BioNTech and Regeneron Achieve Positive Phase II Results for mRNA Cancer Vaccine Combo in Melanoma

1. Positive Phase II Results: BioNTech and Regeneron have announced positive topline results from a Phase II trial evaluating the investigational mRNA cancer immunotherapy BNT111 in combination with the PD-1 checkpoint inhibitor Libtayo (cemiplimab) in patients with advanced melanoma.
2. Primary Endpoint Met: The trial met its primary endpoint, demonstrating a statistically significant improvement in overall response rate (ORR) compared to historical controls in patients with anti-PD-(L)1 relapsed/refractory advanced melanoma.
3. BNT111 Platform: BNT111 is an mRNA-based off-the-shelf cancer immunotherapy developed using BioNTech’s proprietary FixVac platform, which targets specific tumor-associated antigens shared by many cancer patients.
4. Combination Therapy: The combination of BNT111 and Libtayo showed a significant improvement in ORR compared to historical controls, with monotherapy with BNT111 or Libtayo also demonstrating clinical activity.
5. Fast Track and Orphan Designations: BNT111 has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of anti-PD-1-refractory/relapsed, unresectable Stage III or IV melanoma.
6. Future Plans: BioNTech and Regeneron plan to present the data at a forthcoming medical conference and submit it for publication in a peer-reviewed journal.
7. Competitive Landscape: The success of BNT111 and Libtayo in this trial positions them to compete with other mRNA-based cancer vaccines, such as the combination of mRNA-4157/V940 and Keytruda being developed by Merck and Moderna.