Immune-Onc Therapeutics Doses First Patient with IO-108 in Global Phase 1b/2 Liver Cancer Study in Collaboration with Roche
Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage biopharmaceutical company focused on developing innovative therapies in immunology and oncology, has announced a significant milestone in its ongoing efforts to combat liver cancer. The company has dosed the first patient in a Phase 1b/2 clinical trial evaluating IO-108, an advanced antibody therapy targeting LILRB2 (also known as ILT4), as a first-line treatment for locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC). This groundbreaking study is being conducted in collaboration with Roche and involves a combination therapy approach using Roche’s atezolizumab (Tecentriq®) and bevacizumab (Avastin®).
Advancing Cancer Treatment Through Myeloid Cell Inhibition
IO-108 is a pioneering antibody designed to inhibit LILRB2, a myeloid cell inhibitory receptor that plays a crucial role in immune suppression within the tumor microenvironment. By targeting this receptor, IO-108 has the potential to reprogram myeloid cells, reduce immune suppression, and enhance anti-tumor immune responses. This approach is particularly promising for patients with HCC, a form of liver cancer with limited effective treatment options.
“IO-108 has demonstrated promising clinical efficacy as a monotherapy and has a well-established safety profile when combined with standard-of-care treatments,” stated Charlene Liao, Ph.D., Chief Executive Officer of Immune-Onc. “Dosing the first patient in this trial is a major milestone for Immune-Onc and, more importantly, for patients battling advanced liver cancer. We are thrilled to collaborate with Roche to explore how this novel combination could improve current treatment paradigms and offer new hope to those in need.”
The Significance of the Atezolizumab-Bevacizumab Combination in HCC
Atezolizumab and bevacizumab have already established themselves as a first-line standard of care for HCC. This combination was the first cancer immunotherapy regimen approved by the U.S. Food and Drug Administration (FDA) for HCC and is recommended by the National Comprehensive Cancer Network (NCCN). The therapy works by harnessing the immune system to attack cancer cells while also inhibiting angiogenesis, a process by which tumors develop new blood vessels to sustain growth.
The addition of IO-108 to this established regimen is expected to provide enhanced anti-tumor efficacy by modulating the immune environment in HCC tumors. By reducing immune suppression and enhancing T-cell activation, the triplet combination could potentially lead to improved clinical outcomes for patients with this aggressive disease.
Study Design and Objectives
This Phase 1b/2 study is part of Roche’s Morpheus-Liver program, a global initiative aimed at evaluating innovative combination therapies for liver cancer. The trial is designed as a randomized, controlled study to assess the safety and efficacy of IO-108 in combination with atezolizumab and bevacizumab compared to the standard-of-care doublet therapy.
Key Features of the Study:
- Patient Population: The study will enroll patients with locally advanced, metastatic, and/or unresectable HCC who have not received prior systemic treatment.
- Enrollment: 40 patients will be recruited across 25 clinical sites worldwide for the IO-108-containing arm, which will be compared to an active control arm receiving atezolizumab and bevacizumab.
- Primary Endpoint: The primary measure of success will be the objective response rate (ORR), assessing how many patients experience tumor shrinkage or complete response to the treatment.
- Secondary Endpoints: Key secondary outcomes include progression-free survival (PFS) and overall survival (OS), critical metrics for determining the long-term benefit of the treatment.
Under the terms of the collaboration agreement, Roche will oversee study operations while Immune-Onc will provide IO-108 for the trial. Importantly, Immune-Onc retains global rights to IO-108, positioning the company strategically for future commercial opportunities if the therapy proves effective.
Understanding Hepatocellular Carcinoma (HCC)
HCC is the most common form of liver cancer, accounting for approximately 90% of all cases in the United States. According to the American Cancer Society, more than 800,000 people worldwide are diagnosed with liver cancer each year, and the disease remains a major cause of cancer-related deaths, responsible for more than 700,000 fatalities annually. The burden of liver cancer is expected to grow significantly, with an estimated 55% increase in incidence and a 56% rise in mortality rates between 2020 and 2040.
The leading causes of HCC include chronic liver disease conditions such as:
- Chronic Hepatitis B and C Infections – Long-term viral infections contribute to liver inflammation and cirrhosis, increasing the risk of HCC.
- Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) – These metabolic conditions, often linked to obesity and diabetes, are emerging as major risk factors for liver cancer.
- Alcohol-Related Liver Disease (ALD) – Chronic alcohol consumption can cause liver damage and fibrosis, eventually leading to cirrhosis and an elevated risk of cancer.
- Cirrhosis from Various Causes – Regardless of the underlying cause, cirrhosis significantly raises the likelihood of developing HCC.
Due to the aggressive nature of HCC and the limited treatment options available, there is a critical need for new therapeutic approaches that can improve patient survival and quality of life.
The Future of IO-108 in Liver Cancer Therapy
Immune-Onc’s innovative approach to targeting myeloid cell inhibitory receptors has the potential to transform cancer immunotherapy. If successful, IO-108 could represent a breakthrough in treating HCC and potentially other cancers characterized by immune suppression in the tumor microenvironment.
Beyond this study, Immune-Onc is also actively exploring IO-108 in other cancer indications, aiming to broaden its impact across various tumor types. Given the promising early data from IO-108 as a monotherapy and in combination settings, researchers and industry experts are optimistic about its potential to address the unmet medical needs in oncology.
As clinical trials progress, Immune-Onc and Roche remain committed to advancing scientific innovation and bringing new, life-extending treatments to patients worldwide. With this latest milestone, the companies reaffirm their dedication to tackling one of the most challenging cancers and improving outcomes for those affected by HCC.
For more details on the trial, visit clinicaltrials.gov or refer to the official announcements from Immune-Onc and Roche.
