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Patent Awarded for Engineered T-Cell Cancer Therapy

Human T-cell

Scanning electron micrograph of a healthy human T-cell (NIH.gov)

17 Apr. 2019. An experimental treatment using a person’s modified T-cells from the immune system to attack solid tumor cancers received a U.S. patent. The Patent and Trademark Office awarded patent number 10,259,855 to inventors at the Wistar Institute in Philadelphia, which licensed the rights exclusively to Anixa Biosciences Inc. in San Jose, California.

Anixa is developing treatments initially for ovarian cancer with the licensed Wistar technology. That technology is based on T-cells, white blood cells in the immune system altered to express chimeric antigen receptors, being adopted as treatments for some blood-related cancers, such as leukemia. For these blood-related cancers, the engineered T-cells seek out and bind to a protein called CD19 found on the surface of B cells — another type of white blood cell — associated with several blood-related cancers.

Solid-tumor cancers, however, require other targets. In the Wistar-Anixa approach, described in the patent, the chimeric antigen receptor T-cells, or CAR T-cells, are modified to target proteins found on ovarian tumors. While expressed on ovarian tumor cells, these proteins, known as follicle-stimulating hormone receptors, are rarely found on healthy cells. Thus treatments seeking out these proteins are likely to cause fewer adverse effects than many current chemotherapies.

The patent covers the entire process of extracting T-cells from the patient, modifying the T-cells to add chimeric antigen receptors, expanding the volume of modified T-cells in the lab, priming the patient’s immune system with chemotherapy, and returning the modified T-cells to the patient. The patent also covers solid tumors other than those found in the ovaries, including prostate, breast, colon, pancreas, urinary bladder, kidney, lung, liver, stomach, and testis. Anixa says follicle-stimulating hormone receptors may be expressed on the surface of ovarian cells, but they’re also found on blood vessels that feed other solid tumors. In addition, the patent text covers primary tumors and those that spread to other parts of the body.

In January 2017, a team from Wistar Institute led by Jose Conejo-Garcia, one of the inventors on the patent, published a study testing modified T-cells that target follicle-stimulating hormone receptors in lab cultures and mice grafted with several types of human ovarian cancer. The researchers found the engineered T-cells attacked only the tumor cells across all of the ovarian cancer types in the mice, and not the surrounding healthy tissue.

In the study, mice receiving the altered T-cells showed measurable therapeutic effects, including clearance of the tumors in some cases. Moreover, the modified T-cells persisted in the mice, providing immunity against a later introduction of ovarian tumor cells. And the researchers reported longer survival times among the T-cell recipient mice, without noticeable toxicity.

Science & Enterprise reported in November 2017 on Anixa — then known as ITUS Corp. — licensing the technology from Wistar. In that same month, the company began a collaboration with Conejo-Garcia, who moved to Moffitt Cancer Center in Tampa, Florida, to advance the technology through preclinical stages.

“This technology,” says Amit Kumar, Anixa’s president and CEO in a company statement, “takes advantage of specific hormone–hormone receptor biology to address malignancies and may hold promise to be the one of the first successful CAR-T therapies against solid tumors.  While our initial focus is the treatment of ovarian cancer, the technology covered by the patent is broad and may also be effective in treating other solid tumors by exploiting an anti-angiogenesis mechanism of action.”

Anixa expects to file an investigational new drug application to FDA, in effect requesting permission to begin clinical trials, by the end of the year.

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