The US Food and Drug Administration (FDA) has approved Anbogen Therapeutics’ investigational new drug (IND) application for oral HDAC1/2/3 inhibitor ABT-301 in preparation for a Phase I/II trial.
The study will investigate the therapy in conjunction with tislelizumab and bevacizumab in those with metastatic colorectal cancer (mCRC).
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The international, multi-centre, open-label trial is set to enrol 66 subjects with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC.
It aims to assess the preliminary efficacy and safety of the triplet therapy. Subjects in Australia and Taiwan are planned to be enrolled.
BeOne Medicines will supply the programmed cell death protein 1 (PD-1) monoclonal antibody, tislelizumab, for the trial.
Last September, Anbogen announced a drug supply partnership with BeOne Medicines, focusing on the combination of ABT-301 and tislelizumab for a global Phase II trial.
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By GlobalDataAccording to the company, ABT-301 has previously been tested as a single agent in a Phase I trial involving 23 subjects. It did not show neutropenia or cardiac toxicity, which are common side effects of other HDAC inhibitors.
Anbogen noted that approximately 95% of mCRC subjects are classified as having “cold tumours” (pMMR or non-MSI-H), which typically respond poorly to existing immunotherapies.
The company also plans to proceed with the therapy’s clinical development and seek worldwide licensing and strategic collaborations to expedite market entry.
It is set to launch its Series B fundraising to attract partners dedicated to advancing cancer treatments and worldwide expansion.
Anbogen’s portfolio includes two core assets: ABT-301, which improves the tumour microenvironment; and ABT-501, a peptide drug conjugate (PDC) targeting LHRH-receptor tumours via a delivery system.
