Elraglusib Clinical Program Advanced in Ewing Sarcoma After Positive Ph 1 Trial Demonstrates CRs and PRs in R/R Ewing Sarcoma
“We are highly encouraged by the responses observed in refractory and resistant EWS, a disease where treatment options are extremely limited beyond frontline chemotherapy,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “With these promising clinical signals in hand, we are advancing our development plans focused on EWS by pursuing a Phase 2 trial and plan to meet with regulators to discuss potential registration path in this indication.”
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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.”
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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.