Medicago and GSK Start Phase 3 Trial of Adjuvanted COVID-19 Vaccine Candidate
Fast Track designation granted by US FDA
Feasibility study initiated of a vaccine candidate to address emerging variants
Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago s plant-derived COVID-19 vaccine candidate in combination with GSK s pandemic adjuvant, as part of the ongoing Phase 2/3 study. Medicago received approval from Canadian and US regulatory authorities to proceed with enrollment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. In parallel, Medicago has also initiated a feasibility study of a vaccine candidate to address the emerging COVID-19 variants.
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The phase IIa proof-of-concept findings from ViiV Healthcare s innovative early pipeline of medicines show the antiviral activity, safety and tolerability of GSK 254 and support its continued study in phase IIb
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, presented positive data from its phase IIa proof-of-concept study of the investigational maturation inhibitor GSK3640254 (GSK 254). The study showed the antiviral activity of GSK 254, establishing a relationship between dose and antiviral response, with the 140 mg and 200 mg doses showing the greatest reduction in plasma HIV-1 RNA. These findings were presented today at the (virtual) 2021 Conference on Retroviruses and Opportunistic Infections (CROI).
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· New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults · If results are positive, Phase 3 study to start in Q2 2021, with vaccine expected to be available in Q4 2021 · In parallel, development work on new SARS-CoV-2 variants underway Sanofi and GlaxoSmithKline (GSK) announced today the initiation of a new Phase 2 study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase 3 evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate. Over the past few weeks, our teams have worked to refine the antigen formulation of our recombinant-protein vaccine, based on learnings from our initial Phase 1/2 study. said Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur. We are confident that our vaccine candidate has strong potential