IND follows encouraging findings of necrosis, inflammation and T cell infiltration in tumor biopsy of patient in lowest dose cohort SAN JOSE, Calif. , July 23, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX ), a biotechnology company focused on the treatment and prevention of cancer, today announced that its collaborator, Moffitt Cancer Center (Moffitt), has received approval by the U.
S. Food and Drug Administration (FDA) of an individual patient Investigational New Drug Application (IND) to allow a second dose of its CAR-T therapy for a patient that may be demonstrating clinical activity to the initial treatment. Dr.
Robert Wenham , Chair, Department of Gynecologic Oncology at Moffitt, and the principal investigator of the trial, stated, "In the first cohort and at the lowest dose administered, despite an initial increase in tumor size that met criteria for progression, one patient has remained off new therapy for many months with no new disease. Even her tumor marker that was initially elevating later began to fall. A biopsy demonstrated tumor with necrosis, inflammation and T cell infiltration by Immunohistochemistry (IHC).
Based on these findings, we sought approval from the FDA to administer a second treatment to her, aiming to increase the likelihood of a partial or complete response. Recently, we received that approval from the FDA." "I am pleased with the very long duration absent of any further disease and the possible response .