BioNTech's mRNA Immunotherapy Shows Promise in Advanced Melanoma

BioNTech has reported promising phase 2 results for its mRNA immunotherapy candidate, BNT111, in a subgroup of patients with advanced melanoma. The EudraCT clinical trial has been investigating the efficacy of BNT111 in combination with Regeneron’s PD-1 checkpoint inhibitor, Libtayo (cemiplimab), in patients with stage 3 or 4 melanoma whose disease had progressed despite prior anti-PD-L1 treatment.

Melanoma, one of the leading causes of cancer-related deaths worldwide, claims approximately 58,000 lives annually. The prognosis is particularly grim for patients with anti-PD-1 refractory or relapsed, unresectable stage 3 or 4 melanoma.

BNT111, an investigational mRNA immunotherapy, is developed using BioNTech’s FixVac platform. This platform employs a fixed combination of four mRNA-encoded tumor-associated antigens designed to elicit both an innate and tumor-antigen-specific immune response against cancer cells expressing one or more of these antigens. The therapy is administered as a uridine mRNA-lipoplex formulation.

The ongoing EudraCT trial results revealed that the combination of BNT111 and Libtayo achieved a statistically significant overall response in patients, meeting the primary efficacy endpoint. Moreover, the combination was well tolerated, and the safety profile aligned with previous clinical trials of BNT111 combined with anti-PD-L1 treatments.

Professor Özlem Türeci, BioNTech’s Chief Medical Officer and co-founder, expressed optimism about the phase 2 results, stating, "These phase 2 results mark a significant step towards our vision of personalized cancer medicine. We envision mRNA as a centerpiece in future cancer treatment paradigms, particularly for patients with anti-PD-L1 refractory or resistant melanoma."

In 2021, BNT111 combined with Libtayo received Fast Track designation from the US Food and Drug Administration (FDA) for treating anti-PD-1-refractory/relapsed, unresectable stage 3 or 4 melanoma. Additionally, the mRNA immunotherapy was granted Orphan Drug designation by the FDA for treating stage 2b through 4 melanoma.

Recently, in July, four versions of Pfizer and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine, Comirnaty JN.1, were approved by the Medicines and Healthcare products Regulatory Agency for use in adults and children, including infants. This approval followed the European Medicines Agency’s human medicine committee recommendation of the vaccine for individuals aged six months and older.

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