NextPoint Therapeutics Announces Clinical Entry of NPX372, a First-in-Class B7-H7–Targeted T Cell Engager to Treat Solid Tumors

Initiates first-in-human clinical studies of an IgG-like CD3 bispecific designed with a wide therapeutic index to selectively redirect T cells to B7-H7–expressing tumors, including lung adenocarcinoma, renal cell carcinoma and pancreatic adenocarcinoma

Clinical trial design with efficient dose escalation algorithm and biomarker strategy allows rapid data readout and enables optimized dosing and response

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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, today announced 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.

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.”

About NextPoint Therapeutics
NextPoint is launching a new world of precision therapeutics through its leading scientific work on the novel B7-H7 axis. Our team of proven drug developers is advancing a T-cell engager with wide therapeutic window, an antibody-drug conjugate with our proprietary linker technology, and a multi-functional checkpoint inhibitor. Our innovative approach integrates foundational science with a defined clinical biomarker to identify the right patient population for each B7-H7-directed modality, so that we can deliver first-in-class therapies to a broad range of cancer patients with B7-H7 upregulation including those who do not benefit from currently approved therapies such as PD-1/L1 inhibitors. To learn more, visit nextpointtx.com.