On February 27, 2025 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, reported that the first patient has been dosed with IO-108 in a global clinical collaboration with Roche (Press release, Immune-Onc Therapeutics, FEB 27, 2025, View Source [SID1234650732]). The Phase 1b/2 trial is designed to evaluate IO-108, a first-in-class antibody targeting LILRB2 (also known as ILT4), in combination with Roche’s atezolizumab and bevacizumab as a potential first-line treatment for patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC).
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"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," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "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."
The atezolizumab and bevacizumab combination is the first cancer immunotherapy regimen approved by the U.S. Food and Drug Administration for HCC and is the standard of care recommended by the National Comprehensive Cancer Network. By modulating myeloid cells in the tumor environment, IO-108 may reduce immune suppression, thereby enhancing the overall anti-tumor response and the potential to improve patients’ clinical outcomes.
The trial, sponsored by Roche, is expected to enroll 40 patients across 25 sites worldwide in the IO-108-containing arm. This arm will be compared to an active control arm of the atezolizumab and bevacizumab combination.
ABOUT THE RANDOMIZED CLINICAL TRIAL
The Phase 1b/2 global, randomized HCC study is part of Roche’s Morpheus-Liver program. It will evaluate IO-108 in combination with atezolizumab and bevacizumab versus atezolizumab and bevacizumab, the standard of care in patients with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment.
Initially, 40 patients will be enrolled across 25 sites worldwide in the IO-108 triplet combination, which will be compared to an active control arm of the atezolizumab and bevacizumab doublet combination. The study’s primary endpoint is objective response rate, and key secondary endpoints include progression-free survival and overall survival.
Under the terms of the clinical collaboration agreement, Roche will manage the study operations, and Immune-Onc will supply IO-108 to support the trial while retaining global rights to IO-108.
Tecentriq (atezolizumab) and Avastin (bevacizumab) are registered trademarks of Genentech, a member of the Roche Group.
Learn more about the trial here.
ABOUT HEPATOCELLULAR CARCINOMA
According to the American Cancer Society1, more than 800,000 people are diagnosed with liver cancer each year worldwide. It is also one of the leading causes of cancer deaths worldwide, accounting for more than 700,000 deaths each year. The number of people diagnosed is predicted to rise, with the incidence of liver cancer increasing by 55.0% and the number of deaths increasing by 56.4% between 2020 and 20402. Hepatocellular carcinoma is the most common form of liver cancer in the United States, making up almost 90% of cases3. Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD), and cirrhosis resulting from these conditions4.
ABOUT IO-108
IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards the myeloid checkpoint, LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A, and CD1d. Clinical data from the U.S. Phase 1 dose escalation study of IO-108 (NCT05054348) was selected as an oral presentation at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and published in the Journal for ImmunoTherapy of Cancer in 2024, which demonstrated a favorable safety profile and encouraging clinical benefit utilizing IO-108 as a monotherapy and in combination with anti-PD-1 across multiple tumor types. A global, randomized Phase 1b/2 study is underway to evaluate IO-108 in combination with atezolizumab and bevacizumab as a potential first-line therapy for hepatocellular carcinoma (HCC).