NextPoint Therapeutics Announces IND Clearance from the FDA to Advance NPX887, a Novel Therapeutic Targeting HHLA2 to Reactivate Exhausted T and NK Cells in HHLA2+ Solid Tumors

On December 7, 2023 NextPoint Therapeutics, a clinical-stage biotechnology company developing precision immuno-oncology therapeutics targeting the novel HHLA2 pathway, reported the acceptance of its investigational new drug (IND) application by the U.S. Food & Drug Administration (FDA) for NPX887 (Press release, NextPoint Therapeutics, DEC 7, 2023, View Source [SID1234638273]). The company plans to initiate a first-in-human Phase I clinical trial in early 2024 evaluating NPX887 in patients with solid tumors known to express HHLA2, a tumor antigen strongly upregulated in many human cancers.

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"NPX887 represents our second clinical program targeting the HHLA2 checkpoint axis. NextPoint’s approach is to advance therapeutics targeting this axis from different angles to prevent tumors from cloaking themselves from the immune system," said Leena Gandhi, MD, PhD, Chief Medical Officer of NextPoint Therapeutics. "This important milestone allows us to advance our clinical evaluation of NPX887 and brings us one step closer to our goal of expanding treatment options for patients with cancer."

About NPX887

NPX887 is a fully human monoclonal antibody targeting HHLA2 (B7-H7), a novel immune checkpoint and tumor target antigen highly expressed in many cancers independently of PD-L1. NPX887 is designed to prevent immune escape in solid tumors by blocking KIR3DL3-mediated immunosuppression upon binding to HHLA2. Treatment with NPX887 is believed to promote T and NK cell antitumor activity within the tumor microenvironment.