First Patient Dosed in the I-SPY-P1 TRIAL in Breast Cancer
“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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“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.