Biotheus announced an exclusive global license and collaboration agreement where BioNTech will be developing, manufacturing, and commercializing PM8002 globally ex-Greater China. In contrast, Biotheus retains the rights to exploit PM8002 in Greater China. PM8002 is currently being tested in Phase 2 studies in China to evaluate the efficacy and safety of the candidate as a monotherapy or in combination with chemotherapy in patients with advanced solid tumors.
Under the terms of the agreement, Biotheus will receive an upfront payment of $55 million and is eligible to receive additional development, regulatory, and sales milestone payments potentially totaling over $1 billion as well as tiered royalties on potential future product sales. The transaction is expected to close in Q4 2023, subject to customary closing conditions, including clearance under the Hart-Scott-Rodino ("HSR") Antitrust Improvements Act, and regulatory clearances.
PM8002 is a bispecific antibody candidate with humanized anti-PD-L1 single heavy-chain variable (VHH) domains fused to an anti-VEGF-A IgG1 antibody containing Fc-silencing mutations. PM8002 has demonstrated a positive safety profile and encouraging antitumor activity presumably through reduced systemic toxicity by enriching anti-VEGF activity into the tumor microenvironment at this year's ASCO Annual Meeting and ESMO Congress 2023.
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