Immune-Onc Therapeutics has entered into a clinical trial partnership with Roche for a Phase Ib/II clinical trial of IO-108 plus atezolizumab and bevacizumab to treat hepatocellular carcinoma (HCC), the most common type of liver cancer.
IO-108 is an LILRB2 directed antibody of Immune-Onc while atezolizumab and bevacizumab is Roche’s cancer immunotherapy combination regimen.
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The combination of atezolizumab and bevacizumab is currently the US Food and Drug Administration-approved standard of care for this condition.
Roche will carry out and sponsor the randomised, international Phase Ib/II trial, which is part of its Morpheus-Liver programme.
It is designed to assess IO-108 plus atezolizumab and bevacizumab (triplet) versus the existing standard regimen of atezolizumab and bevacizumab (doublet) as the first-line treatment of locally advanced, metastatic, and/or unresectable HCC.
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The study aims to enrol 40 subjects, who have not previously received systemic treatment, across 25 global sites to assess the efficacy, safety, and pharmacodynamics of the triplet against the doublet.
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By GlobalDataObjective response rate is the trial’s primary endpoint while progression-free survival and overall survival will be evaluated as key secondary endpoints.
Roche will oversee the trial operations while Immune-Onc will provide the IO-108 needed for the study and hold worldwide rights to the antibody.
Immune-Onc Therapeutics CEO and board chair Charlene Liao said: “We are excited to work with Roche to accelerate the development of IO-108.
“IO-108 has demonstrated clinical activity and an acceptable safety profile across multiple solid tumours as a monotherapy and in combination with T cell checkpoint inhibitors.
“The collaboration marks a significant milestone in establishing IO-108 as the preferred myeloid checkpoint inhibitor for combination with standard of care immunotherapy regimens in solid tumours.”
In a Phase I dose escalation trial in the US, IO-108 was shown to have a favourable safety profile and clinical benefit as a single agent, as well as for use along with anti-PD-1 to treat multiple tumour types.
