FDA OKs Mersana’s XMT-1536 for Clinical Investigation in Ovarian, Other Solid Tumors

FDA OKs Mersana’s XMT-1536 for Clinical Investigation in Ovarian, Other Solid Tumors
Mersana Therapeutics is advancing its antibody-drug conjugate XMT-1536 into clinical development for ovarian and other tumor types, after the U.S. Food and Drug Administration cleared the company's investigational new drug (IND) application. XMT-1536 is a first-in-class antibody drug conjugate (ADC), a kind of drug that uses an antibody linked to a toxic payload, which targets specific tumor cells. XMT-1536 targets a protein called sodium-dependent phosphate transport protein 2b (NaPi2b) present in 75 to 90 percent of non-squamous, non-small cell lung cancer (NSCLC) and epithelial ovarian cancer. The FDA's OK cleared the way for the initiation of Phase 1 clinical trials evaluating the drug's safety and preliminary signs of efficacy in patients with NaPi2b-positive tumors. “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,” Donald A. Bergstrom, chief medical officer, Mersana, said in a press release. "Currently, patients with advanced epithelial ovarian ca
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