19 October 2021 - - US-based biotechnology company Celcuity Inc. (NASDAQ: CELC) has forged a clinical trial collaboration with the University of Rochester Wilmot Cancer Center and biopharmaceutical company Puma biotechnology (NASDAQ: PBYI) to conduct a Phase 2 clinical trial, the company said.

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 US tasked with developing new approaches to diagnosing and treating cancer.

Puma will supply Nerlynx, its pan-HER inhibitor currently approved by the US Food and Drug Administration 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.

Celcuity is a clinical-stage biotechnology company seeking to extend the lives of cancer patients by pursuing an integrated companion diagnostic and therapeutic strategy.

Its CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies.

Its therapeutic efforts are focused on in-licensing and developing molecularly targeted therapies that address the same cancer driver its companion diagnostics can identify. Celcuity is headquartered in Minneapolis.