• FDA grants Fast Track designation to DPTX3186, Dewpoint’s first in class condensate modulator for gastric cancer
• Designation provides increased FDA engagement, rolling review eligibility, and potential for accelerated development
• Follows recent IND opening, and Orphan Drug Designation, as Dewpoint prepares to initiate a Phase 1a/2a clinical trial this year
  

BOSTON, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Dewpoint Therapeutics announced today 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 intended to facilitate the development and expedite the review of new therapies that address serious conditions with unmet medical need. The designation provides Dewpoint with increased access to the FDA through more frequent communications, eligibility for rolling review of future New Drug Application (NDA) components, and the potential for accelerated timelines based on alignment with the agency.

“We are honored that the FDA has recognized the urgency of gastric cancer and the promise of our condensate-based approach,” said Isaac Klein, MD PhD, 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.”

DPTX3186 is a first in class small molecule designed to modulate the oncogenic function of β-catenin, a central driver of gastric cancer and multiple other solid tumors. By sequestering β-catenin in a drug-induced condensate, the therapy aims to reduce aberrant β-catenin signaling while preserving normal cellular function. The FDA recently opened the company’s IND for DPTX3186, granted the program an Orphan Drug Designation, and Dewpoint is now initiating a Phase 1a/2a clinical trial across leading cancer centers in the United States.

“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 Ameet Nathwani, MD, Chief Executive Officer 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.”

Gastric cancer remains one of the leading causes of cancer mortality worldwide, with few effective targeted options for patients. Dewpoint expects to dose the first patient in the DPTX3186 clinical trial before the end of the year.

About Dewpoint
Dewpoint is a clinical-stage biotech company, leading the application of biomolecular condensate biology towards the development of a new generation of therapeutics to address diseases of high unmet need. The realization that a vast range of conditions are regulated by or arise from the dysfunction of condensates has provided new possibilities for modulating the function of high-value targets previously deemed ‘undruggable’, opening unexplored avenues to identify hundreds of novel therapeutic targets. Dewpoint’s proprietary AI/ML-powered state-of-the-art integrated platform underlies a drug discovery pipeline that spans multiple therapeutic areas, including oncology, neurodegenerative, cardiopulmonary, and metabolic diseases. Through collaborations with Bayer, Novo Nordisk, and Mitsubishi Tanabe Pharma Corporation, Dewpoint pushes the boundaries to accelerate the translation of condensate biology into medicine for patients suffering from difficult-to-treat diseases. Learn more at Dewpointx.com and follow us on LinkedIn. 

About Condensates   
Condensates are membraneless organelles that form dynamically throughout the cell via a process called phase separation. These subcellular compartments organize and concentrate molecules within cells to enable a diversity of key biochemical processes. The dysregulation of biomolecular condensates has been observed in many diseases, including cancer, diabetes, cardiopulmonary and neurological disorders. Condensate-modulating drugs (c-mods) potentially provide novel therapeutic options for complex diseases and historically undruggable targets. Learn more about condensate science at Condensates.com.