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.

The latest development builds on an existing partnership analysing the combination of BioNTech’s FixVac candidate BNT111 along with Libtayo to treat advanced melanoma. 

Furthermore, there exists an agreement between BioNTech and Regeneron to progress the clinical development of the combination therapy for prostate cancer.

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. 

“We look forward to further building on our successful collaboration with Regeneron to accelerate the clinical development of BNT116 in our growing mRNA oncology pipeline.”

In February this year, BioNTech entered a multi-target research collaboration with Medigene to develop T-cell receptor-based cancer immunotherapies.