Arovella Therapeutics Ltd (ASX:ALA) has welcomed positive pre-investigational new drug (IND) meeting feedback from the US Food and Drug Administration (FDA) ahead of first-in-human trials assessing ALA-101 in treatment of lymphoma and leukaemia.
The feedback provides a clear path forward to submitting an IND for ALA-101, with no major changes proposed for the development program.
Given the highly complex nature of manufacturing allogeneic CAR-iNKT cell therapy treatments, the FDA validation from this pre-IND meeting was vital to ensure ALA’s plans align with FDA expectations.
The company expects to file its IND early in the first quarter of 2025.
Valuable feedback for future studies
“The valuable and positive feedback we received from the FDA was excellent and aligns clearly with our development plans for ALA-101,” Arovella CEO and managing director Dr Michael Baker said.
“For a complex therapeutic like off-the-shelf CAR-iNKT cells, our team has done a commendable job reaching this key milestone.
“We look forward to receiving acceptance for our IND and executing our plan to advance ALA-101 into the clinic over the coming months.
“Due to the platform nature of Arovella’s CAR-iNKT cells, the learnings for ALA-101 throughout the IND application process can be applied to our additional solid tumour programs, such as ALA-105.”
About ALA-101
ALA is developing invariant Natural Killer T cells (iNKT cells) with Chimeric Antigen Receptors (CAR) that can be introduced to immune cells to target cancer cells.
ALA-101 is a CAR19-iNKT cell-based treatment modified to produce a CAR that targets CD19, an antigen found on the surface of numerous cancer types.
In 2023, more than 140,000 people were diagnosed with CD19-positive lymphomas and leukaemias in the US alone, leading to more than 40,000 deaths.