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DRUG:

IO-202

i
Other names: IO-202, IO202, IO 202
Company:
Immune-Onc Therap
Drug class:
ILT-3 inhibitor
4ms
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, Immune-Onc Therapeutics | Recruiting --> Active, not recruiting
Enrollment closed
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LILRB4 (Leukocyte Immunoglobulin Like Receptor B4)
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Venclexta (venetoclax) • azacitidine • IO-202
6ms
Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors (clinicaltrials.gov)
P1, N=22, Completed, Immune-Onc Therapeutics | Active, not recruiting --> Completed | N=200 --> 22
Trial completion • Enrollment change • Combination therapy • Metastases
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LILRB4 (Leukocyte Immunoglobulin Like Receptor B4)
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Keytruda (pembrolizumab) • IO-202
11ms
IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML (clinicaltrials.gov)
P1, N=106, Recruiting, Immune-Onc Therapeutics | Trial completion date: May 2025 --> Jan 2027 | Trial primary completion date: Dec 2023 --> Jan 2026
Trial completion date • Trial primary completion date
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LILRB4 (Leukocyte Immunoglobulin Like Receptor B4)
|
Venclexta (venetoclax) • azacitidine • IO-202
1year
Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors (clinicaltrials.gov)
P1, N=200, Active, not recruiting, Immune-Onc Therapeutics | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy • Metastases
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Keytruda (pembrolizumab) • IO-202
over1year
Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors (clinicaltrials.gov)
P1, N=200, Recruiting, Immune-Onc Therapeutics | Trial primary completion date: Apr 2023 --> Apr 2024
Trial primary completion date • Combination therapy • Metastases
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Keytruda (pembrolizumab) • IO-202
over1year
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
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LILRB4 (Leukocyte Immunoglobulin Like Receptor B4) • LAIR1 (Leukocyte Associated Immunoglobulin Like Receptor 1)
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IO-202 • IO-106 • IO-108 • IO-312
over1year
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)
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
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APOE (Apolipoprotein E) • LILRB4 (Leukocyte Immunoglobulin Like Receptor B4)
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PGR expression • LILRB4 overexpression
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Venclexta (venetoclax) • azacitidine • IO-202
4years
[VIRTUAL] A First-in-Human (FIH) Phase 1 Study of the Anti-LILRB4 Antibody IO-202 in Relapsed/Refractory (R/R) Myelomonocytic and Monocytic Acute Myeloid Leukemia (AML) and R/R Chronic Myelomonocytic Leukemia (CMML) (ASH 2020)
Major exclusion criteria include: 1) HSCT within 60 days, on calcineurin inhibitors, or chronic GVHD; 2) chemotherapy, radiotherapy, or investigational agents within 7 days; 3) significant cardiac disease; 4) active infection; 5) uncontrolled CNS leukemia; and 6) hyperleukocytosis ( > 25 x 109/L, although hydroxyurea is permitted). If there is a >80% probability of DLTs being > 20%, the study will be paused to further evaluate the safety findings. A planned protocol amendment will evaluate combination therapies with IO-202, including IO-202 + azacitidine.
P1 data
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CD8 (cluster of differentiation 8)
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azacitidine • hydroxyurea • IO-202