FDA clears IND application for NEOK002 in Solid Tumors

“Securing our second IND clearance in just six weeks highlights the team’s productivity and dedication, and positions NEOK with strong momentum as we advance toward our clinical milestones,” said Mayank Gandhi, CEO of NEOK Bio. “Our bispecific ADCs are designed to improve the therapeutic window of ADCs and have the potential to target a wider range of tumors, overcome drug resistance, increase internalization rates, and improve the safety profile by increasing selectivity and reducing off-tumor toxicity.”

Share:

More News

“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.