A Phase 2 Study of Anti-Siglec-15 Antibody, NC318, in Combination with Pembrolizumab (NCT04699123) Demonstrates Clinical Activity in Patients with Advanced PD-1 Axis Inhibitor Refractory NSCLC
• Data presented at the 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Singapore
BELTSVILLE, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the presentation of Phase 2 clinical data by collaborators at the Yale Cancer Center demonstrating clinical benefit in patients with advanced, PD-1 axis inhibitor refractory non-small cell lung cancer (NSCLC) treated with a combination regimen of NC318, a Siglec-15 (S15) monoclonal antibody (mAb), and pembrolizumab, an anti-PD-1 antibody.
NC318 is a humanized IgG1 mAb against S15 that blocks interactions of S15 with myeloid cells and T lymphocytes within the tumor microenvironment, relieving immune inhibitory signaling. In an earlier monotherapy study from NextCure, NC318 demonstrated single agent activity in a Phase 1/2 dose escalation trial (NCT03665285) for patients with advanced solid tumors (Tolcher et al, SITC 2019).
The ongoing NCT04699123 study is a randomized trial designed to assess the safety and efficacy of NC318 alone or in combination with pembrolizumab. The combination portion of the study is assessing efficacy in NSCLC subjects who have experienced disease progression on, or after, PD-1 axis inhibitor therapy. Key findings from the trial include:
“Based on these early encouraging results, Yale is continuing to enroll patients to gain further evidence of clinical activity of NC318,” said Solomon Langermann, Ph.D., NextCure’s chief scientific officer. “We look forward to continuing our collaboration with Drs. Herbst and Gettinger and the Yale Cancer Center.
“We are excited that this investigator-initiated trial, part of our NCI Lung SPORE (Specialized Program of Research Excellence), is providing new insights into the mechanisms and treatment of immune therapy resistance. We look forward to reporting more data in the future,” said Roy Herbst, M.D., Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology; Deputy Director, Yale Cancer Center; Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital; Assistant Dean for Translational Research, Yale School of Medicine; Director, Center for Thoracic Cancers, Yale Cancer Center and Smilow Cancer Hospital.
Details of the presentation are as follows:
Title: A Phase 2 study of NC318 alone or in combination with pembrolizumab in patients with advanced NSCLC
NextCure has maintained a longstanding relationship with clinician scientists at Yale University stretching back to the company’s founding. NextCure’s scientific founder Dr. Lieping Chen, a leader in immunology and medical oncology, is the United Technologies Corporation Professor in Cancer Research and Professor of Immunobiology, Dermatology and Medicine (Medical Oncology) at Yale University. The immunosuppressive properties of S15 were discovered by Dr. Chen at Yale University. NextCure has exclusively licensed technologies relating to S15 from Yale University, and has since collaborated with Yale University to continue development of NC318, as well as other immuno-oncology candidates, through sponsored research and clinical trial agreements.
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