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Pfizer, Celcuity Partner on Phase II Breast Cancer Trial of Vizimpro, Xalkori

NEW YORK – Cancer diagnostics firm Celcuity on Thursday said its CELsignia Multi-Pathway Activity Test will be used to select patients for a clinical trial evaluating the combination of two Pfizer drugs, dacomitinib (Vizimpro) and crizotinib (Xalkori), in HER2-negative, metastatic breast cancer.

In the Phase II trial, sponsored by the Sarah Cannon Research Institute, Celcuity will use CELsignia to identify HER2-negative, metastatic breast cancer patients whose tumors have hyperactive HER2 and c-MET signaling pathways. The diagnostics firm will fund patient-related costs for the study, which will begin enrolling patients in the second half of this year.

Pfizer will supply dacomitinib for the trial, which is currently marketed in the US as a treatment for EGFR-mutated, metastatic non-small cell lung cancer, and crizotinib, which is available for metastatic NSCLC with ALK or ROS1 rearrangements. The plan in this Phase II trial to combine dacomitinib and crizotinib is based on data from animal models, in which simultaneously blocking EGFR, HER1/2/3, and c-MET pathways caused regression of tumors with hyperactive HER2 and c-MET signaling.

"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," Celcuity CEO Brian Sullivan said in a statement. "According to our studies, approximately 20 percent 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."

Celcuity has inked a number of collaborations to use CELsignia to select patients in drug development trials. The test is designed to identify patients who, despite not having genomic or proteomic driver mutations, have disrupted oncogenic pathways promoting cancer growth and progression. In December, the company partnered with Puma Biotechnology, Massachusetts General Hospital, University of California, Los Angeles, and Vanderbilt University to evaluate neratinib (Puma's Nerlynx) in patients with hormone receptor-positive, HER2-negative breast cancer.