GERMANY – BioNTech, a German pharmaceutical company, has announced that the first patient has been treated in its BNT111 phase 2 cancer medication trial.
Currently, the study is evaluating the Company’s therapeutic cancer vaccine candidate BNT111 in combination with Libtayo (cemiplimab), an anti-PD-1 monoclonal antibody, in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma.
Melanoma is a type of skin cancer that develops when melanocytes (the cells that give the skin its tan or brown color) start to grow out of control or can be refereed to hyperpigmentation.
BNT111 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 and is fully owned by BioNTech.
More than 90% of melanomas in patients express at least one of the four tumor-associated antigens encoded in BNT111 (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE).
The BNT111-01 trial which is being conducted in collaboration with Regeneron, an American biotechnology company, 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 trial phase which evaluates the efficacy, tolerability, and safety of BNT11 in combination with Libtayo that’s being co-developed by Regeneron and Sanofi, a French pharmaceutical giant.
The trials will have a total of 120 patients enrolled with an evaluation of BNT111 combined with Libtayo and as well as BNT111 as a single agent done.
This Phase 2 clinical trial is based on previous results from the Phase 1 Lipo-MERIT dose escalation trial (NCT02410733) that demonstrated a favorable safety profile in 89 patients with advanced melanoma.
As BioNTech aims to rapidly advance its broad oncology pipeline and expects to bring additional candidates into late-stage clinical development and towards market entry within the next five years, the company also plans to start randomized phase 2 trials of it mRNA vaccine product candidate BNT113 and BNT122.