BioNTech to Test mRNA-Based Cancer Vaccine with Regeneron’s anti-PD1 Drug in Melanoma Patients

The German Biotech, which has been making the rounds for its heavily touted coronavirus vaccine is collaborating with Regeneron for a melanoma targeting combo therapy.

By Ruchi Jhonsa, Ph.D.

On July 31st, BioNTech announced a strategic collaboration with Regeneron to develop combination immunotherapy for melanoma patients who have failed to respond to commonly available anti-PD-1 therapies. The companies will combine BioNTech’s mRNA-based cancer immunotherapy and Sanofi and Regeneron’s anti-PD-1 drug, Libtayo in a Phase 2 trial, details related to which will be disclosed in the third quarter of 2020, with a goal of initiating the trial in the fourth quarter of 2020.

Cancer immunotherapy is a cancer treatment that works by targeting proteins that hide cancer from the immune system. This mode of treatment has been effective in treating multiple cancer types. However, “despite recent advances with anti-PD1 therapies for patients with melanoma, most patients fail to obtain a durable benefit,” said Israel Lowy, M.D., Ph.D., senior vice president of translational science and oncology at Regeneron, in a statement. The pair believes that their combination will augment the immune system’s ability to effectively recognize melanoma in multiple ways and hopefully improve immune targeting to control cancer.

According to the terms of the deal, the duo will contribute their respective drugs to the study and split the costs evenly. Additionally, each party will retain full commercial rights for its respective products and record revenues related to its own product.

Developed by Regeneron using its proprietary VelocImmune technology, Libtayo was approved in the US in 2018 for metastatic cutaneous squamous cell carcinoma, the second most common form of skin cancer. Like Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, Libtayo blocks PD-1 interaction with PD-L1 and PD-L2 ligands that are responsible for blocking the anti-tumor response, resulting in increased tumor surveillance and decreased tumor size. Currently, it is jointly marketed by Sanofi and Regeneron as part of a collaboration agreement between the two companies.

BNT111, on the other hand, is an experimental cancer vaccine developed by BioNTech to elicit an immune response to four antigens heavily expressed in melanoma: NY-ESO-1, MAGE-A3, tyrosinase, and TPTE. Similar to its coronavirus vaccine, BNT111 is also made up of mRNA. However, in this case, there are four different mRNAs-one for each antigen, optimized to induce antigen-specific CD8+ and CD4+ T cell responses. BNT111 is currently being studied in the Lipo-MERIT study where it has demonstrated clinical anti-tumor activity as a monotherapy and in combination with checkpoint inhibitors in patients with advanced melanoma after prior checkpoint blockade.

“We believe our FixVac platform represents a powerful new drug class of mRNA immunotherapies against cancer. We look forward to working together with Regeneron to advance this product candidate into potentially registrational clinical trials,” said Ugur Sahin, CEO, and Co-founder of BioNTech.

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References

1. https://investors.biontech.de/news-releases/news-release-details/biontech-announces-strategic-collaboration-regeneron-advance

Author

Ruchi Jhonsa