STARLIGHT-1 Trial Advanced into Ph 2 Following Positive DSMB Recommendation
“The advancement of EB103 into the expansion phase of STARLIGHT-1is a pivotal milestone for Estrella,” said Cheng Liu, PhD, Chief Executive Officer of Estrella. “The excellent safety profile and a 100% complete response rate observed in the high-dose cohort in Phase I demonstrated EB103’s potential to overcome the toxicity barriers that have historically restricted CD19 CAR-T use. We believe EB103 may significantly expand the commercial reach of cell therapy and deliver a best-in-class solution to a broader NHL population, including high-risk subgroups previously ineligible for commercial CAR-T.”
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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.