Benzinga | Jan 27, 2021 05:36PM EST

Celcuity Announces Breast Cancer Clinical Trial Collaboration with Sarah Cannon and Pfizer to Study New Drug Regimen

- Trial will evaluate the efficacy and safety of Pfizer's targeted therapies, VIZIMPRO(r) and XALKORI(r), in patients with metastatic HER2-negative breast cancer selected by Celcuity's CELsignia Multi-Pathway Activity Test

- First clinical trial to treat patients diagnosed with hyperactive HER2 and c-Met signaling breast cancers with matching targeted therapies

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 Sarah Cannon Research Institute, the research arm of Sarah Cannon, and Pfizer Inc., a global biopharmaceutical company, to conduct a Phase II clinical trial.

This open-label Phase II trial will evaluate the efficacy and safety of two Pfizer targeted therapies, VIZIMPRO(r), a pan-HER inhibitor, and XALKORI(r), a c-Met inhibitor, in patients with previously treated metastatic HER2-negative breast cancer selected with Celcuity's CELsignia Multi-Pathway Activity Test. Under the agreement, Sarah Cannon Research Institute will serve as the sponsor and Erika Hamilton, MD, a medical oncologist and Director of the Breast Cancer and Gynecologic Cancer Research Program for Sarah Cannon Research Institute at Tennessee Oncology, will serve as the principal investigator of this study. Sarah Cannon Research Institute, one of the world's leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom, has been a clinical trial leader in the majority of approved cancer therapies over the last decade.

"This clinical trial could lay the groundwork for a new treatment paradigm for patients with metastatic HER2-negative breast cancer who stop responding to current standard-of-care drug regimens," said Dr. Hamilton. Added Dr. Hamilton, "We are eager to begin working with Celcuity and exploring their novel CELsignia technology to identify patients whose tumors may respond to these targeted therapies."

Pfizer will supply VIZIMPRO and XALKORI, targeted therapies currently approved by the U.S. Food and Drug Administration to treat metastatic non-small cell lung cancer. Celcuity will provide its CELsignia Multi-Pathway Activity Test to select patients with HER2-negative metastatic breast cancer who have hyperactive HER2 and c-Met signaling pathways for the trial and will fund the patient-related trial costs. Based on Sarah Cannon's estimate of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after the protocol is activated and final results 12-15 months later. Celcuity expects enrollment to begin in the second quarter of 2021.

Celcuity believes there is significant clinical interest in finding new diagnostic tests and targeted therapies for patients with metastatic HER2-negative breast cancer whose disease progressed on prior therapies. The anti-tumor effect of blocking EGFR/HER1, HER2, HER3, and c-Met pathways when the HER2 and c-Met pathways are hyperactive has been demonstrated in animal models.1

This study represents Celcuity's fourth clinical trial collaboration with a leading cancer research organization and a pharmaceutical company, and the second one announced in the past month. In December, Celcuity announced a clinical trial collaboration with Massachusetts General Hospital, UCLA, and Vanderbilt to evaluate Puma Biotechnology's pan-HER inhibitor, NERLYNX, in patients with hormone receptor-positive, HER2-negative breast cancer. Each of the four collaborations rely on a CELsignia Pathway Activity test to select patients who have a dysregulated oncogenic pathway not associated with a corresponding genomic or proteomic mutation.

"We are excited about the opportunity to collaborate with Dr. Hamilton, Sarah Cannon Research Institute, and Pfizer on this important clinical trial," said Brian Sullivan, CEO and co-founder of Celcuity. "This will be our first collaboration that uses our CELsignia Multi-Pathway Activity Test to select patients who have both HER2 and c-Met hyperactive signaling tumors for a clinical trial. According to our studies, approximately 20% of HER2-negative breast cancers have hyperactive HER2 and c-MET signaling. For this group of patients, this trial represents a critical step towards a potential new therapeutic option."