BioNTech-Regeneron add 3rd tumor type to partnership testing cancer vaccines with Libtayo

BioNTech wants to run it back with Regeneron, extending a partnership first announced in 2020 to combine a cancer vaccine with the approved treatment Libtayo in the clinic, this time for advanced non-small cell lung cancer. 

This latest announcement is a spitting image of the two companies’ second collaboration combining one of BioNTech’s mRNA-based vaccine candidates with Regeneron and Sanofi’s PD-1 inhibitor Libtayo in melanoma, where both companies shared costs of the trial. And just like last time, they declined to share the financial details behind the agreement. 

BioNTech's BNT116, a part of the FixVac program, is at the heart of the latest partnership. The companies have also previously applied a FixVax candidate to prostate cancer, and will now extend that into lung cancer. The companies will jointly work on clinical trials in various patient populations for advanced NSCLC, starting with phase 1/2 studies in the first-line setting. BioNTech is footing the bill for a separate, smaller trial on a subset of NSCLC patients.

This is BioNTech's sixth candidate from the FixVac platform, which develops vaccines with antigens specific to each type of cancer. The hope is that the shots will boost the T cell response in combination with the PD-1 inhibitor. 

Tuesday’s announcement marks the third time BioNTech has turned to Libtayo as a 1-2 punch in cancer treatment, the first being in 2019 when a vaccine candidate was studied as an additive treatment in prostate cancer. The companies did not share clinical costs in that earlier research.

But for the melanoma deal, BioNTech and Regeneron made things more official, splitting the costs. The combo agreement followed phase 1 data from BioNTech showing its vaccine, in combination with anti-PD-1 treatments, resulted in a partial response in six out of 17 patients. The vaccine was granted FDA fast track designation in November 2021 and is currently in phase 2. 

Germany-based BioNTech has ascended in the past three years thanks to its partnership with Pfizer on the mRNA COVID-19 vaccine Comirnaty, granting wide financial freedom to work on a pipeline chock full of potential cancer therapies. Of the company’s 14 mRNA-based cancer treatments in development, 11 are in the clinic and four are in phase 2 trials.