Benzinga | Dec 17, 2020 07:08AM EST

NextCure Provides Updates On NC318 Clinical Program; Says At This Time, No Longer Plans To Initiate Study Of NC318 In Combination With Chemotherapy

BELTSVILLE, Md., Dec. 17, 2020 (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 provided an update on the clinical trial program for NC318, its first-in-class immunomedicine against Siglec15 (S15), a novel immunomodulatory target.



"As we continue to review and analyze the available clinical and laboratory data on the NC318 program, including recently generated biomarker data, we are working to modify the clinical program to enable us to select S15-positive patients for enrollment in ongoing and future trials," said Michael Richman, NextCure's president and chief executive officer. "We remain encouraged regarding the potential of NC318 as a novel oncology treatment, given the evidence of clinical activity seen to date and recent biomarker data that continue to indicate NC318's ability to modulate immune activity. We anticipate providing additional detail in early 2021 on the next steps for the program after a new chief medical officer is on board and has had sufficient time to review the program."

Key Updates to NC318 Clinical Program

* The two objective responder patients in the Phase 1 portion of the company's ongoing Phase 1/2 clinical trial of NC318 are continuing to receive drug and remain on study at over 104 weeks and over 78 weeks.

* The company is continuing to enroll head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer patients. As previously announced, a confirmed partial response (PR) has been observed in the HNSCC cohort, which supports advancing into the stage 2 portion of the Simon 2-stage trial. The patient remains on study at over 32 weeks.

* NC318 continues to be well-tolerated, with treatment-related adverse events (TRAEs) primarily grades 1-2. The only observed grade 3-4 TRAE was an infusion reaction in one patient.

* In the Phase 2 portion of the company's current trial, patients were selected based on tumors with a PD-L1 tumor proportion score (TPS) of less than 50%. S15 expression was analyzed retrospectively in all pretreatment biopsies successfully obtained from Phase 2 patients. Of the evaluable biopsies collected, 13% of the patients enrolled had S15-positive tumors under that criterion. Overall, the selection criterion did not result in enough S15-positive patients.

* The ongoing Phase 2 trial is being modified for S15 selection and the company expects to begin pre-selecting patients for enrollment based on S15 expression in the first quarter of 2021 in order to assess response rates in patients selected for S15 positivity.

* Biomarker analysis demonstrated an increase in peripheral immune modulation markers.

* Scientific evidence supports a combination with anti-PD-1 therapy and the company is planning to study that combination in NSCLC patients. At this time, the company no longer plans to initiate a study of NC318 in combination with chemotherapy.