BioNTech has extended its existing collaboration with Regeneron to advance the development of its FixVac candidate BNT116, in combination with the latter’s Libtayo (cemiplimab) to treat advanced non-small cell lung cancer (NSCLC).

Under the expanded collaboration, the companies will jointly conduct clinical trials to assess the combination therapy, and equally, share development costs for the trials.

The partnership will initially conduct Phase 1/2 studies to evaluate BNT116 and Libtayo combination for the first-line treatment of advanced NSCLC.

In addition, BioNTech will fund and conduct a Phase 1 clinical trial of the combination in further subpopulations with NSCLC, under a separate agreement.

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.”

BNT116 is an investigational mRNA-based cancer vaccine candidate, BioNTech has developed based on its unique FixVac platform.

The candidates developed using the FixVac platform are said to contain a fixed combination of mRNA-encoded non-mutated antigens, shared across patients with a defined cancer type.

BioNTech and Regeneron have previously teamed up to combine their complementary immunotherapies to treat melanoma and prostate cancer.

Under their previous agreement, the two companies have evaluated the combination of FixVac candidate BNT111 with Libtayo, in treating advanced melanoma.

BNT111 has received the Fast Track Designation from US FDA, in November last year, and is currently being studied in a Phase 2 trial.

In addition, the companies are also studying the combination of Libtayo and FixVac candidate BNT112, in Phase 1 clinical trial, to treat prostate cancer.

Libtayo is a programmed death receptor-1 (PD-1) inhibitor, being jointly developed by Regeneron and Sanofi.