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.
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.
Monoclonal antibodies have been identified as a key innovation area for cancer therapy by GlobalData, with multiple companies investing to develop antibody therapies for various indications. In December 2023, AbbVie partnered with BigHat Biosciences to identify and develop antibody therapies in oncology and neuroscience indications.