On October 10, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, reported it has entered into a clinical trial collaboration and supply agreement with BeiGene to evaluate 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 (Press release, Immune-Onc Therapeutics, OCT 10, 2022, View Source [SID1234621871]).
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"We are delighted to partner with BeiGene. The preclinical and clinical data to date of our first-in-class LILRB antagonists IO-108 and IO-202 have shown that there is great potential in combining our myeloid checkpoint inhibitors with T cell checkpoint inhibitors, such as tislelizumab, to potentially improve clinical outcomes," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "By expanding our reach with BeiGene in China, we have an opportunity to treat a broader array of patients with significant unmet medical needs."
"We are thrilled to partner with Immune-Onc to evaluate the combination of tislelizumab with their novel myeloid checkpoint inhibitors IO-108 and IO-202," added Lai Wang, Ph.D., Global Head of R&D of BeiGene. "Based on strong preclinical and emerging clinical data, we believe there is good synergy between PD-1 and LILRB antagonists for the treatment of solid tumors. We look forward to working with Immune-Onc to explore the possibility of combination therapy with our products, which may bring more treatment options to cancer patients in China."
Under the terms of the collaboration, Immune-Onc will sponsor and fund the IO-108 and IO-202 clinical trials in China, and BeiGene will provide tislelizumab. Immune-Onc retains global development and commercial rights to IO-108 and IO-202.
ABOUT IO-108
IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s annual meeting and the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity.
The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation. To date, IO-108 has been well tolerated with 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 a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors.
ABOUT IO-202
IO-202 is a humanized IgG1 monoclonal antibody 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. In hematologic malignancies, preclinical studies showed that IO-202 converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of blood cancer cells. In the context of solid tumors, preclinical data presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in an immune competent model in vivo.
IO-202 has two ongoing clinical studies in the U.S.: Its first Phase 1 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 U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020 and Fast Track designation for relapsed or refractory AML in 2022. The second Phase 1 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).