Biotheus partners with BioNTech to take their anti-tumour therapy global

Innovative biotech company Biotheus has signed a deal with BioNTech to manufacture, market, and distribute their latest anti-tumour therapy around the world. 

Biotheus is a company based in China focusing the development of novel antibodies for oncology and inflammatory disease treatment, from discovery through to delivery. The company has pioneered several innovative technologies in antibody discovery and cell therapy with a view to targeting tumour cells. 

Their latest candidate, PM8002, is a bispecific antibody with humanised anti-PD-L1 single heavy-chain variable (VHH) domains fused to an anti-VEGF-A IgG1 antibody, containing Fc-silencing mutations. The candidate targets PD-L1, which cancer cells commandeer to bypass the immune system, and VEGF-A, another protein that encourages tumour growth. 

Currently, PM8002 is undergoing a Phase II clinical trial in China, to assess the safety and efficacy of the treatment as a monotherapeutic or in combination with chemotherapy in patients with advanced solid tumours. At ESMO Congress 2023, Biotheus announced that PM8002 has showed a positive safety profile so far. 

In the new partnership, Biotheus retains the rights to manufacture and commercialise PM8002 in Greater China, and BioNTech will take on the development, manufacturing, and distribution across the rest of the world. 

Xiaolin Liu, Co-founder, Chairman, and CEO of Biotheus commented: 

"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." 

The details of the partnership state that Biotheus is set to receive $55 million as an initial payment, and could accrue up to $1 billion after further development and sales globally, on top of predicted royalties. 

BioNTech presented positive results for its own therapy, the CAR-T cell candidate BNT211 at ESMO Congress 2023, for the treatment of advanced solid tumours. The results are from an ongoing Phase I/II clinical trial, the first in-human phase, with the aim of determining the optimal dose for carrying forward into a Phase II trial.

Sources

Biotheus. Biotheus Enters Into Strategic Partnership with BioNTech to Develop and Commercialize Bispecific Antibody Candidate Targeting PD-L1 and VEGF in Multiple Solid Tumor Indications. [Date accessed 09/11/2023] www.biotheus.com/news/307.html

BioNTech. BioNTech Presents Positive Phase 1/2 Data Update for CAR-T Cell Therapy Candidate BNT211 in Advanced Solid Tumors at ESMO Congress 2023. [Date accessed 09/11/2023] https://investors.biontech.de/news-releases/news-release-details/biontech-presents-positive-phase-12-data-update-car-t-cell