LAIR1

Strength of clinical data presented to date support a registrational CMML study PALO ALTO, Calif.--(BUSINESS WIRE)-- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced the company will present additional positive interim Phase 1b expansion cohort data for IO-202 in patients with chronic myelomonocytic leukemia (CMML) at the 2024 European Hematology Association (EHA) Annual Meeting held virtually and in Madrid, Spain, June 13 – 16. CMML is a rare hematologic malignancy with poor survival outcomes, incurable with conventional therapy, and has no effective standard of care. Currently, hypomethylating agents (HMA), including azacitidine (AZA), are the only FDA-approved treatment option for CMML with only a 7-17% complete remission (CR) rate. Promising early-cycle responses, including a 53.8% (7 out of 13) CR rate (4 CR, 1 CR equivalent, and 2 CR bilineage), based on International Working Group 2023 response criteria, were observed in CMML patients treated with IO-202 in combination with AZA, with CRs lasting ten months and ongoing. The Phase 1b interim data continue to demonstrate that IO-202 is well tolerated. “Chronic myelomonocytic leukemia remains a disease with poor prognosis and risk of progression into acute myeloid leukemia (AML), resulting in a critical need for innovative medicines,” said IO-202 Phase 1b investigator Courtney DiNardo, M.D., MSCE, professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, Houston, TX. “We are encouraged by Phase 1b trial data showing early and sustained complete remissions among CMML patients, regardless of their prognosis or mutation status. This supports the potential of IO-202 in combination with azacitidine as a frontline therapy for CMML patients, and we are pleased to share these data with the medical community at EHA this year.” “IO-202 has favorable tolerability, a well-understood mechanism of action, and a consistent efficacy response that supports further study as a treatment option in both AML and CMML patients,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “We look forward to continued collaborations with our investigators and the FDA to plan and conduct our registrational study in frontline CMML patients.” Poster presentation details: Abstract Number: P792 (here) Title: Targeting LILRB4 (ILT3) Using IO-202 in Patients with Chronic Myelomonocytic Leukemia (CMML): Interim Efficacy, Safety, and Mechanism of Action Data from the Phase 1b Expansion Cohort Presenter: Ahmed Aribi, M.D., assistant professor, Division of Leukemia, City of Hope in Duarte, CA Session Title: Myelodysplastic Syndromes – Clinical Session Date and Time: Friday, June 14, 6-7 p.m. CEST ABOUT CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML) CMML is a rare form of blood cancer, occurring in 4 of every 1,000,000 people in the United States each year,1 or about 1,100 annual cases.2 CMML is characterized by a high monocyte count (>1x109/L peripheral monocytes with monocytes ≥ 10% of white blood count) and dysplastic features in the bone marrow.1 Current FDA-approved therapies for CMML are all hypomethylating agents, including azacitidine, only achieving a 7%-17% complete response rate.1 ABOUT LILRB4 (also known as ILT3) LILRB4, also known as ILT3, is an immune-modulatory transmembrane protein found on monocytes and monocyte-derived cells. LILRB4 is expressed on certain hematologic cancer cells, such as myelomonocytic leukemia blasts, and on certain pathogenic cells involved in autoimmunity and inflammatory processes. ABOUT IO-202 IO-202 is a first-in-class IgG1 antibody with specific, high-affinity binding to LILRB4 and depletes LILRB4 positive cells via antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. As such, IO-202 is a targeted therapy with broad potential in blood cancers and autoimmune and inflammatory diseases. IO-202 has completed the dose escalation part of the first-in-human, multicenter, open-label Phase 1 study in the U.S., and the data was presented at the European Hematology Association (EHA) Congress in 2023. This Phase 1 trial has advanced to the dose expansion stage to evaluate IO-202 in combination with azacitidine (NCT04372433) in patients with newly diagnosed chronic myelomonocytic leukemia (CMML) who have not received any hypomethylating agents (HMA). The U.S. Food and Drug Administration granted IO-202 Fast Track Designations for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory CMML, respectively. The FDA has also granted IO-202 Orphan Drug Designations for the treatment of AML and CMML, respectively. ABOUT IMMUNE-ONC THERAPEUTICS, INC. Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage biopharmaceutical company developing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors. Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB). 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 1b/2 clinical development for solid tumors, and IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), in Phase 1b clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). IO-202 is also being evaluated for immunology and inflammation applications. Additional assets in Immune-Onc’s pipeline include IO-312 (a novel bispecific antibody targeting LILRB4 and CD3), IO-106 (first-in-class antagonist antibody targeting LAIR1), and undisclosed immunology and oncology programs. Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene, Regeneron and Roche, to support its global product development plans for IO-108 and IO-202. It 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 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 and follow us on X and LinkedIn. Chronic myelomonocytic leukemia: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Mar 1;97(3):352-372. doi: 10.1002/ajh.26455. Epidemiology of myelodysplastic syndromes and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the NAACCR and SEER programs. Blood. 2008 Jul 1;112(1):45-52. doi: 10.1182/blood-2008-01-134858 View source version on businesswire.com: Contacts MEDIA CONTACT Tara Cooper The Grace Group tara@gracegroup.us media@immuneonc.com 650-303-7306 Source: Immune-Onc Therapeutics, Inc. View this news release online at:

▎药明康德内容团队编辑 6月11日，LG化学公司宣布其自主研发的抗癌新药“LB-LR1109”已在美国正式启动1期临床试验，并已开始招募受试者。根据LG化学公司新闻稿，LB-LR1109是一款靶向LILRB1的抗体药物。 白细胞免疫球蛋白样受体亚家族B（LILRB）是一个主要在髓系细胞中表达的蛋白家族，家族成员包括LILRB1~5以及一个亲缘接近的成员LAIR1。根据LG化学公司新闻稿， LILRB1蛋白不仅在免疫细胞T细胞里表达，而且在NK细胞（自然杀伤细胞）、巨噬细胞等其它免疫细胞的表面也同时出现。因此，靶向LILRB1的抗体区别于那些只单纯作用在T细胞等单一免疫细胞的免疫检查点抑制剂。 LB-LR1109为靶向LILRB1的单抗药物，该药物旨在干扰免疫检查点信号分子LILRB1（在多种免疫细胞中出现的）与癌细胞中出现防止免疫细胞攻击的蛋白质HLA-G相结合，同时起到激活体内免疫细胞整体功能的作用。2023年12月，LB-LR1109获得美国FDA批准开展临床试验。 本次在美国启动的临床试验计划将在韩国、美国召开，招募对象为原发性或转移性实体瘤患者，目的是评估LB-LR1109的安全性、耐药性、药物代谢动力学及药物效应动力学特性等。此外，LG化学在新闻稿中表示，其将通过与抗癌新药研发公司AVEO强化合作关系，进一步制定后续临床开发和申请许可的相关战略计划。 参考资料：[1] LG化学首次自主研发的免疫检查点抑制剂启动Ⅰ期临床试验. Retrieved June 11, 2024, from https://mp.weixin.qq.com/s/mI_nPCIjOcPzrLwaZ-0xCw 本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

– IO-202, in combination with azacitidine, has demonstrated clinically meaningful benefit for frontline CMML patients – – IO-202 is a first-in-class humanized IgG1 monoclonal antibody targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3) – PALO ALTO, Calif.--(BUSINESS WIRE)-- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced the company will present Phase 1b interim data for IO-202 in patients with chronic myelomonocytic leukemia (CMML) at the 2024 European Hematology Association (EHA) Annual Meeting held virtually and in Madrid, Spain, June 13 – 16. Promising early responses, including 4 out of 5 efficacy evaluable patients achieving complete remission (CR), were observed in the Phase 1b expansion study of hypomethylating agents-naïve CMML patients using the preliminary recommended Phase 2 dose of IO-202 in combination with azacitidine (AZA). Hypomethylating agents, including AZA, are the only FDA-approved treatment option for CMML, with only a 7-17% CR rate.1 Phase 1b interim data demonstrate that IO-202 is well tolerated in combination with azacitidine. All patients who achieved CR exhibited high baseline LILRB4 expression on bone marrow blasts, supporting the mechanism of action of IO-202 as a targeted therapy with antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Study enrollment is ongoing, and additional clinical data will be presented at EHA. “CMML is an incurable cancer with a poor prognosis and limited treatment options. We are highly encouraged by the early complete responses seen in our evaluable patient pool,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “We believe that the addition of IO-202 to the standard of care treatment, such as azacitidine, has the potential to change the treatment landscape of CMML.” Poster presentation details: Abstract Number: P792 (here) Title: Targeting LILRB4 (ILT3) Using IO-202 in Patients with Chronic Myelomonocytic Leukemia (CMML): Interim Efficacy, Safety, and Mechanism of Action Data from the Phase 1b Expansion Cohort Presenter: Ahmed Aribi, M.D., assistant professor, Division of Leukemia, City of Hope in Duarte, CA Session Title: Myelodysplastic Syndromes – Clinical Session Date and Time: Friday, June 14, 6-7 p.m. CEST ABOUT CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML) CMML is a rare form of blood cancer, occurring in 4 of every 1,000,000 people in the United States each year, 1 or about 1,100 annual cases.2 CMML is characterized by the presence of a high monocyte count (>1x109/L peripheral monocytes with monocytes ≥ 10% of white blood count) along with dysplastic features in the bone marrow.1 Current FDA-approved therapies for CMML are all hypomethylating agents, including azacitidine, only achieving a 7%-17% complete response rate.1 ABOUT LILRB4 (also known as ILT3) LILRB4, also known as ILT3, is an immune-modulatory transmembrane protein found on monocytes and monocyte-derived cells. LILRB4 is expressed on certain hematologic cancer cells, such as myelomonocytic leukemia blasts, and on certain pathogenic cells involved in autoimmunity and inflammatory processes. About IO-202 IO-202 is a first-in-class IgG1 antibody with specific, high-affinity binding to LILRB4 and depletes LILRB4 positive cells via antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. As such, IO-202 is a targeted therapy with broad potential in blood cancers and autoimmune and inflammatory diseases. IO-202 has completed the dose escalation part of the first-in-human, multicenter, open-label Phase 1 study in the U.S., and the data was presented at the European Hematology Association (EHA) Congress in 2023. This Phase 1 trial has advanced to the dose expansion stage to evaluate IO-202 in combination with azacitidine (NCT04372433) in patients with newly diagnosed chronic myelomonocytic leukemia (CMML) who have not received any hypomethylating agents (HMA). The U.S. Food and Drug Administration granted IO-202 Fast Track Designations for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory CMML, respectively. The FDA has also granted IO-202 Orphan Drug Designations for the treatment of AML and CMML, respectively. ABOUT IMMUNE-ONC THERAPEUTICS, INC. Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage biopharmaceutical company developing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors. Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB). 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 1b/2 clinical development for solid tumors, and IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), in Phase 1b clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). IO-202 has the potential to be the best-in-class antibody therapy for lupus and can extend to other indications in immunology and inflammation. Additional assets in Immune-Onc’s pipeline include IO-312 (a novel bispecific antibody targeting LILRB4 and CD3), IO-106 (first-in-class antagonist antibody targeting LAIR1), and undisclosed immunology and oncology programs. Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene, Regeneron and Roche, to support its global product development plans for IO-108 and IO-202. It 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 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 and follow us on X and LinkedIn. Chronic myelomonocytic leukemia: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Mar 1;97(3):352-372. doi: 10.1002/ajh.26455. Epidemiology of myelodysplastic syndromes and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the NAACCR and SEER programs. Blood. 2008 Jul 1;112(1):45-52. doi: 10.1182/blood-2008-01-134858