BioNTech and Regeneron Achieve Significant Response Rate Success in Phase 2 Trial for mRNA Cancer Immunotherapy BNT111

1. Positive Phase 2 Results: BioNTech announced positive topline results from a Phase 2 clinical trial for the mRNA cancer immunotherapy candidate BNT111 in combination with the PD-1 checkpoint inhibitor cemiplimab.
2. Primary Endpoint Met: The trial demonstrated a statistically significant improvement in the overall response rate (ORR) compared to historical controls in patients with anti-PD-(L)1 relapsed/refractory advanced melanoma.
3. Treatment Combination: BNT111 was evaluated in combination with cemiplimab, showing a synergistic effect that enhanced clinical activity.
4. Fast Track and Orphan Drug Designations: BNT111 received Fast Track and Orphan Drug designations from the FDA in 2021 for the treatment of anti-PD-1-refractory/relapsed, unresectable Stage III or IV melanoma.
5. Future Plans: BioNTech and Regeneron plan to present the trial data at a forthcoming medical conference and submit the findings for publication in a peer-reviewed scientific journal.
6. FixVac Platform: BNT111 is based on BioNTech’s proprietary FixVac platform, which utilizes a fixed combination of four mRNA-encoded, tumor-associated antigens to trigger an immune response against cancer cells.
7. Safety Profile: The treatment was well tolerated, with a safety profile consistent with previous clinical trials assessing BNT111 in combination with anti-PD-(L)1-containing treatments.