Dewpoint Therapeutics Receives FDA Orphan Drug Designation For DPTX3186, A Novel Therapy Targeting Gastric Cancer

Dewpoint Therapeutics, a biotechnology company recognized as a pioneer in condensate biology, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational therapy DPTX3186 for the treatment of gastric cancer. This designation follows the recent opening of Dewpoint’s Investigational New Drug (IND) application for DPTX3186, marking the company’s official transition to a clinical-stage biotech and the launch of the first human trial of a condensate-modulating therapeutic.

Isaac Klein, MD, PhD, Chief Scientific Officer and Head of R&D at Dewpoint Therapeutics, stated that the FDA’s decision to grant Orphan Drug Designation represents an important validation of both the company’s scientific approach and the therapeutic promise of condensate biology. He noted that this recognition underscores the agency’s confidence in Dewpoint’s mechanism of action and highlights a shared commitment to developing new treatment options for patients battling gastric cancer, a disease with limited effective therapies and poor survival outcomes.

The FDA’s Orphan Drug Designation program aims to encourage the development of medicines for rare diseases or conditions affecting fewer than 200,000 people in the United States. The designation offers multiple incentives to support and accelerate drug development, including seven years of market exclusivity following approval, exemption from certain FDA fees, tax credits for qualified clinical trials, and eligibility for enhanced regulatory guidance and expedited review processes.

DPTX3186 is an orally administered small-molecule condensate modulator designed to selectively inhibit oncogenic Wnt/β-catenin signaling, a pathway frequently dysregulated in gastric and other cancers. Unlike traditional Wnt inhibitors that have faced safety limitations, DPTX3186 works by redistributing β-catenin into an inactive condensate state within tumor cells, effectively reducing its cancer-promoting activity while minimizing toxicity. The program also integrates a condensate-based biomarker strategy that allows researchers to directly measure pharmacodynamic responses in patient samples, providing a more precise and data-driven approach to therapy monitoring.

Dewpoint Therapeutics plans to begin dosing the first patient with DPTX3186 before the end of 2025 at leading cancer centers across the United States. The advancement of DPTX3186 into clinical trials represents a significant milestone for Dewpoint, demonstrating the potential of condensate biology to unlock new mechanisms for drug discovery and deliver novel treatments for patients with rare and hard-to-treat cancers.