Benzinga | Dec 23, 2020 07:07AM EST

Celcuity Reports Clinical Trial Collaboration With Massachusetts General Hospital, Puma Biotech To Conduct Phase 2 Trial

Celcuity Inc. (NASDAQ:CELC), a clinical stage biotechnology company utilizing its 3rd generation companion diagnostics to identify new targeted therapeutic options for cancer patients, today announced a clinical trial collaboration with Massachusetts General Hospital and Puma Biotechnology, a biopharmaceutical company, to conduct a Phase II clinical trial.

This open-label Phase II trial will evaluate the efficacy and safety of Puma's drug, NERLYNX (neratinib), and FASLODEX (fulvestrant), an AstraZeneca drug, in previously treated metastatic HR-positive (HR+), HER2-negative (HER2-) breast cancer patients selected with Celcuity's CELsignia HER2 Activity Test. Under the agreement, Massachusetts General Hospital will serve as the sponsor and Dr. Aditya Bardia, a medical oncologist at Massachusetts General Hospital and assistant professor at Harvard Medical School, will serve as the principal investigator of this study, while the UCLA Jonsson Comprehensive Cancer Center and the Vanderbilt-Ingram Cancer Center will serve as co-sponsors. Each of these institutions is amongst the United States' 51 NCI-Designated Comprehensive Cancer Centers tasked with developing new approaches to diagnosing and treating cancer.

Puma will supply NERLYNX, its pan-HER inhibitor currently approved by the U.S. Food and Drug Administration ("FDA") for early and late-stage HER2-positive breast cancer. Celcuity will provide its CELsignia HER2 Activity Test to select HR+, HER2- metastatic breast cancer patients who have hyperactive HER2-driven signaling pathways for the trial and will fund the patient-related trial costs. Based on its estimates of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after the protocol is activated and final results 12 to 15 months later. Celcuity expects enrollment to begin in the second quarter of 2021.

The goal of the trial is to demonstrate that previously treated HR+, HER2- metastatic breast cancer patients who have hyperactive HER2 signaling tumors, as identified by the CELsignia test, respond to treatment with NERLYNX in combination with FASLODEX, a hormonal therapy that targets the estrogen receptor. Celcuity believes there is significant clinical interest in finding new diagnostic tests and targeted therapies for metastatic HR+, HER2- breast cancer patients whose disease progressed on prior therapies. Of particular interest are new therapeutic combinations that can overcome resistance to anti-estrogen therapies like FASLODEX. The blockade of estrogen receptor and HER2 pathways when the HER2 pathway is hyperactive using a combination of NERLYNX and FASLODEX has been demonstrated in animal models.1

"We are excited about the opportunity to collaborate with Dr. Bardia, Massachusetts General Hospital, UCLA, Vanderbilt, and Puma Biotechnology on this important clinical trial," said Brian Sullivan, CEO and Co-Founder of Celcuity. "This will be our first collaboration to study metastatic breast cancer patients selected for treatment using our CELsignia HER2 Activity Test. Our two current clinical trials are studying the efficacy of anti-HER2 therapies in early-stage breast cancer patients. Approximately 20% of the 280,000 HER2- breast cancer patients receiving drug treatment annually have tumors with hyperactive HER2 signaling, according to our studies.2 For these patients, this trial represents a critical step towards a potential new therapeutic option."