Anixa Biosciences revealed that the U.S. FDA has requested additional information regarding its CAR-T being developed in partnership with Moffitt Cancer Center and until then, the study has been placed on clinical hold.
This CAR-T therapy — which targets ovarian cancer — was invented by a team led by Dr. Jose Conejo-Garcia. Dr. Conejo-Garcia is currently Chair of the Department of Immunology at Moffitt Cancer Center, where the IND enabling studies were performed, and where the clinical trial will be conducted, under the leadership of Dr. Robert Wenham, Chair of Gynecological Oncology at MCC.
Anixa and Moffitt filed an IND in late March. Anixa has a worldwide, exclusive commercial license to the technology, which is considered a new type of CAR-T known as CER-T (Chimeric Endocrine Receptor T-cell) therapy.
Moffitt said it expects the FDA to provide a letter detailing the specific information needed within the next 30 days. Once Moffitt and Anixa assemble and submit information addressing the request, the FDA will continue its review of the IND.
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