Anbogen and BeiGene Partner for Colorectal Cancer Drug Combo Evaluation

Anbogen, a clinical-stage biotechnology company, announced a significant drug supply collaboration with BeiGene to assess a combination therapy for metastatic colorectal cancer (mCRC). This partnership focuses on evaluating Anbogen's HDAC inhibitor, ABT-301, alongside BeiGene's anti-PD-1 antibody, tislelizumab, specifically targeting patients with mismatch repair–proficient (pMMR) or microsatellite stable (MSS) mCRC. BeiGene will provide tislelizumab for the study, which will be conducted as a global Phase II trial.

Colorectal cancer remains a prevalent disease worldwide, with over 1.9 million new cases diagnosed in 2020. Immune checkpoint inhibitors (ICIs) have become a cornerstone treatment for mCRC with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H). However, these innovative therapies are effective for only a small subset of patients, as less than 5% of mCRC cases exhibit dMMR/MSI-H characteristics. Thus, there remains a significant unmet medical need for the 95% of patients with pMMR/MSS tumors who do not respond to ICIs.

ABT-301, a novel HDAC inhibitor, has demonstrated a promising safety and pharmacokinetic profile in a previous Phase 1 study when used as a single agent. Preclinical research suggests that ABT-301 can enhance the efficacy of anti-PD-1/anti-PD-L1 therapies by boosting CD8+ cytotoxic T cells and reducing monocytic myeloid-derived suppressor cells within both the tumor and the bloodstream, as well as inhibiting angiogenesis. These immunological enhancements might extend the effectiveness of ICIs in colorectal cancer patients. The upcoming Phase II trial aims to explore the efficacy of combining ABT-301 and tislelizumab, with and without Bevacizumab, in treating pMMR/MSS mCRC patients who face considerable unmet needs.

"We are excited to partner with BeiGene to investigate this promising combination therapy," stated John Hsu, CEO of Anbogen. "ABT-301 has shown potential in preclinical studies, and we believe that combining it with tislelizumab could provide a new therapeutic option for patients with colorectal cancer."

The clinical trial will be conducted across multiple centers and will evaluate the safety, tolerability, and preliminary efficacy of the combination therapy in patients with advanced MSS CRC. Patient enrollment for the study is expected to commence in the first quarter of 2025.

Anbogen is a clinical-stage biotech company that successfully completed a US$20 million Series A financing round in 2024. The company is dedicated to developing precision anti-cancer drugs and is committed to research and development innovations aimed at improving the lives of cancer patients globally. Founded by Dr. Joe Shih, in line with national science and technology policy, Anbogen's team boasts extensive experience in new drug development from their work at the National Health Research Institutes and in the biopharma industry.

The company is currently developing two clinical-stage assets. ABT-101 is being tested in non-small cell lung cancer (NSCLC) patients with HER2 exon20 insertion mutations, while ABT-301 is being investigated in pMMR/MSS mCRC patients in combination with anti-PD-1 therapies.