Kite Pharma and Juno's R&D Strategy to Reshape Cancer Treatment
April 21, 2016 (Last Updated: 12:30pm PT)
By Mark Terry, BioSpace.com Breaking News Staff
Companies working in the cutting-edge field of immuno-oncology—reprogramming the body’s immune system to better target cancer cells—are significantly changing the face of cancer treatment. The Motley Fool took a look at two companies, Juno Therapeutics and Kite Pharma that are leading the way in this area.
Both companies are working on chimeric antigen receptor T-cell therapy, called CAR-T. Although fairly simple in theory, in practice it’s fairly complicated and there are concerns that because the treatment is so individualized, it will be labor-intensive and expensive. The techniques, require taking patients’ T cells from the blood, then reengineering them by using a viral vector to express a chimeric receptor specific for a specific antigen associated with cancer. In this case, specifically CD19, which is expressed in B-cell blood cancers. The cells are then reinfused back into the patient.
On June 4, Juno, located in Seattle, announced promising data from its Phase I clinical trial of JCAR015. Fifty-one patients with relapsed or refractory acute lymphoblastic leukemia (ALL) were treated with either cyclophosphamide or fludarabine/cyclophosphamide followed by an infusion of JCAR015. In 23 of 30 patients, a complete response was observed in patients with morphologic disease and 18 out of 20 in patients with minimal disease.
“The ongoing efficiency and duration of response for a large percentage of patients, specifically those who do not go on to stem cell transplant, continues to be impressive,” said Mark Gilbert, Juno’s chief medical officer, in a statement. “These findings provide us with further confidence about our development strategy and the ongoing Phase II ROCKET pivotal trial.”
Kite Pharma, headquartered in Santa Monica, California, announced yesterday that it had officially opened a commercial manufacturing facility to produce CAR-T product candidates for clinical trials, as well as the possible launch and commercialization of its lead CAR-T product candidate, KTE-C19. KTE-C19 is currently in a clinical trial for chemorefractory diffuse large B-cell lymphoma (DLBCL) and other B-cell cancers. It hopes to have a commercial launch in 2017.
“Establishing world-class manufacturing capability has always been a priority for Kite,” said Timothy Moore, Kite’s executive vice president of Technical Operations, in a statement. “Through our continuous efforts to optimize manufacturing, supply chain and quality control, our proprietary process now reduces the time from when a patient’s materials are shipped to our facility to when the engineered T cells are returned to the patient to approximately 14 days, one of the fastest in the industry.”
Both companies may have approvals in 2017.
“If all goes to plan,” writes Todd Campbell, for The Motley Fool, “success in blood cancer indications will be followed up by success in treating other types of cancer by targeting different proteins expressed by them. For example, Juno Therapeutics is already conducting some early stage studies to determine if targeting proteins common in non-small cell lung cancer and ovarian cancer make for good targets. Although it’s too early to know if these other approaches will be as successful as targeting CD19, the potential is big enough that industry watchers will want to stay tuned.”