Positive FDA Type D Meeting Outcome
Highlights:
Positive feedback on reagent testing requirements during Type D meeting with US FDA
Arovella expects to file its IND application for ALA-101 in the current quarter
MELBOURNE, AUSTRALIA 28 October 2025: Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell therapy platform, is pleased to announce that it has today held a Type D meeting with the United States Food and Drug Administration (FDA) and received positive feedback on testing requirements for a critical reagent used in its CAR-iNKT manufacturing process. The agency provided clear guidance on testing requirements for the reagent and Arovella has already completed much of the testing required.
The Company is now working to generate the additional data requested by the FDA and expects to file its IND application for ALA-101 before the end of CY25.
Arovella’s CEO and MD, Dr Michael Baker, commented, “We are pleased with the feedback from the FDA which confirms our pathway to IND. Taking the time to engage with the agency has provided us with valuable and constructive feedback, enabling us to move forward with confidence in submitting our IND application this quarter and progressing ALA-101 into clinic early in 2026.”
ALA-101 is a next-generation "off-the-shelf" CAR-iNKT cell therapy that targets CD19+ B cell lymphomas and leukaemias. CD19 is an antigen found on the surface of many blood cancers. Certain blood cancers also express CD1d, which when bound to a glycolipid, can be recognised by iNKT cells, making CAR-iNKT cells dual targeting.