Immune-Onc Therapeutics Announces Orphan Drug Designation of IO-202 (Anti-LILRB4) for Treatment of AML and Poster Presentation at ASH 2020

– “Trials in Progress” poster presentation at the American Society of Hematology (ASH) Annual Meeting to detail mechanisms of action, preclinical data and trial design –

– IO-202, targeting the immune inhibitory receptor LILRB4 (also known as ILT3), is being evaluated in a Phase I trial for acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) –

Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation status for its first-in-class antagonist antibody IO-202 for treatment of acute myeloid leukemia (AML). In addition, the company announced acceptance of its “Trials in Progress” poster presentation for IO-202 at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting is taking place virtually December 5-8, 2020.

Orphan Drug Designation qualifies the sponsor for various development incentives of the Orphan Drug Act, including exemption of FDA application fees and tax credits for qualified clinical testing, to advance the evaluation and development of products that demonstrate promise for the diagnosis and treatment of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation can also convey seven years of marketing exclusivity for a drug approved to treat an orphan disease in the United States.

“Receiving orphan drug designation for IO-202 in AML is another important milestone for Immune-Onc and underscores the need for effective new treatments for this aggressive and hard-to-treat cancer,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “We are pleased with the progress we are making in advancing IO-202. As outlined in our ASH poster presentation, IO-202 holds promise for AML patients because it demonstrates novel mechanisms of action in overcoming immune suppression. IO-202 is one of several programs in our pipeline that target the LILRB family of immune inhibitory receptors. We are excited to continue our momentum in evaluating IO-202 and Immune-Onc’s preclinical candidates in other cancers, including solid tumors, in the near future.”

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