Germany's BioNTech SE (BNTX) announced Friday that the first patient has been treated in its Phase 2 Clinical Trial of mRNA-based BNT111 in patients with Advanced Melanoma in the EU.
The Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899) is evaluating the company's therapeutic cancer vaccine candidate BNT111 in combination with Libtayo (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma.
BNT111, fully owned by BioNTech, is the lead product candidate from BioNTech's FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer.
Libtayo is an anti-PD-1 monoclonal antibody, being co-developed by Regeneron and Sanofi.
The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone. The primary endpoint is the overall response rate of BNT111 in combination with Libtayo. Secondary endpoints include overall response rate in the single agent arms, duration of response, and safety. BioNTech retains global commercial rights to BNT111.
The trial is being conducted in collaboration with Regeneron, and was reviewed and approved by the regulatory authorities in Spain, Germany, Italy and Poland as well as in the United Kingdom, the United States and Australia.
The company also plans to start randomized Phase 2 trials with mRNA vaccine product candidates in two additional programs in 2021.
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