Checkpoint inhibitors can be lifesaving for some cancer patients, but in melanoma, at least half of patients don’t respond to drugs like Merck’s Keytruda and Bristol Myers Squibb’s Opdivo. And those who do often develop resistance to the drug. BioNTech and Regeneron are teaming up to help those patients.
The duo will carry out a phase 2 study of BioNTech’s mRNA cancer immunotherapy in combination with Sanofi and Regeneron’s Libtayo, the sixth PD-1 inhibitor to score FDA approval. They will test the combo in patients with advanced melanoma whose cancer cannot be treated with surgery and that got worse after trying a different anti-PD-1 medicine—or didn’t respond in the first place.
“Despite recent treatment advances with anti-PD-1 therapies for patients with melanoma, most patients fail to obtain a durable benefit. The combination of Libtayo and BNT111 FixVac has the potential to augment the immune system’s ability to effectively recognize melanoma in multiple ways and hopefully improve immune targeting to control the cancer,” said Israel Lowy, M.D., Ph.D., senior vice president of translational science and oncology at Regeneron, in a statement.
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The partners will contribute their respective drugs to the study and split the costs evenly, according to the statement. They plan to kick off the trial in the fourth quarter of 2020.
Libtayo was first approved in 2018 for metastatic cutaneous squamous cell carcinoma (CSCC), the second most common form of skin cancer. BNT111 is the most advanced of five clinical programs based on BioNTech’s FixVac platform. It targets four antigens that are commonly expressed in patients with melanoma: NY-ESO-1, MAGE-A3, tyrosinase and TPTE.
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“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 BioNTech CEO Ugur Sahin, M.D., in the statement.
In the meantime, both companies are working on programs targeting SARS-CoV-2, the virus that causes COVID-19. BioNTech, along with partner Pfizer, have kicked off a 30,000-patient study for their mRNA vaccine. And Regeneron is testing an antibody cocktail as a treatment for COVID-19 infection, as well as a preventive measure.