NPX372, Novel T-Cell Engager in Solid Tumors, Gains IND Clearance

The FDA has cleared the investigational new drug (IND) application for NPX372, a first-in-class T-cell engager (TCE) for the treatment of patients with solid tumors, specifically lung adenocarcinoma, renal cell carcinoma, and pancreatic adenocarcinoma, according to the manufacturer.¹

With the clearance, the company will initiate human studies of the IgG-like CD3 bispecific TCE. The agent is 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,” Leena Gandhi, MD, PhD, chief medical officer of NextPoint Therapeutics said in a news release. “This IND clearance enables us to accelerate the delivery of targeted immune therapy to broad patient populations in need. 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 agent is based on the B7-H7 axis, which is specific to tumor epithelial cells and largely absent from normal tissue, making it a more selective target for a T-cell engager. The axis acts as a potent immune checkpoint that allows tumor cells to evade T-cell surveillance. Widely expressed in various solid tumors (often where PD-L1 is absent), B7-H7 correlates with poor prognosis, metastasis, and increased tumor grade. It is considered a promising immunotherapy target, with potential for boosting anti-tumor immunity and inhibiting tumor-related angiogenesis.

Other technology highlighting the B7-H7 axis include data on NPX125, the company’s antibody drug conjugate, presented previously during the American Association for Cancer Research Annual Meeting 2025 in Chicago.²

REFERENCES

1. NextPoint Therapeutics Announces Clinical Entry of NPX372, a First-in-Class B7-H7–Targeted T Cell Engager to Treat Solid Tumors. News release. February 9, 2026. Accessed February 10, 2026. https://tinyurl.com/48ssjufr

2. Loeuillard E, Etemad-Gilbertson BA, Hewitt SL, et al. B7-H7 is a novel ADC target for solid tumors and shows potent activity with multiple payload-linker technologies. Cancer Res. 2025;85 (8_Suppl_1): 7336. doi:10.1158/1538-7445.AM2025-7336