German biotechnology firm BioNTech SE (BNTX) has revealed that the first patient has been dosed in its Phase 2 trial of the BNT111 cancer vaccine for advanced melanoma. BioNTech is a pioneer in immunotherapies for cancers, infectious diseases, and other chronic diseases. The company has a broad portfolio of oncology treatment candidates, protein replacement therapies, small molecule immunomodulators, novel antibodies, and cell therapies.
The Phase 2 trial is studying the efficacy of BNT111 administered with Libtayo (cemiplimab) for the treatment of anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma. The trial is conducted in collaboration with biotechnology company Regeneron (REGN), which has co-developed Libtayo with Sanofi.
The BNT111-01 trial has received regulatory approval in the U.S., the U.K., Australia, Poland, Italy, Germany, and Spain. The trial plans to enroll 120 patients and will evaluate the impact of BNT111 and Libtayo when dosed alone and in combination.
BioNTech’s shares were up nearly 2% in pre-market trading on June 21. (See BioNTech stock charts on TipRanks)
Özlem Türeci, Managing Director and Chief Medical Officer of BioNTech said, “BNT111 has already shown a favorable safety profile and encouraging preliminary results in early clinical evaluation. With the start of patient treatment in our Phase 2 trial, we are encouraged to continue on our initial path to realize the potential of mRNA vaccines for cancer patients.”
Redburn Partners analyst Simon Baker recently downgraded the stock from Hold to Sell with a price target of $146 (31.3% downside potential). In a research note to investors, Baker said that the company is overvalued and advises waiting for an attractive entry point.
Overall, the stock has a Hold rating based on 2 Buys, 6 Holds, and 1 Sell. The average BioNTech analyst price target of $182.0 implies 14.3% downside potential to current levels. The company’s shares have gained 270% over the past year.