Celcuity Inc. announced a clinical trial collaboration with Sarah Cannon Research Institute, the research arm of Sarah Cannon, and Pfizer Inc. 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®, a pan-HER inhibitor, and XALKORI®, 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. 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.