HREC approves initiation of FIH Ph 1/2 Trial of ML-016 in Advanced Cancers with Lung and/or Liver Involvement
“Securing HREC approval is a critical milestone that brings us closer to providing hope of improved health to patients suffering from cancers of the lungs and liver, including metastatic lesions originating from other organs or tissue in the body,” said Dr. Mauro Ferrari, the President and CEO of BrYet. “Furthermore, it supports our innovative approach to oncology, based upon targeting the molecular transport phenotype of cancer lesions in the lungs and liver.”
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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.