FDA Supports Dewpoint Therapeutics’ DPTX3186 With Fast Track Designation For Gastric Cancer Treatment

Dewpoint Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DPTX3186, the company’s first-in-class oral condensate modulator targeting the Wnt/β-catenin pathway, for the treatment of gastric cancer. Fast Track designation is designed to speed the development and review of therapies that address serious conditions with unmet medical needs. This status allows Dewpoint to engage with the FDA more frequently, submit portions of its New Drug Application (NDA) on a rolling basis, and potentially benefit from accelerated review timelines when aligned with the agency.

Isaac Klein, MD, PhD, Chief Scientific Officer and Head of R&D at Dewpoint, stated that the Fast Track designation acknowledges both the urgent need for new gastric cancer therapies and the potential of Dewpoint’s condensate-based approach. He noted that DPTX3186 represents a novel way to modulate disease-relevant biology and could provide meaningful treatment options for patients with limited alternatives. The designation provides a structured pathway to advance the program efficiently.

DPTX3186 is a small molecule designed to modulate the oncogenic activity of β-catenin, a key driver in gastric cancer and other solid tumors. The therapy works by sequestering β-catenin in a drug-induced condensate, reducing aberrant signaling while preserving normal cellular function. Dewpoint’s IND for DPTX3186 has recently been opened by the FDA, and the program has received Orphan Drug Designation. The company is now initiating a Phase 1a/2a clinical trial at leading cancer centers across the United States.

Dewpoint CEO Ameet Nathwani, MD, emphasized that Fast Track designation highlights the promise of condensate modulators to address serious diseases through a novel biological approach. He added that the regulatory pathway will allow the company to advance DPTX3186 more efficiently, helping deliver new therapies faster to patients with high unmet needs. Gastric cancer remains one of the leading causes of cancer-related deaths worldwide, with limited effective targeted treatments. Dewpoint expects to dose the first patient in the DPTX3186 trial before the end of the year.