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Latest Pfizer, BioNTech COVID-19 vaccine commitment will send 120M doses to Japan

Plus early efficacy data for the biotech's melanoma RNA vaccine

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BioNTech and Pfizer have agreed to provide Japan with 120 million doses of its COVID-19 vaccine, a week after closing a 100 million dose procurement deal with the U.S.

The agreement came as the German company reported data in melanoma for the most advanced mRNA vaccine from its FixVac platform.

Partners BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) started a global Phase II/III trial on Monday of BNT162b2, one of four mRNA vaccine candidates the partners have been testing (see “Two Lead mRNA Vaccines Enter Pivotal Testing”).

The companies plan to supply Japan with doses starting in 1H21, pending approval. They hope FDA approval or Emergency Use Authorization could come as early as October.

Financial terms are undisclosed, but BioNTech and Pfizer said the timing and volume of the order were factors in the price.

Separately, BioNTech reported preliminary Phase I data this week showing not only that its melanoma cancer vaccine as monotherapy led to partial responses in checkpoint inhibitor-experienced patients, but also that responses increased when it combined the RNA vaccine with a PD-1 inhibitor.

The biotech reported the efficacy data from 42 evaluable patients with unresectable melanoma in the Lipo-MERIT study of BNT111 in Nature.

In the 25 patients who received BNT111 alone, one showed a complete metabolic remission of metastatic lesions; three (12%) had partial responses and seven (28%) achieved stable disease. Six of the 17 patients (35%) treated with BNT111 plus a PD-1 inhibitor had partial responses.

An exploratory interim analysis revealed that induction of CD4+ and CD8+ T cell immunity accompanied the clinical responses. Of 50 samples tested, 75% revealed an immune response against at least one of the four tumor-associated vaccine antigens.

BNT111, one of five FixVac vaccines in the clinic, delivers four tumor antigens (see “BioNTech’s Approach to Matching Technologies to Tumors”).

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