FDA provides IND Clearance for NEOK002 Targeting Solid Tumors
Dr. Yuelei Shen, President and CEO of Biocytogen, said: “We are pleased to see one of our partnered molecules reach this important stage of development. This milestone further validates the quality, developability, and therapeutic potential of fully human bispecific antibodies discovered using our RenLite® platform, which features a common light chain design. We look forward to the continued clinical advancement of the program.”
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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.