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NextCure Presents Updated Clinical Data from NC318 Phase 1/2 Clinical Trial at the 34th Annual Meeting of Society for Immunotherapy of Cancer (SITC) and Announces Initiation of Phase 2 Portion of the Trial
NC318 was well toleratedSingle agent activity observed in multiple tumor types, including a CR and a PR in NSCLCInitiated Phase 2 portion of the Phase 1/2
About this update from Nextcure, Inc.
[{"type":"text","content":"NC318 was well toleratedSingle agent activity observed in multiple tumor types, including a CR and a PR in NSCLCInitiated Phase 2 portion of the Phase 1/2 monotherapy trial and plans for a combo trial with standard of care chemotherapies BELTSVILLE, Md., Nov. 09, 2019 (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 that updated clinical results from the Phase 1 portion of its ongoing trial with NC318, a monoclonal antibody targeting Siglec-15 (S15), were presented at the SITC annual meeting. S15 is a novel immunomodulatory protein that is expressed on highly immunosuppressive cells called M2 macrophages and on tumor cells. In addition, NextCure announced the initiation of the Phase 2 portion of its ongoing Phase 1/2 clinical trial of NC318.\n Updated Results from the Phase 1 Portion of the Phase 1/2 TrialAs of November 9, 2019, 49 patients had been dosed across seven dose cohorts between 8 mg and 1,600 mg, administered every two weeks: The most common tumor types enrolled included: non-small cell lung cancer (NSCLC) (13 patients), ovarian cancer (seven patients), melanoma (seven patients), breast cancer (four patients) and colorectal cancer (three patients).All of the patients enrolled were heavily pre-treated with a median of three prior therapies.All 13 NSCLC patients were PD-1 refractory, with a median of four prior therapies.Data show that NC318 was well tolerated, and the only dose-limiting toxicity was a grade 3 pneumonitis in the 1,600 mg cohort.Treatment-related adverse events occurring in more than 5% of subjects were diarrhea, infusion reactions, fatigue, headaches, pruritis and elevations in lipase and amylase. Most treatment-related adverse events were easily manageable, asymptomatic or mild or moderate, except for one grade 3 episcleritis/uveitis and two cases of grade 3 pneumonitis.Immune-related adverse events such as vitiligo, uveitis and pneumonitis were observed.Data from the trial indicate activity in multiple tumor types including durable stable disease in patients with NSCLC, endometrial cell cancer, ovarian cancer, squamous cell carcinoma, Merkel cell cancer and head and neck cancer (ongoing for 16 to 55 weeks as of Nov...