October 27, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SANTA MONICA, Calif. -- Kite Pharma, Inc. and Seattle-based Alpine Immune Sciences, Inc. established a partnership potentially worth more than $530 million to develop protein-based immuno-oncology therapies, the companies jointly announced this morning.
Under the terms of the deal, Kite will engineer two of Alpine’s protein-based immunotherapies from that company’s transmembrane immunomodulatory protein (TIP) technology, into chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates. The scientists will focus on what Alpine’s Chairman Mitchell Gold calls the “Immune synapse,” which is the interface between the T-Cells and the antigens they target. Alpine said early data from its TIP technology is showing “great promise” in hematologic cancers. Arie Belldegrun, chairman and chief executive officer of Kite, said Alpine’s TIP technology can be incorporated into engineered T cell therapies to “advance CAR and TCR product candidates into multiple tumor types.”
Kite will make an upfront payment to Alpine of $5 million and additional payments to support Alpine’s research. Alpine will be eligible to receive milestone payments based upon the successful achievement of pre-specified research, clinical, and regulatory milestones totaling $530 million plus low single-digit royalty payments on product sales, according to the deal. Kite will receive an exclusive, worldwide license to research, develop and commercialize engineered autologous T cell therapies incorporating two programs coming from the AIS platform.
Immuno-oncology is a therapy field exploding with potential for developing treatments for cancer by harnessing the body’s own immune system to fight cancer infections. The idea of immune-oncology has been around for years, with one drug, Proleukin having been shown to be quite effective, although with several side effects.
T cells are cells present in all humans that survey potential infections and contaminations. When T cells detect an infection, they kill contaminated cells and start amplifying significantly until the infection is resolved. Chimeric Antigen Receptor T-Cell Therapies (CAR-T) are engineered in a laboratory to recognize a specific antigen in a cell and then administered into a cancer patient. The CAR-T cells should, if all goes as planned, multiply within the body and target the antigen and eliminate the threat. It’s an idea that many pharmaceutical companies are developing, including AstraZeneca PLC, Nektar Therapeutics, Jounce Therapeutics, Bristol-Myers Squibb Company, Pfizer Inc., Merck & Co., Roche and more. There is a belief that immunotherapies could replace traditional chemotherapy for cancer treatments, which makes the companies developing these treatments attractive to investors.
Kite is certainly no stranger to immuno-oncology therapies. The company has been working on a number of experimental CAR-T cancer treatments, including KTE-C19, being developed for the treatment of patients with refractory aggressive non-Hodgkin’s lymphoma (NHL) who have failed prior chemotherapy treatments and have a poor prognosis. KTE-C19 is designed to genetically modify a patient’s T cells to express a Chimeric Antigen Receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. KTE-C19 has had some negative press after the death of a patient, but Kite said it was determined the experimental medication had no role in the death of the patient with a low prognosis. Belldegrun said the death was a sad circumstance, but after the data was examined by outside agents, the drug was ruled to not be an issue. Patients enrolled in the study have already undergone multiple treatments for non-Hodgkin’s lymphoma that were not successful, Belldegrun said. Belldegrun said Kite is looking to move KTE-C19 into Phase II trials by the end of this year.
Kite and competitor Juno Therapeutics are having a dispute over patent on JCAR015, Juno‘s lead candidate in the CAR-T cell therapy. Juno’s drug is very similar to KTE-C19. After consulting with intellectual property rights attorneys, Belldegrun said based on their conclusion, Kite believes they have freedom to continue operations.
