BioNTech and Regeneron Advance BNT116 mRNA Vaccine and Libtayo® Combination into Clinical Development for First-Line NSCLC Treatment

On March 9, BioNTech announced the expansion of its strategic research and development collaboration with Regeneron to jointly advance the clinical trial combining BioNTech’s candidate cancer vaccine BNT116 with the PD-1 inhibitor Libtayo (cemiplimab) for the treatment of patients with advanced non-small cell lung cancer (NSCLC).

BNT116 is a cancer vaccine developed based on BioNTech's FixVac technology platform. It expresses a set of shared tumor-associated antigens frequently expressed in NSCLC. These antigens, expressed through mRNA, can elicit strong and precise innate and adaptive immune responses. The two parties plan to collaborate on a Phase 1/2 clinical trial to evaluate the safety and efficacy of BNT116 in combination with Libtayo for the first-line treatment of patients with advanced NSCLC.

▲Introduction to the FixVac Technology Platform (Image Source: BioNTech Official Website)

Previously, the two companies have collaborated to evaluate the effect of cancer vaccine BNT111 in combination with Libtayo for the treatment of advanced melanoma. The phase 2 clinical trial assessing this combination therapy is currently underway. BNT111 has already been granted Fast Track designation by the US FDA.

References:

[1] BioNTech and Regeneron Expand Strategic Collaboration to Advance Clinical Development of FixVac and Libtayo® (cemiplimab) Combination in NSCLC. Retrieved March 8, 2022, from https://investors.biontech.de/news-releases/news-release-details/biontech-and-regeneron-expand-strategic-collaboration-advance

(Original text has been abridged)

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