COVID competition heating up, HIV competition just got a...

COVID competition heating up, HIV competition just got a setback, but we're novel ... and if we get up on hiv.... Lux will upgrade to the top of the line Hilux

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vaccine for $500M, eyeing commercialization, flu combination

Amber Tong

Senior Editor

Sanofi is handing Novavax $500 million upfront to bring the biotech’s Covid-19 vaccine into the fold, with dual goals of co-commercializing the current vaccine and developing combo vaccines that can tackle both Covid and flu.

The deal also carries $700 million in development, regulatory and launch milestones, meaning Novavax can bag up to $1.2 billion total.

The French pharma giant is also licensing Novavax’s adjuvant technology for use in other vaccine development — earmarking $200 million per product — and taking a minority equity investment in Novavax of less than 5%. Shares of Maryland-based Novavax $NVAX, which have fallen precipitously from its pandemic peak, surged almost 140% at one point in premarket trading Friday.

Jean-François Toussaint

“With flu and COVID-19 hospital admission rates now closely mirroring each other, we have an opportunity to develop non-mRNA flu-COVID-19 combination vaccines offering patients both enhanced convenience and protection against two serious respiratory viruses,” Jean-Francois Toussaint, Sanofi’s global head of vaccines R&D, said in a statement.

Sanofi has yet to disclose which specific flu vaccine it will seek to combine with Novavax’s Covid vaccine, or any timelines related to development. It expects to run a Phase 1/2 study of the combo shot for safety and immunogenicity data before a Phase 3, with endpoints to be decided, a spokesperson told Endpoints News.

Sanofi’s vaccine ambitions

Despite inking vaccine collaborations early in the Covid pandemic, Sanofi ended up playing a relatively small role. Its GSK-partnered shot only earned a European approval in late 2022 and was never authorized in the US, and the company gave up on its mRNA work soon after acquiring partner Translate Bio.

Nonetheless, Sanofi has talked up how the $3.2 billion Translate buyout, added to its existing vaccine technologies, gives it “the largest development toolbox in the industry.” That includes a suite of flu vaccines, made with inactivated as well as recombinant technologies, that it will now look to combine with the Novavax Covid shot.

In the statement, Toussaint underscored the potential for “improved tolerability and thermostability, without compromise on efficacy,” as upsides for protein-based vaccines.

“Evidence has shown that convenience could be important for people in staying up to date on their immunizations,” the spokesperson added.

Deal details

John Jacobs

Starting in 2025, Sanofi will book sales of Novavax’s adjuvanted Covid vaccine and take on certain R&D, regulatory and commercial expenses. That’s excluding countries where Novavax already has existing partnerships — India, Japan and South Korea — or advanced purchase agreements.

Under the deal, Novavax is set to receive tiered double-digit percentage royalty payments on those sales — as well as sales of any future Covid-flu combination vaccines, for which Sanofi will be solely responsible.

“While the vaccination coverage rate for Covid-19 is declining, which was expected post pandemic, we believe it should stabilize and may increase in future,” the Sanofi spokesperson wrote, adding that a combo vaccine could improve the coverage rate.

For Novavax, which recorded $984 million in 2023, the partnership allows it to refocus on R&D and pipeline expansion, CEO John Jacobs said. It ended the first quarter of 2024 with $496 million in cash, cash equivalents and restricted cash, according to an earnings update Friday.

Editor’s note: The story has been updated to include comments from Sanofi and reflect Novavax’s stock gain.

May 10, 2024 11:33 AM EDTR&DCell/Gene TxExcision BioTherapeutics’ attempt to gene edit HIV disappoints. The company will now revamp vector: #ASGCT24Lei Lei WuNews ReporterBALTIMORE — HIV patients who received a CRISPR-based gene editing treatment developed by Excision BioTherapeutics saw the virus rebound, and now the company is going back to the lab to develop the experimental treatment with a new vector.In Excision’s Phase 1 study, five patients received a gene editing therapy for HIV. Three patients were taken off their standard antiretroviral therapy, but then had to return to standard treatments, according to clinical trial results shared Friday at the American Society of Gene & Cell Therapy’s annual meeting in Baltimore.Two of the three patients saw no meaningful suppression of the virus, rebounding at three and four weeks. The third patient saw delayed viral rebound for 16 weeks before returning to standard antiviral treatment. The company said that’s a signal of the treatment’s potential.Antiretroviral therapy can stop HIV from actively reproducing, but it can’t get rid of the viral DNA that has integrated into a person’s cells, making the disease difficult to cure. Excision’s gene editing treatment was an attempt to cure the disease by using CRISPR to slice out HIV DNA that has interspersed itself across a patient’s cells.So far, the HIV field has seen very little success with attempts to cure the disease. Researchers believe that a very long-acting therapy could act like a functional cure, especially when compared to current treatments that have to be taken regularly.“It’s really hard,” said lead investigator Rachel Presti of the Washington University School of Medicine in St. Louis. “But there’s a lot more movement in the field now.”In the five patients treated, Excision’s therapy appeared safe with no serious side effects.One patient did not meet the criteria to be taken off their antiretroviral therapy, and the researchers are awaiting efficacy results from another patient in the second treatment cohort, after which the trial will be completed.Excision is pivoting to a next-generation vector that it hopes will be more effective. CEO Daniel Dornbusch did not provide a timeline for when the company would put the next iteration of the therapy into human trials, saying it depended on several factors, including discussions with the FDA.AUTHORLei Lei WuNews [email protected]@leilei_wuumore like this iTeos to raise $120M; Xbrane and STADA to out-license Lucentis biosimilar May 10, 2024 Tessera unveils promising in vivo gene editing treatment for sickle cell in an increasingly competitive field: #ASGCT24 May 10, 2024 After FTC scrutiny of Sanofi deal, Maze finds a new Pompe partner in Shionogi May 10, 2024

DYOR