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ALX Oncology and Quantum Leap Healthcare Collaborative™ Announce First Patient Dosed in the I-SPY-P1 TRIAL in Breast Cancer

Tuesday, March 14, 2023

ALX Oncology Holdings Inc. and Quantum Leap Healthcare Collaborative have announced the initiation of the I-SPY-P1-TRIAL, a Phase 1 study investigating the combination of evorpacept, a CD47 blocker, with ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody-drug conjugate, for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer. The first patient has been dosed in this multi-center, open-label study arm, which aims to evaluate the safety, tolerability, and efficacy of this novel drug combination.

Dr. Laura Esserman, co-founder of Quantum Leap and Professor of Surgery and Radiology at the University of California San Francisco, highlighted the potential of evorpacept as a transformative approach to enhance the immune response against breast cancer with minimal toxicity. The combination of a CD47 blocker with a HER2-directed antibody-drug conjugate presents a promising strategy for patients who have developed resistance to other therapies and are in need of new treatment options. The I-SPY Phase 1 program is designed to rapidly assess the safety of novel therapy combinations and qualify them for testing in the high-risk early stage setting in the I-SPY 2.2 TRIAL, where successful responses lead to patient cure. The collaboration between ALX Oncology and Quantum Leap aims to expedite the development of this therapeutic combination to improve patients' lives with more effective and less toxic treatment options.


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