German federal authority approves CTA to initiate Ph 1/2a trial of CC-38 in patients with metastatic CRC and metastatic prostate cancer
“This CTA approval marks a major milestone for CuraCell and affirms the strength of our science and clinical strategy,” said Jonas Båtelson, CEO of CuraCell. “Our dedicated team, together with our expert collaborators, has worked tirelessly to advance our first TIL therapy from bench to bedside. This is a big step forward in our mission to provide curative treatments for the toughest and most deadly solid tumors.”
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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.