Gotistobart (BNT316/ONC-392)
Overview
A next-generation, pH-sensitive anti-CTLA-4 antibody designed to deplete regulatory T cells within tumors while sparing normal tissue, co-developed with OncoC4 since a March 2023 strategic collaboration ($200M upfront to OncoC4, costs and profits split on PD-(L)1 combination studies, BioNTech holding exclusive worldwide commercialization rights). It is BioNTech's fourth late-stage oncology asset alongside BNT327, trastuzumab pamirtecan, and elfetabart drozuntecan.
Pivotal, two-stage Phase 3 PRESERVE-003 trial (691 patients total) versus docetaxel in metastatic squamous NSCLC after progression on a PD-(L)1 inhibitor. Stage-1 data presented at ELCC 2026 (March 2026) showed a 54% reduction in risk of death; the pivotal stage 2 (~478 more patients) is ongoing across 160 sites globally, with updated overall-survival data due at WCLC 2026 (Seoul, September 12-15, 2026). The FDA granted Orphan Drug Designation in squamous NSCLC in January 2026, on top of a 2022 Fast Track designation.