NextCure Provides Update on Clinical Trial Activities Due to Impact of COVID-19 Pandemic
BELTSVILLE, Md., April 13, 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 company's clinical trial activities due to the impact of the COVID-19 pandemic.
?The COVID-19 pandemic has put significant strain on our clinical trial sites, and has raised concerns around monitoring patient safety,? said Michael Richman, NextCure?s president and chief executive officer. ?We, like others in our industry, are working closely with our clinical partners and taking the necessary steps to adjust our protocols and timelines as required during this challenging time. We will continue to support ongoing activities for patients enrolled in the Phase 2 portion of our Phase 1/2 NC318 monotherapy trial and will work with trial sites to enroll new patients as appropriate. We have made the decision to delay initiating our NC318 combination trial and NC410 trial until matters improve and look forward to starting these trials. We would like to thank our employees, investigators and clinical sites, patients, collaborators and vendors, who have been strongly supportive during this difficult period and demonstrated great resiliency in the face of new challenges.? 2020 Pipeline Updates Previous guidance is being updated as follows:- NextCure expects to report initial biomarker data from the Phase 1 portion of its Phase 1/2 NC318 monotherapy trial midyear.
- Due to the COVID-19 pandemic, the company has decided to temporarily delay starting the NC318 combination clinical trial in non-small cell lung cancer with standard-of-care chemotherapies.
- Given the enrollment slowdown, initial data reporting from the Phase 2 portion of the Phase 1/2 NC318 monotherapy clinical trial is expected to be delayed.
- NextCure filed an investigational new drug application for its second product candidate, NC410, received FDA clearance for clinical studies and was prepared to start the Phase 1 portion of a Phase 1/2 clinical trial in March. However, due to the COVID-19 pandemic, the company has decided to temporarily delay initiating that trial.
Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 Media Inquiries Shai Biran, Ph.D. MacDougall (781) 591-3481