NextCure, a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, provided an interim update for the phase 2 portion of its NC318 monotherapy phase 1/2 trial.
Based on the current enrollment criteria and clinical response data, at this time the company does not plan to advance the non-small cell lung cancer (NSCLC) and ovarian cancer cohorts into the stage 2 portion of the Simon 2-stage trial. The analysis of biomarker data for these cohorts has been delayed and is not yet complete. The company will evaluate whether to pursue additional monotherapy studies in NSCLC and ovarian cancer after a review of that information. The company continues to enroll in head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer cohorts. One confirmed partial response has been observed in HNSCC and this indication has been advanced to the stage 2 portion of the Simon 2-stage trial. The company is continuing to assess Siglec-15 (S15) biomarker data as a basis for patient selection.
“While the monotherapy data in the NSCLC and ovarian cancer cohorts are disappointing, we continue to evaluate patient selection criteria for our ongoing NC318 clinical trials,” said Michael Richman, NextCure’s president and chief executive officer. “We expect to provide an NC318 clinical data update and additional biomarker data in the fourth quarter of 2020.”
NextCure also announced that Kevin N. Heller, M.D., the company’s chief medical officer, has resigned, effective August 4, 2020 to pursue a new opportunity. Dr. Heller will serve as a consultant to the company. The company has initiated a search for a new chief medical officer.
“We thank Kevin for all of his work on behalf of the company and look forward to his continued support as a clinical consultant,” said Mr. Richman.
The phase 2 component of the phase 1/2 clinical trial is designed as a single-arm trial to evaluate the efficacy of NC318 at a 400 mg dose administered every two weeks. NextCure expects to enroll up to 100 patients with NSCLC, ovarian cancer, head and neck cancer and triple-negative breast cancer. The primary endpoints are safety and tolerability, and secondary endpoints include response rate, progression-free survival, duration of response and overall survival.
NC318 is a first-in-class immunomedicine against S15, a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15. NextCure believes NC318 has the potential to treat multiple cancer types.