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Celcuity Studying Nerlynx Activity in HER2-Negative Breast Cancer With Hyperactive HER2 Signaling

NEW YORK – Celcuity on Monday said it has partnered with the University of Rochester Wilmot Cancer Center and Puma Biotechnology to explore the activity of neratinib (Puma's Nerlynx) plus chemotherapy in metastatic breast cancer patients whose tumors are HER2-negative but have hyperactive HER2 signaling pathways.

Celcuity will use CELsignia, its HER2 activity test, to identify eligible patients for the Phase II trial and will fund patients' trial-related costs. In order to partake in the trial, patients must have had prior treatment for metastatic disease, have brain metastases, and have hyperactive HER2 signaling pathways as determined by CELsignia.

Currently, patients with HER2-positive or HER2-overexpressing breast tumors are eligible to receive HER2 targeted therapy and are identified using immunohistochemistry and/or fluorescence in situ hybridization assays, but according to Celcuity, these tests aren't capturing all treatment eligible patients. Instead of measuring gene expression or testing for mutations, Celcuity's CELsignia measures cell adhesion activities from patients' live tumor cells and quantifies dysregulated cell signaling pathways.

According to Brian Sullivan, Celcuity's cofounder and CEO, roughly one-fifth of HER2-negative breast cancer patients receiving treatment each year have hyperactive HER2 signaling in their tumors. "For these patients, this trial represents a critical step towards a potential new therapeutic option," he said.

The Phase II trial, which will begin enrollment by mid-2022 and generate interim results a year later, is designed to determine whether patients selected by CELsignia will respond to the combination of neratinib and the chemotherapy capecitabine. Puma will provide its pan-HER inhibitor neratinib for the trial. The drug is already available in the US as an extended adjuvant treatment for early-stage HER2-positive breast cancer and in combination with chemotherapy for metastatic HER2-positive breast cancer.

The University of Rochester Wilmot Cancer Center will be the trial's official sponsor, and Ajay Dhakal, a medical oncologist at the center, will be principal investigator.

Celcuity is also using its CELsignia test to identify breast cancer patients with hyperactive HER2 and c-MET signaling eligible for a Phase II trial of neratinib and Novartis' c-Met inhibitor capmatinib (Tabrecta).