Immune-Onc Therapeutics Announces Clinical Collaboration with Roche for First-Line Treatment of Hepatocellular Carcinoma

▎WuXi AppTec Content Team Report

February 20,Yiming Biomedical Technology (Hangzhou) Co., Ltd. (Immune-Onc Therapeutics announced a collaboration with Roche to initiate a Phase 1b/2 clinical trial evaluating itsTargeting LILRB2 (ILT4) Potential "First-in-class" antibody IO-108In collaboration with RocheAnti-PD-L1 monoclonal antibody AtezolizumabAndAnti-VEGF Monoclonal AntibodyBevacizumab, for the first-line treatment of patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC).

IO-108 is a fully human IgG4 monoclonal antibody that canBinds with high affinity and specificity to the myeloid checkpoint LILRB2 (also known as ILT4), blocking the interaction of LILRB2 in the tumor microenvironment with ligands associated with cancer immune suppression, including HLA-G, ANGPTLs, SEMA4A, and CD1d.。Atezolizumab combined with bevacizumab is a first-line immunotherapy regimen for hepatocellular carcinoma approved by the U.S. FDA and is also a standard treatment recommended by the National Comprehensive Cancer Network (NCCN).

According to the press release from Yiming Biomedical Technology (Hangzhou) Co., Ltd., the Phase 1 dose-escalation study data of IO-108 in the United States was presented at the 2023 American Association for Cancer Research (AACR) Annual Meeting, showing good safety across multiple tumor types. Treatment with IO-108 as a monotherapy or in combination with anti-PD-1 antibodies demonstrated positive clinical benefits. IO-108 monotherapy and its combination with...Anti-PD-1 Antibody(Pembrolizumab, Cemiplimab, or Tislelizumab) in combination are being studied in expanded cohorts of adult patients with various cancers.

The global randomized Phase 1b/2 clinical trial conducted by Yiming Biomedical Technology (Hangzhou) Co., Ltd. in collaboration with Roche is part of Roche's Morpheus-Liver project. The trial will evaluate IO-108 in combination with atezolizumab and bevacizumab ("triple therapy") compared to the standard therapy of atezolizumab and bevacizumab ("double therapy") inPatients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma who have not received prior systemic therapyEfficacy in China.In the early stage of the trial, 40 liver cancer patients will be recruited globally across 25 centers to receive IO-108 triple therapy, with a randomized comparison against the dual therapy control group.The primary endpoint was the objective response rate, and key secondary endpoints included progression-free survival and overall survival.

Under the terms of the clinical collaboration agreement, Roche is responsible for the operation of this clinical trial, and Yiming Biomedical Technology (Hangzhou) Co., Ltd. will provide the IO-108 drug to support the trial while retaining global rights to IO-108.

CEO and Chairman of Yiming Biomedical Technology (Hangzhou) Co., Ltd.Dr. Liao Xiaoling"We are very pleased to accelerate the development of IO-108 with Roche."IO-108 monotherapy or combination therapy with T-cell checkpoint inhibitors has demonstrated clinical activity and acceptable safety in various solid tumors.This collaboration marks an important milestone for IO-108 as the preferred myeloid cell immune checkpoint inhibitor in combination with standard immunotherapy for the treatment of solid tumors."

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