On January 23, 2025 Parabilis Medicines (formerly Fog Pharmaceuticals), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer, reported the presentation of a trial-in-progress poster on the Company’s first-in-human clinical trial evaluating FOG-001, the first and only direct inhibitor of β-cateninTCF4, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium taking place in San Francisco from January 23-25, 2025 (Press release, Parabilis Medicines, JAN 23, 2025, View Source [SID1234649861]).

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FOG-001 is being evaluated in a Phase 1/2 clinical trial (NCT05919264). The multicenter, open-label, non-randomized trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of FOG-001 in patients with microsatellite stable colorectal cancer (MSS CRC) and other solid tumors with Wnt pathway activating mutations (WPAM+). The trial plans to enroll patients in multiple third-line MSS CRC cohorts as both a monotherapy and in combination with FOLFOX+bevacizumab, anti-PD-1/PD-L1, or trifluridine/tipiracil+bevacizumab.

At the 2025 J.P. Morgan Healthcare Conference, Parabilis provided an update on the trial’s progress. The Company disclosed that more than 60 patients with locally advanced or metastatic solid tumors have been dosed with FOG-001 to date, and that early clinical data demonstrate monotherapy antitumor activity and in-tumor target engagement. Preliminary Phase 1/2 data are expected to be shared publicly in 2025.

Full details of the poster are as follows:

Title: "A Phase 1/2 study of FOG-001, a first-in-class direct β-catenin:TCF inhibitor, in patients with colorectal cancer, hepatocellular carcinoma, and other locally advanced or metastatic solid tumors"
Abstract Number: TPS322
Presentation Date and Time: January 25, 2025, 7:00-7:55 a.m. PST
Session Information: Trials in Progress Poster Session C
Location: Level 1, West Hall, Moscone West

About FOG-001
FOG-001 is an investigational first-in-class competitive inhibitor of β-catenin interactions with the T-cell factor (TCF) family of transcription factors, and is currently in clinical development. By directly targeting the β-cateninTCF4 protein-protein interaction, FOG-001 is intended to block the Wnt signaling pathway irrespective of the various APC and beta-catenin mutations that typically drive disease.

FOG-001 combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: FOG-001 acts inside the cell where it binds directly to the key oncogenic driver β-catenin; and FOG-001 blocks the Wnt pathway at the most downstream node, disrupting the interaction between β-catenin and the transcription factor TCF, thereby abrogating the signal transmission by which Wnt pathway mutations are believed to drive oncogenesis. FOG-001 is currently being evaluated in a first-in-human Phase 1/2 clinical trial in patients with locally advanced or metastatic solid tumors.