Arie Belldegrun, MD, FACS
Amgen and Kite Pharma have announced that they will collaborate on the development of novel chimeric antigen receptor (CAR) T-cell immunotherapies, with Amgen providing cancer targets and Kite offering its engineered autologous cell therapy (eACTTM
“CAR T-cell therapies have generated great excitement in cancer immunotherapy and show very promising results in patients with advanced cancers who otherwise would have no treatment options,” said Arie Belldegrun, MD, FACS, Kite’s president and chief executive officer. “Identifying targets that are uniquely expressed in cancer, but not normal tissue is the bottleneck of the entire engineered T-cell approach.”
The companies hope that combining Amgen’s collection of cancer targets with Kite’s T-cell engineering process will further the success of CAR T-cell therapies for cancer treatment. Under the agreement, a joint steering committee identified a pool of targets from which each side has preselected its own targets.
Kite will conduct all preclinical research as well as cell manufacturing and processing through the Investigational New Drug (IND) filing. Each company will take responsibility for clinical development and commercialization of their selected candidates.
Amgen will provide Kite with an upfront payment of $60 million and fund R&D costs through the IND filing. Each company is eligible for up to $525 million in milestone payments for the other company’s candidates, based on successful completion of regulatory and commercialization milestones, plus tiered high single- to double-digit royalties for sales and licensing of respective intellectual property.
In 2012 Kite entered into a cooperative research and development agreement with the National Cancer Institute (NCI), gaining access to peripheral blood autologous T cells engineered with NCI’s proprietary tumor-specific T-cell receptors (TCRs) and CARs directed to multiple hematological and solid tumor types. Belldegrun noted that the collaboration with Amgen does not involve existing therapeutic candidates accumulated in partnership with NCI’s Steven Rosenberg, MD, PhD, but rather focuses on novel targets contributed by Amgen.
“Each product resulting from our collaboration with Amgen will feature a novel CAR gene construct specific for a different cancer antigen not currently in development at Kite,” said Belldegrun. “This collaboration is not about our existing product candidates. We believe working with both Amgen and the National Cancer Institute will secure the best products for cancer immunotherapies.”
While the number and identity of the targets was not disclosed, David Chang, MD, PhD, executive vice president and chief medical officer for Kite, gave more details. “The current partnership focuses on CAR T technology, not T-cell receptors. The targets are cell surface proteins that are amenable to the CAR T-cell approach. Amgen offers an in-depth understanding of the biology of the targets and will provide antibody reagents against the targets. Half of the preselected candidates will go to Kite and half will go to Amgen.”
Kite announced in late December 2014, that it filed an IND application for its most advanced product candidate, KTE-C19, an anti-CD19 CAR T-cell therapy for treatment of patients with refractory aggressive non-Hodgkin lymphoma.2
In a phase 1/2 clinical trial of the treatment, 12 of 13 patients with advanced B-cell malignancies had complete (8) or partial (4) remissions, and 4 of 7 patients with refractory diffuse large B-cell lymphoma had complete remissions.
Belldegrun hopes to build on the strength of the CAR T-cell approach, stating, "We believe that the therapeutic candidates resulting from the collaboration will have the potential to dramatically transform CAR approaches and to become some of the most powerful therapies for the treatment of cancer.”
Kite Pharma. Amgen and Kite Pharma Announce Strategic Cancer Immunotherapy Collaboration to Advance the Application of Novel Chimeric Antigen Receptor (CAR) T Cell Therapies. http://ir.kitepharma.com/releasedetail.cfm?ReleaseID=889466. Accessed January 5, 2015.
Kite Pharma. Kite Pharma Submits Investigational New Drug Application for Phase 1/2 Trial of KTE-C19, Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, for the Treatment of Refractory Aggressive Non-Hodgkin Lymphoma. http://ir.kitepharma.com/releasedetail.cfm?ReleaseID=888707. Accessed January 5, 2015.