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Arovella Seeks FDA Green Light for First-in-Human Trial of Lead CAR-iNKT Therapy

Story Highlights
  • Arovella has filed a U.S. FDA IND application for ALA-101, its lead allogeneic CAR-iNKT therapy.
  • IND clearance would allow Phase 1 trials in CD19-positive blood cancers in Australia and the U.S., advancing Arovella to clinical stage.
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Arovella Seeks FDA Green Light for First-in-Human Trial of Lead CAR-iNKT Therapy

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Arovella Therapeutics Limited ( (AU:ALA) ) has shared an update.

Arovella Therapeutics has submitted an Investigational New Drug application to the U.S. Food and Drug Administration for its lead allogeneic CAR-iNKT cell therapy candidate, ALA-101, targeting CD19-positive non-Hodgkin’s lymphoma and leukaemias. Clearance of the application would enable the company to launch a first-in-human Phase 1 trial in relapsed or refractory CD19-positive blood cancers, with trial sites planned in both Australia and the United States under a more efficient regulatory pathway, marking Arovella’s transition toward becoming a clinical-stage biotech and potentially strengthening its position in the competitive cell therapy market.

More about Arovella Therapeutics Limited

Arovella Therapeutics Limited is an ASX-listed biotechnology company developing an invariant natural killer T (iNKT) cell therapy platform licensed from Imperial College London to treat blood cancers and solid tumours. Its lead product, ALA-101, is an allogeneic CAR-iNKT cell therapy targeting the CD19 antigen found on various haematological malignancies, and the company is also expanding into solid tumour therapies using CLDN18.2-targeting and IL-12-TM technologies.

Average Trading Volume: 1,205,507

Technical Sentiment Signal: Sell

Current Market Cap: A$92.49M

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