BioNTech, Regeneron To Evaluate FixVac-Based Cancer Vaccine/Libtayo Combo In NSCLC

  • BioNTech SE BNTX has expanded its strategic collaboration with Regeneron Pharmaceuticals Inc REGN to its FixVac candidate BNT116 combined with Libtayo (cemiplimab) in advanced non-small-cell lung cancer (NSCLC). 
  • Under the terms of the agreement, the companies plan to jointly conduct clinical trials to evaluate the combination in different patient populations with advanced NSCLC and share development costs equally. 
  • Regeneron and Sanofi SA SNY are jointly developing Libtayo.
  • The investigational mRNA-based cancer vaccine BNT116 is based on BioNTech's FixVac platform. 
  • It consists of a fixed combination of shared tumor-associated antigens that were identified to be frequently expressed in NSCLC. 
  • The companies plan to develop the collaboration beginning with Phase 1/2 clinical trials in the first-line treatment setting in advanced NSCLC. 
  • Additionally, under a separate agreement, BioNTech plans to conduct and sponsor a Phase 1 LuCa-MERIT-1 trial evaluating the combination of BNT116 and Libtayo in further subpopulations with NSCLC.
  • Price Action: BNTX shares are down 1.35% at $124.55, REGN stock is down 0.68% at $614.38 during the market session on the last check Tuesday.
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