Novavax believes that the Sanofi vaccine contract is a model of future transactions, some beyond infectious diseases

Novavax’s alliance with Sanofi is at the right time for troubled vaccine developers. Its protein-based Covid-19 vaccine has never reached the high income earned by messenger RNA vaccines for the novel coronavirus. The restructuring cuts employee numbers and R&D spending, but Novavax’s financial report still marks concerns about the company’s ability to continue.

Sanofi’s partnership was injecting Novavax for $500 million more than a year ago, eliminating immediate financial concerns. Starting this year, Sanofi will record sales of Covid-19 shot vaccine Nuvaxovid and pay Novavax royalties to those sales. This deal is more than just a financial lifeline. In addition to sharing the commercialization of Nuvaxovid, Sanofi can also look at the potential combination of Covid-19 with its own flu vaccine. Pharmaceutical giants can also use Novavax’s adjuvants to explore in their own vaccines. Ruxandra Draghia-Akli, executive vice president of research and development, said the agreement is the blueprint for the alliance Novavax is now pursuing.

“It’s a multifaceted partnership, and we think it’s a model, or something that can be developed with other partners,” she said in an interview at the recent Bio International conference in Boston.

Draghia-Akli’s experience includes posts on Johnson & Johnson and Merck, where she led drug discovery and vaccine research efforts to address many infectious diseases. She joined the company last November and is a newbie to Novavax. Although Draghia-Akli led the R&D work at Novavax, she said that research is now an integral part of the company’s business development strategy.

R&D as a BD strategy

The Sanofi Alliance has allowed novavax to freely develop its own covid/flu vaccine combination, and the company has such a vaccine candidate in its Phase 3 test. Novavax plans to place it with partners. The rest of the pipeline is preclinical. Data for pandemic flu candidates are from the non-human primate challenge study. Draghia-Akli said the data will be released soon and Novavax expects the plan to be developed in partnership with government entities as pandemic flu remains a global focus for public health officials.

Novavax is also developing a vaccine for respiratory syncytial virus (RSV), which will target two other respiratory virus targets – a triple vaccine. The other two goals have not been made public. Draghia-Akli said that while the RSV market is large, it has been solved by an independent vaccine. Novavax can be distinguished by a single shot to solve multiple pathogens. For this study, Novavax uses artificial intelligence and machine learning techniques to optimize the design of vaccine portfolios.

The rest of Novavax’s pipeline goes far beyond respiratory illness. Novavax, with its preclinical vaccine candidate, aims to match the efficacy of GSK Shingrix while improving the tolerance of the vaccine, is based on two-phototherapy. Draghia-Akli cites the Centers for Disease Control figures, pointing out that 40% of people who get the first shot are unable to get a second shot due to adverse reactions. Other non-respiratory vaccine targets in the pipeline are Clostridium difficile, an intestinal infection. For all preclinical programs, Novavax intends to proof of concept and then put it in the hands of partners. The cooperation plan goes beyond these vaccines.

Novavax’s proprietary adjuvant is called Matrix-M. Matrix-M is made from compounds extracted from the bark of natural Chile, which enhances the immune response to the vaccine in a way that does not cause serious reactions. The adjuvant is already included in Nuvaxovid. Draghia-Akli said Novavax’s data showed that this accessibility is working with other vaccine platforms. Although Matrix-M is key to candidates in the Nuvaxovid and Novavax pipelines, it is also a strategic partnership asset. Draghia-Akli said Novavax is building partnerships with companies interested in incorporating adjuvants into their vaccines. These collaborations bring the company into new therapeutic areas, such as oncology. Draghia-Akli said a coalition with undisclosed partners is evaluating different formulations of matrix-M with targeted tumor antigens to see if the combination leads to a better cancer vaccine. This study was preclinical.

Recommendations for changing COVID-19 vaccines

As for Nuvaxovid, this independent Novavax Covid-19 vaccine was approved by the FDA in May, and the regulatory decision covers those ages 65 and older. For people between the ages of 12 and 65, Nuvaxovid has been approved for at least one potential condition, which puts them at a higher risk of severe outcomes from Covid-19 infection. Moderna’s next-generation mRNA Covid-19 vaccine, MNEXSPIKE, recently received FDA approval, with the same age and risk factor recommendations.

“This change is actually what we think is going to happen, not only the Novavax vaccine, but all Covid vaccines,” Draghia-Akli said. “If you are looking at recommendations from other countries, they are age-based. We need to remember a lot of things there. The vast majority of individuals who are vaccinated have 65 and over. The label also requires vaccination from 12 to 64 individuals with at least one risk factor. If you are studying, and you are studying.” [web] There are many on-sites at the CDC. ”

While the latest approvals for Novavax and Moderna Covid-19 vaccines are consistent with discussions by the CDC’s Advisory Committee on Immunization Practice (ACIP), the committee meeting at this week’s committee meeting has a brand new lineup. Earlier this month, Secretary of Health and Human Services Robert F. Kennedy Jr. Draghia-Akli provided a diplomatic response when asked to comment on the new ACIP and its implications for vaccine developers and vaccine recommendations.

“I don’t think we can predict what they are going to do or recommend or not,” she said. “We are in learning mode like everyone else.”

Discussion of the Covid-19 vaccine is part of the final agenda of Wednesday’s ACIP meeting; the RSV vaccine will be voted on. Thursday’s agenda covers flu vaccines; chikungunya; anthrax; and measles, mumps and rubella. The committee will vote on influenza vaccines and recommendations for thimerosal-containing influenza vaccines, which were once part of the elderly vaccine. Some groups speculate that ethyl-containing ingredients can cause autism. Studies have found no association between autism and thimerosal, which is no longer widely used in vaccines.

Photo: Nathan Howard/Bloomberg