On February 12, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported that the research team lead by Dr. Jose Conejo-Garcia, Chair of the Department of Immunology at Moffitt Cancer Center, Anixa’s development partner, has completed and validated the reformulation of the viral vector necessary for its CAR-T program (Press release, Anixa Biosciences, FEB 12, 2020, View Source [SID1234554216]).

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Last year, Anixa announced, that in order to improve the potential efficacy of its CAR-T therapy, it would reformulate the viral vector used to infect and engineer each individual patient’s T-cells. The purpose was to increase the expression level of the Follicle Stimulating Hormone (FSH) on the engineered, autologous T-cells. With the successful viral vector reformulation, verification and validation, the new viral formulation is now being manufactured under Good Manufacturing Practice (GMP) conditions. This manufacturing process is expected to take approximately three months and Anixa and Moffitt remain on track to file the Investigational New Drug (IND) application in 2020.

CAR-T therapy requires the extraction and isolation of an individual’s T-cells, followed by engineering these cells to enable them to more effectively kill cancer. These cells are then expanded and reinfused into the patient. Engineering these cells is performed by using a virus that itself has been engineered. The engineered virus initially infects the T-cells. Successive to infection, the virus induces the cellular machinery of the patient’s T-cell to create on its surface, the "homing missiles" which in the case of Anixa’s therapy are FSH molecules. It is expected that a T-cell with more FSH on the surface will be more effective at targeting ovarian cancer.

Dr. Amit Kumar, President and CEO of Anixa stated, "We are pleased to have completed this first milestone in our development program and remain confident in our previously stated development timeline."

"Our laboratory completed the reformulation of the viral vector, and we have demonstrated its ability to increase the concentration of FSH on the surface of transformed human T-cells. We expect the increased expression of FSH to provide better efficacy of our drug for ovarian cancer patients. We are looking forward to taking this therapy into the clinic as soon as possible," stated Dr. Conejo-Garcia.