World News: 22:05 GMT Saturday 9th November 2019. [NextCure via Globe Newswire via SPi World News]
BELTSVILLE, Md., Nov. 09, 2019 (GLOBE NEWSWIRE) -- (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.
“NC318 has been well tolerated in the Phase 1 trial, and the only dose-limiting toxicity was a grade 3 pneumonitis in the 1,600 mg cohort,” said Kevin N. Heller, M.D., NextCure’s chief medical officer. “It is encouraging to see single-agent activity among NSCLC patients refractory to PD-1 therapies, including a durable complete response and a durable partial response. Given what appears to be the non-overlapping expression of PD-L1 and S15, the results to date support the potential of NC318 to block S15-mediated immune suppression among a patient population unlikely to respond to PD-1/PD-L1-directed therapies.”
“There is a real need for new treatment options for patients who do not respond to current therapies. The tolerability and initial anti-tumor activity with NC318 reinforces our belief that NC318 has the potential to be a new therapy for patients with solid tumors and low levels of PD-L1 expression or who do not respond to current anti-PD-1/PD-L1 treatments,” said Michael Richman, NextCure’s president and chief executive officer. “In addition, the initiation of the Phase 2 portion of the trial is an important milestone for the NC318 program and reflects NextCure’s continued commitment to developing novel medicines to improve the lives of patients with cancer. We look forward to reporting initial data from the Phase 2 portion of the trial by the end of 2020. These findings also revalidate the importance of the approach of our FIND-IO discovery platform in identifying targets like S15 that can impact immune function.”
Slides from the SITC presentation will be posted on NextCure’s website on the “Events and Presentations” tab at .
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 approximately 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. Additional doses and dose administration schedules may be considered. The company expects to report initial data from the Phase 2 portion of the trial by the end of 2020.
Timothy Mayer, Ph.D.
Chief Operating Officer
Shai Biran, Ph.D.
Globe Newswire: 22:05 GMT Saturday 9th November 2019
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