NEW YORK – Anixa Biosciences said on Monday that it has dosed the first ovarian cancer patient in a Phase I trial of its follicle-stimulating hormone receptor (FSHR)-targeted autologous cell therapy.
The therapy involves harvesting patients' T cells, engineering them into chimeric endocrine receptor (CER) T cells, and reinfusing them into the patient, where they target FSHR, a receptor found at high levels only on granulosa ovarian cells. San Jose, California-based Anixa is calling the treatment "a new type of CAR-T."
According to the firm, one of the main challenges of applying CAR T-cell therapies to solid tumors is the lack of clear antigens that enable targeting cells affected by malignancy while sparing healthy tissue. With the CER T-cell technology, instead of targeting an antigen, the firm is going after FSHR, a hormone receptor, which is expressed exclusively on ovarian cells.
The Phase I trial, which is taking place at the Moffitt Cancer Center, will enroll up to 48 ovarian cancer patients. Anixa's primary goal is to assess the treatment's safety and maximum tolerated dose as well as preliminary efficacy.
"If our unique CAR-T approach is successful, it could serve as a model for future targeted CAR-T therapies in other cancer types," Jose Conejo-Garcia, the chair of Moffitt's department of immunology and co-inventor of the CER-T technology, said in a statement.
The US Food and Drug Administration cleared an investigational new drug application for the cell therapy last year after having put a clinical hold on the therapy and requesting more information. The firm, which has exclusive, worldwide licensing rights to the technology, announced it was initiating the ovarian cancer trial in April.