Regeneron and BioNTech Partner on Immunotherapy Combo for Melanoma


Although Mainz, Germany-based BioNTech is getting a lot of attention because of its partnership with Pfizer on a COVID-19 vaccine, the mRNA company has a broader approach than just infectious diseases. Now, Regeneron Pharmaceuticals and BioNTech have inked a strategic collaboration to combine BioNTech’s BNT111 FixVac product candidate and Regeneron and Sanofi’s checkpoint inhibitor Libtayo (cemiplimab) for the treatment of melanoma.

Regeneron and BioNTech plan to run a randomized Phase II trial in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous melanoma. Melanoma is the deadliest form of skin cancer, taking the lives of more than 63,000 people around the world each year.

BNT111 is one of five clinical stage FixVac products in BioNTech’s overall development pipeline. It is an mRNA immunotherapy that targets four molecules often expressed in melanoma—NY-ESO-1, MAGE-A3, tyrosinase, and TPTE. In an ongoing Phase I trial, it has shown anti-tumor activity alone and in combination with checkpoint inhibitors in advanced melanoma after previous checkpoint blockade.

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

Under the terms of the deal, the two companies will equally split development costs for the study and will both contribute their compounds for the trial. They will retain full commercial rights for their own products and record revenues separately.

They expect to release more details for the planned Phase II trial in the third quarter, with a goal of beginning the trial in the fourth quarter.

Regeneron and Sanofi recently announced they were no longer developing Libtayo with their own anti-CD38 drug Sarclisa (isatuximab) in melanoma. PharmaPhorum notes that melanoma was the first cancer targeted by checkpoint inhibitors. Both Bristol Myers Squibb’s Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) were approved as second-line therapies for melanoma very close together. Since that initial approval, PD-1/PD-L1 checkpoint inhibitors have been approved for the first-line setting, with a combination of Opdivo and Bristol Myers Squibb’s CTLA4 inhibitor Yervoy (ipilimumab), a different type of checkpoint inhibitor, becoming the “go-to therapy” for cancer physicians.

However, about 30% to 40% of melanoma patients respond with a long-lasting response to checkpoint inhibitors, most other drugs either are totally ineffective or stop working over time, resulting in cancer reoccurrence.

Regeneron and BioNTech’s collaboration means they hope that using their two drugs together will overcome the mechanisms of resistance seen in some cancers. The Phase II trial will focus on patients with advanced melanoma that can’t be treated surgically and who are refractory to or have relapsed after PD-1 checkpoint inhibitor therapy.

“The combination of Libtayo and BBNT111 … 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, Regeneron’s head of translational science.

Sanofi reported Libtayo sales outside the U.S. of $32 million in the first half of this year. Regeneron handles U.S. sales, but has yet to make its second-quarter report. In the first quarter, Regeneron reported slightly under $62 million sales.

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