Anixa Biosciences Receives Addl Information Request From FDA For CAR-T IND Application

Anixa Biosciences Inc. (ANIX) said Thursday that the U.S. Food and Drug Administration has provided details of the additional information it is requesting regarding its Chimeric Antigen Receptor-T cell therapy or CAR-T being developed in partnership with Moffitt Cancer Center.

The company said it submitted Investigational New Drug application for the study in March, and the FDA subsequently requested additional information before approving the trial. The details of that information request have now been provided by the FDA.

Anixa and Moffitt expect that the requested information can be assembled and provided to the FDA within approximately 30 days, after which the FDA will again respond within 30 days after the submission.

The company said it will strive to file its submission as soon as possible and it will seek to initiate the clinical trial before the end of the year.

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