Anixa Biosciences and Moffitt Cancer Center are seeking to develop a more potent version of their immunotherapy candidate for ovarian cancer, based on chimeric antigen receptor (CAR) T-cell technology, to make it more powerful against ovarian cancer.
The optimization efforts may take an additional year, postponing the filing of an Investigational New Drug with the U.S. Food and Drug Administration to late 2020, and the beginning of clinical trials to 2021.
“Our technology is the most cutting-edge science and as R&D results mandate, and for the welfare of patients, we must provide the best possible chance of success,” Jose Conejo-Garcia, MD, PhD, who invented the product and is a chair of Moffitt’s immunology department, said in a press release. “The Anixa and Moffitt teams will strive to get into the clinic as soon as possible with the best possible therapy.”
CAR T-cell therapy is a novel and rapidly emerging therapy building on the genetic modification of a patient’s immune cells to make them able to specifically recognize and attack cancer cells.
It involves extracting the immune T-cells (cells with the ability to directly kill malignant cells) from a patient’s blood. Then, in the lab, a viral vector (modified to be harmless) is used to introduce a gene coding for a special receptor, called a chimeric antigen receptor (CAR), into the patient’s T-cells.
This receptor targets protein markers that are expressed at the surface of tumor cells, enabling CAR T-cells to find and kill the cancer cells. Large numbers of the CAR T-cells are then grown in the lab and infused back into the patient.
Joined by Moffitt Cancer Center, Anixa is developing CAR T-cell therapy candidates for ovarian cancer, as well as other solid tumors. For the treatment of ovarian cancer, this involves transforming the patient’s T-cells to make them produce follicle stimulating hormone (FSH). This will enable CAR T-cells to recognize and bind to those cells that display the follicle-stimulating hormone receptor at their surface, which is the case for most ovarian cancer cells.
Data from Conejo-Garcia‘s lab indicate that additional genetic engineering can greatly improve the therapy’s potency for killing ovarian cancer cells. For that, researchers at Moffitt will create an optimized viral vector that boosts the production of FSH and then verify in the lab if this change leads to a more powerful anticancer activity.
“Making this change would result in a radically superior therapy and give us a dramatically greater chance of success against ovarian cancer,” Amit Kumar, PhD, Anixa’s president and CEO, said.
Robert Wenham, MD, chair of the Moffit’s gynecologic oncology department, will be the lead investigator in the upcoming trial.
“Based on the preclinical data and promise of this CAR-T therapy, I look forward to launching the clinical trial with the more optimized therapy in order to give our patients the best chance of a successful outcome,” he said.
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