Austrian Regulatory Green Light Enables ADC Combination Testing and Ph 1 Site Expansion for ES2B-C001
CEO Bent Frandsen Commented, “The approval of this amendment enables us to evaluate ES2B-C001 in combination with standard-of-care HER2-targeted ADCs, representing an important step in exploring synergistic treatment strategies for HER2-expressing breast cancers. We are especially pleased to receive this early approval, helping us accelerate patient enrolment and data readout.”
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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.