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Celcuity Using CELSignia Test to Select Breast Cancer Patients for Phase II Trial of Tabrecta, Nerlynx

NEW YORK – Celcuity on Tuesday said it will use its CELSignia Multi-Pathway Activity Test to identify breast cancer patients eligible for enrollment in a Phase II clinical trial evaluating the combination of Novartis' c-Met inhibitor capmatinib (Tabrecta) and Puma Biotechnology's pan-HER inhibitor neratinib (Nerlynx).

The Phase II trial is being sponsored by MD Anderson Cancer Center, and Celcuity is covering patient-related costs. Novartis will supply capmatinib, which is approved in the US for metastatic non-small cell lung cancer with MET exon14 skipping mutations, and Puma will supply neratinib, which is approved for early-stage and advanced HER2-overexpressing breast cancer.

The aim within the trial will be to use Minneapolis-headquartered Celcuity's CELsignia test to enroll breast cancer patients who have normal HER2 expression but still have hyperactive HER2 and c-MET signaling that can be interrogated by the capmatinib-neratinib combination. The company will begin enrolling patients in 2021 and expects to report interim results in 12 to 15 months after the study protocol is activated and final results 12 to 15 months after that.

Celcuity estimated that around 20 percent of breast cancer patients have tumors with hyperactive HER2 and c-MET signaling, despite having normal HER2 expression. By using its test to identify these patients, Celcuity is hoping to expand the molecularly defined indication for neratinib and capmatinib.

Researchers have demonstrated the potential benefit of simultaneously blocking EGFR, HER and c-MET pathways in animal models. "My research has focused on mechanisms of resistance that occur when a breast cancer tumor is under therapeutic pressure, and key pathways, including HER2 and c-Met, are activated," Bora Lim, a medical oncologist at Baylor College of Medicine and a co-principal investigator of the study, said in a statement, adding that the trial could pave the way for a new treatment option and allow researchers to learn more "about the hidden biology of breast cancer."

The latest study represents the fifth such deal with a drugmaker and cancer center in which Celcuity's CELsignia test is being used to identify patients who have dysregulated cancer-associated pathways but who are not identified by traditional companion diagnostics that assess a gene mutation or expression. Earlier this year, the company said its test will be used in a Phase II trial sponsored by the Sarah Cannon Research Institute to identify HER2-negative, metastatic breast cancer patients who will receive Pfizer's pan-HER inhibitor dacomitinib (Vizimpro) and c-MET inhibitor crizotinib (Xalkori).