DPTX3186, a first-in-class oral condensate modulator, has received FDA fast track designation in gastric cancer.
The FDA has granted fast track designation to DPTX3186, a first-in-class oral condensate modulator targeting the Wnt/β-catenin pathway, for the treatment of patients with gastric cancer.1
This small molecule therapy was designed to selectively modulate the oncogenic function of β-catenin, which is a key driver of gastric cancer and other solid tumors. Through the redistribution of β-catenin into an inactive, drug-induced condensate, the therapy aims to reduce aberrant β-catenin signaling while preserving normal cellular function.
“We are honored that the FDA has recognized the urgency of gastric cancer and the promise of our condensate-based approach,” Isaac Klein, MD, PhD, chief scientific officer and head of Research & Development at Dewpoint Therapeutics, stated in a news release.1 “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 previously received orphan drug designation from the FDA for the treatment of patients with gastric cancer on October 29, 2025.2 This decision followed an October 21, 2025, announcement from Dewpoint Therapeutics regarding the opening of an investigational new drug application (IND) for DPTX3186.3 Accordingly, the company is initiating a phase 1a/2a clinical trial of DPTX3186 at leading cancer centers in the United States, and partnering with key opinion leaders in gastric and other Wnt-driven cancers.1,3
This study will assess the agent’s safety, pharmacokinetics, and early efficacy as a monotherapy, focusing primarily on patients with metastatic gastric cancer. 3DPTX3186-containing combination regimens and additional tumor types will be explored in planned expansion cohorts. The company anticipates dosing the first patient before the end of 2025.
“Fast Track designation reflects a recognition of the promise that our condensate modulators may hold to address serious diseases through a new biological lens,” Ameet Nathwani, MD, chief executive officer of Dewpoint Therapeutics, added.1 “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.”
Preclinical data for DPTX3186 were shared in several presentations at the 2025 AACR Annual Meeting.4 The rationale behind the agent’s development centered on the established involvement of the Wnt/β-catenin pathway in the progression of multiple tumor types.
In these studies, DPTX3186 significantly disrupted formation of the β-catenin nuclear condensate depot and led to downregulation of β-catenin–driven gene transcription, resulting in cancer cell killing.
DPTX3186 also demonstrated robust cytotoxic activity across a broad panel of gastric cancer cell lines encompassing diverse molecular profiles. In vivo, the agent showed marked antitumor activity in both patient-derived and cell line–derived xenograft models of gastric cancer, accompanied by downregulation of Wnt pathway–associated proteins in the plasma proteome.
