Immune-Onc Therapeutics Announces IO-108 Phase I Clinical Trial Results Selected for Oral Presentation at AACR Annual Meeting 2023

– Oral presentation highlights interim clinical data from Phase 1 dose escalation study of IO-108, a novel myeloid checkpoint inhibitor targeting LILRB2 (ILT4) as a monotherapy and in combination with pembrolizumab in patients with solid tumors –

– Company announces late-breaking abstract from new preclinical program, IO-312, a novel LILRB4 x CD3 bispecific antibody for acute myeloid leukemia –

PALO ALTO, Calif.–(BUSINESS WIRE)–#AML–Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced that Phase 1 dose escalation data for IO-108, a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) is selected for oral presentation at the American Association for Cancer Research (AACR) Annual Meeting being held April 14 – 19, 2023 in Orlando, Florida. In addition, 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.

“We are very excited that our interim clinical data of IO-108 is selected for oral presentation at AACR 2023. This reflects the clinical significance and broad market potential of IO-108 as monotherapy and in combination with an anti-PD-1 for treatment in a variety of solid tumors. Such a distinguished recognition, together with the acceptance of our IO-312 late breaking abstract for poster presentation at the meeting, signifies the strength and breadth of our pioneering myeloid checkpoint inhibitor programs across multiple cancer types,” said Charlene Liao, Ph.D., founder, chief executive officer and board chair of Immune-Onc. “Immune-Onc has built a strong oncology pipeline guided by our deep expertise in myeloid biology and drug development, and we are proud that our first-in-class myeloid checkpoint inhibitors are demonstrating clinical benefits in Phase 1 studies for patients with some of the hardest-to-treat cancers.”

Details of Immune-Onc’s AACR 2023 presentations 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., assistant member, Developmental Cancer Therapeutics Laboratory and co-medical director, Providence Melanoma Program, 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 in the U.S. (NCT05054348) has completed dose escalation and is actively enrolling several expansion cohorts, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab). 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. The company is also actively enrolling a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or tislelizumab).

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, 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 www.immune-onc.com and follow us on Twitter and LinkedIn.

Contacts

Tara Cooper

The Grace Communication Group

[email protected] [email protected] 650-303-7306