On February 9, 2026 NextPoint Therapeutics, a clinical-stage biotechnology company developing a new world of precision therapeutics through its leading scientific work on the novel B7-H7 axis, reported the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate clinical development of NPX372, a first-in-class T cell engager (TCE) for the treatment of patients with solid tumors.
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B7-H7 is highly specific to tumor epithelial cells and largely absent from normal tissue, setting it apart as a much cleaner and more selective target for a T cell engager. NPX372 is an IgG-like bispecific T cell engager designed to drive target expression–proximal cytotoxicity while minimizing non-specific T cell activation. In preclinical studies, NPX372 demonstrated complete tumor regression in solid tumor models, while displaying great tolerability in relevant preclinical safety assessment and no evidence of cytokine release syndrome.
"T-cell engagers represent a novel approach to delivering sustained anti-tumor immune responses to cancer patients," said Leena Gandhi, MD, PhD, Chief Medical Officer of NextPoint Therapeutics. "This IND clearance enables us to accelerate the delivery of targeted immune therapy to broad patient populations in need, including patients with lung adenocarcinoma, renal cell carcinoma and pancreatic adenocarcinoma. Our clinical program deploys an efficient dose escalation algorithm and utilizes a novel biomarker assay to select patients with the highest chance of benefit from a B7-H7 targeting TCE."
"The NPX372 IND clearance represents the strategic initiation of our clinical use of B7-H7 as a highly specific tumor-targeting antigen for potent direct tumor killing therapeutics," said Ivan Cheung, Chief Executive Officer of NextPoint Therapeutics. "The ideal expression profile of B7-H7 and the meticulous construct design of NPX372, along with a clinical trial design that enables fast and impactful data readouts, position NPX372 as a frontrunner in the emerging T cell engager field for solid tumors."
(Press release, NextPoint Therapeutics, FEB 9, 2026, View Source [SID1234662552])