Mersana Shares Climb As FDA Grants Fast Track Status To Triple-Negative Breast Cancer Candidate

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Mersana Therapeutics’ MRSN lead candidate XMT-1660 for the treatment of adult patients with advanced or metastatic triple-negative breast cancer (TNBC).

XMT-1660 being evaluated in a Phase 1 trial, investigating the safety, tolerability and anti-tumor activity in patients with solid tumors, including in breast, endometrial and ovarian cancers.

The initial dose escalation and dose expansion portions of the trial will evaluate the safety, tolerability and efficacy of XMT-1660.

Anna Protopapas, President and Chief Executive Officer, commented: "While breast cancer remains an area of high unmet need, TNBC is associated with particularly poor outcomes and very limited treatment options. XMT-1660 has demonstrated promising anti-tumor effects in preclinical studies, and we are excited to have recently initiated our Phase 1 trial to investigate its safety and clinical activity. This Fast Track designation allows for a potentially accelerated regulatory review of XMT-1660 as we seek to offer a new therapy for patients living with a range of B7-H4 expressing tumors.”

XMT-1660 is a B7-H4-directed Dolasynthen antibody drug conjugate with a precise, target-optimized drug-to-antibody ratio (DAR 6) and the company's clinically validated DolaLock microtubule inhibitor payload with controlled bystander effect

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

Price Action : Mersana shares are trading around 3 percent higher at $8.01 on Monday during pre-market session.