Cancer Trial Data for FOG-001 to be Presented by Parabilis at ASCO GI Cancers Symposium
Parabilis Medicines, formerly known as Fog Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing transformative treatments for cancer patients, today announced that it will present a trial-in-progress poster at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium. The presentation will showcase data from the company’s first-in-human clinical trial of FOG-001, the first and only direct inhibitor of β-cateninTCF4. The event will take place in San Francisco from January 23-25, 2025.
Parabilis Medicines, a clinical-stage biopharmaceutical company committed to developing innovative treatments for cancer, is currently evaluating its lead drug, FOG-001, in a Phase 1/2 clinical trial (NCT05919264). This multicenter, open-label, non-randomized trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of FOG-001 in patients with microsatellite stable colorectal cancer (MSS CRC) and other solid tumors driven by Wnt pathway activating mutations (WPAM+). The study is enrolling patients in multiple third-line MSS CRC cohorts and is testing FOG-001 both as a monotherapy and in combination with standard chemotherapy regimens such as FOLFOX plus bevacizumab, anti-PD-1/PD-L1 inhibitors, or trifluridine/tipiracil plus bevacizumab.
At the 2025 J.P. Morgan Healthcare Conference, Parabilis provided an update on the progress of the clinical trial. The company revealed that over 60 patients with locally advanced or metastatic solid tumors have been treated with FOG-001 to date. Early clinical data from these patients suggest that FOG-001 demonstrates monotherapy antitumor activity and engages the target in tumors. The company expects to share preliminary Phase 1/2 data publicly in 2025, which will provide more insight into the drug’s potential to treat solid tumors with Wnt pathway mutations.
As part of the 2025 ASCO Gastrointestinal Cancers Symposium, Parabilis will present a trial-in-progress poster that highlights the study’s ongoing efforts and early findings. The poster will be presented under the 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.” The abstract number for this presentation is TPS322, and it will take place on January 25, 2025, from 7:00–7:55 a.m. PST during the Trials in Progress Poster Session C at the Moscone West Convention Center in San Francisco.
FOG-001 is a novel, first-in-class competitive inhibitor of β-catenin interactions with the T-cell factor (TCF) family of transcription factors. This investigational drug targets the Wnt signaling pathway, which is often activated in various cancers due to mutations in the APC or β-catenin genes. By directly blocking the interaction between β-catenin and TCF, FOG-001 aims to inhibit the downstream signaling that drives tumor growth, regardless of the mutations that typically promote disease. This mechanism of action makes FOG-001 distinct from other Wnt/β-catenin pathway modulators, as it operates inside the cell and disrupts the critical β-catenin:TCF interaction at the most downstream node in the pathway.
FOG-001’s ability to block the Wnt signaling pathway at its core offers a promising approach to treating cancers with mutations in this pathway, which are common in a variety of solid tumors. As a result, FOG-001 holds the potential to treat cancers that are difficult to target with traditional therapies, providing a novel treatment option for patients with locally advanced or metastatic solid tumors.
The trial’s design includes multiple cohorts for patients with colorectal cancer, liver cancer, and other solid tumors with Wnt pathway mutations. By evaluating FOG-001 as both a monotherapy and in combination with established cancer treatments, the trial aims to assess the drug’s potential to improve outcomes for patients with limited treatment options. Early signs of efficacy, coupled with the ongoing monitoring of safety and tolerability, will provide crucial data for the future development of FOG-001.
Parabilis Medicines, formerly known as Fog Pharmaceuticals, was founded with the goal of developing groundbreaking cancer therapies. The company leverages its Helicon discovery platform, which engineers stabilized helical peptide therapeutics to target traditionally undruggable proteins. This versatile platform allows Parabilis to create therapies for multiple areas of unmet need in oncology, including protein-protein interactions, targeted protein degraders, and radiopharmaceuticals.
FOG-001 is the lead asset in Parabilis’ pipeline and represents the company’s commitment to addressing the challenges associated with targeting the Wnt/β-catenin pathway in cancer. In addition to FOG-001, Parabilis is advancing other first-in-class programs designed to target critical signaling pathways and promote better outcomes for cancer patients.
Parabilis is headquartered in Cambridge, Massachusetts, and has raised more than $500 million in funding to date from prominent life sciences investors. The company’s strong financial backing and innovative approach position it to make significant strides in the development of new cancer therapies. As clinical trials progress and additional data becomes available, Parabilis aims to expand treatment options for cancer patients and contribute to the ongoing efforts to overcome cancer’s challenges. With its focus on precision medicine and cutting-edge drug development, Parabilis is committed to making a lasting impact on the oncology landscape.
