Pharma Focus Asia

Biotheus and BioNTech Partner for Bispecific Antibody in Solid Tumor Treatment

Tuesday, November 07, 2023

Biotheus Inc. is a clinical-stage biotechnology company specializing in the development of biologics for the treatment of oncology and inflammatory diseases. The company recently announced an exclusive global license and collaboration agreement with BioNTech. Under this agreement, BioNTech will be responsible for developing, manufacturing, and commercializing PM8002 globally, except for Greater China, where Biotheus will retain the rights to exploit PM8002. PM8002 is currently in Phase 2 studies in China to assess its safety and efficacy as a monotherapy or in combination with chemotherapy for patients with advanced solid tumors.

According to the terms of the agreement, Biotheus will receive an initial payment of $55 million, along with potential additional payments related to development, regulatory milestones, and sales milestones, which could total over $1 billion. Biotheus will also be entitled to tiered royalties on potential future product sales. The transaction is expected to be completed in the fourth quarter of 2023, pending standard closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act and regulatory approvals.

PM8002 is a bispecific antibody candidate that combines humanized anti-PD-L1 single heavy-chain variable (VHH) domains with an anti-VEGF-A IgG1 antibody containing Fc-silencing mutations. It has demonstrated a positive safety profile and promising antitumor activity, which is likely due to reduced systemic toxicity and enhanced anti-VEGF activity within the tumor microenvironment. These findings were presented at this year's ASCO Annual Meeting and ESMO Congress in 2023.

Biotheus, expressed optimism about their collaboration with BioNTech, stating that Biotheus' innovative platform, combined with BioNTech's expertise, will enable them to advance PM8002 through multi-regional clinical trials with the goal of making it available to patients worldwide.



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