China-based biotech BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has entered into a clinical study cooperation and supply agreement with US-headquartered Immune-Onc Therapeutics. The collaboration aims to assess Immune-Onc’s first-in-class myeloid checkpoint inhibitors IO-108 and IO-202 in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, as part of its clinical development programs in China. Under the terms of the agreement, Immune-Onc will sponsor and fund the clinical trials for IO-108 and IO-202 in China, while BeiGene will provide tislelizumab. Immune-Onc retains global development and commercial rights to IO-108 and IO-202.
IO-108: Clinical Development and Mechanism
IO-108 is a fully human IgG4 monoclonal antibody (mAb) with high affinity and specificity towards 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. Preclinical data demonstrate that IO-108 functions as a myeloid checkpoint inhibitor, promoting innate and adaptive anti-cancer immunity. The ongoing Phase I study for IO-108 in adult cancer patients in the US (NCT05054348) has completed dose escalation. To date, IO-108 has been well tolerated and has demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab, an anti-PD-1 antibody. The company is actively enrolling for a Phase I clinical trial in China to evaluate IO-108 in solid tumors.
IO-202: Clinical Development and Mechanism
IO-202 is a humanized IgG1 mAb with high affinity and specificity towards LILRB4 (also known as ILT3). It blocks the interaction of LILRB4 with multiple ligands, including ApoE and Fibronectin, and has broad potential as an immunotherapy in both blood cancers and solid tumors. IO-202 has two ongoing clinical studies in the US: Its first Phase I trial is currently enrolling patients with acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) as a monotherapy and in combination with azacitidine (NCT04372433). The US FDA granted IO-202 Orphan Drug Designation status for the treatment of AML in 2020 and Fast Track Designation status for relapsed or refractory AML in 2022. The second Phase I trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 (NCT05309187).
Future Outlook
The collaboration between BeiGene and Immune-Onc underscores the potential of combining innovative myeloid checkpoint inhibitors with established anti-PD-1 therapies. By leveraging the strengths of both companies, the partnership aims to advance the development of new treatment options for patients with various cancers.-Fineline Info & Tech
