GSK and Sanofi Team Up on COVID-19 Vaccine, Aim for Clinic This Year

Xconomy National — 

[Updated, 3:13 p.m. See below.] Pharmaceutical giants GlaxoSmithKline and Sanofi are teaming up on COVID-19 research, aiming to combine their respective technologies in a new vaccine that could start clinical trials in coming months.

The full details of the agreement, which was announced Tuesday, are still being finalized. But the companies say the vaccine would use antigen (the substance that prompts an immune response) from Sanofi (NYSE: SNY) and adjuvant (material that enhances the immune response) from GlaxoSmithKline (NYSE: GSK). They added that if successful, their combined capabilities will enable them to manufacture a vaccine at scale and distribute it globally.

“Our aim is to start trials for this candidate vaccine in the second half of this year, and if successful, have it available in the second half of 2021,” Emma Walmsley, GSK’s CEO, said in a video presentation. “This would be a significantly faster timeline than for normal vaccine development and teams from both companies are starting work on it urgently.”

Sanofi is contributing COVID-19 antigen produced using its recombinant DNA technology. It’s the same technology the company used to develop a vaccine for another coronavirus, SARS, in 2003. The vaccine was developed under an agreement with the US Biomedical Advanced Research Authority (BARDA). The SARS outbreak fizzled out before Sanofi could bring a vaccine into clinical testing but the company has resurrected the research, which is now being directed toward COVID-19 in a collaboration with BARDA.

While many vaccines are made with viruses that are cultured in chicken eggs, Sanofi’s technology instead uses bioreactors to produce the antigen. The company says its technology can produce an exact genetic match to the proteins found on the surface of the novel coronavirus. Sanofi has combined this antigen with the vaccine platform that is the basis for Flublok, the influenza vaccine that the company markets in the US. Speaking on a conference call in late March, Sanofi executive David Loew said that basing a COVID-19 vaccine from the earlier SARS research and leveraging the existing Flublok technology will enable the company to move quickly.

Meanwhile, GSK brings to the alliance its pandemic adjuvant technology, AS03. A GSK spokesman explained in an email that it’s the same adjuvant that was used in the company’s H1N1 and H5N1 pandemic flu vaccines. Because the adjuvant enables the production of more vaccine doses in a shorter amount of time, it permits “antigen sparing,” which means GSK can use a smaller amount of the antigen per dose. That in turn enables the company to produce more vaccine. The spokesman added that during the H1N1 pandemic, the adjuvant multiplied GSK’s vaccine capacity fourfold. Walmsley said that her company and Sanofi combined have the capacity to make hundreds of millions of vaccine doses by the end of 2021. [Paragraph updated with additional details from GSK.]

In a research note, SVB Leerink analysts Geoffrey Porges and Daina Graybosch wrote that the pairing of two vaccine giants increases the probability of success compared to other research efforts. But they also expressed caution about the companies’ speedy timeline projections. A vaccine specialist told the firm that some side effects may take six months to a year to emerge, and regulators will want to see long-term safety data. Even under an accelerated regulatory pathway, the specialist estimated that a COVID-19 vaccine would need two years to gain enough data to support approval, which would be followed by large post-marketing studies. “Therefore, we think the one year development timeline suggested by GSK and Sanofi may not be realistic despite their expertise in the space,” Porges and Graybosch wrote. [Paragraph added with analyst comments.]

The collaboration between Sanofi and GSK is the latest among a growing number of industry alliances for COVID-19 research, including previously announced collaborations involving both companies. Last month, Sanofi announced its recombinant DNA research would be conducted in parallel to work aiming to develop a messenger RNA vaccine with Lexington, MA-based Translate Bio (NASDAQ: TBIO). GSK announced last week that it is making a $250 million investment in San Francisco-based Vir Biotechnology (NASDAQ: VIR). That collaboration is developing antibody drugs, vaccines, and genomic-based products.

Photo by Flickr user GSK via a Creative Commons license