ARD103, our priority product, is an autologous CAR-T cell manufactured by DashCAR® technology with an ultra-fast processing time and stem cell-like phenotypes. ARD103 specifically targeted C-type lectin-like molecule-1 (CLL-1) antigen on both blast cells and leukemia stem cells of acute myeloid leukemia (AML), and was demonstrated to mediate in vitro cytotoxicity, in vivo tumor growth inhibition and ex vivo anti-tumor activity. CLL-1 is highly expressed on both myeloid blasts and leukemia stem cells (LSCs) but is absent on normal hematopoietic stem cells (HSCs), suggesting CLL-1 as an excellent therapeutic target for AML and other potential myeloid malignancies.

The pre-IND meeting consultation with the US FDA was conducted in Q4, 2023, and the following non-clinical studies on CMC and safety evaluation were executed. FDA has cleared ARD103 IND application for a phase 1/2 clinical trial in patients with relapsed/refractory AML and MDS in Oct, 2024. The phase 1/2 clinical trial is an open-label, dose-escalation and expansion study to evaluate the safety and efficacy of ARD103 in r/r AML and MDS patients (NCT06680752).

FDA has granted Orphan Drug Designation (ODD) to ARD103 for AML.