Mersana Therapeutics, a leading biopharmaceutical company, recently reported that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Phase 1 trial of XMT-2056. As a result, shares of Mersana Therapeutics surged by 8% to reach $1.20.
Despite experiencing an 84% decline in the stock price over the past year, this recent announcement brings new hope to the company and its investors.
XMT-2056 is an innovative systemically administered Immunosynthen antibody-drug conjugate. It has been specifically designed to target a novel human epidermal growth factor receptor 2 epitope. By activating signaling in both tumor-resident immune cells and tumor cells, XMT-2056 aims to provide a promising solution for the treatment of solid tumors expressing HER2.
The Phase 1 open-label trial focuses on studying XMT-2056 in patients with advanced or recurrent solid tumors expressing HER2. These tumors may include breast, gastric, colorectal, and non-small-cell lung cancers. The trial will assess the safety, tolerability, and exposure of XMT-2056 through both dose escalation and dose expansion phases.
Moreover, XMT-2056 has been granted orphan drug designation by the FDA for the treatment of gastric cancer, further recognizing its potential as a valuable therapeutic option. Mersana Therapeutics has also partnered with GSK in August 2022 to develop and commercialize XMT-2056 globally. However, GSK has yet to exercise their exclusive option.
Overall, this significant development signifies a major milestone for Mersana Therapeutics, demonstrating remarkable progress in their pursuit of advancing innovative treatments for cancer patients.