FDA Clears IND Application for MDG1015 for Multiple Solid Tumor Indications
“We are very excited to reach this milestone with our lead program MDG1015 which reinforces our ambition to become a leading company with a range of different TCR-guided therapies for patients suffering from multiple advanced solid tumor types,” said Selwyn Ho, CEO of Medigene AG. “In preclinical studies, MDG1015 has shown strongly enhanced and persistent T cell-driven anti-tumor activity and the ability to mitigate the effects of PD-L1, one of the major immunosuppressive signals present in the tumor microenvironment of solid cancers which hinder the effectiveness of TCR-T therapies. This very first FDA clearance of an IND Application for a Medigene TCR-T therapy represents a pivotal achievement, and we look forward to commencing our MDG1015 phase 1 study EPITOME1015-I targeting multiple solid tumors, subject to additional financing.”
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