Dewpoint Therapeutics announced that the FDA has accepted its Investigational New Drug (IND) application for DPTX3186, a first-in-class condensate modulator targeting oncogenic Wnt/β-catenin signaling in solid tumors.
Developed in collaboration with Evotec, DPTX3186 is an oral small molecule designed to disrupt biomolecular condensates that drive tumor-promoting gene expression. The forthcoming first-in-human Phase 1/2 trial will enroll patients with advanced gastric and colorectal cancers characterized by hyperactive Wnt signaling, with initial dosing anticipated before year-end.
The candidate originates from Dewpoint’s proprietary condensate-modulating platform, which employs AI- and ML-enabled screening tools to identify compounds capable of selectively disrupting diseased protein interactions without affecting physiological condensates. Preclinical studies showed robust tumor inhibition and regression across multiple Wnt-driven models while maintaining favorable safety profiles.
Chief Executive Officer Ameet Nathwani described the IND milestone as “a defining moment for condensate biology,” emphasizing its potential to transform drug discovery against previously undruggable oncogenic targets. The collaboration with Evotec allowed seamless integration from discovery to clinical readiness within an accelerated timeframe.
This IND marks the first clinical application of Dewpoint’s condensate science—a new therapeutic paradigm aiming to expand treatment options for difficult-to-target malignancies such as gastric and colorectal cancers.
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