Sanofi and GSK resume work on COVID-19 vaccine

Sanofi and GSK resume work on COVID-19 vaccine

access_time2021-02-23 10:00:30

Following an earlier setback in their collaboration on an adjuvanted recombinant protein-based COVID-19 vaccine program last December, France’s Sanofi (Euronext: SAN) and the UK’s GlaxoSmithKline (LSE: GSK) are moving forward again.

Sanofi and GSK today announced today the initiation of a new Phase II study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase III 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 I/II study,” said Thomas Triomphe, executive vice president and head of Sanofi Pasteur. “We are confident that our vaccine candidate has strong potential and we are very encouraged by the latest pre-clinical data. This new Phase II study will enable us to identify the final vaccine formulation for adults of all ages. We have demonstrated our commitment to focusing efforts and capabilities towards the global fight against the pandemic, and this new study takes us a step closer to achieving our primary goal of developing a COVID-19 vaccine with a good efficacy and safety profile,” he added.

Roger Connor, president of GSK Vaccines, added: “We are pleased to be starting this new Phase II study. The world needs multiple vaccines and we are confident that combining our proven pandemic adjuvant system with this improved antigen formulation will have significant potential as the pandemic evolves. We look forward to further progressing this vaccine candidate to Phase III in Q2 2021, if this Phase II study is successful.”

In parallel to the new Phase II study and recognizing the global emergence of new SARS-CoV-2 variants and their potential impact on vaccine efficacy, Sanofi has commenced development work against new variants, which will be used to inform next stages of the Sanofi/GSK development program.

The new Phase II trial is a randomized, double-blind, multicenter dose finding study conducted in adults aged 18 years of age and older to evaluate the safety, reactogenicity, and immunogenicity of two injections given 21 days apart. The trial will include equal numbers of adults 18 to 59 years and those 60 years and above.

Three different antigen doses with a fixed dose of adjuvant will be tested in a total study population of 720 volunteers, in the USA, Honduras and Panama. Results of the Phase II trial will inform the Phase III protocol.

In December 2020, the Sanofi/GSK vaccine program was delayed after trial participants were mistakenly given a less concentrated dose, resulting in data that showed a weaker immune response in older people.

In the partnership between the two companies, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza. The recombinant technology combined with GSK’s adjuvant offers the advantages of stability at temperatures used for routine vaccines, the ability to generate high and sustained immune responses, and the potential to prevent virus transmission.

Sanofi is also developing a messenger RNA COVID-19 vaccine in partnership with Translate Bio (Nasdaq: TBIO). Encouraging pre-clinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans. Sanofi and Translate Bio are planning to start a Phase I/II study in first-quarter 2021.


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