FDA accept NextPoint Therapeutics IND for HHLA2 targeting mAb
The US Food and Drug Administration (FDA) has accepted Massachusetts-based Nextpoint Therapeutics’ investigational new drug (IND) application for NPX887 to treat patients with HHLA2-positive tumours. NPX887 is a first-in-class monoclonal antibody that acts by blocking the activity of killer cell immunoglobulin like receptor 3DL3 (KIR3DL3). KIR3DL3, expressed on T cells and natural killer (NK) cells in the tumour microenvironment, suppresses immune responses following engagement with HHLA2. Nextpoint’s other HHLA2-targeting therapy NPX267 is currently being investigated in a Phase Ia/Ib clinical trial, which started in July 2023. The open-label trial enrols 131 subjects with metastatic solid tumours, including epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC), as well as other indications. The study is evaluating the pharmacokinetics and immunogenicity of NPX267 in a dose escalation and an expansion stage, with an estimated completion date of January 2026. In the announcement accompanying the clearance, chief medical officer of Nextpoint 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.” In December 2022, Nextpoint raised $80m in a Series B financing round led by Leaps by Bayer, the investment arm of Bayer AG, and Sanofi Ventures, the venture capital arm for Sanofi. Nextpoint announced that it would use the financing to advance its two lead precision immunooncology programmes into the clinic. Nextpoint entered into a manufacturing agreement with ProBioGen back in August 2022 for an antibody candidate, indicated for the treatment of cancers. Under the terms of the deal, ProBioGen initiated an agreement where it will use the CHO.RIGHT cell line and DirectLuck transposase platform for its manufacturing process. Hong Kong-based biotech Harbour BioMed currently has an HHLA2 targeting therapy, HBM-1020 in a Phase I clinical trial. According to GlobalData’s Pharma Intelligence Center, HBM-1020 is under development to treat solid tumours, metastatic renal cell carcinoma, metastatic colorectal cancer, and breast cancer. GlobalData is the parent company of Pharmaceutical Technology.
NextPoint plans to kickstart the first-in-human Phase I clinical trial in early 2024, investigating NPX887 in patients with HHLA2-positive tumours.
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