Immune-Onc Therapeutics Enters into Clinical Collaboration with BeiGene in China

� Collaboration with BeiGene is part of Immune-Onc’s global clinical development strategy targeting the LILRB family of myeloid checkpoints –

PALO ALTO, Calif.–(BUSINESS WIRE)–#ILT3–Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced 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.

“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’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, 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 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).

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.

Contacts

MEDIA
Tara Cooper

The Grace Communication Group

tara@gracegroup.us
media@immuneonc.com
650-303-7306