Moffitt Cancer Center to do Further Work on Anixa Biosciences CAR-T Drug—Delaying IND

Dec 15, 2019 | Cancer, CAR-T Therapy, Moffitt Cancer Center, Oncology, Ovarian Cancer

Moffitt Cancer Center to do Further Work on Anixa Biosciences CAR-T Drug—Delaying IND

Moffitt Cancer Center has partnered with Anixa Biosciences, Inc. (ANIX) to develop chimeric antigen receptor T-cell (CAR-T) technology. Dr. Jose Conejo-Garcia, the inventor of Anixa’s CAR-T technology and the Chair of the Department of Immunology at Moffitt, reports that experimental results from his laboratory indicate the potential efficacy of this technology as a treatment for ovarian cancer could be greatly improved through additional genetic engineering.

The Disease Challenge

Ovarian cancer is deadly and mortality rates have changed significantly in recent decades. Most women relapse after initial therapy. The pre-clinical data for the CAR-T therapy, initially developed at Moffitt, looks promising.

CAR-T Mechanics

CAR-T therapy commences with the extraction and isolation of T-cells from individual cancer patients. A viral vector is then used to transform these T-cells to produce on their surface a molecule that enables the cell, once re-infused into the patient, to find cancer cells and kill them. With Anixa’s CAR-T therapy, the T-cells are transformed to express on their surface, the follicle stimulating hormone (FSH), which targets cells that are expressing follicle stimulating hormone receptor (FSHR).

Moffitt Labs Results and Decision to Improve the Viral Vector for More Potent Cancer Killer

Now with Dr. Conejo-Garcia’s recent experimental results, it’s indicated that with additional engineering, the transformed cells produced by the viral vector currently being used could express much higher levels of FSH, enabling a more potent cancer killer.

In order to increase the potency of the transformed T-cells, researchers at Moffitt will create an improved viral vector and verify experimentally that it will result in a more powerful cancer therapy.

Delay an Investigatory New Drug Application (IND) to Optimize the Therapy

Hence, the team will delay the filing of an IND with the FDA as the Moffitt team will work to optimize the therapy. This optimization work may take an additional year. It is now forecasted that the IND will be filed in late 2020 with clinical trials commencing in 2021.

Delay Required for Maximizing Potential Upside

CER and President Dr. Amit Kumar noted that although the delay in the IND filing may frustrate investors the reality is that making the purported changes “would result in a radically superior therapy” and offer ANIX the opportunity of greater “success against ovarian cancer, a solid tumor.”

About Moffitt Cancer Center

H. Lee Moffitt Cancer Center & Research Institute is a nonprofit cancer treatment and research center located in Tampa, Florida. Established in 1981 by the Florida Legislature, the hospital opened in October 1986 on the University of South Florida campus. Moffitt is the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida. In 2019, U.S News & World Report ranked Moffitt Cancer Center as the No. 8 cancer hospital in the nation

Lead Research/Investigator

Dr. Jose Conejo-Garcia, the inventor of Anixa’s CAR-T technology and the Chair of the Department of Immunology at Moffitt

Dr. Robert Wenham, Chair of the Department of Gynecologic Oncology, Moffitt


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