BioNTech’s mRNA Cancer Candidate Packs A Punch With Regeneron’s Cemiplimab In Phase 2 Melanoma Trial

1. Treatment with BNT111 + cemiplimab showed a statistically significant overall response in patients with inoperable or advanced-stage anti-PD-1 refractory melanoma compared to therapy with cemiplimab alone.
2. BNT111 was well tolerated by participants.

The Latest

In a collaboration between BioNTech and Regeneron, researchers performed an open-label, randomized phase 2 clinical trial evaluating the efficacy of BioNTech’s BNT111 and Regeneron’s anti-PD-1 inhibitor cemiplimab in the treatment of inoperable or advanced-stage anti-PD-1 inhibitor-resistant melanoma. The study showed that patients taking the combination BNT111/cemiplimab experienced a significantly improved overall response rate and the drug was well tolerated. Next, researchers hope to continue working on the secondary endpoints in this trial and present their full results shortly.

Physician’s Perspective

Melanoma is a type of skin cancer and is the most common cause of skin cancer-related deaths. Repeated exposure to ultraviolet radiation (from the sun or tanning beds) tends to be the most common cause of melanoma. The immune system attempts to fight cancer cells by expressing a protein on their surface called PD-1. PD-1 on T cells binds to PD ligand (PDL) on normal host cells to prevent their degradation. Melanoma cells exploit this checkpoint by expressing their own PDLs which deceive T cells into perceiving the cancerous cells as normal cells. In advanced cancers, one mode of treatment uses anti-PD-1 antibodies to prevent melanoma from using this exploitation. However, some advanced forms of melanoma are resistant to anti-PD-1 antibody treatment. BioNTech’s BNT111 hopes to improve the treatment of anti-PD1 inhibitor-resistant melanoma by targeting this mechanism.

Molecular Target of Therapy

Most melanoma cells express specific antigens on their surface which can be recognized by the immune system as foreign and marked for destruction. BNT111 is an mRNA-based treatment delivered to melanoma cells causing the production of such specific antigens on their surface. This makes cancer cells recognizable to the immune system. Ultimately, BNT111 boosts the immune response towards melanoma and increases the efficacy of cemiplimab when the two are used in combination.

Company History

BioNTech is a biotechnology company based in Germany that specializes in next-generation immunotherapy. The company became well known recently for its collaborative effort with Pfizer in the development of the mRNA-based covid-19 vaccine. Presently, the company has over 30 candidates in various stages of clinical research. These are mRNA-based candidates for the treatment of cancers ranging from lung to colorectal to pancreatic, as well as other diseases like tuberculosis and malaria.

Further reading: https://investors.biontech.de/news-releases/news-release-details/biontech-announces-positive-topline-phase-2-results-mrna

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