The US Food and Drug Administration (FDA) has granted an orphan drug designation to Immune-Onc Therapeutics’ IO-202 for the treatment of a rare blood cancer – chronic myelomonocytic leukaemia (CMML).
IO-202 had previously received a fast track designation from the US FDA as a treatment of relapsed or refractory (r/r) CMML in 2023. The therapy was also granted both orphan drug and fast track designations as a treatment for acute myeloid leukaemia (AML) by the FDA in 2020 and 2022, respectively.
The orphan drug designations allow for an extended market exclusivity of seven years in the US and developmental incentives such as an exemption of FDA application fees and tax credits for qualified clinical testing. The fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling reviews.
IO-202 is a monoclonal antibody that targets leukocyte immunoglobulin-like receptor subfamily B member 4 (LILRB4), which can suppress immunity in solid tumours. It also mediates the T-cell suppression and infiltration of AML cells.
It is being investigated as a monotherapy and in combination with chemotherapy, azacytidine, along with targeted therapy AbbVie/Genentech’s Venclexta (venetoclax), in a Phase I trial (NCT04372433). The study is expected to enrol approximately 106 patients with either r/r AML or r/r CMML. It is expected to conclude in 2026, as per ClinicalTrial.gov.
A second Phase I trial (NCT05309187) investigating IO-202 in combination with a PD-1 immune checkpoint inhibitor, MSD’s Keytruda (pembrolizumab) is also currently underway. The study enrolled approximately 200 patients with advanced solid tumours and is expected to be completed in April.
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