Mersana Therapeutics announce FDA clearance of IND application for new drug XMT-1536
Mersana Therapeutics (MA, USA) have announced FDA clearance of their new drug IND application for XMT-1536, which enables Phase 1 clinical trials to begin. Mersana are a biopharmaceutical company that specialize in the discovery and development of antibody–drug conjugates.
Anna Protopapas, President and Chief Executive Officer at Mersana, commented: “The clearance of this IND, our second in a year, marks an important milestone for the company as we continue to move our novel pipeline of product candidates into the clinic. This achievement is a result of our dedicated employees who are focused on executing our important mission of creating therapies with meaningful clinical benefit for patients.”
The new drug, XMT-1536, is an antibody–drug conjugate that targets NaPi2b, which is expressed in types of tumors including epithelial ovarian cancer and non-squamous non-small cell lung cancer. The drug is composed of Mersana’s Dolaflexin platform conjugated to a NaPi2b antibody and during preclinical studies demonstrated greater than 50% median tumor regression in 53% of patient-derived ovarian cancer xenograft models unselected for NaPi2b expression.
Donald Bergstrom, Chief Medical Officer at Mersana, concluded: “We are excited to be moving XMT-1536 into clinical development as a first-in-class and potentially best-in-class ADC against NaPi2b, a target with outstanding properties for ADC development on the Dolaflexin platform.
“Currently, patients with advanced epithelial ovarian cancer, non-squamous NSCLC and other NaPi2b-expressing tumors have a poor prognosis, and there’s a clear need for better treatment options. We look forward to beginning the clinical investigation of XMT-1536, which has shown promising results in preclinical models.”
