Immune-Onc Therapeutics Announces FDA Clearance of IND Application to Initiate First-In-Human Trial of IO-108, a Novel Antagonist Antibody Targeting LILRB2

PALO ALTO, CA, August 12, 2021 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for IO-108, a novel antagonist antibody targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) for the treatment of solid tumors. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer’s annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor. IO-108 reprograms immune-suppressive myeloid cells toward a pro-inflammatory phenotype, leading to enhanced innate and adaptive anti-tumor immunity.

The Phase 1, multicenter, dose-escalation study will consist of a monotherapy cohort and a combination therapy cohort to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-108 alone and in combination with pembrolizumab, an anti-PD-1 antibody. Biomarkers will be assessed to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals. After determination of the recommended Phase 2 dose, Immune-Onc plans to evaluate the efficacy, safety, and tolerability of IO-108 in combination with pembrolizumab and as monotherapy in indication-specific expansion cohorts.

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