Moderna announced during its annual Vaccines Day event on Wednesday that it has secured up to $750 million in funding from asset management firm Blackstone Life Sciences to advance its mRNA-based flu program.
In exchange for its funding commitment, Blackstone will be eligible for cumulative commercial milestones and low-single digit royalties on sales of products from Moderna’s flu portfolio. The Massachusetts-based biotech will retain all rights to its flu assets. The Blackstone haul will not affect Moderna’s 2024 “research and development framework” of approximately $4.5 billion and the company said it will reflect the funding as a reduction in its R&D expenses.
Moderna CEO Stéphane Bancel in a statement said that the additional support from Blackstone will help the company run late-stage studies for its flu assets, allowing it to achieve its “ambition” of launching “multiple vaccine products in the next few years and deliver the greatest possible impact to people through mRNA medicines.”
Moderna’s flu pipeline includes nine assets, including the Phase III mRNA-1010 vaccine candidate, which is being developed for seasonal flu. In September 2023, the company released an interim analysis for the Phase III P303 study of mRNA-1010, which showed that the vaccine candidate met all of its co-primary endpoints and elicited high antibody titers for all four A and B influenza strains, as compared to a currently approved flu shot.
During Wednesday’s Vaccines Day event, Moderna also revealed that mRNA-1010 is currently being assessed in an older adult extension phase of P303. The company is expecting to file regulatory submissions for mRNA-1010 within the year.
In addition to mRNA-1010, Moderna is working on four other flu shots—mRNA-1021, mRNA-1030, mRNA-1011 and mRNA-1012—all of which are currently in Phase II studies. The company is also developing combination vaccines for flu, COVID-19 and respiratory syncytial virus (RSV).
Beyond its Blackstone flu partnership, Moderna on Wednesday provided updates for the company’s other pipeline assets including its next-generation COVID-19 vaccine mRNA-1283, which aced its Phase III NEXTCove trial and induced a stronger immune response against the Omicron BA.4/BA.5 and original SARS-CoV-2 strains, as opposed to a licensed coronavirus vaccine.
Moderna also unveiled data from its Phase II/III ConquerRSV study, which showed that its vaccine candidate mRNA-1345 reached a vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease (LRTD), defined by at least two symptoms.
The company has filed for the regulatory approval of mRNA-1345 for the prevention of RSV-LRTD and acute respiratory disease in older adults aged 60 years and older. Moderna expects the FDA’s decision this year.
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