReport, as of 17:00 on November 15, 2020, the global cumulative number of confirmed cases exceeded 54.37 million, and the number of deaths exceeded 1.31 million.

Recently,GlaxoSmithKline(GSK) and Medicago jointly announced the initiation of a Phase 2/3 clinical trial to evaluate the efficacy, safety, and immunogenicity of their plant-derived COVID-19 candidate vaccine, CoVLP. Based on the positive results from the Phase 1 clinical trial, Medicago decided to use GSK’s pandemic adjuvant for the Phase 2/3 trial.Clinical Trials。

Coronavirus-like particle COVID-19 candidate vaccine (CoVLP) is a plant-derived recombinant COVID-19 vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs).

This Phase 2/3Clinical TrialA multipart design was employed to confirm that the selected CoVLP formulation and immunization regimen (3.75 μg of CoVLP combined with GSK’s pandemic adjuvant, administered in two doses 21 days apart) exhibited acceptable immunogenicity and safety in healthy adults aged 18–64 years and in older subjects aged 65 years and above.

Nathalie Landry, Executive Vice President of Scientific and Medical Affairs at Medicago, stated: “The Phase 1 results for our adjuvanted candidate vaccine are highly encouraging and fully support further clinical evaluation.”

GSK Chief Medical Officer Thomas Breuer stated, “This is multipleGlaxoSmithKlineFirst COVID-19 Candidate Vaccine in Collaboration Initiates Phase 2/3 TrialClinical Trial, which also represents a significant step forward in our contribution to the global fight against the pandemic. We are encouraged by the highly promising Phase 1 results of Medicago’s COVID-19 vaccine candidate combined with GSK’s pandemic adjuvant. The proven dose-sparing capability and robust immune response elicited by GlaxoSmithKline’s adjuvant give us confidence in partnering with Medicago to deliver an effective vaccine with an acceptable safety profile.”

The Phase 2 component of this Phase 2/3 trial is a randomized, observer-blind, placebo-controlled study designed to evaluate the safety and immunogenicity of an adjuvanted, recombinant, plant-derived COVID-19 vaccine candidate in subjects aged 18 years and older. This part of the study will be conducted at multiple sites in Canada and the United States, enrolling a population comprising healthy adults (aged 18–64 years) and older adults (aged ≥65 years). In each age group, more than 300 subjects will be randomized in a 5:1 ratio to receive either the adjuvanted CoVLP vaccine candidate or placebo, with older adults further stratified into two age cohorts (65–74 years and ≥75 years) in a 2:1 ratio. All subjects will be followed for 12 months after the last vaccination to assess the safety and durability of the immune response to the vaccine candidate.

The Phase 3 portion of this trial, scheduled to begin by the end of 2020, employs an event-driven, randomized, observer-blind, placebo-controlled design to evaluate the efficacy and safety of the CoVLP formulation versus placebo in more than 30,000 participants across North America, Latin America, and/or Europe, encompassing the same or a broader population.

Medicago is a biopharmaceutical company headquartered in Quebec, Canada, and a pioneer in plant-derived therapeutics. Founded in 1999, the company firmly believes that innovative approaches and rigorous research will bring new solutions to healthcare.

The company’s mission is to improve global health outcomes by leveraging innovative plant-based technologies to rapidly respond to emerging global health challenges. Currently, the company is dedicated to advancing treatments for life-threatening diseases worldwide.

Previously, Medicago had demonstrated its first-response capability during an influenza pandemic. In 2009, the company produced a research-grade candidate vaccine against H1N1 in just 19 days. In 2012, Medicago produced 10 million doses of monovalent vaccine for the Defense Advanced Research Projects Agency (DARPA), under the U.S. Department of Defense, within one month.Influenza VaccineCandidate product. In 2015, Medicago also demonstrated in principle that it could rapidly produce a monoclonal antibody cocktail against Ebola for the Biomedical Advanced Research and Development Authority (BARDA) under the U.S. Department of Health and Human Services. (Bioon.com)

Original Source: Medicago and GSK announce start of Phase 2/3 clinical trials of adjuvanted COVID-19 vaccine candidate