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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...

NC318 was well tolerated



Single agent activity observed in multiple tumor types, including a CR and a PR in NSCLC



Initiated 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,A 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.Updated Results from the Phase 1 Portion of the Phase 1/2 Trial
As 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. A A 



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 November 9, 2019).



Durable responses were observed in patients who received NC318, including one complete response (ongoing at 55 weeks), one partial response (ongoing at 28 weeks) and four stable diseases in NSCLC (ongoing for 16 to 40 weeks) and 14 stable diseases overall (ongoing for 16 to 42 weeks).



15 patients remain on study in the Phase 1 portion of the trial, including seven patients with NSCLC.



All responses were based on investigator tumor assessments per RECIST v1.1.

a??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,a?? said Kevin N. Heller, M.D., NextCurea??s chief medical officer.A a??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.a??a??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,a?? said Michael Richman, NextCurea??s president and chief executive officer. a??In addition, the initiation of the Phase 2 portion of the trial is an important milestone for the NC318 program and reflects NextCurea??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-IOTM discovery platform in identifying targets like S15 that can impact immune function.a??Slides from the SITC presentation will be posted on NextCurea??s website on the a??Events and Presentationsa?? tab at https://ir.nextcure.com/events-and-presentations.
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