Biotheus has signed an exclusive global license and collaboration deal with BioNTech under which BioNTech will take on the development, manufacturing, and commercialisation of PM8002 on a global scale, excluding Greater China, while Biotheus will retain the rights to exploit PM8002 within Greater China.

PM8002 is currently undergoing Phase 2 studies in China to assess its efficacy and safety as a monotherapy or in combination with chemotherapy for patients with advanced solid tumours.

The terms of the agreement entail an upfront payment of $55m to Biotheus, and they are also eligible to receive additional payments linked to development, regulatory milestones, and sales milestones, with the potential to exceed $1bn.

Additionally, Biotheus will receive tiered royalties on any future product sales resulting from this collaboration.

The completion of the transaction is anticipated in the fourth quarter of 2023, subject to standard closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act and regulatory approvals.

PM8002 is a bispecific antibody candidate featuring humanised anti-PD-L1 single heavy-chain variable (VHH) domains fused to an anti-VEGF-A IgG1 antibody, incorporating Fc-silencing mutations. It has demonstrated a favourable safety profile and promising antitumor activity.

This activity is believed to result from reduced systemic toxicity and enhanced anti-VEGF activity within the tumour microenvironment, as presented at this year’s ASCO Annual Meeting and ESMO Congress 2023.

Biotheus co-founder, chairman, and CEO Xiaolin Liu said: “Biotheus’ innovative platform has the capability to expedite preclinical research, bolstering our impressive innovative pipeline of products with encouraging efficacy and safety including PM8002.

“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.”