- DPTX3186, a first-in-class beta-catenin condensate modulator, received Orphan Drug Designation and Fast Track Designation from FDA
- Clinical entry validates condensate modulator discovery platform and its potential to address historically intractable targets through a novel mechanism
BOSTON, Feb. 04, 2026 (GLOBE NEWSWIRE) — Dewpoint Therapeutics, Inc., a clinical-stage biotechnology company pioneering condensate-modulating therapeutics, today announced that the first patient has been dosed in a Phase 1a/2a clinical trial evaluating its lead beta-catenin program in patients with advanced solid tumors, with a focus on gastric cancer.
The investigational therapy, DPTX3186, is a first-in-class small molecule designed to modulate beta-catenin signaling by altering its behavior within biomolecular condensates. Dysregulated beta-catenin signaling is a central oncogenic driver across multiple cancers, including gastric cancer, yet has historically resisted conventional drug discovery approaches.
The molecule has received both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA), underscoring the significant unmet medical need in the targeted patient populations and the potential of the program to address it.
“This milestone is a powerful validation of Dewpoint’s core scientific thesis,” said Isaac Klein, M.D., Ph.D., Chief Scientific Officer of Dewpoint Therapeutics. “We set out to show that understanding and modulating biomolecular condensates has the potential to unlock targets that have long been considered undruggable. Dosing the first patient with a beta-catenin condensate modulator demonstrates that this approach is not only biologically compelling, but clinically actionable.”
The study is a multi-center, dose-escalation trial designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamic activity, and early efficacy in patients with advanced or refractory solid tumors. The trial includes translational biomarker assessments intended to confirm pathway engagement and inform dose selection and subsequent clinical development.
“Reaching the clinic with a beta-catenin modulator is a defining moment for Dewpoint,” said Ameet Nathwani, M.D., Chief Executive Officer of Dewpoint Therapeutics. “This achievement reflects years of foundational science translated through a disciplined and differentiated discovery engine. It reinforces our belief that condensate modulation represents a fundamentally new and scalable way to build medicines for serious diseases.”
Dewpoint’s beta-catenin program is the first clinical validation of the company’s condensate-modulating platform, which has produced a growing pipeline of condensate modulators across oncology, neurology, and cardiometabolic disease.
About Dewpoint Therapeutics
Dewpoint is a clinical-stage biotechnology company applying condensate biology to the discovery and development of novel therapeutics. The recognition that many diseases are driven by dysfunction of biomolecular condensates creates new opportunities to modulate high-value and historically undruggable targets. Dewpoint’s proprietary AI-powered integrated platform supports a pipeline spanning oncology, neurology, and cardiometabolic disease, with strategic collaborations including Bayer and Novo Nordisk. Learn more at Dewpointx.com and follow us on LinkedIn.
About Condensates
Condensates are membraneless organelles that form dynamically within cells through a process known as phase separation. These compartments organize and concentrate biomolecules to regulate diverse cellular functions. Dysregulation of biomolecular condensates has been implicated in many diseases, including cancer, diabetes, cardiopulmonary disease, and neurodegenerative disorders. Condensate-modulating drugs, or c-mods, represent a new therapeutic modality with the potential to address complex diseases and historically undruggable targets. Learn more at Condensates.com.