Immune-Onc Therapeutics has dosed the first subject in the Phase Ib/II trial of IO-108 plus Roche’s atezolizumab and bevacizumab as a potential first-line treatment for hepatocellular carcinoma (HCC).
The combination therapy is intended for individuals with locally advanced, metastatic, and/or unresectable HCC.
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Sponsored by Roche, the trial is part of its Morpheus-Liver programme and is designed to assess the fully human Immunoglobulin G4 (IgG4) monoclonal antibody with the combination.
It is expected to enrol 40 subjects across 25 sites globally in the IO-108 arm, which will be compared against an active control arm consisting of the atezolizumab and bevacizumab combination.
Objective response rate is the primary endpoint, with progression-free survival and overall survival being the secondary endpoint.
Immune-Onc Therapeutics CEO Charlene Liao said: “IO-108 has demonstrated promising clinical efficacy as a single agent and has a well-established safety profile to combine with different standard of care regimens. Dosing the first patient in this trial represents a significant advancement for Immune-Onc and, more importantly, for people battling advanced liver cancer.
“We are excited to work with Roche to investigate how this combination therapy with IO-108 could enhance the current standard of care and offer improved outcomes for those who urgently need new therapeutic options.”
As per the clinical partnership agreement terms, Roche will oversee the operation of the study, with Immune-Onc supplying IO-108 and retaining worldwide rights to the antibody.
Approved by the US Food and Drug Administration for HCC, the combination of atezolizumab and bevacizumab received the National Comprehensive Cancer Network’s recommendation as the standard of care.
IO-108 may diminish immune suppression by using myeloid cell modulation in the tumour environment, potentially improving the overall anti-tumour response.
The antibody has a ‘high’ affinity and specificity towards the myeloid checkpoint leukocyte immunoglobulin like receptor B2 (LILRB2).
