BioNTech SE and OncoC4, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Gotistobart (also known as BNT316 or ONC-392) for the treatment of squamous non-small cell lung cancer (sqNSCLC). This designation is intended for potential therapies addressing rare diseases or specific patient populations with limited treatment options. Gotistobart is currently being evaluated in a global Phase 3 clinical trial (PRESERVE-003) for patients with metastatic sqNSCLC whose disease progressed following prior immunotherapy and chemotherapy. In addition to the Orphan Drug Designation, Gotistobart previously received FDA Fast Track status in 2022 for the treatment of metastatic non-small cell lung cancer in patients whose disease progressed after anti-PD-$(L)$1 therapy.

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