BioNTech and Regeneron’s mRNA Cancer Vaccine Combo Clears Phase II in Melanoma

Positive Phase II Results::
BioNTech's mRNA immunotherapy BNT111, in combination with Regeneron's PD-1 inhibitor cemiplimab (Libtayo), has shown significant improvement in overall response rate (ORR) in patients with advanced melanoma, meeting its primary efficacy endpoint.

Clinical Trial Details::
The Phase II trial (BNT111-01) is evaluating the clinical activity and safety of BNT111 in combination with cemiplimab in patients with unresectable stage III or IV melanoma who have progressed after previous PD-(L)1 treatment.

Targeted Antigens::
BNT111 targets four non-mutated melanoma-associated antigens (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE), which are expressed in over 90% of cutaneous melanoma cases.

Combination Therapy::
The combination of BNT111 and cemiplimab has been well-tolerated, with a safety profile consistent with previous studies. This combination originally received fast track designation from the FDA in 2021.

Future Plans::
BioNTech and Regeneron plan to present the data at a forthcoming medical conference and submit the results for publication in a peer-reviewed journal.

Competitive Landscape::
BioNTech and Regeneron are set to compete with Merck and Moderna, who are advancing their own mRNA cancer vaccine mRNA-4157/V940 in combination with Keytruda (pembrolizumab) in advanced melanoma.

Technological Advancements::
BNT111 uses BioNTech’s proprietary uridine mRNA chemistry and lipoplex formulation for delivery, representing a significant step towards personalized cancer medicine.