FDA Grants Orphan Drug Designation to DPTX3186 in Gastric Cancer

The FDA has granted orphan drug designation to the first-in-class condensate modulator DPTX3186 as a potential therapeutic option for patients with gastric cancer.¹

DPTX3186 is an oral, small-molecule condensate modulator that is intended to selectively target oncogenic Wnt/β-catenin signaling via the redistribution of β-catenin into an inactive condensate state within tumor cells. The mechanism is designed to address prior safety issues associated with Wnt inhibition.

“The FDA’s decision to grant orphan drug designation to DPTX3186 is an extraordinary validation of both the promise of condensate biology and the importance of our work in gastric cancer,” Isaac Klein, MD, PhD, chief scientific officer and head of R&D at Dewpoint Therapeutics, stated in a news release. “This recognition reflects the agency’s confidence in our mechanism, our science, and our shared goal of bringing new hope to patients facing this devastating disease.”

The orphan drug designation followed an October 21, 2025, news release from Dewpoint Therapeutics announcing the opening of an investigational new drug (IND) application for DPTX3186.² Under the IND application, the company intends to investigate DPTX3186 in a phase 1/2 trial in conjunction with Evotec, leading cancer centers, and researchers with expertise in gastric and other Wnt-driven cancers.

“Evotec’s depth of experience and proven track record in advancing first-in-class small molecules through their Evotec INDiGO platform made them an ideal partner for this effort,” Ameet Nathwani, chief executive officer of Dewpoint Therapeutics, stated in the October 21 news release. “Their scientific rigor and development agility were instrumental in helping us take a novel condensate-derived mechanism from concept to IND. For a young biotech company like Dewpoint moving into the clinic for the first time, working alongside a partner of Evotec’s caliber significantly de-risked and accelerated our path to the clinic.”

Dewpoint Therapeutics plans to dose the first patient in the phase 1/2 trial before the end of 2025.^1,2

“Dosing our first patient this year will be a defining moment for condensate biology and Dewpoint,” Klein stated in a prior news release.² “DPTX3186 is the only molecule of its kind: an oral small-molecule condensate modulator tackling a historically undruggable pathway with a differentiated safety profile. Its discovery on our platform, the bespoke biomarker strategy, and the caliber of partners supporting this trial reflect the transformative potential of condensate science to rewrite what is possible in drug discovery and development.”

What preclinical data have been reported for DPTX3186?

At the 2025 AACR Annual Meeting, researchers presented preclinical findings for the beta catenin condensate modulator.³ The rationale behind the development of the agent stemmed from the known association of the Wnt/beta catenin pathway and progression of multiple different cancer types.

In preclinical research, DPTX3186 demonstrated significant effects on the formation of the beta catenin nuclear condensate depot, and it also led to the downregulation of beta catenin-driven gene transcription and cancer cell killing.

Furthermore, DPXT3186 produced robust cytotoxic activity in a large panel of gastric cancer cells, which included a diverse molecular landscape. DPTX3186 displayed significant antitumor activity across a panel of patient-derived and cell line–derived xenograft gastric cancer models in vivo, along with the downregulation of the Wnt pathway–associated plasma proteome.

“Taken together these results underscore the activity of DPTX3186 in gastric cancer and highlight its potential to meet the high unmet need in this indication,” lead study author Kip West, PhD, head of Translational Science at Dewpoint Therapeutics, and colleagues wrote in the conclusion of the poster presentation.

References

1. FDA grants orphan drug designation to Dewpoint Therapeutics’ DPTX3186 for the treatment of gastric cancer. News release. Dewpoint Therapeutics. October 29, 2025. Accessed October 30, 2025. https://dewpointx.com/fda-grants-orphan-drug-designation-to-dewpoint-therapeutics-dptx3186-for-the-treatment-of-gastric-cancer/
2. Dewpoint Therapeutics announces an open IND for first-in-class condensate modulator DPTX3186 for Wnt-driven cancers. News release. Dewpoint Therapeutics. October 21, 2025. Accessed October 30, 2025. https://dewpointx.com/dewpoint-therapeutics-announces-an-open-ind-for-first-in-class-condensate-modulator-dptx3186-for-wnt-driven-cancers/
3. West K, Baumann, Talbot A, et al. Beta catenin c-mods are orally bioavailable small-molecules targeting Wnt-driven tumors. Presented at: 2025 AACR Annual Meeting; April 25-30, 2025; Chicago, IL. Abstract 1751.