Immune-Onc Therapeutics Doses First Patient in Phase 1 Clinical Trial of IO-108 in Patients with Advanced Solid Tumors in China
– IO-108 is the first LILRB2-targeting antibody administered to Chinese patients –
– Implementation of IO-108 program in China initiates Immune-Onc’s global clinical development plan; Phase 1 trial has completed dose escalation in the U.S. in solid tumor patients –
PALO ALTO, CA, September 9, 2022 -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced the first patient has been treated with IO-108, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4), in a Phase 1 clinical trial in China for patients with advanced solid tumors.
The multicenter Phase 1 trial in China will evaluate the safety, tolerability, pharmacokinetics, and efficacy of IO-108 alone and in combination with anti-PD-1 as a potential treatment option for patients with advanced solid tumors.
The implementation of the IO-108 program in China is part of the Company’s strategic plan to develop IO-108 globally. A Phase 1 trial for IO-108 has completed dose escalation in the U.S. in solid tumor patients, which determined a preliminary recommended Phase 2 dose (RP2D) and multiple expansion cohorts have now opened. The objective of the Phase 1 trial in China is to leverage the clinical data obtained in the U.S. to enable concurrent clinical development in China and the U.S. and accelerate the overall IO-108 development program. Immune-Onc is leading the way in China in the development and potential commercialization of myeloid checkpoint inhibitors, such as IO-108.
“IO-108 is the very first LILRB2-targeting antibody administered to patients in China,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “The successful initiation of this study in China supports our vision and mission in developing first-in-class immunotherapy globally. This is an important milestone for the company and further demonstrates our global clinical and regulatory capabilities.”
“We are excited to work with top institutions and investigators in China to potentially bring a first-in-class therapeutic to Chinese patients. As a myeloid checkpoint inhibitor, IO-108 has demonstrated the ability to relieve immunosuppression in the tumor microenvironment by blocking LILRB2. The combination of IO-108 and anti-PD-1 may enable more patients across multiple solid tumor types to benefit from immune checkpoint inhibitors,” commented by Maggie Gu, China general manager of Immune-Onc. “We are planning to advance additional novel myeloid checkpoint inhibitors in our portfolio to clinical trials in China to bring new therapeutic options to patients and address high unmet medical needs.”
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’s annual meeting and the 2022 American Association for Cancer Research 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. This data enables the company to accelerate the global development of IO-108 in multiple expansion cohorts in select cancers as a monotherapy and in combination with T cell checkpoint inhibitors. The IO-108 Phase 1 clinical trial in China (NCT05508100) is currently enrolling patients.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that inhibit immune suppression in the tumor microenvironment.
Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. 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 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (bi-specific antibody targeting LILRB4), and multiple undisclosed programs for solid tumors and hematologic malignancies.
Immune-Onc 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 a strategic 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 Twitter and LinkedIn.
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