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

Wednesday, March 15, 2023

ALX Oncology Holdings Inc., a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Quantum Leap Healthcare Collaborative ("Quantum Leap") today announced that the first patient has been dosed in the I-SPY-P1-TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer. Sponsored by Quantum Leap, this Phase 1 (open-label), multi-center study arm will investigate evorpacept, a CD47 blocker, in combination with ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody-drug conjugate ("ADC"), to determine the safety, tolerability and efficacy of this drug combination.

"Evorpacept is a potentially transformative approach to strengthen the anticancer immune response against breast cancer with minimal added toxicity," said Laura Esserman, M.D., co-founder of Quantum Leap, Professor of Surgery and Radiology at the University of California San Francisco, CA. "The combination of a novel CD47 blocker with a HER2-directed ADC represents a promising strategy for patients with advanced breast cancer who develop resistance to other therapies and are in urgent need of new treatment options. The I-SPY Phase 1 program is designed to rapidly assess safety of novel therapy combinations that will help advanced cancer patients, but also rapidly qualify them to be tested in the high-risk early stage setting in the I-SPY 2.2 TRIAL, where complete responses result in curing patients. We are excited to collaborate with ALX Oncology to accelerate the development of this therapeutic combination with the goal of improving patients' lives, with more effective and less toxic therapies."



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