On May 22, 2023 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that, in conjunction with its partner Moffitt Cancer Center, it has commenced treatment of the second patient in the ongoing clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer (Press release, Anixa Biosciences, MAY 22, 2023, View Source [SID1234631907]).
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This study (NCT05316129) is a dose-escalation Phase 1 trial to evaluate safety and to determine the maximum tolerated dose of follicle stimulating hormone receptor T-cells and to preliminarily assess clinical activity. The study is being conducted at Moffitt Cancer Center. All patients being enrolled in the trial have disease that is progressing and have failed at least two, but often more, therapeutic interventions. This patient received the same dose of engineered T-cells as the first patient in the trial, and the next (third) patient is expected to also receive the same dose. The successive three-patient cohort is expected to receive a higher dose of cells.
The CAR-T approach used for Anixa’s therapy is known as chimeric endocrine receptor T-cell (CER-T) since the target of the engineered T-cells is an endocrine receptor. While CAR-T therapy has shown efficacy in some hematological tumors, reproducing the same results with solid tumors, such as ovarian cancer, has proven challenging. One of the reasons for this difficulty is that effective CAR-T therapy needs a specific antigen to recognize that is only present on target cancer cells in order to avoid negatively affecting healthy cells. The cell therapy being evaluated in Anixa’s Phase 1 study differs from traditional CAR-T in that it targets the follicle stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells in healthy adult females.
"We are optimistic about the potential of this therapy to impact ovarian cancer patients who are out of all other options. Our goal is to increase enrollment at a responsible rate that enables us to understand the impact that our therapy is exhibiting," stated Dr. Robert Wenham, the principal investigator of this trial at Moffitt Cancer Center.
"We are pleased to have treated the second patient in our ovarian cancer CAR-T clinical study," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We anticipate an increase in the rate of patient recruitment, and expect the third and potentially last patient of the current dose cohort to be treated soon. Since this is the early stage of patient enrollment, we are announcing publicly the treatment of the second patient, but it is not our intent to announce enrollment of each subsequent patient. We will make periodic announcements when warranted."
About Anixa’s CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.