Anixa Biosciences and Moffitt Cancer Center have completed the development and validation of a new viral vector designed to improve the efficacy of their immunotherapy candidate for ovarian cancer, based on CAR T-cell technology.
The vector’s manufacturing is now ongoing under Good Manufacturing Practice conditions — those ensuring that medicines are consistently produced in high quality, from batch to batch — and is expected to take approximately three months.
At this point, Anixa and Moffitt remain on track to file an Investigational New Drug with the U.S. Food and Drug Administration in 2020. Clinical trials are expected to begin in 2021.
“We are pleased to have completed this first milestone in our development program and remain confident in our previously stated development timeline,” Amit Kumar, PhD, president and CEO of Anixa, said in a press release.
CAR T-cell therapy is a form of immunotherapy that harnesses a patient’s own immune system so it can better fight cancer cells. It involves collecting the patient’s immune T-cells (cells with the ability to fight cancers) and genetically modifying them in the lab to produce a chimeric antigen receptor, or CAR, that targets a specific cancer protein.
Anixa and Moffit have been working on a CAR T-cell therapy candidate, in which T-cells are modified to produce follicle stimulating hormone (FSH), to treat ovarian cancer.
The approach makes use of the common receptor-ligand interaction to bring immune cells and cancer cells together, but rather than making T-cells produce a receptor, they produce a ligand that specifically targets a protein receptor called the follicle-stimulating hormone receptor on the surface of ovarian cancer cells.
After the T-cell modification process is complete, the number of T-cells is expanded and the cells are put back into the patient’s body. In theory, a T-cell with more FSH on its surface is more effective at targeting ovarian cancer and starting an immune response that kills cancer cells.
Anixa and Moffitt began working in December on the reformulation of the viral vector used to carry the genetic sequence of FSH into T-cells, so that the virus would be more effective at increasing the amount of FSH at the surface of each patient’s T-cells.
“Our laboratory completed the reformulation of the viral vector, and we have demonstrated its ability to increase the concentration of FSH on the surface of transformed human T-cells,” said Jose Conejo-Garcia, MD, PhD, chair of immunology at Moffitt.
“We expect the increased expression of FSH to provide better efficacy of our drug for ovarian cancer patients,” he added. “We are looking forward to taking this therapy into the clinic as soon as possible.”