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Join BioNTech at WCLC 2026: Learn More About Gotistobart and the PRESERVE-003 Trial in sqNSCLC

August 26, 2026

Estimated Read Time:

1–2 minutes

Join BioNTech at WCLC 2026 to learn more about gotistobart (BNT316/ONC-392), an investigational antibody designed to reignite antitumor immunity by depleting Tregs through targeting CTLA-4.^1-3 Featuring pH-sensitive dissociation from CTLA-4 and an optimized Fc domain, gotistobart is designed to support Treg depletion within the tumor microenvironment while helping minimize peripheral immune activation.^2,4,5This lifts immunosuppression and allows effector immune cell infiltration and activation, leading to tumor cell death.⁴

Gotistobart is being evaluated in PRESERVE-003, a Phase 3, randomized study compared with docetaxel in patients with metastatic sqNSCLC whose disease has progressed following PD-(L)1 inhibitor and platinum-doublet chemotherapy. The study is designed to evaluate the efficacy and safety of gotistobart, with overall survival as the primary endpoint and objective response rate, progression-free survival, and safety as key secondary endpoints.⁶

At WCLC 2026, updated overall survival results from Stage 1 of PRESERVE-003 will be presented at a mini-oral presentation (Abstract MO07.04) on Monday, September 14, 2026, at 5:25 PM KST.

Visit us at the BioNTech Booth (booth #823) to learn more about the gotistobart mechanism of action, explore the PRESERVE-003 clinical trial, view our full pipeline, and engage with the BioNTech team.

In collaboration between BioNTech and OncoC4.
Gotistobart (BNT316/ONC-392) is an investigational drug and has not been approved for marketed use by any regulatory agency.
CTLA-4, cytotoxic T-lymphocyte–associated protein 4; Fc, fragment crystallizable; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein 1; PD-L1, programmed death ligand 1; sqNSCLC, squamous NSCLC; Treg, regulatory T cell.

References: 1. Kai H, et al. J Clin Oncol. 2023;41(suppl 16); abstract 9024. 2. Zhang Y, et al. Cell Res. 2019;29(8):609-627. 3. Cho BC, et al. Nat Med. 2026;32(6):2245-2253. 4. Du X, et al. Cell Res. 2018;28(4):433-447. 5. Liu R, et al. Antibodies (Basel). 2020;9(4):64. 6. ClinicalTrials.gov identifier: NCT05671510. Accessed June 30, 2026. https://clinicaltrials.gov/study/NCT05671510

Learn About PRESERVE-003