IND Application filed for ML-016 for Advanced Solid Tumors with Lung and/or Liver Mets

“Submitting our first IND application is a major step forward for BrYet, bringing us closer to delivering new therapeutic options for advanced cancer patients worldwide,” said Dr. Mauro Ferrari, President and CEO of BrYet. “This milestone reflects decades of scientific research behind our unique approach to treating cancer, based on our proprietary platform for targeting phenotypes.”

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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.