On April 17, 2025 Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company, reported a sponsored research collaboration with Virginia Commonwealth University (VCU) to investigate Aramchol’s potential in overcoming drug resistance in gastrointestinal (GI) cancers. Under the Sponsored Project Agreement, VCU scientists will study Aramchol in preclinical models of advanced GI malignancies – focusing on colorectal and hepatocellular (liver) cancers – in combination with standard-of-care treatments (Press release, Galmed Pharmaceuticals, APR 17, 2025, View Source [SID1234651976]). The goal is to determine whether Aramchol’s novel mechanism of action can prevent or reverse resistance to therapies such as targeted kinase inhibitors and chemotherapies, thereby enhancing their efficacy against these aggressive tumors.
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This collaboration addresses a critical unmet need: GI cancers (including colon and liver cancers) are among the leading causes of cancer mortality worldwide, and treatment options are often limited by therapy resistance. By targeting Stearoyl-CoA Desaturase 1 (SCD1) – a key enzyme in fatty acid metabolism implicated in cancer progression – Aramchol offers a novel therapeutic strategy. Recent breakthrough research published in Nature Communications (View Source) has highlighted the role of lipid metabolic pathways (notably SCD1) in driving drug resistance in GI tumors. Leveraging these insights, the Galmed–VCU project will explore Aramchol’s ability to reprogram tumor metabolism and sensitize cancer cells to existing treatments, potentially delivering a breakthrough in resistance reversal for patients with few alternatives.
" A large proportion of patients with advanced HCC gain no long-term benefit from the approved 2nd line systemic therapy of tyrosine kinase inhibitors (TKIs) due to drug resistance, which keeps HCC a highly fatal disease. Most HCC patients receiving TKIs develop resistance within 6 months of treatment. Previous studies showed that SCD1 is highly expressed in some liver cancers, and its inhibition sensitizes cancer cells to TKIs" said Paul Dent, Ph.D. Professor, School of Medicine Biochemistry and Molecular Biology Virginia Commonwealth University. "The aim of the collaboration is to overcome mechanisms of drug resistance in cells exposed to Aramchol and FDA approved drugs. Based on these findings we would contemplate developing safe drug combinations that will block and circumvent drug resistance in HCC."
Strategic Expansion and Market Implications
For Galmed, the partnership with VCU is part of a strategic expansion beyond its historical focus on fibrotic liver diseases into the oncology arena. Aramchol (an oral therapy with a strong safety profile demonstrated in NASH/fibrosis trials) is the most clinically advanced SCD1 inhibitor, and its dual action on metabolic and fibrotic pathways presents a unique opportunity in cancer treatment. Allen Baharaff, President and CEO of Galmed, noted that this program aligns with the Company’s growth strategy and commitment to addressing diseases with high unmet need:
"HCC is the only major cancer for which death rates have not improved over the last 10 years. Tyrosine kinase inhibitors (TKIs) such as Sorafenib, Regorafenib and Lenvatinib are pivotal molecular targeted agents in advanced HCC.
"The clinical benefit of TKIs based systemic therapy for advanced HCC is limited due to drug resistance mediated by dysregulated lipid metabolism. Consequently, monoclonal antibodies (MABs) such as Atezolizumab & bevacizumab emerged as the first-line therapy for patients with HCC. However as 75% of patients are refractory to or intolerant to MABs and because of their high cost, the cost effectiveness is limited. Targeting lipid metabolism with Aramchol, a potent SCD1 inhibitor, is a promising emerging strategy to overcome TKIs therapy resistance in HCC and a combination of the two agents could replace MABs as a cost-effective 1st line treatment."
Through this sponsored research, Galmed and VCU seek to generate proof-of-concept data on Aramchol’s efficacy in an oncology setting. Positive findings could lay the groundwork for subsequent clinical development in cancer, expanding Galmed’s pipeline and creating value for investors and stakeholders. The Company’s extended patent runway for Aramchol (protected through 2035) further enhances the commercial prospects of any new oncological application by providing a long horizon for development and potential market exclusivity.
Galmed will provide funding and Aramchol materials, while VCU’s researchers – including experts from the VCU Massey Comprehensive Cancer Center – will conduct the studies and analyze outcomes. The collaboration leverages VCU’s deep expertise in cancer biology and drug resistance models along with Galmed’s decade-long experience with Aramchol in metabolic diseases. Both parties believe this partnership can accelerate the path toward a first-in-class therapy that tackles cancer resistance mechanisms head-on.