IO-202 / Immune-Onc Therap - LARVOL DELTA

A phase 1 study of IO-202, an anti-LILRB4 antibody, in chronic myelomonocytic leukemia and acute myeloid leukemia. (PubMed, Blood Neoplasia) - P1 | "Herein, we present the phase 1a dose escalation data of IO-202 as monotherapy and in combination with azacitidine (AZA) in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and R/R chronic myelomonocytic leukemia (CMML), and the phase 1b dose expansion data of IO-202 combined with AZA for the treatment of hypomethylating agent (HMA)-naïve CMML. Overall, the data support a future pivotal study of IO-202 + AZA in patients with HMA-naïve CMML. This trial was registered at www.clinicaltrials.gov as #NCT04372433."

Clinical • Journal • P1 data • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • Thrombocytopenia • Transplantation • LILRB4

IO-202-CL-001: IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML (clinicaltrials.gov) - P1 | N=67 | Completed | Sponsor: Immune-Onc Therapeutics | Active, not recruiting ➔ Completed | N=106 ➔ 67 | Trial completion date: Jan 2027 ➔ Jan 2025 | Trial primary completion date: Jan 2026 ➔ Jan 2025

Enrollment change • Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • LILRB4

Immune-Onc Therapeutics Presents Updated Data from Phase 1b Study of IO-202 Highlighting Promising Efficacy and Safety Data in CMML Patients at 2024 American Society of Hematology (ASH) Annual Meeting (Businesswire) - P1b | N=106 | NCT04372433 | Sponsor: Immune-Onc Therapeutics | "The updated results from this trial in hypomethylating agent-naïve CMML showed that IO-202, in combination with AZA, achieved a complete remission (CR) rate of 50.0% and an overall response rate (ORR) of 66.7% among the 18 efficacy evaluable patients based on the International Working Group (IWG) 2023 response criteria for higher-risk myelodysplastic syndromes.1 Further analysis revealed that efficacy favors patients with high LILRB4 expression, who achieved a CR rate of 83.3% (5/6) and an ORR of 100% (6/6). Responses were observed in patients across all subgroups, including those with proliferative disease, elevated blast counts, unfavorable mutations, and high symptom scores....In this study, treatment with IO-202 in combination with AZA enabled 38.9% of the patients to successfully bridge to HCT."

P1 data • Chronic Myelomonocytic Leukemia

IO-202-CL-001: IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML (clinicaltrials.gov) - P1 | N=106 | Active, not recruiting | Sponsor: Immune-Onc Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • LILRB4

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 (EHA 2024) - P1 | "Hypomethylating agents (HMA) including azacitidine (AZA) are the only FDA-approved treatment option for CMML with only 7% to 17% Complete Remission (CR) rate. IO-202 has been shown to be safe and well tolerated in combination with AZA. Promising early responses,including 80% CR rate (4 out of 5) were observed in CMML patients. Enrollment is ongoing and additional datawill be presented at the Congress."

Clinical • P1 data • Bone Marrow Transplantation • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • LILRB4

Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: Immune-Onc Therapeutics | Active, not recruiting ➔ Completed | N=200 ➔ 22

Combination therapy • Enrollment change • Metastases • Trial completion • Oncology • Solid Tumor • LILRB4

Immune-Onc Therapeutics to Present Additional Positive Interim Data from IO-202 Phase 1b Expansion Cohort in Patients with Chronic Myelomonocytic Leukemia (CMML) at 2024 European Hematology Association (EHA) Annual Congress (Businesswire) - P1b | N=106 | NCT04372433 | Sponsor: Immune-Onc Therapeutics | "Immune-Onc Therapeutics...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....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."

P1 data • Chronic Myelomonocytic Leukemia

Immune-Onc Therapeutics Announces Presentation of IO-202 Phase 1b Interim Data of Patients with Chronic Myelomonocytic Leukemia (CMML) at 2024 European Hematology Association (EHA) Annual Congress (Businesswire) - P1b | N=106 | NCT04372433 | Sponsor: Immune-Onc Therapeutics | "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)....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."

P1 data • Trial status • Chronic Myelomonocytic Leukemia

Immune-Onc Therapeutics Announces Orphan Drug Designation Granted by US FDA for IO-202 (Anti-LILRB4) for the Treatment of Chronic Myelomonocytic Leukemia (CMML) (Businesswire) - "Immune-Onc Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for IO-202 for the treatment of chronic myelomonocytic leukemia (CMML)....IO-202 is a first-in-class antagonist antibody with specific, high affinity binding to Leukocyte Immunoglobulin-Like Receptor subfamily B4 (LILRB4) and serves as a targeted therapy with broad potential in blood cancers, autoimmune and inflammatory diseases."

Orphan drug • Chronic Myelomonocytic Leukemia

IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML (clinicaltrials.gov) - P1 | N=106 | Recruiting | Sponsor: Immune-Onc Therapeutics | Trial completion date: May 2025 ➔ Jan 2027 | Trial primary completion date: Dec 2023 ➔ Jan 2026

Monotherapy • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • LILRB4

Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Active, not recruiting | Sponsor: Immune-Onc Therapeutics | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Oncology • Solid Tumor

A FIRST-IN-HUMAN PHASE 1 STUDY OF IO-202 (ANTI-LILRB4 MAB) IN ACUTE MYELOID LEUKEMIA (AML) WITH MONOCYTIC DIFFERENTIATION AND CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML) PATIENTS (EHA 2023) - P1 | "In combination therapy, 1 AML patient with high LILRB4 expression who was refractory to azacitidine and venetoclax based combination therapy achieved CR, ongoing at 7+ months. IO-202 is safe and well tolerated as monotherapy and in combination with AZA. Encouraging responses, including monotherapy activity, ongoing CR in an AML patient with high LILRB4 expression, and PR and Optimal Marrow Response in CMML patients, were observed. PD biomarker data supported proposed MOA."

Clinical • P1 data • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Fatigue • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Pain • APOE • LILRB4

Immune-Onc Therapeutics Presents IO-202 Phase 1 Data in Patients with Relapsed or Refractory AML and CMML at the EHA Annual Meeting 2023 (Businesswire) - P1 | N=122 | NCT04372433 | Sponsor: Immune-Onc Therapeutics | "Immune-Onc Therapeutics...today announced Phase 1 data for IO-202...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 annual meeting...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."

P1 data • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Immune-Onc Therapeutics | Trial primary completion date: Apr 2023 ➔ Apr 2024

Combination therapy • Metastases • Trial primary completion date • Oncology • Solid Tumor

Novel Myeloid Checkpoint Inhibitors Targeting the LILRB (ILT) Family Members (PEGS 2023) - "These include IO-108, an antagonist antibody targeting LILRB2 (ILT4), in Phase I clinical development for solid tumors and IO-202; an antagonist antibody targeting LILRB4 (ILT3), in Phase I 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."

Checkpoint inhibition • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • LAIR1 • LILRB4

[VIRTUAL] IO-202, a first-in-class LILRB4 antagonist antibody, activates dendritic cells and inhibits solid tumor growth in preclinical studies (AACR 2021) - P1 | "In conclusion, our data suggest that LILRB4 functions as a myeloid checkpoint in multiple cancer types and that IO-202, the first-in-class LILRB4 antagonist antibody, enhances dendritic cell function and T cell activation in vitro and anti-tumor immunity in a solid tumor model in vivo. These data demonstrate the therapeutic potential of IO-202 as a myeloid checkpoint inhibitor for solid tumors."

Preclinical • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Oncology • Solid Tumor

IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML (clinicaltrials.gov) - P1 | N=122 | Recruiting | Sponsor: Immune-Onc Therapeutics | Trial completion date: Mar 2024 ➔ May 2025

Monotherapy • Trial completion date • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Immune-Onc Therapeutics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Oncology • Solid Tumor

Immune-Onc Therapeutics to Present Trial in Progress Poster for Phase 1 Study of IO-202 in Patients with Advanced Solid Tumors at the Society for Immunotherapy of Cancer Annual Meeting (Businesswire) - "Immune-Onc Therapeutics, Inc...announced that it will present a Trial in Progress poster at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held in Boston and virtually from November 8 –12, 2022...The poster presentation will highlight the trial design, dosing regimen, and study protocol for the company's ongoing Phase 1 clinical trial of IO-202, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with advanced solid tumors...This study consists of two parts: a dose escalation portion to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-202 alone and in combination with pembrolizumab, an anti-PD-1; and a dose expansion portion using the recommended Phase 2 dose of IO-202 in combination with pembrolizumab or other anti-PD-1s in multiple solid tumor types."

Clinical protocol • Oncology • Solid Tumor

Immune-Onc Therapeutics Enters into Clinical Collaboration with BeiGene in China (Businesswire) - "Immune-Onc Therapeutics, Inc...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....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."

Licensing / partnership • Oncology • Solid Tumor

IO-202 as Monotherapy and IO-202 Plus Azacitidine in Patients in AML and CMML (clinicaltrials.gov) - P1 | N=119 | Recruiting | Sponsor: Immune-Onc Therapeutics Inc | N=44 ➔ 119

Enrollment change • Monotherapy • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Immune-Onc Therapeutics to Participate in the Raymond James LILRB/ILT Symposium on Myeloid Checkpoint Therapeutics in Cancer (Businesswire) - "Immune-Onc Therapeutics, Inc...announced the Company will present at the virtual LILRB/ILT Symposium: A Deep Dive into Myeloid Checkpoint Therapeutics in Cancer on Tuesday, April 26, 2022, at 2:00 PM EDT...will provide a corporate overview, including recent clinical development progress and anticipated milestones for 2022 and beyond. Dr. Chengcheng (Alec) Zhang, Professor of Physiology at UT Southwestern Medical Center and Scientific Founder of Immune-Onc, will give an expert presentation on the LILRB/ILT family of receptors as myeloid checkpoint targets in immuno-oncology at 2:30 PM EDT...Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development, including IO-108...in Phase 1 clinical development for solid tumors and IO-202....in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors."

Clinical • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Immune-Onc Therapeutics Doses First Patient in Phase 1 Clinical Trial of IO-202, a First-in-Class Myeloid Checkpoint Inhibitor Targeting LILRB4, in Patients with Advanced Solid Tumors (Businesswire) - "Immune-Onc Therapeutics...announced that the first patient has been dosed in the Company’s Phase 1 clinical trial of IO-202, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with advanced solid tumors (NCT05309187)....Phase 1 multicenter dose-escalation and dose-expansion trial evaluating IO-202 as a monotherapy and in combination with an anti-PD-1 is initiated and expected to enroll 200 patients with advanced solid tumors....This is the second clinical trial for the IO-202 program..."

Trial status • Oncology • Solid Tumor

Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Not yet recruiting | Sponsor: Immune-Onc Therapeutics Inc

Combination therapy • New P1 trial • Oncology • Solid Tumor

Immune-Onc Therapeutics Receives FDA Fast Track Designation for IO-202, the First Anti-LILRB4 Myeloid Checkpoint Inhibitor, for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML) (Businesswire) - "Immune-Onc Therapeutics, Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IO-202...for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML)."

Fast track designation • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology