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2020-06-02T16:14:25.000Z

FDA clears IO-202, a novel LILRB4 antibody, for investigation as a new drug in AML

Jun 2, 2020
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On May 29, 2020, the United States Food & Drug Administration (FDA) cleared IO-202, an antibody targeting leukocyte immunoglobulin-like receptor B4 (LILRB4), for investigation as a new drug treatment for acute myeloid leukemia (AML) in patients with monocytic differentiation and chronic myelomonocytic leukemia (CMML).1

Key features1

IO-202:

  • A first-in-class monoclonal antibody that blocks the signaling of LILRB4, an immune inhibitory receptor
  • The first T cell activator for AML
  • Known to activate T cell cytotoxicity against leukemia cells in preclinical studies and block tumor infiltration

Study Design1,2

  • Phase I, multicenter, open-label, dose-escalation and dose expansion study, to determine the optimal dose of IO-202 in adult patients with AML with monocytic differentiation and in those with CMML
  • Will assess IO-202 as a monotherapy or in combination with azacitidine
    • For the dose escalation phase, dose cohorts will be treated with intravenous (IV) IO-202 monotherapy, in ascending doses every 2 weeks, followed by IO-202 every 2 weeks at the same dose in combination with IV or subcutaneous azacitidine, 75 mg/m2 for 7 days every 28 days
    • For the expansion phase, IV IO-202 monotherapy will be given at the recommended phase II dose and frequency; combination therapy will consist of IV IO-202 every 2 weeks at the recommended phase II dose and frequency with IV or subcutaneous azacitidine, 75 mg/m2 for 7 days every 28 days
  • Primary outcomes will evaluate the safety and tolerability of IO-202
  • Secondary outcomes will evaluate pharmacokinetics, pharmacodynamics, and clinical activity of IO-202

Biomarkers assessment will also enable a mechanistic understanding of the clinical data and inform future trials.

  1. Immune-Onc Therapeutics. Immune-Onc Therapeutics IND application for first-in-human trial of IO-202, a novel antibody for the treatment of acute myeloid leukemia, receives FDA clearance. https://www.immune-onc.com/news/2020-05-29-io-202-ind-clearance. Published May 29, 2020. Accessed June 1, 2020.
  2. Clinicaltrials.gov. IO-202 as monotherapy and in combination with azacitidine in AML and CMML. https://www.clinicaltrials.gov/ct2/show/study/NCT04372433?term=IO-202&draw=2&rank=1. Updated May 4, 2020. Accessed June 1, 2020.

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