Mersana Therapeutics, Inc. (NASDAQ:MRSN) received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its drug candidate XMT-2056 or the treatment of gastric cancer.
The company is planning to start a clinical study evaluating XMT-2056 for gastric and other cancers.
Anna Protopapas, President and Chief Executive Officer, commented : “The FDA's decision to grant orphan drug designation to XMT-2056 for the treatment of gastric cancer is an important recognition of its potential in this area of high unmet medical need, We are eager to bring XMT-2056 and its unique mechanism of action into the clinic mid-year to investigate its safety, tolerability and anti-tumor activity in gastric and other cancers.”
Mersana anticipates to intiate a Phase 1 trial of XMT-2056 in a range of HER2 expressing tumors, such as breast, gastric and non-small-cell lung cancers, in mid-2022.
FDA grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. It also provides benefits of seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.
Mersana Therapeutics shares are trading high 4 percent at $3.42 in the pre-market session
