Kite Pharma Asks FDA to Pave Way Toward It Holding Clinical Trials of Its Myeloma Therapy KITE-585

Kite Pharma has submitted an investigational new drug application to the U.S. Food and Drug Administration that would pave the way toward clinical trials of its myeloma therapy KITE-585.

The agency must approve the application before Kite can begin testing the therapy in people with relapsed or refractory multiple myeloma.

KITE-585 is a chimeric antigen receptor T-cell therapy. It targets a protein called B-cell maturation antigen, or BCMA, that is found on the surface of most multiple myeloma tumors.

Because the protein is crucial to myeloma cells’ survival and growth, it is a good target for chimeric antigen receptor T-cell treatments, also known as CAR T-cell therapies.

Those therapies use a patient’s own immune cells to combat their disease. The first step is to collect a patient’s immune cells from a blood sample.

Then scientists engineer them in a lab to produce special receptors known as chimeric-antigen receptors, or CARs. The receptors recognize a specific protein, or antigen, on the surface of cancer cells. Scientists multiply the number of cells until they are in the millions, then return them to a patient so they can fight the cancer.

KITE-585 has shown promise as a myeloma fighter in several preclinical-trial studies. The company used the results to support its investigational new drug application.

The therapy delayed tumor progression and increased survival in mice with multiple myeloma, researchers discovered. The studies also demonstrated that KITE-585 targeted only cancer cells with BCMA, leaving healthy cells unharmed.

Kite presented the findings at the annual meeting of the American Association for Cancer Research in Washington, April 1-5.

“KITE-585 has the potential to become Kite’s next significant advance in cell therapy for patients with cancer,” Dr. David Chang, the company’s executive vice president of research and development, said in a press release. The development effort, which included drug “candidate screening, engineering, and testing by Kite’s internal research team,” reflects Kite’s “deep experience in CAR design and cellular therapeutics,” he said.

“As we look ahead, we are confident that the cutting-edge design and manufacturing process of KITE-585, together with our proven capability with engineered T cells, will support rapid execution of the clinical program,” Chang concluded.