BioNTech and BMS announce global partnership for BNT327 (PD-L1/VEGF-A bsAb) development across multiple solid tumors

BioNTech and Bristol Myers Squibb announced a global co-development and co-commercialization partnership for BNT327 (PD-L1/VEGF-A bsAb), which is in development across multiple solid tumors of focus for Gilead including lung and breast cancers (BioNTech PR, Presentation; BMS PR).

Key Takeaways:

• This partnership is the largest in a string of licensing and collaboration agreements within the increasingly competitive PD-(L)1/VEGF bispecific class
  • The deal between BioNTech and BMS is worth up to $11.1B, with BMS paying $1.5B in an upfront payment, $2B in non-contingent anniversary payments through 2028, and up to $7.6B in milestone payments; profit/loss will be shared 50:50
  • BioNTech had previously gained BNT327 via acquisition of Biotheus for up to $950M, expanding on its prior development and commercialization partnership with Biotheus
  • Other key deals involving PD-1/VEGF bsAbs have included Akeso/Summit for ivonescimab ($500M upfront; up to $5B), Merck/LaNova for LM-299 ($588M upfront; up to $3.3B), and most recently Pfizer/3SBio for SSGJ-707 ($1.25B upfront; up to $6B); note that Pfizer also has a clinical trial collaboration with Summit to evaluate ivonescimab in combination with Pfizer’s ADCs
• Initial clinical focus for BNT327 will remain lung cancer (NSCLC, ES-SCLC) as well as breast cancer (TNBC) though early-stage trials are also evaluating BNT327 in GYN (incl. EC), GI, GU, and other solid tumors as monotherapy and combination regimens
  • In lung, BioNTech has initiated a P3 ROSETTA-Lung01 study for BNT327 + chemo in 1L ES-SCLC and a P2/3 ROSETTA-Lung03 study for BNT327 + chemo in 1L NSCLC; multiple late-stage China only trials are ongoing in 2L SCLC (P3), 1L SCLC (P2/3), and 2L+ EGFRm NSCLC (P2/3)
  • In breast, a global P3 trial of BMT327 + chemo in 1L TNBC is planned to initiate by end of 2025 while a Chinese only P3 trial in 1L TNBC is ongoing
• BMS’ oncology/IO legacy and infrastructure could help to accelerate and broaden the development of BNT327 across solid tumors, including in combination with other agents from each company’s pipeline, to gain or maintain a competitive advantage over other PD-1/VEGF bsAbs
  • BioNTech has already been evaluating BNT327 in combination with BNT325 (TROP2 ADC) in a P1/2 solid tumor study that includes NSCLC and TNBC (first results at AACR 2025; Abs 648/14) and is planning for additional near-term P1/2 trials in combination with BNT323 (HER2 ADC), BNT324 (B7-H3 ADC), and BNT326 (HER3 ADC)
• Despite continued industry confidence in this class, uncertainty remains around the translatability of results from China-only populations to global populations
  • Notably, Summit recently announced that the P3 HARMONi trial of ivonescimab + chemo in 2L+ EGFRm NSCLC – the first global P3 readout for this class – reached statistical significance for the PFS but not OS primary endpoint at the primary analysis, leaving its regulatory future unclear