Anbogen Receives FDA Clearance to Initiate Phase 1/2 Trial of ABT-301 Triplet Therapy for Advanced Colorectal CancerUSA - EnglishAPAC - EnglishIndia - English

Anbogen Receives FDA Clearance to Initiate Phase 1/2 Trial of ABT-301 Triplet Therapy for Advanced Colorectal Cancer USA - English APAC - English India - English News provided by Anbogen Therapeutics Aug 04, 2025, 02:29 ET Share this article Share to X Share this article Share to X TAIPEI , Aug. 4, 2025 /PRNewswire/ -- Anbogen Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ABT-301, enabling the initiation of a Phase 1/2 clinical trial in combination with tislelizumab and bevacizumab for patients with metastatic colorectal cancer (mCRC). This open-label, multi-center international study plans to enroll 66 patients with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC to evaluate the safety and preliminary efficacy of the triplet therapy. Enrollment is planned in Taiwan and Australia . Tislelizumab, a PD-1 monoclonal antibody, used in this trial is provided by BeOne Medicines (formerly known as BeiGene). Further details on this collaboration were disclosed by Anbogen in a press release dated September 27, 2024 . ABT-301 is an oral HDAC1/2/3 inhibitor. Preclinical studies have shown that it promotes CD8+ cytotoxic T cell infiltration and activity, enhances antigen presentation, and inhibits M-MDSCs cells, effectively modulating the tumor microenvironment and converting "cold tumors" into "hot tumors" to improve the efficacy of immune checkpoint inhibitors. ABT-301 also exhibits pro-apoptotic, anti-angiogenic, and tumor metabolic regulation effects. As a single-molecule, multi-modality anti-cancer agent, ABT-301 aims to enhance tumor treatment when combined with the two antibody drugs. Notably, in a previous Phase 1 monotherapy clinical trial involving 23 participants, ABT-301 did not exhibit neutropenia or cardiac toxicity, which are commonly observed in other HDAC inhibitors—further supporting its suitability for use in combination immunotherapy. Approximately 95% of mCRC patients are pMMR or non-MSI-H types—commonly referred to as "cold tumors"—which respond poorly to current immunotherapies. Only around 5% of patients with deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) "hot tumors" typically benefit from immune checkpoint inhibitors. According to GlobalData, an estimated 370,000 new pMMR/non-MSI-H patients in second-line or later settings are diagnosed annually across the U.S., China , Japan , and the top five European markets (UK, France , Germany , Spain , and Italy ), representing a potential market size of USD $9 billion . Anbogen stated that the FDA's IND approval marks a key milestone in the development of ABT-301, demonstrating the safety profile of the triplet therapy and advancing it into clinical stages. The company emphasized that the study targets the majority of patients (over 90%) with poor responses to immunotherapy, aiming to provide a novel treatment option and address this unmet clinical need. Looking ahead, Anbogen will continue to advance the clinical development of ABT-301 while pursuing global licensing and strategic partnerships to accelerate commercialization and market entry. The company is also launching its Series B fundraising to attract strategic partners committed to advancing innovative cancer therapies and global expansion. About Anbogen Therapeutics Anbogen Therapeutics is a clinical-stage biotechnology company committed to developing precision oncology therapies that improve the lives of cancer patients worldwide. The company currently has two core assets: ABT-301, a HDAC1/2/3 inhibitor with immune-modulating capabilities, enhances the tumor microenvironment and boosts immune responses. It significantly improves the efficacy of immune checkpoint inhibitors (ICIs) in metastatic colorectal cancer (mCRC), offering a new treatment pathway for the majority of patients who do not benefit from ICIs. ABT-501 is a novel Peptide Drug Conjugate (PDC) that targets LHRH-receptor tumors using a proprietary delivery system. It has shown strong efficacy and safety in triple-negative breast cancer models, with potential for broader cancer applications. For more information, please visit Anbogen's official website at www.anbogen.com . SOURCE Anbogen Therapeutics 21 % more press release views with Request a Demo × Modal title