CAMBRIDGE, Mass. — NextPoint Therapeutics said it has received clearance from the U.S. Food and Drug Administration to begin first-in-human clinical studies of NPX372, a first-in-class T cell engager designed to treat patients with solid tumors.
The clearance of the Investigational New Drug application allows the clinical-stage biotechnology company to initiate studies of NPX372, an IgG-like CD3 bispecific engineered to selectively redirect T cells to tumors expressing B7-H7. The company said the program targets solid tumors including lung adenocarcinoma, renal cell carcinoma, and pancreatic adenocarcinoma.
B7-H7 is largely absent from normal tissue and is highly specific to tumor epithelial cells, making it a more selective target for T cell–based therapies, according to the company. NPX372 was designed to promote tumor-specific cytotoxicity while minimizing non-specific T cell activation. In preclinical studies, the candidate demonstrated complete tumor regression in multiple solid tumor models and showed favorable tolerability, with no evidence of cytokine release syndrome.
“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.
NextPoint said its clinical trial incorporates an efficient dose-escalation algorithm and a biomarker-driven patient selection strategy intended to enable rapid data readouts and optimized dosing.
“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 T cell engager.”
Cheung said the expression profile of B7-H7, combined with the design of NPX372 and a clinical strategy focused on rapid and meaningful data generation, positions the program as a competitive entrant in the emerging T cell engager field for solid tumors.
