Parabilis Medicines to Present Overview of Ongoing Phase 1/2 Study of FOG-001, a β-cateninTCF4 Inhibitor, at Upcoming Medical Meetings

Parabilis Medicines, a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, today announced the presentations of trial-in-progress posters on the Company’s first-in-human clinical trial evaluating FOG-001, the first and only direct inhibitor of β-catenin_TCF4, at the ASCO Annual Meeting, which begins on May 30 in Chicago, Illinois, and the ESMO Gastrointestinal Cancers Congress 2025, which begins on July 2 in Barcelona, Spain.

FOG-001 is being evaluated in a Phase 1/2 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 solid tumors with Wnt pathway activating mutations (WPAM+), including colorectal cancer (CRC) and desmoid tumors.

More than 65 patients with locally advanced or metastatic tumors have been dosed with FOG-001 to date, and early clinical data demonstrate monotherapy antitumor activity and in-tumor target engagement. Phase 1/2 data are expected to be shared publicly in 2025.

The trial is currently enrolling patients with desmoid tumors in its monotherapy arm. It is also enrolling multiple cohorts of microsatellite-stable CRC (MSS-CRC) patients to evaluate combination regimens of FOG-001, supported by strong scientific rationale:

• Combinations with FOLFOX+bevacizumab and trifluridine/tipiracil+bevacizumab: Paired biopsy data from the ongoing FOG-001 trial indicate that FOG-001 drives reduction in markers of stemness and upregulation of the angiogenesis pathway, pointing to potentially greater susceptibility to both chemotherapy and bevacizumab. Preclinical studies employing patient-derived xenograft (PDX) mouse models indicate FOG-001 can significantly deepen and extend the benefit of both chemotherapy backbone agent 5-FU and bevacizumab.
• A second combination regimen, pairing FOG-001 with PD-1 checkpoint inhibitors, is supported by paired biopsy data from the ongoing trial indicating that FOG-001 induces the Merck tumor inflammation signature in otherwise immunologically “cold” tumors. Preclinical studies in MC38 mouse models suggest this potential, demonstrating synergistic combination efficacy between FOG-001 and PD-1 checkpoint inhibitors. These observations indicate that FOG-001 could improve CRC responses to immunotherapy, which currently has minimal to no monotherapy efficacy in MSS-CRC.

ASCO poster information:

Title: “A Phase 1/2 study of FOG-001, a first-in-class direct β-catenin:TCF inhibitor, in patients with colorectal cancer (CRC) and other locally advanced or metastatic solid tumors”
Abstract Number: TPS3169
Date and Time: June 2, 2025, 1:30-4:30 p.m. CDT
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Location: Hall A – Posters and Exhibits

ESMO GI poster information:

Title: “FOG-001 – a first-in-class direct β-catenin:TCF inhibitor, in patients with colorectal cancer (CRC) and other locally advanced or metastatic solid tumors: Phase 1/2 study design”
Presentation Number: 145TiP
Date and Time: July 3, 2025, 3:30-4:30 p.m. CET
Session: Poster display session
Location: Foyer

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-catenin_TCF4 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.

About Parabilis Medicines
Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer. Through its Helicon discovery platform, Parabilis is engineering precisely tuned, stabilized helical peptide therapeutics that have the potential to unlock a large number of traditionally undruggable targets. This versatile platform enables applications for Helicons across three main areas: functional inhibitors of intracellular protein-protein interactions, targeted protein degraders, and targeted radiopharmaceuticals.

Parabilis is advancing a pipeline of first-in-class programs across these three domains, led by FOG-001, its clinical-stage β-catenin_TCF4 inhibitor. Parabilis is headquartered in Cambridge, Mass., and is well-capitalized, with more than $500 million raised to date from leading life sciences investors. For more information, please visit: www.parabilismed.com

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