KIR3DL3

Progressing clinical programs NPX267 and NPX887 in parallel to interrogate HHLA2/B7-H7 axis from multiple angles for optimizing targeted immuno-oncology therapeutic approaches CAMBRIDGE, Mass.--(BUSINESS WIRE)-- NextPoint Therapeutics, a clinical-stage biotechnology company developing a new class of precision oncology therapeutics targeting the novel HHLA2 pathway, announced today that the first patient has been dosed with NPX887 in a Phase 1 first-in-human clinical trial for the treatment of patients with solid tumors expressing HHLA2/B7-H7, a tumor antigen strongly upregulated in many human tumors independently of PD-L1. The study is a Phase 1a/1b open-label, multi-center trial (NCT06240728) consisting of a dose escalation and an expansion stage to evaluate the tolerability, pharmacokinetics, immunogenicity and biomarker-based selection of NPX887 in patients with solid tumor malignancies including non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC) and other solid tumor types known to express HHLA2/B7-H7. “The launch of NPX887, our second clinical program targeting the HHLA2/B7-H7 axis, marks an important step in broadening our therapeutic targeting of this novel pathway to reactivate the immune system to fight cancer,” commented Leena Gandhi, MD, PhD, Chief Medical Officer of NextPoint Therapeutics. “Together with NPX267, our first clinical program targeting the KIR3DL3 receptor for HHLA2, we are well-positioned to interrogate how best to exploit this pathway to effectively treat patients whose tumors express HHLA2 as an independent checkpoint of tumor-immune response from PD-L1. Our goal for both clinical programs is to leverage HHLA2 as a biomarker to enable precision selection of patients most likely to benefit. Both NPX267 and NPX887 have the potential for monotherapy benefit in selected patient populations.” 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 which results from binding to HHLA2. Treatment with NPX887 is believed to promote both T and NK cell antitumor activity within the tumor microenvironment. To learn more, visit (NCT06240728). About NextPoint Therapeutics NextPoint is advancing the field of immuno-oncology through its leading scientific work on the novel HHLA2 axis, also known as B7-H7. Our innovative approach integrates foundational science with a defined clinical biomarker strategy to deliver a new class of monotherapies for patients who do not benefit from PD-1/L1 inhibitors and other therapies. NextPoint is simultaneously advancing therapeutic approaches utilizing the unique upregulation of HHLA2 in cancer as an anchor for tumor-targeting therapeutic modalities. Our team of proven drug developers is working closely with our renowned scientific founders to launch a new world of precision immuno-oncology and beyond. To learn more, visit nextpointtx.com.

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- NextPoint Therapeutics , a clinical-stage biotechnology company developing precision immuno-oncology therapeutics targeting the novel HHLA2 pathway, today announced the acceptance of its investigational new drug (IND) application by the U.S. Food & Drug Administration (FDA) for NPX887. 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. “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. About NextPoint Therapeutics NextPoint is advancing the field of immuno-oncology through its leading scientific work on the novel HHLA2 pathway. Our innovative approach integrates foundational science with a defined clinical biomarker strategy to deliver a new class of monotherapies for patients who do not benefit from PD-1/L1 inhibitors. Our team of proven drug developers is working closely with our renowned scientific founders to launch a new world of precision immuno-oncology. To learn more, visit nextpointtx.com .

- First-in-class monoclonal antibody targeting KIR3DL3, the inhibitory receptor for HHLA2, designed to reverse immune suppression in the tumor microenvironment - The study will assess safety, tolerability and inform dosing strategy CAMBRIDGE, Mass.--(BUSINESS WIRE)-- NextPoint Therapeutics, a clinical-stage biotechnology company developing precision immuno-oncology therapeutics targeting the novel HHLA2 pathway, announced today that the first patient has been dosed with NPX267 in a Phase 1 first-in-human clinical trial for the treatment of patients with solid tumors known to express HHLA2, a tumor antigen strongly upregulated in many human tumors independently of PD-L1. The Phase 1a/1b open-label, multi-center study (NCT05958199) consists of a dose escalation and an expansion stage to evaluate the tolerability, pharmacokinetics, immunogenicity and biomarker strategy of NPX267 in patients with metastatic solid tumors including epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) and other indications. Killer cell immunoglobulin-like receptor 3DL3 (KIR3DL3) is expressed on effector T cells and natural killer (NK) cells in the tumor microenvironment and is an inhibitory receptor for the tumor antigen HHLA2, expressed on a range of solid tumors. Binding of KIR3DL3 to HHLA2 is believed to allow tumors to cloak themselves and hide from immune cells. “Many cancers hijack the HHLA2 pathway to evade the immune system, whose signaling mechanisms were independently co-discovered by NextPoint’s scientific co-founders, Dr. XingXing Zang and Dr. Gordon Freeman,” said Detlev Biniszkiewicz, PhD, Chief Executive Officer of NextPoint Therapeutics. “Because HHLA2 is expressed independently of PD-L1 and is often highly expressed in PD-L1-negative cancers, targeting the HHLA2-KIR3DL3 interaction is a promising new approach for patients with cancer.” “We are excited to launch the clinical evaluation of NPX267, our lead therapeutic program targeting the HHLA2 pathway,” said Leena Gandhi, MD, PhD, Chief Medical Officer of NextPoint Therapeutics. “This study will provide important data on the therapeutic activity of NPX267 as well as the mechanism of HHLA2-mediated immunosuppression via KIR3DL3 and inform our clinical strategy for developing precision immunotherapeutic treatments for patients.” About NPX267 NPX267 is a first-in-class monoclonal antibody targeting KIR3DL3, the inhibitory receptor for the HHLA2 pathway (B7-H7), and is designed to prevent immune escape in solid tumors. By blocking the binding of KIR3DL3 on exhausted T and NK cells to HHLA2 expressed on tumor cells, NPX267 may be able to reactivate tumor antigen-primed immune cells in HHLA2-expressing solid tumors. Preventing KIR3DL3-mediated immune suppression may enhance anti-tumor immune responses for patients with HHLA2-positive cancers – a tumor antigen expressed independently of PD-L1. To learn more, visit (NCT05958199). About NextPoint Therapeutics NextPoint is advancing the field of immuno-oncology through its leading scientific work on the novel HHLA2 pathway. Our innovative approach integrates foundational science with a defined clinical biomarker to deliver a new class of monotherapies for patients who will not benefit from PD-1/L1 inhibitors. Our team of proven drug developers is working closely with our renowned scientific founders to launch a new world of precision immuno-oncology. To learn more, visit nextpointtx.com.