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.
CEO and Managing Director Dr Michael Baker said the IND filing reflects the strength of the company's scientific and manufacturing platform and represents Arovella’s transition toward becoming a clinical-stage biotechnology company.