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FDA grant orphan drug designation to XMT-2056 for treatment of gastric cancer

Published on 20/05/22 at 11:18am

Mersana Theapeutics has announced that the FDA has granted orphan drug designation to XMT-2056, the company’s lead Immunosynthen STING-agonist ADC, for the treatment of gastric cancer. XMT-2056 is designed to offer a differentiated and complementary therapeutic approach to existing and emerging solid tumour treatments.

Mersana is a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need.

According to the American Cancer Society, gastric cancer accounts for approximately 1.5% of all new cancers diagnosed in the US every year, with an estimated 26,560 new cases reported in 2021. The FDA grants orphan drug designation to a drug or biologic intended to treat a rare disease or condition impacting fewer than 200,000 individuals in the US.

“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,” said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. “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-tumour activity in gastric and other cancers.”

The orphan drug designation qualifies Mersana for potential incentives, including tax credits for certain trials, exemption from user fees, and the potential for seven years of market exclusivity following approval, if granted.

Mersana developed XMT-2056 leveraging a differentiated antibody that binds to a novel HER2 epitope, providing the opportunity, as demonstrated in preclinical studies, for treatment both as monotherapy, and in combination with a variety of agents, including other anti-HER2 therapies.

Ana Ovey

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