SANTA MONICA, Calif., Jan. 19, 2015 (GLOBE NEWSWIRE) — Kite Pharma, Inc., (KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT(TM)) products for the treatment of cancer, today announced presentations on the Company’s rapid, six-day manufacturing process for the production of Kite’s lead product candidate, KTE-C19. The manufacturing technology enables a patient’s T cells to be genetically modified using a gammaretroviral vector 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. Kite recently announced filing with the FDA an investigational new drug (IND) application to conduct a Phase 1/2 clinical trial of KTE-C19 for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL).
Presentations taking place at this week’s Scale-Up and Manufacturing of Cell-Based Therapies IV, an Engineering Conferences International conference, being held in San Diego, California, include:
Oral Presentation: “Production of autologous T cells for multi-center trials”
Presenter: Marc Better, Ph.D., Vice President, Product Sciences, Kite Pharma
Summary: To prepare for Kite-sponsored multicenter trials, Kite, in conjunction with the National Cancer Institute Surgery Branch, has developed a rapid and efficient proprietary process for the generation of anti-CD19 CAR T cells. Because refractory B cell malignancies can progress quickly, it is important to reduce the time between patient sample collection by apheresis and administration of the engineered T cells. In addition to a rapid, six-day timeframe, elements of the KTE-C19 manufacturing process include: efficient T cell stimulation and growth without anti-CD3/anti-CD28 beads; a robust closed system production, amenable to cGMP operations; rapid cell growth in serum-free cell culture medium; and cryo-preserved product that is transportable to multiple clinical sites. Further processing optimization was achieved while maintaining key parameters (including cell subset composition and T cell expansion).
Date and Time: Monday, January 19, 2015, 12:10 — 12:30PM Pacific Time
Poster Presentation: “Scale-up and Recovery of a Gammaretroviral Vector”
Authors: Timothy Langer, Marc Better, Yeuh-Wei Shen, Xiao-Chi Jia, all of Kite Pharma
Summary: Gammaretroviral vectors can be produced in large quantities and with high titers for ex vivo gene delivery in adoptive cell therapies. Using a process implemented at the National Cancer Institute as a basis, Kite is scaling up production of a retroviral vector to support multicenter clinical trials of an engineered T cell product. Kite’s team implemented new process engineering, replacing previous filtration techniques with bioprocessing filters and allowing for streamlined manufacturing operations suitable to cGMP production.
Date and Time: Monday, January 19, 2015, 8:30 — 10:00PM Pacific Time
About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on eACT(TM) designed to restore the immune system’s ability to recognize and eradicate tumors. In partnership with the NCI Surgery Branch through a Cooperative Research and Development Agreement (CRADA), Kite is advancing a pipeline of proprietary eACT(TM) peripheral blood product candidates, both CAR (chimeric antigen receptor) and TCR (T cell receptor) products, directed to a wide range of cancer indications. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com.
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our ability to manufacture and process KTE-C19; our ability to meet the demands of multicenter clinical trials; our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates and advancing a clinical trial of KTE-C19; and our ability to protect our proprietary technology and enforce our intellectual property rights. Various factors may cause differences between Kite’s expectations and actual results as discussed in greater detail in Kite’s filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended September 30, 2014. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
- Health Care Industry
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Kite Pharma Announces Presentations Highlighting Cancer Immunotherapy T Cell Manufacturing Process
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