U.K. locks down access to recombinant protein vaccine via GSK, Sanofi deal, its fourth for COVID-19
Plus updates on Kodak, Akiko Iwasaki and Reata
As the U.K. pushes to secure access to several mechanistically diverse vaccines, the country’s procurement deal with GSK and Sanofi on Wednesday checks the recombinant protein vaccine box. The product has yet to enter the clinic, but the partners expect approval could come in 1H21.
Additional developments this week include a new lease on life for Kodak, the latest from Akiko Iwasaki’s lab and Reata’s move to repurpose bardoxolone methyl.
U.K. Vaccine Taskforce Chair Kate Bingham told BioCentury last week that the country aims to acquire six to eight vaccines across four buckets: adenovirus, mRNA, adjuvanted protein and whole inactivated virus (see “U.K. Secures Access to Two More Vaccines”).
Wednesday’s deal is the U.K.’s fourth vaccine supply agreement. The country has secured 30 million doses of a mRNA vaccine from BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE); 60 million doses of an inactivated whole virus vaccine from Valneva SE (Euronext:VLA); and 100 million of an adenovirus vaccine from AstraZeneca plc (LSE:AZN; NYSE:AZN) and the University of Oxford. The U.K. is also providing funding to develop Imperial College London's mRNA vaccine.
Sanofi (Euronext:SAN; NASDAQ:SNY) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) have agreed to supply 60 million doses of their vaccine to the U.K.
Sanofi, which expects to start a Phase I/II trial in September and a Phase III study by year-end, hopes approval could come in 1H21.
The partners are scaling up manufacturing in parallel and expect to be able to produce up to 1 billion doses per year.
GSK CEO Emma Walmsley said this week that the pharma is in advanced procurement deal discussions with the U.S. and EU. The company also plans to provide a supply of the vaccine starting next year to the Access to COVID-19 Tools (ACT) Accelerator. The collaboration was created in April by global health and private sector organizations (see “WHO Seeks $18B for Vaccines Advanced Market Commitments”).
The partners also provided updates Wednesday on separate COVID-19 programs. GSK, which is backing a cross-reactive mAb from Vir Biotechnology Inc. (NASDAQ:VIR), expects a Phase II/III study to start this quarter in high-risk outpatients.
Additionally, Sanofi is developing an mRNA vaccine with Translate Bio Inc. (NASDAQ:TBIO), and plans to start a Phase I trial by year-end.
Reata Pharmaceuticals Inc. (NASDAQ:RETA) said the New York University Grossman School of Medicine will begin a Phase II trial of its chronic kidney disease (CKD) therapy bardoxolone methyl in patients with COVID-19.
The disease can cause kidney dysfunction in patients, the company said, with acute kidney injury occurring in up to 28% of all hospitalized patients and up to 72% of those who do not survive COVID-19.
The NFE2L2 activator is intended to reduce inflammation by restoring mitochondrial function, reducing oxidative stress and inhibiting pro-inflammatory signaling. Reata is conducting Phase III trials of bardoxolone to treat CKD in patients with Alport syndrome or autosomal dominant polycystic kidney disease (see “Reata Rebound”).
Longitudinal immune differences
Separately, Yale University’s Iwasaki and her colleagues have generated longitudinal immune profiles in hospitalized moderate and severe COVID-19 patients -- information that could provide guidance regarding what treatments might be most beneficial at different disease stages. In a Nature paper published Monday, they described a core COVID-19 cytokine profile common to moderate and severe COVID-19 patients; and showed that profiles were similar until about 10 days after symptom onset.
They found two signatures -- one including coagulopathy markers -- associated with severe disease; and linked ICU admittance to overt innate and adaptive immune activation including sustained high serum levels of IFNα and IFNλ. They also associated severe disease to type-2 immune markers including eosinophils and IgE production.
Kodak developing pharma ops
Eastman Kodak Company (NYSE:KODK) is following in the footsteps of Fujifilm Holdings Corp. (Tokyo:4901) by launching a pharmaceuticals unit.
The U.S. International Development Finance Corp. signed a letter of interest to provide a $765 million loan to support the initiative by which Kodak Pharmaceuticals will produce APIs for the Strategic National Stockpile, providing 25% of APIs used in non-biologic, non-antibacterial, generic pharmaceuticals once fully operational.
The funds will go towards repurposing and expanding the company’s New York and Minnesota facilities.
Kodak shares have gained $1,038% since the deal was announced, closing Thursday at $29.83 with a market cap of $1.3 billion.
IFNα - Interferon α
IFNλ - Interferon λ
NFE2L2 (NRF2) - Nuclear factor (erythroid-derived 2)-like 2