FDA Grants Fast Track Status to New Gastric Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted fast track designation to DPTX3186, a first in class oral condensate modulator targeting the Wnt/β-catenin pathway, for the treatment of gastric cancer, according to a news release from Dewpoint Therapeutics.

In simpler terms, this drug adjusts a cell-growth pathway called Wnt/β-catenin, which can influence how cancer develops and responds to treatment.

“We are honored that the FDA has recognized the urgency of gastric cancer and the promise of our condensate-based approach” said Dr. Isaac Klein, chief scientific officer and head of R&D at Dewpoint Therapeutics. “DPTX3186 represents a new way of modulating disease relevant biology and has the potential to bring a meaningful option to patients with limited treatments available. Fast track designation provides an important framework to advance this program with greater efficiency and speed.”

Fast track designation helps speed the development and review of new treatments for serious conditions that still need better options. It gives Dewpoint more direct communication with the FDA, allows parts of a future new drug application to be reviewed as they are ready, and may help move the process along more quickly if the agency agrees.

“Fast track designation reflects a recognition of the promise that our condensate modulators may hold to address serious diseases through a new biological lens,” said Dr. Ameet Nathwani, CEO of Dewpoint Therapeutics. “It also provides an important regulatory framework that can help us advance DPTX3186 more efficiently, maximizing the speed and impact with which we can deliver novel therapies to patients in diseases with high unmet need.”

The FDA recently opened the company’s investigational new drug application for DPTX3186, granted the program an orphan drug designation and cleared Dewpoint to begin a phase 1a/2a clinical trial at major cancer centers in the United States.

What is DPRX3186 and How Does it Work?

DPTX3186 is a first-in-class small molecule designed to adjust the cancer-driving activity of β-catenin, a key force behind gastric cancer and several other solid tumors. The treatment creates a drug-induced condensate that pulls in β-catenin, aiming to lower abnormal signaling while keeping normal cell function intact.

Condensates are structures inside cells that form without membranes and help organize important molecular activity. When these structures are disrupted, they can contribute to diseases including cancer, diabetes, heart and lung conditions and neurological disorders. Drugs that modulate condensates may offer new ways to treat complex diseases and targets that have been difficult to reach with traditional medicines.

Gastric cancer remains one of the leading causes of cancer death worldwide and has limited targeted treatment options. Dewpoint expects to dose the first patient in the DPTX3186 trial before the end of the year.

According to the National Cancer Institute’s website, it begins in the cells lining the stomach, an organ in the upper abdomen that breaks down food as part of the digestive tract. Nearly all stomach cancers are adenocarcinomas, which start in mucus-producing cells in the stomach’s innermost lining. These cancers can form near the top of the stomach where it meets the esophagus, called gastric cardia cancer, or in other areas of the stomach, known as non-cardia gastric cancer.

Under a microscope, adenocarcinomas may appear intestinal, meaning the cells look more like normal cells, or diffuse, which tend to look less like normal cells, grow faster and be harder to treat. Other, less common cancers can also form in the stomach, including gastrointestinal neuroendocrine tumors, gastrointestinal stromal tumors and primary gastric lymphomas. Rarely, cancers such as squamous cell carcinoma, small cell carcinoma and leiomyosarcoma may also begin in the stomach.

Reference

1. “FDA Grants Fast Track Designation to Dewpoint Therapeutics’ DPTX3186 for the Treatment of Gastric Cancer.” Dewpoint Therapeutics. News Release. Nov. 17, 2025.”

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