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
14 Mayo 2024 - 11:00AM
Business Wire
– 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) –
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 www.immune-onc.com 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
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MEDIA CONTACT Tara Cooper The Grace Group
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