Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage biopharmaceutical company dedicated to advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced a Phase 1b/2 clinical trial collaboration with Roche to evaluate Immune-Onc’s IO-108, a first-in-class antibody targeting LILRB2 (also known as ILT4), in combination with Roche’s atezolizumab and bevacizumab for the first-line treatment of patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC). Atezolizumab and bevacizumab is the first cancer immunotherapy combination regimen approved by the U.S. Food and Drug Administration for this setting and is the recommended standard of care by the National Comprehensive Cancer Network.

“We are excited to work with Roche to accelerate the development of IO-108,” said Charlene Liao, Ph.D., chief executive officer and board chair of Immune-Onc. “IO-108 has demonstrated clinical activity and an acceptable safety profile across multiple solid tumors as 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 tumors.”

Under the collaboration, Roche will sponsor and conduct the global, randomized Phase 1b/2 trial to evaluate the safety, efficacy and pharmacodynamics of IO-108 in combination with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab, the standard of care treatment regimen for advanced liver cancer. 

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 (“triplet”) versus atezolizumab and bevacizumab (“doublet”), 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 presented at the 2023 American Association for Cancer Research annual meeting and 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. IO-108 is being studied in several expansion cohorts in adult cancer patients as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab, cemiplimab or tislelizumab). 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). 

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage biopharmaceutical company dedicated to discovering and developing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB). Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1b/2 clinical development for solid tumors, and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1b clinical development for the treatment of acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). IO-202 has the potential to be the best-in-class antibody therapy for lupus and can extend to other indications in immunology and inflammation. Additional assets in Immune-Onc’s pipeline include IO-312 (a novel bispecific antibody targeting LILRB4 and CD3), IO-106 (first-in-class antagonist antibody targeting LAIR1), and undisclosed immunology and oncology programs.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene, Regeneron and Roche, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on X and LinkedIn.

MEDIA CONTACT
Tara Cooper
The Grace Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306