BioNTech and Bristol Myers Squibb Partner to Advance Bispecific Antibody BNT327 for Solid Tumours

Tuesday, June 03, 2025

BioNTech and Bristol Myers Squibb have entered a global strategic agreement to jointly develop and commercialise BNT327, a next-generation bispecific antibody aimed at treating various solid tumours.

BNT327 is currently being assessed in several ongoing clinical studies, including global Phase 3 trials in extensive-stage small cell lung cancer (ES-SCLC) and non-small cell lung cancer (NSCLC). A Phase 3 trial in triple-negative breast cancer (TNBC) is expected to begin by the end of 2025. Over 1,000 patients have received the candidate to date, and results from early studies suggest the dual-action approach may offer enhanced benefits across multiple tumour types.

BNT327 is designed to restore the immune system's ability to detect and attack tumour cells by inhibiting PD-L1, while also targeting VEGF-A to counter the tumour’s immune evasion and disrupt blood supply to cancerous tissues. The therapy is intended to focus anti-VEGF activity directly in the tumour microenvironment, aiming to reduce systemic side effects and improve the efficacy of combination therapies. This dual mechanism supports its potential as a backbone therapy across a wide range of solid tumours.

The investigational therapy targets two established cancer pathways – PD-L1 and VEGF-A – within a single molecule, with the aim of enhancing treatment outcomes through a combined immunotherapy and anti-angiogenic effect.

The agreement enables both companies to co-develop and co-commercialise the product, sharing associated development and manufacturing costs equally. Each partner retains the option to explore additional uses for BNT327 independently, including combining it with their own pipeline therapies.

Bristol Myers Squibb will make an upfront payment of $1.5 billion to BioNTech and further non-contingent payments of $2 billion through 2028. BioNTech may also receive up to $7.6 billion in milestone-based payments linked to development, regulatory, and commercial achievements. Profit and loss from the global sales of BNT327 will be shared equally.

The clinical programme includes over 20 trials planned or underway, spanning more than 10 different cancer types. BioNTech also plans to evaluate BNT327 in combination with its antibody-drug conjugate (ADC) candidates.

If approved, BNT327 could represent a significant step forward in broadening the treatment landscape for patients with difficult-to-treat cancers.

 

Source: bms.com