IO-202 (anti-LILRB4) is well tolerated, with encouraging clinical responses in both monotherapy and combination therapy FDA granted Fast Track designation to IO-202 for the treatment of relapsed or refractory CMML PALO ALTO, Calif.--(BUSINESS WIRE)-- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage oncology company dedicated to the discovery and development of novel biotherapeutics by targeting inhibitory receptors on myeloid cells, today announced Phase 1 data for IO-202, a first-in-class humanized IgG1 monoclonal antibody targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3). Data from the dose escalation part of the Phase 1 study evaluating patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) will be presented during a poster session at the European Hematology Association (EHA) Annual Meeting in Frankfurt, Germany on June 9, 2023. “AML is the most common form of acute leukemia in adults in the U.S. and is characterized by high rates of relapsed and refractory disease. Monocytic AML is especially in need of break-through medicine as it is often resistant to standard-of-care treatment. CMML is a rare leukemia overlap syndrome characterized by the accumulation of monocytes in the blood and bone marrow, with both myeloproliferative and myelodysplastic features,” said IO-202 Phase 1 investigator, Courtney DiNardo, M.D., MSCE, associate professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, Houston, TX. “These results, showing strong safety and promising clinical activity as both monotherapy and in combination with a standard-of-care chemotherapy for monocytic AML and CMML, suggest that LILRB4 may be an important therapeutic target for hard-to-treat blood cancers.” “We are very encouraged with the efficacy data of IO-202 as a single agent and in combination with azacitidine in heavily pre-treated patients with R/R AML and CMML,” said Paul Woodard, MD, chief medical officer of Immune-Onc. “Based on the data, we have developed a patient enrichment strategy for the ongoing dose expansion phase of the study to select AML patients who would most likely respond to IO-202. We are also pleased to receive the FDA Fast Track designation for IO-202 for the treatment of R/R CMML, which follows the R/R AML Fast Track designation received in 2022. We look forward to working closely with the FDA and trial investigators to accelerate the clinical development of IO-202 in hematologic malignancies.” The Phase 1 multicenter, open-label, dose escalation study of IO-202 assessed the safety and tolerability of IO-202 in successive cohorts of patients with R/R AML with monocytic differentiation and R/R CMML as its primary objective. Secondary and exploratory objectives included pharmacokinetics, immunogenicity, pharmacodynamic (PD) biomarker effects, and clinical response rate of IO-202 as a monotherapy and in combination with azacitidine (AZA). Treatment with IO-202 was well tolerated. There were no dose-limiting toxicities observed and a maximum tolerated dose was not reached. In the monotherapy treatment cohorts, one CMML patient demonstrated clinical benefit for more than one year and one AML patient achieved a partial response (PR). In combination therapy cohorts, Complete Remission (CR) has been achieved and is on-going for over 10 months in an AML patient with high LILRB4 expression. Additionally, 3 out of 5 CMML patients achieved clinical benefit including Optimal Marrow Response. Based on the promising results of the dose escalation part of the study and utilizing a biomarker driven patient selection strategy, the Company has opened dose expansion cohorts to enroll AML patients with monocytic differentiations and high LILRB4, and CMML patients (IO-202-CL-001; NCT04372433). Poster presentation details are as follows: Abstract Number: P536 Title: A first-in-human Phase 1 study of IO-202 (anti-LILRB4 mAb) in Acute Myeloid Leukemia (AML) with monocytic differentiations and Chronic Myelomonocytic Leukemia (CMML) patients. Presenter: Courtney DiNardo, M.D., MSCE, Associate Professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, Houston, TX Session Title: Acute myeloid leukemia – Clinical Session Date and Time: Friday, June 9, 6:00 p.m. - 7:00 p.m. CEST Abstracts and full session details can be accessed through the EHA Online Program Planner ABOUT IO-202 IO-202 is a humanized IgG1 monoclonal antibody (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 in blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 causes depletion of cells expressing high LILRB4 through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), 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.: The Phase 1 trial is currently enrolling expansion cohorts of patients with monocytic (LILRB4 high) acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) in combination with standard-of-care agents such as azacitidine +/- venetoclax (NCT04372433). The U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020, as well as Fast Track designations for relapsed or refractory AML in 2022 and relapsed or refractory CMML in 2023. 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 oncology company dedicated to the discovery and development of novel biotherapeutics by targeting inhibitory receptors on myeloid cells. 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 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 (a novel bispecific antibody targeting LILRB4 and CD3 (LILRB4 x CD3)), and multiple undisclosed programs for solid tumors and hematologic malignancies. Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, 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 Twitter and LinkedIn. View source version on businesswire.com: Contacts MEDIA CONTACT Tara Cooper The Grace Communication Group tara@gracegroup.us media@immuneonc.com 650-303-7306 Source: Immune-Onc Therapeutics, Inc. View this news release online at:

临床1期快速通道临床结果孤儿药免疫疗法

2023-04-17

·BioSpace

Immune-Onc Therapeutics to Present Encouraging Phase 1 Data for IO-108 at AACR Annual Meeting 2023

– Phase 1 data show encouraging clinical benefit for IO-108 as a monotherapy and when combined with pembrolizumab, suggesting potential to overcome resistance to T-cell checkpoint inhibitors – – Preclinical data for IO-312, a novel bispecific antibody targeting LILRB4 (ILT3) and CD3 (LILRB4 x CD3) will be presented as a late-breaking poster at AACR 2023 – PALO ALTO, Calif.--(BUSINESS WIRE)-- Immune-Onc Therapeutics Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced encouraging Phase 1 dose escalation data for IO-108, a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4). The data will be presented in an oral session at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida, April 18. Preclinical data for IO-312, a novel bispecific antibody targeting LILRB4 (ILT3) and CD3 (LILRB4 x CD3) will also be presented on April 18 as a late-breaking poster at AACR 2023. “We are very encouraged to see promising signs of clinical activity across multiple solid tumor types and a favorable safety pro our first-in-class myeloid checkpoint inhibitor, IO-108,” said Charlene Liao, Ph.D., chief executive officer and board chair of Immune-Onc. “Our data demonstrates the utility of IO-108 as a new therapeutic modality to address key unmet needs for patients with solid tumors that do not respond to, develop resistance to, or relapse following, treatment with T cell checkpoint inhibitors.” The Phase 1 dose escalation study of IO-108 is intended to evaluate primary objectives of safety and tolerability, and secondary and exploratory objectives of pharmacokinetics, immunogenicity, pharmacodynamic (PD) biomarker effects, and antitumor activity of IO-108 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. The trial enrolled 25 advanced cancer patients with relapsed/refractory solid tumors. Patients received escalating doses of IO-108 (60 mg -1800 mg) intravenously once every three weeks (Q3W). Treatment with IO-108 was well-tolerated to the maximum administered dose (1800 mg Q3W); the maximum tolerated dose was not reached. Among 23 evaluable patients (11 monotherapy, 12 combination therapy plus 1 crossover), results showed 1 complete response and 4 stable disease patients in the monotherapy cohorts and 3 partial responses and 4 stable disease patients in the combination cohorts. The 4 responding patients remain on study with an ongoing treatment duration of 8 to 12+ months as of abstract submission. Clinical benefit correlated with baseline characteristics and post-treatment changes in PD biomarkers including reprogramming of myeloid cells and activation of T cells. “Treating patients who are refractory to treatment with T-cell immune checkpoint inhibitors remains an ongoing challenge across many tumor types,” said IO-108 Phase 1 investigator, Matthew H. Taylor, M.D., Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon. “I am very encouraged by these results, particularly the complete response to IO-108 monotherapy treatment in the Merkel cell carcinoma patient who had progressed on prior anti-PD-1 treatments. These findings suggest that LILRB2 is a critically important immunotherapy target.” The initial data from dose escalation supports further development of IO-108. The preliminary recommended Phase 2 dose (RP2D) is 1200 mg Q3W which is projected to achieve full receptor occupancy in at least 90% of patients. The ongoing IO-108 Phase 1 study is actively enrolling several biomarker-driven dose expansion cohorts, using IO-108 at RP2D as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab, cemiplimab or tislelizumab), both in the U.S. and China. Immune-Onc oral and poster presentation details are as follows: Abstract Number: 9498 Title: A first-in-human phase 1 trial of IO-108, an antagonist antibody targeting LILRB2 (ILT4), as monotherapy and in combination with pembrolizumab in adult patients with advanced relapsed or refractory solid tumors: Dose escalation study Presenter: Matthew H. Taylor, M.D., Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon Session Title: Novel Immunotherapy Combination Clinical Trials Session Date and Time: Tuesday, April 18, 2:30 p.m. - 4:30 p.m. ET Presentation Number: CT040 Abstract Number: LB217 Title: A novel bispecific LILRB4/CD3 antibody with potent killing of monocytic acute myeloid leukemia cells Presenter: Charlene Liao, Ph.D., chief executive officer of Immune-Onc Therapeutics, Inc. Session Title: Late-Breaking Research: Immunology 2 Session Date and Time: Tuesday, April 18, 9:00 a.m. - 12:30 p.m. ET Location: Poster Section 36, Poster Board #10 Abstracts and full session details can be accessed through the AACR Online Program Planner 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 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 has completed dose escalation in the U.S. (NCT05054348) and is actively enrolling several expansion cohorts, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab, cemiplimab or tislelizumab), both in the U.S. and China. 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. 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 reverse 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, a first-in-class 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, a first-in-class antagonist antibody targeting LAIR1, IO-312, a novel bispecific antibody targeting LILRB4 and CD3 (LILRB4 x CD3), and multiple undisclosed programs. Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, 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 Twitter and LinkedIn.

临床1期AACR会议临床结果免疫疗法

2023-03-16

·PRNewswire

Leading MS/PML Experts Recommend Genetic Testing to Prevent Fatal Brain Infection

Experts argue preventative screening should become new standard of care NEWPORT BEACH, Calif., March 16, 2023 /PRNewswire/ -- In an editorial in the journal Frontiers in Neurology, two leading multiple sclerosis (MS) experts are advocating for genetic testing to identify MS patients who are at higher risk of developing a devastating side effect from their medications. People with MS are faced with the excruciating decision of whether they should take medications that are effective in slowing the progression of the disease, but may also trigger this potentially fatal complication, a rare brain infection called progressive multifocal leukoencephalopathy (PML). Continue Reading "I would have taken the test in a minute. If I knew I was positive, I wouldn't have taken Tysabri." Tweet this The two authorities, Joseph Berger, MD, and Hans-Peter Hartung, MD, write, "The availability of a simple, relatively inexpensive test that can identify the genes that put one at risk for PML would be enormously helpful in the management of patients. The widespread use of such testing could potentially allow the physician to use alternative therapies that do not carry the same risk of PML." Dr. Berger is MS Division Chief at the University of Pennsylvania Perelman School of Medicine and Dr. Hartung is Neurology Chair of Heinrich Heine University in Düsseldorf, Germany and a Specialty Chief Editor for Frontiers in Neurology The editorial was written in support of a recently published study that confirmed a strong link between four genetic mutations and PML. The original study, also published in Frontiers in Neurology, found that these four variants were far more common among patients who took PML-linked drugs and developed PML than patients who took those drugs and did not develop PML. Neither of the editorial authors were affiliated with the original study. PML Patient and Tysabri Inventor Support Genetic Testing "Preventative screening for these variants should become part of the standard of care," said Dr. Lawrence Steinman, whose lab developed Tysabri, a breakthrough MS treatment that carries a Black Box Warning for PML. And when Franklin Jordan, 58, a PML survivor who developed the side-effect after taking Tysabri, learned about the availability of the genetic test, he said, "I would have taken the test in a minute. If I knew I was positive, I wouldn't have taken Tysabri." It is expected that preventative screening will become a routine part of patient care, as recommended by Drs. Berger, Hartung, and Steinman. But to fill the immediate need, the PML Foundation is currently offering a free test online. Simpler than a COVID swab, the at-home saliva test is processed in a CLIA-certified lab by PreventionGenetics, a leader in the field for almost 20 years. The free test is available at pmlrisktest.org. PML is caused by the JC virus, which is very common but remains dormant in the vast majority of carriers. However, certain immune-modifying drugs, including those used to treat MS, have been found to induce PML in rare cases. Many MS medications currently carry a PML warning, including Tysabri, Ocrevus, and Rituxan, as well as Gilenya, Kesimpta, Mavenclad, Mayzent, Ponvory, and Tecfidera. But it's not just MS drugs that can lead to PML; medications widely prescribed for blood cancers and organ transplants, as well as autoimmune diseases like inflammatory bowel disease, lupus, and rheumatoid arthritis also include PML warnings on their drug labels. Drug-induced PML is on the rise as more powerful immunosuppressant therapies are developed. Since 2011, drug-induced PML cases reported to the FDA have more than doubled. And in 2022 alone, there were nearly 600 cases in the FDA's adverse event reporting system. In that database, over 70 drugs have been linked to PML. Link to editorial: doi.org/10.3389/fneur.2023.1146027 The original study was funded by Emerald Lake Safety LLC and Population Bio, Inc. About Emerald Lake Safety Emerald Lake Safety (ELS) conducts research into the mechanisms behind Serious Adverse Events associated with marketed pharmaceuticals. We conduct clinical and genomic research both on our own and in conjunction with leading academics and scientists from around the world. For more information visit . About Population Bio Population Bio is a precision medicine company with a mission to make pharmaceuticals safer and more effective. By discovering disease-relevant genetic biomarkers, Population Bio helps develop targeted therapies and companion diagnostics faster and more cost effectively. Population Bio's patented technology platform is currently addressing complex neurological diseases such as Alzheimer's, Parkinson's, and Autism, as well as women's health conditions such as Endometriosis. For more information visit . Press Contact: Amy Losak 917-520-1207 [email protected] SOURCE Emerald Lake Safety LLC and Population Bio, Inc.

100 项与 Immune-based therapeutics(Phigenix, Inc.) 相关的药物交易

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