FDA provides IND requirements for the development of ALA-101 in first-inhuman clinical trials for lymphoma and leukaemia
Arovella’s Chief Executive Officer and Managing Director, Dr Michael Baker, commented, “The valuable and positive feedback we received from the FDA was excellent and aligns clearly with our development plans for ALA-101. 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.”
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