BioNTech reports promising data on BNT316, Phase 3 trial slated for Q3
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BioNTech (NASDAQ:BNTX) reported promising data from a mid-stage clinical study for its therapy candidate BNT316/ONC-392 in the treatment of metastatic non-small cell lung cancer, or NSCLC, the most prevalent form of the disease.
The German biotech company said preliminary data from a Phase 1/2 study showed anti-tumor activity was observed in 29.6% of the patients who took the anti-CTLA-4 antibody therapy, with the drug largely well tolerated. The trial consisted of 27 patients with metastatic PD-L1-resistant NSCLC.
The data is being presented this week at the annual meeting of the American Society of Clinical Oncology. BNT316/ONC-392, also known as gotistobart, was co-developed with OncoC4.
BioNTech said that it intends to begin a Phase 3 pivotal trial for the drug in Q3. The FDA granted fast-track status to the therapy in 2022.
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