On April 24, 2023 IngenOx Therapeutics, the Oxford biopharma company reported that the Hong Kong Drug Office had given approval for a Phase II clinical trial to proceed in treatment-resistant hepatocellular cancer (HCC) patients, combining its drug zabadinostat with an immune checkpoint inhibitor (Press release, IngenOx Therapeutics, APR 24, 2023, View Source [SID1234632031]).
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Immune checkpoint inhibitors (ICI) are being increasingly used in the treatment of advanced HCC liver cancer. Although some patients show lasting responses, the development of resistance to therapy is common. Collaborative academic research has shown that IngenOx’s zabadinostat reverses resistance to immune checkpoint resistance in pre-clinical HCC models.
These results provide a scientific rationale for the clinical development of zabadinostat in combination with an ICI, as a therapy for liver cancer which has become resistant to checkpoint blockade therapy. IngenOx is supporting the Phase II clinical trial which is designed to test the safety and effectiveness of zabadinostat combined with a checkpoint inhibitor in ICI-resistant HCC patients, compared with a tyrosine kinase inhibitor such as lenvatinib or sorafenib.
Obtaining Hong Kong Drug Office Approval and issuing the Clinical Trial Certificate is a key milestone in moving the study towards to first-patient-in.
David Kerr, CMO of IngenOx and Professor of Cancer Medicine at the University of Oxford, commented:
"The compelling findings from the pre-clinical studies give us increased confidence that we can recapitulate these encouraging results in man. Our sophisticated trial design will give us clinical data to seek accelerated approval from the regulatory authorities but stay true to our commitment to precision medicine by generating additional potential biomarkers to further improve clinical outcomes."