Anbogen Therapeutics (ABT), a precision medicine biotech company, announced a major breakthrough today with the U.S. FDA’s approval to initiate Phase I/II clinical trials for its small-molecule drug ABT-301, in combination with an immune checkpoint inhibitor and an anti-angiogenic inhibitor. This triple-combination therapy will target advanced metastatic colorectal cancer (mCRC), particularly “cold tumors” that account for 90% of patients who respond poorly to current immunotherapies, offering renewed hope for this underserved population.
An Emerging Biotech Star: Funding and R&D in Parallel
Founded in 2019 as a spin-off from Taiwan’s National Biotechnology and Pharmaceutical Program spearheaded by former Vice President Chen Chien-Jen, Anbogen Therapeutics quickly demonstrated strong R&D capabilities. Co-founded by veteran chemist Chuan Shih, drug development experts Tsu-An Hsu and Hsing-Pang Hsieh, and supported by a team of leading scientists with global experience, the company started with two pipeline drugs already advancing into clinical development:
- ABT-101: Targeting non-small cell lung cancer (NSCLC) caused by HER2 Exon20 mutations. It has received FDA approval to enter Phase Ib/II clinical trials, with plans to expand indications through basket trials.
- ABT-301: Successfully completed a Phase I clinical trial in 2018 with support from Taiwan’s national biotech initiative.
Strengthened by this foundation, Anbogen closed a $20 million Series A and A+ financing round in July 2024, led by CDIB Capital and joined by Taiwan’s National Development Fund and other venture investors. The company has now launched a Series B round to accelerate global expansion and commercialization.
ABT-301 Triple Therapy: Exposing “Cold Tumors” for Precise Attack
The FDA-cleared trial will recruit 66 participants worldwide, focusing on pMMR/non-MSI-H colorectal cancer, which represents about 95% of advanced cases. These tumors lack recognizable immune markers, making them resistant to existing immunotherapies—a challenge representing an unmet medical need estimated at $9 billion in market potential.
ABT-301, an oral HDAC inhibitor, acts as a “tumor awakener” by remodeling the tumor microenvironment, converting cold tumors into “hot tumors” responsive to immunotherapy. This transformation enhances the effectiveness of the PD-1 monoclonal antibody tislelizumab, which directly attacks cancer cells, while bevacizumab disrupts tumor blood supply. Together, the triple regimen forms a synergistic strategy to maximize anti-cancer efficacy.
Importantly, in its earlier single-agent Phase I trial, ABT-301 demonstrated a favorable safety profile, avoiding common toxicities seen in similar drugs, such as leukopenia or cardiotoxicity. This safety advantage makes it a strong candidate for combination regimens.
Addressing Unmet Needs and Looking Ahead
CEO Po-Ren Hsueh highlighted that Anbogen aims to position itself as a “second-wave innovator” in drug development. The FDA’s IND clearance for ABT-301 marks a critical milestone, and the company will move forward with clinical advancement while actively seeking global licensing and strategic partnerships. The goal is to deliver novel treatment options for late-stage colorectal cancer patients long underserved by existing therapies.
Beyond ABT-101 and ABT-301, Anbogen’s pipeline includes ABT-501, a peptide-drug conjugate, and the ABT-200 series, small-molecule inhibitors targeting pan-KRAS mutations. Through these programs, Anbogen strives to develop breakthrough therapies for hard-to-treat cancers and establish itself as a global leader in precision oncology drug development.
Resource: 安邦生技再創里程碑：ABT-301三聯療法獲美FDA核准執行，鎖定晚期大腸直腸癌「冷腫瘤」龐大市場
