92Bio, Inc. Doses First Patient in Phase 1 Clinical Trial of NTB-928 in Platinum-Resistant Ovarian Cancer

— NTB-928 is a bispecific T-cell engager engineered for selective killing of FOLR1-overexpressing tumor cells while sparing FOLR1-positive normal tissues —

HAYWARD, Calif.--(BUSINESS WIRE)--92Bio, Inc. (www.92biotech.com), a clinical-stage biotechnology company developing next-generation T-cell engaging antibodies (TCEs), today announced dosing of the first patient in a Phase 1 clinical trial evaluating NTB-928 for the treatment of platinum-resistant ovarian cancer. The trial is being conducted at multiple US sites, with the first patient dosed at START New York-Long Island under the direction of Principal Investigator Dr. Geraldine O'Sullivan Coyne, MD.

NTB-928 combines an affinity-tuned anti-CD3 moiety with an avidity-dependent FOLR1-binding arm for tumor versus normal selectivity. The dual-mechanism design enables potent killing of FOLR1-overexpressing ovarian cancer cells while sparing normal tissues that express trace FOLR1—a key limitation of conventional approaches targeting this antigen. Notably, FOLR1 is overexpressed in greater than 75% of ovarian cancer. Preclinical data supporting NTB-928's differentiated selectivity profile have been published in Oncoimmunology (Avanzino et al., 2022).

The ongoing Phase 1, single-arm, open-label trial utilizes a Bayesian Optimal Interval dose-escalation design with backfill (BOIN-BF) to evaluate the safety, tolerability, and preliminary activity of NTB-928.

"Dosing the first patient in this study is a defining moment for 92Bio," said Ben Buelow, MD, PhD, Chief Executive Officer of 92Bio. "NTB-928 was purpose-built to solve the selectivity challenge that has constrained FOLR1 targeted T-cell engagers in ovarian cancer. Its unique combination of affinity-tuned CD3 engagement and avidity-dependent FOLR1 binding positions it specifically as a best-in-class candidate for patients with ovarian cancer, and generally for FOLR1-positive malignancies beyond that."

“The initiation of this study represents an important step forward in evaluating a novel approach for patients with platinum-resistant ovarian cancer, where significant unmet needs remain,” said Geraldine O'Sullivan Coyne, MD, Principal Investigator at START New York-Long Island who dosed the first patient. “We are proud to support the clinical development of NTB-928 and grateful for the strong collaboration between START, 92Bio, and Northwell Health Cancer Institute. Milestones like this are only possible through a shared commitment to advancing research and expanding opportunities for patients.”

About NTB-928

NTB-928 is a fully human bispecific T-cell engaging antibody targeting FOLR1 and CD3. Its selectivity derives from two synergistic design features: an affinity-tuned anti-CD3 arm that drives potent anti-tumor T-cell activation with reduced cytokine secretion, and a bivalent FOLR1-binding arm that confers avidity-dependent binding to tumor cells overexpressing FOLR1 but not to normal cells expressing trace FOLR1. Neither feature alone is sufficient for selectivity; both are required. In preclinical studies, NTB-928 demonstrated robust tumor clearance in vitro, ex vivo and in vivo with a favorable safety profile (Avanzino BC et al., Oncoimmunology, 2022; doi: 10.1080/2162402X.2022.2113697).

About 92Bio, Inc.

92Bio, Inc. is a clinical-stage biotechnology company focused on developing differentiated T-cell engaging antibodies for the treatment of hematologic and solid tumors. The company's proprietary platform enables the engineering of bispecific antibodies with tumor-selective binding profiles designed to maximize efficacy while minimizing on-target, off-tumor toxicity. 92Bio is headquartered in Hayward, CA.