BioNTech and Regeneron have expanded their strategic partnership for advancing BNT116 plus Libtayo (cemiplimab) to treat advanced non-small cell lung cancer (NSCLC).
Based on the FixVac platform of BioNTech, BNT116 is an investigational messenger ribonucleic acid (mRNA)-based cancer vaccine.
It comprises a fixed combination of shared tumour-linked antigens found to be commonly expressed in NSCLC
Regeneron and Sanofi are co-developing Libtayo, an inhibitor of programmed death-1 (PD-1).
Under the deal, the companies will jointly carry out clinical trials of the combination therapy in various subject groups with advanced NSCLC
In the initial stage, the companies will commence Phase I/II trials of BNT116 plus Libtayo as first-line therapy for advanced NSCLC.
The companies will equally share the development costs for the studies.
Furthermore, under a different agreement, BioNTech intends to sponsor and carry out a Phase I trial LuCa-MERIT-1 assessing the combination treatment in additional NSCLC subpopulations
Currently, BioNTech is sponsoring and analysing FixVac candidate BNT112 plus Libtayo for prostate cancer in a Phase I trial.
BioNTech co-founder and chief medical officer Özlem Türeci said: “Advancing the sixth FixVac product candidate based on uridine mRNA into clinical development underlines the versatility and potential of this platform.
“We believe that a potent vaccine that induces strong T cell responses against shared tumour associated antigens combined with PD-1 blockade that further enables the activated T cell repertoire will help to address the high unmet medical need in this indication
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