Yesterday we learned the exciting news that the FDA has granted Breakthrough Therapy designation for an investigational immunotherapy LLS is supporting through our Therapy Acceleration Program (TAP).
The therapy, KTE-C19, being developed by Kite Pharma, is another example of a chimeric antigen receptor (CAR), an approach that genetically engineers patients’ immune T cells and reintroduces them into the body to kill cancer cells. KTE-C19 is crafted by removing patients' T cells and genetically engineering them to home in on the protein CD19, expressed by a variety of blood cancers. The FDA conferred its breakthrough designation to KTE-C19's Phase II non-Hodgkin lymphoma program, which LLS is supporting.
The breakthrough designation expedites the review of therapies for life-threatening conditions.
Kite has presented data from earlier phase clinical trials this week during the American Society of Hematology (#ASH15) Annual Meeting in Orlando that shows some encouraging preliminary findings.
John Byrd, M.D., of the Ohio State University Comprehensive Cancer Center, is one of the world’s renowned scientists in the field of blood cancer. LLS has been supporting his work for the better part of two decades. While Byrd has, of late, turned his attention to the problem of finding better therapies for patients with acute myeloid leukemia (AML), it is in chronic lymphocytic leukemia (CLL) that he has made his mark.
Byrd defined the mechanism of action in rituximab, the antibody that targets the CD20 protein expressed on the surface of B-cells. Rituximab was the first therapy to extend lives of patients with CLL. Further, Byrd led the Phase 3 clinical trial that led to the FDA approval in 2014 of ibrutinib, a therapy that targets the BTK protein found on the surface of B-cells. Ibrutinib has changed the standard of care for patients with CLL. Byrd currently leads an LLS Specialized Center of Research (SCOR) grant, a major collaborative effort bringing together an interdisciplinary team of investigators to undertake groundbreaking research.
Today at the American Society of Hematology (#ASH15) Annual Meeting we turn our attention to lymphoma, and in particular emerging immunotherapy approaches to treat this blood cancer that affects the lymphatic system, a key player in the body’s immune system. Exciting progress is being made on this front.
Several LLS-funded researchers were among a group at a session entitled “Novel Immunotherapy Strategies in Lymphoma.”
One presenter, Craig Moskowitz, M.D., of Memorial Sloan Kettering Cancer Center, shared findings from a Phase 1 study of a therapy called denintuzumab mafodotin (SGN-CD19A).
This investigational drug is what is known as a monoclonal antibody drug conjugate - an antibody (a protein used by the immune system to neutralize pathogens) combined with a cytotoxic agent that kills cancer cells. The antibody helps deliver the toxin directly to the cancer cells with minimal impact to surrounding cells.
Moskowitz said therapy was well tolerated by patients in a Phase 1 trial, and showed durable responses. A Phase 2 study is now beginning.