DPTX-3186 / Dewpoint Therap - LARVOL DELTA

Genomic determinants of response to the Wnt/Beta-catenin condensate modulator DPTX3186 in gastric cancer PDX models and implications for clinical development (AACR 2026) - "Specifically, mutations in oncogenes that are associated with greater beta-catenin activity confer greater response to DPTX3186, reinforcing the specificity of the condensate mechanism for wnt-driven tumors. These results demonstrate the promising therapeutic potential of DPTX3186 in gastric cancer, outline our patient selection strategy for the ongoing clinical trial, and provide a roadmap for the clinical selection of high responders to condensate-modulating anti-cancer agents."

Clinical • Gastric Cancer • Oncology • Solid Tumor • CTNNB1

Pharmacological targeting of oncogenic condensates in cancer: mechanistic insights and therapeutic opportunities. (PubMed, Acta Pharmacol Sin) - "We further highlight recent translational advances-exemplified by DPTX-3186, a first-in-class condensate modulator granted FDA Orphan Drug Designation for Wnt-driven gastric cancer-that underscore the clinical promise of condensate-directed therapies. Finally, we discuss key mechanistic, pharmacodynamic, and biomarker-related challenges that must be addressed to fully integrate condensate biology into next-generation precision oncology."

Journal • Review • Gastric Cancer • Oncology • Solid Tumor

Dewpoint Therapeutics…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 (GlobeNewswire) - "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."

Trial status • Gastric Cancer

DPTX3186 in Wnt Pathway Activated Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Dewpoint Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Breast Cancer • Colorectal Cancer • Gastric Cancer • Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

DPTX3186 in Wnt Pathway Activated Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Dewpoint Therapeutics

New P1 trial • Solid Tumor

FDA Grants Fast Track Designation to Dewpoint Therapeutics’ DPTX3186 for the Treatment of Gastric Cancer (GlobeNewswire) - "...Dewpoint is now initiating a Phase 1a/2a clinical trial across leading cancer centers in the United States....Dewpoint expects to dose the first patient in the DPTX3186 clinical trial before the end of the year."

Fast track • New P1/2 trial • Gastric Cancer

FDA Grants Orphan Drug Designation to Dewpoint Therapeutics’ DPTX3186 for the Treatment of Gastric Cancer (GlobeNewswire) - "Dewpoint expects to dose the first patient with DPTX3186 before year-end 2025 at leading cancer centers in the United States."

New trial • Orphan drug • Gastric Cancer

Dewpoint Therapeutics Announces an Open IND for First-in-Class Condensate Modulator DPTX3186 for Wnt-Driven Cancers (GlobeNewswire) - "Dewpoint plans to begin dosing its first patient before the end of 2025 in a combined Phase 1/2 trial conducted in partnership with leading cancer centers and key opinion leaders in gastric and other Wnt-driven cancers."

IND • New P1/2 trial • Solid Tumor

Dewpoint Therapeutics…announced the closing of its Series D financing to advance DPTX3186, a first-in-class condensate modulator (c-mod), into clinical trials by year-end 2025 and deliver early clinical proof-of-concept by the end of 2026 (GlobeNewswire) - "It will also accelerate development of Dewpoint’s first-in-class c-mod targeting MYC...while strengthening ongoing collaborations with Bayer, Novo Nordisk, and Mitsubishi Tanabe Pharma. The financing provides operational runway into early 2027."

Financing • New trial • Gastric Cancer • Ovarian Cancer

Beta catenin c-mods are orally bioavailable small-molecules targeting Wnt-driven tumors (AACR 2025) - "The development candidate DPTX3186 is an orally bioavailable small molecule that demonstrates strong anti-tumor activity across multiple tumor types driven by various defects along the Wnt/beta catenin pathway and modulates Wnt pathway activity in vivo. Profound pharmacological efficacy, including regressions and complete responses, has been observed in murine models of gastric cancer. Collectively, these findings highlight the potential of condensate biology to target previously undruggable, high-value oncology targets, paving the way for novel treatments for patients with significant unmet medical needs."

Gastric Cancer • Oncology • Solid Tumor • CTNNB1

Dewpoint Therapeutics announces upcoming presentations at AACR 2025 (GlobeNewswire) - "Dewpoint will present two posters at AACR; Condensate modulators (c-mods) demonstrate robust anti-tumor effects across multiple types of cancer; C-mods modulate the oncogenic function of historically undruggable targets MYC and beta catenin."

Preclinical • Oncology • Ovarian Cancer

Dewpoint Therapeutics Announces Nomination of First C-Mod Development Candidate DPTX3186 for Treatment of Wnt-Driven Cancers (GlobeNewswire) - "Dewpoint Therapeutics Inc...announced today the nomination of its first development candidate, DPTX3186, an orally administered small molecule condensate modulator (c-mod) inhibiting the oncogenic function of beta catenin, as a potential therapeutic agent for the treatment of Wnt-driven cancers....DPTX3186 demonstrates activity across various beta catenin/Wnt-driven tumor cell types, while exhibiting minimal toxicity in healthy cells. In patient-derived and cell-derived xenograft models it displays significant tumor growth inhibition including regression and tumor stasis....'We anticipate filling the IND in mid-2025, followed by the commencement of Phase 1 clinical trial in the second half of 2025'."

IND • New molecule • New P1 trial • Oncology • Solid Tumor

Dewpoint Therapeutics and ConcertAI Announce the First Phase of their Translational Oncology Partnership (GlobeNewswire) - "Dewpoint Therapeutics and ConcertAI announced the first phase of their Translational Oncology partnership, aligned around Dewpoint’s latest drug candidate, DPTX3186...The first phase of the partnership will support DPTX3186 development by optimizing patient stratification through the synergy between Dewpoint’s AI/ML-powered discovery and development platform, and ConcertAI’s clinico-genomic data sets and the CARAai platform. Future phases of the partnership are anticipated to similarly support other candidates in Dewpoint’s oncology pipeline, including a second beta catenin c-mod with indications for other Wnt-driven tumor types, set for investigational new drug (IND) in 2025, and a c-mod for MYC, another ‘undruggable’ oncogene, set for IND in 2026."

Commercial • IND • Oncology