Phase 1 Study Initiated to Explore Safety/Efficacy of CAR T Cells in Ovarian Cancer


A phase 1 trial which will evaluate the safety and efficacy of chimeric antigen receptor T-cell therapy in ovarian cancer has begun.

A phase 1 trial evaluating the safety and efficacy of a novel chimeric antigen receptor (CAR) T-cell therapy in ovarian cancer has been initiated, according to a press release by Anixa Biosciences, Inc (Anixa).1

“We strongly believe that our unique targeting approach differentiates our CER-T platform from traditional CAR T approaches and that CER-T has potential to work in solid tumors where other therapies have failed," stated Amit Kumar, MD, president, chief executive officer, and chairman of Anixa, in a statement .

There have been positive results shown in regard to efficacy in CAR T-cell therapy in some hematological tumors. However, getting the same results with solid tumors, including ovarian cancer, has been challenging as in order to avoid negatively impacting the healthy cells of a patient, effective CAR T-cell therapy needs a specific antigen to recognize and target only cancer cells.

This CAR T-cell approach is known as a new chimeric endocrine receptor T-cell (CER-T) and targets the engineered T-cells as an endocrine receptor. The CER-T therapy being evaluated in this phase 1 study differs from traditional CAR T as it targets the follicle stimulating hormone receptor (FSHR).

"CAR T therapies are rapidly becoming an important player in cancer therapy, and our lab has developed a technology that has the potential to target tumors by using an existing biological mechanism that is well understood. If our CER-T approach is successful, it could serve as a model for future targeted CAR-T therapies in other cancer types. The goal in cancer therapy has always been to kill cancer cells with limited damage to healthy tissue, and we look forward to seeing how this CER-T therapy may be able to accomplish that in solid tumors, which have historically proven challenging to eradicate with cell therapy," said Jose R. Conejo-Garcia, MD, PhD, chair of the Department of Immunology at Moffitt Cancer Center and co-inventor of the CER-T technology, in the press release.

The CAR T technology approach is an autologous cell therapy made up of engineered T-cells. These T-Cells target the FSHR, and which research has shown is exclusively expressed on ovarian cells in healthy adult females.

Although CAR T-cell therapy has shown positive results within some liquid tumors, there has not been any unequivocal positive data within solid tumors in humans. According to Anixa, 1 of the primary reasons CAR T efficacy in solid tumors has not been demonstrated yet is due to the lack of known antigens on the surface of solid tumor cells. One must review the key characteristics of the successes in liquid tumors in order to understand how to get the same outcomes in solid tumors.

CAR T cells have demonstrated effectiveness in leukemias and lymphomas that result when B-cells become cancerous, and the FDA even approved CAR-T therapies for B-cell tumors that target CD-19, a highly specific protein on B-cells, in February, 2022. Because CD-19 is selective to B-cells and does not exist on other cells in the body, CAR T is designed to attack this protein and will not target other cells or organs in the body.

Though the CAR T-cell therapy will kill healthy B-cells as well as the cancerous B-cells, the patient can survive without any B-cells so long as they receive proper care.

"There are limited treatment options for recurrent, chemo-resistant ovarian cancer, and this platform holds immense promise to change that. I am hopeful that this program represents a unique opportunity for us to potentially make a truly game-changing impact for patients with ovarian cancer and other solid tumors," added Robert Wenham, MD, MS, FACOG, FACS, the trial's lead investigator and chair of the Department of Gynecologic Oncology at Moffitt Cancer Center, in the press release.

Anixa biosciences announces the initiation of its ovarian cancer CAR-T phase 1 trial at moffitt cancer center. Anixa Biosciences, Inc. News Release. March 30, 2022. Accessed April 4, 2022.
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