IO-202

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.

P1, N=67, Completed, 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

P1, N=106, Active, not recruiting, Immune-Onc Therapeutics | Recruiting --> Active, not recruiting

P1, N=22, Completed, Immune-Onc Therapeutics | Active, not recruiting --> Completed | N=200 --> 22

P1, N=106, Recruiting, Immune-Onc Therapeutics | Trial completion date: May 2025 --> Jan 2027 | Trial primary completion date: Dec 2023 --> Jan 2026

P1, N=200, Active, not recruiting, Immune-Onc Therapeutics | Recruiting --> Active, not recruiting

P1, N=200, Recruiting, Immune-Onc Therapeutics | Trial primary completion date: Apr 2023 --> Apr 2024

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.

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.

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.