FDA Grants Fast Track to Novel C-Mod DPTX3186 in Gastric Cancer

DPTX3186, a first-in-class, orally available condensate modulating agent (c-mod), has earned FDA fast track designation for the treatment of gastric cancer.¹

The decision follows the recent opening of the agent’s investigational new drug application² as well as an orphan drug designation on October 21, 2025. The fast track designation recognizes the potential of an agent to address serious unmet medical needs,³ enabling expedited development. DPTX3186 is specifically designed to meet the challenges posed by gastric cancer, characterized by heterogeneous presentation and associated targeted treatment resistance.⁴

“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 Research and Development at Dewpoint Therapeutics, 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 [t]rack designation provides an important framework to advance this program with greater efficiency and speed.”

With this designation, Dewpoint Therapeutics, the sponsor, will be imminently launching a phase 1a/2a clinical trial of DPTX3186 in cancer centers across the US. The initial objectives of the study are to evaluate the safety, pharmacokinetics, and preliminary efficacy of DPTX3186 as a single agent in metastatic gastric cancer.² Later on, the agent will be investigated in combination with other therapeutic agents and in additional tumor types. Dewpoint expects to dose the first patient before the end of 2025.

Mechanistic Rationale for DPTX3186

Activation of the Wnt/β-catenin pathway is known to drive malignancy in a wide range of cancers, including gastric cancer.⁵ As such, DPTX3186 is a small molecule designed to modulate the oncogenic function of β-catenin by sequestering β-catenin in a drug-induced condensate. This novel therapeutic approach aims to downregulate aberrant Wnt/β-catenin signaling, inducing cancer cell death.

The agent has shown encouraging efficacy and pharmacokinetics in preclinical studies. In a poster presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting, DPTX3186 exhibited robust antitumor and cytotoxic activity and decreases in β-catenin regulated circulating proteins across a range of models in vivo.⁵ In the gastric cancer model, a tumor regression rate of more than 95% was observed, along with a complete response rate of 50%, highlighting the therapeutic potential of this agent in this indication.

REFERENCES

1. FDA grants fast track designation to Dewpoint Therapeutics’ DPTX3186 for the treatment of gastric cancer. News release. Dewpoint Therapeutics. November 17, 2025. Accessed November 17, 2025. https://tinyurl.com/3wzmnmtk

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 November 18, 2025. https://tinyurl.com/36cxruuc

3. Fast track. US Food & Drug Administration. Updated August 13, 2024. Accessed November 18, 2025. https://tinyurl.com/ms2695jn

4. Luo D, Liu Y, Lu Z, et al. Targeted therapy and immunotherapy for gastric cancer: rational strategies, novel advancements, challenges, and future perspectives. Mol Med. 2025;31(1):52. Published 2025 Feb 8. doi:10.1186/s10020-025-01075-y

5. 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.