Novavax’s alliance with Sanofi came at an opportune time for the beleaguered vaccine developer. Its protein-based Covid-19 vaccine never reached the revenue highs achieved by the messenger RNA vaccines for the novel coronavirus. A corporate restructuring slashed headcount and R&D spending, but Novavax’s financial reports still flagged concerns about the company’s ability to continue.
The Sanofi partnership inked a little more than a year ago infused Novavax with $500 million up front, staving off the immediate financial worries. Starting this year, Sanofi will record sales of the Covid-19 shot vaccine Nuvaxovid, paying Novavax royalties on those sales. The deal is more than a financial lifeline. Beyond sharing in Nuvaxovid’s commercialization, Sanofi can research potential combinations of the Covid-19 shot with its own influenza vaccines. The pharmaceutical giant may also explore using Novavax’s adjuvant in its own vaccines. This agreement is a blueprint for the kinds of alliances Novavax is now pursuing, according to Ruxandra Draghia-Akli, executive vice president, head of research and development.
“It’s a multifaceted partnership and we thought that is a model, or maybe components of that model can be developed with other partners,” she said in an interview during the recent BIO International Convention in Boston.
Draghia-Akli’s experience includes posts at Johnson & Johnson and Merck, where she led drug discovery and vaccine research efforts addressing numerous infectious diseases. She is relatively new to Novavax, having joined the company last November. Though Draghia-Akli leads Novavax’s R&D efforts, she said research is now integral to the company’s business development strategy.
R&D as a BD Strategy
The Sanofi alliance leaves Novavax free to develop its own Covid/influenza combination vaccine, and the company has one such vaccine candidate in Phase 3 testing. Novavax plans to place it with a partner. The rest of the pipeline is preclinical. A pandemic influenza candidate has data from a non-human primate challenge study. Draghia-Akli said data will be published soon and Novavax expects this program will be developed in partnership with government entities, as pandemic influenza continues to be a global concern for public health officials.
Novavax is also developing a vaccine for respiratory syncytial virus (RSV) that would address two additional respiratory virus targets — a triple vaccine. The other two targets remain undisclosed. While the RSV market is large, it is already addressed by standalone vaccines, Draghia-Akli said. Novavax can differentiate by addressing multiple pathogens with a single shot. For this research, Novavax uses artificial intelligence and machine learning technologies to optimize the design of the vaccine combination.
The rest of Novavax’s pipeline goes beyond respiratory disease. With its preclinical shingles vaccine candidate, Novavax aims to match the efficacy of GSK’s Shingrix while improving on the tolerability of that vaccine, which is administered in a two-shot regimen. Draghia-Akli cited Centers for Disease Control figures stating that 40% of people who get the first shot do not get the second one due to adverse reactions. The other non-respiratory vaccine target in the pipeline is C. difficile, a type of gut infection. For all of the preclinical programs, Novavax intends to advance them as far as proof of concept and then place them in the hands of partners. The partnership plans go beyond these vaccines.
Novavax has a proprietary adjuvant called Matrix-M. Made with a compound extracted from the bark of a tree native to Chile, Matrix-M boosts the immune response to a vaccine in a way that does not cause severe reactions. This adjuvant is already included in Nuvaxovid. Draghia-Akli said Novavax has data showing this adjuvant works with other vaccine platforms. While Matrix-M is key to Nuvaxovid and the candidates in Novavax’s pipeline, it is also a strategic partnering asset on its own. Draghia-Akli said Novavax is seeking partnerships with companies interested in incorporating the adjuvant in their vaccines. These collaborations are bringing the company into new therapeutic areas, such as oncology. Draghia-Akli said one alliance with an undisclosed partner is evaluating different formulations of Matrix-M in conjunction with targeted tumor antigens to see if the combination results in a better cancer vaccine. This research is preclinical.
Changing Recommendations for Covid-19 Vaccines
As for Nuvaxovid, this standalone Novavax Covid-19 vaccine received its FDA approval in May, a regulatory decision that covers its use in those age 65 and older. For those between the ages of 12 and 65, Nuvaxovid is approved for those who have at least one underlying condition that places them at higher risk for severe outcomes from a Covid-19 infection. The recent FDA approval of mNEXSPIKE, Moderna’s next-generation mRNA Covid-19 vaccine, has the same age and risk factor recommendation.
“That change actually is something that we believe it’s going to happen to, not only the Novavax vaccine but to all the Covid vaccines,” Draghia-Akli said. “If you are looking at the recommendations in other countries, they are age based. We need to remember a number of things there. The vast majority of the individuals who are getting vaccinated are 65 and older. The label also calls for the vaccination of individuals 12 to 64 that have at least one risk factor. And if you’re looking at the [web] site of the CDC for risk factors, there’s so many.”
While the recent approvals of the Novavax and Moderna Covid-19 vaccines are in line with the discussion of the CDC’s Advisory Committee on Immunization Practices (ACIP) during its last meeting in April, the committee meeting this week has an entirely new roster. Earlier this month, Health and Human Services Secretary Robert F. Kennedy Jr. fired all 17 ACIP members, replacing them with eight hand-picked selections, some of whom have made false or critical statements about vaccines. Asked to comment on the new ACIP and what it could mean for vaccine developers and vaccine recommendations, Draghia-Akli offered a diplomatic response.
“I don’t think that we can predict what they’re going to do or recommend or not recommend,” she said. “We are in the learning mode as everyone else out there.”
Discussion of Covid-19 vaccines is part of the final agenda for the ACIP meeting on Wednesday; votes will be taken on RSV vaccines. Thursday’s agenda covers vaccines for flu; chikungunya; anthrax; and measles, mumps and rubella. The committee will votes on influenza vaccines and recommendations for influenza vaccines containing thimerosal, a preservative that was once part of older vaccines. Some groups have speculated the ethylmercury-containing ingredient causes autism. Studies have found no association between autism and thimerosal, which is no longer widely used in vaccines.
Photo: Nathan Howard/Bloomberg, via Getty Images
