NextPoint Therapeutics has announced that its investigational new drug (IND) application has been accepted by the US Food & Drug Administration (FDA) for NPX887.
With this acceptance, NextPoint Therapeutics now intends to begin a first-in-human Phase I clinical trial in early 2024 analysing NPX887 in patients with solid tumours known to express HHLA2, a tumor antigen that is strongly upregulated in several human cancers.
NextPoint Therapeutics chief medical officer Leena Gandhi said: “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 tumours from cloaking themselves from the immune system.
“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.”
A completely human monoclonal antibody, NPX887 targets HHLA2 (B7-H7), a novel immune checkpoint and tumour target antigen highly expressed in several cancers independently of PD-L1.
It is designed to prevent immune escape in solid tumours by hindering KIR3DL3-mediated immunosuppression upon binding to HHLA2.
The company claimed that the treatment with NPX887 is believed to promote T and NK cell antitumor activity within the tumour microenvironment.
NextPoint is a clinical-stage biotechnology company developing precision immuno-oncology therapeutics targeting the novel HHLA2 pathway.