Biotheus Inc., a clinical-stage biotech company dedicated to biologics for oncology and inflammatory diseases, has entered into an exclusive global license and collaboration agreement with BioNTech under which BioNTech will develop, manufacture and commercialize PM8002 globally ex-Greater China, where Biotheus retains rights. PM8002 is 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.

Biotheus will receive an upfront payment of $55 million and is eligible to receive additional development, regulatory and sales milestones potentially totaling over $1 billion, as well as royalties on potential future product sales. The transaction is expected to close in 4Q23.

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.

“Biotheus’ innovative platform has the capability to expedite preclinical research, bolstering our impressive innovative pipeline of products with encouraging efficacy and safety including PM8002,” said Xiaolin Liu, co-founder, Chairman, and CEO of Biotheus. “Collaborating with industry trailblazer BioNTech, we hope to advance PM8002 through multi-regional clinical trials with the aim to be able to provide it to patients worldwide.”