Mersana Enters Busy Gastric Cancer Space with Orphan Drug Designation

On Thursday, Mersana Therapeutics announced that the U.S. Food and Drug Administration granted an orphan drug designation to one of its lead assets, XMT-2056, which is intended to treat gastric cancer.

Gastric cancer, also known as stomach cancer, accounts for approximately 1.5% of all new cancers diagnosed in the U.S. each year. Early signs of gastric cancer can include stomach discomfort, indigestion, nausea and being bloated, but the disease is typically not diagnosed until it is more advanced, causing symptoms such as blood in the stool, vomiting, weight loss, jaundice and fluid in the abdomen. Because it is often not diagnosed until advanced stages, treatment can be challenging. 

Mersana is coming to the treatment arena with XMT-2056. The therapeutic is a differentiated antibody that binds to a novel HER2 epitope, a growth-promoter protein found on some malignant cells. Mersana is investigating the therapeutic as both a monotherapy and a combinatorial therapy with other anti-HER2 treatments. A Phase I trial is anticipated to begin in mid-2022, and the therapeutic will be evaluated in gastric, breast and non-small-cell lung cancer. 

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