On October 18, 2021 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, reported a clinical trial collaboration with the University of Rochester Wilmot Cancer Center and Puma Biotechnology (Nasdaq: PBYI), a biopharmaceutical company, to conduct a Phase 2 clinical trial (Press release, Celcuity, OCT 18, 2021, View Source [SID1234591471]).

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This open-label Phase 2 trial will evaluate the efficacy and safety of Puma’s drug, NERLYNX (neratinib), and Xeloda (capecitabine), a Genentech/Roche drug, in previously treated patients selected with Celcuity’s CELsignia HER2 Activity Test who have metastatic HER2-negative breast cancer. Under the agreement, The University of Rochester Wilmot Cancer Center will serve as the sponsor and Ajay Dhakal, M.D., a medical oncologist at the University of Rochester Medical Center, will serve as the principal investigator of this study. The University of Rochester Wilmot Cancer Center is one of the 51 NCI-Designated Comprehensive Cancer Centers in the U.S. tasked with developing new approaches to diagnosing and treating cancer.

"This clinical trial could play a key role in creating a new treatment paradigm for metastatic HER2-negative breast cancer patients with brain metastases," said Dr. Dhakal. "We are eager to begin working with Celcuity’s cutting-edge CELsignia technology to identify a new subset of patients who may respond to NERLYNX."

Puma will supply NERLYNX, its pan-HER inhibitor currently approved by the U.S. Food and Drug Administration (FDA) for early and late-stage HER2-positive breast cancer. Celcuity will provide its CELsignia HER2 Activity Test to select HER2-negative metastatic breast cancer patients with brain metastases who have hyperactive HER2-driven signaling pathways for the trial and will fund the patient-related trial costs. Based on its estimates of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after initiation of the trial followed by the final results 12 to 15 months later. Celcuity expects enrollment to begin by early to mid-2022.

The goal of the trial is to demonstrate that previously treated HER2-negative metastatic breast cancer patients with brain metastases who have hyperactive HER2 signaling tumors, as identified by the CELsignia test, respond to treatment with NERLYNX in combination with XELODA, a chemotherapy commonly used in metastatic breast cancer patients. Celcuity believes there is significant clinical interest in finding new diagnostic tests and targeted therapies for metastatic HER2- negative breast cancer patients with brain metastases.

"We are excited about the opportunity to collaborate with Dr. Dhakal, The University of Rochester Wilmot Cancer Center, and Puma Biotechnology on this important clinical trial," said Brian Sullivan, CEO and co-founder of Celcuity. "This will be our first collaboration to study metastatic breast cancer patients with brain metastases selected for treatment using our CELsignia HER2 Activity Test. Patients with HER2-negative breast cancer who have brain metastases have few good options today. Approximately 20% of the 280,000 HER2-negative breast cancer patients receiving drug treatment annually have tumors with hyperactive HER2 signaling.1 For these patients, this trial represents a critical step towards a potential new therapeutic option."