Arovella Therapeutics (ASX:ALA) has filed an Investigational New Drug application with the US Food and Drug Administration for ALA-101, its lead allogeneic CAR-iNKT cell therapy targeting CD19-positive non-Hodgkin’s lymphoma and leukaemias, marking a key regulatory milestone for the company.
Clearance of the IND, which is typically reviewed within 30 days, would allow Arovella to commence a first-in-human Phase 1 clinical trial in patients with relapsed or refractory CD19-positive haematological malignancies and enable trial initiation in both Australia and the United States.
The Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ALA-101, an off-the-shelf iNKT-derived therapy engineered with a CD19-specific chimeric antigen receptor.