Mersana Enters Busy Gastric Cancer Space with Orphan Drug Designation

Gastric Cancer Concept

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. 

Other companies are chipping away at novel therapies for gastric cancer. Enhertu, being co-developed by Daiichi Sankyo and AstraZeneca, is widely known for its use in metastatic breast cancer, but the drug is also being assessed for the treatment of patients with HER2-positive advanced gastric cancer. 

In July 2021, the partners announced that the first patient was dosed in a Phase III trial to evaluate the safety and efficacy of Enhertu in patients with gastric cancer in comparison to the current standard of care combination therapy. Previously, Enhertu has been approved in the U.S. and Japan for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have already undergone a trastuzumab-based regimen.

HiberCell, a company that focuses on oncological treatments that target the adaptive stress response, received Fast Track Designation from the FDA in September 2021 for its candidate HC-5404 which will be evaluated in gastric cancer, renal cell carcinoma and other solid tumors. The company's first therapeutic candidate, HC-5404 is an orally bioavailable inhibitor of key stress response protein kinase PERK that integrates oncogenic signaling and modulates the ability of the cancer cells to survive.

NGM Bio announced this month that it has initiated a Phase I/Ib clinical study of its asset NGM438 for the treatment of patients with advanced solid tumors, including gastric cancer. NGM438 targets LAIR1, a myeloid checkpoint that may play a central role in establishing an immune-suppressive state in the tumor microenvironment. The company presented data that showed the therapeutic may inhibit LAIR1 immune suppression as both a monotherapy and in combination with T cell checkpoint inhibition. Data readouts are anticipated this year and in 2023.

Cue Biopharma has taken a different approach, targeting specifically Wilms’ Tumor 1 (WT1)-positive cancers, including gastric tumors. This month, Cue announced that the FDA accepted its Investigational New Drug application for CUE-102, an interleukin 2 (IL-2) based biologic that selectively activates tumor antigen-specific T cells. Phase I trials will investigate the drug’s efficacy as a monotherapy and focus on dose escalation and expansion. 

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