Gas Permeable Flasks to Grow Tumor Infiltrating Lymphocytes (TIL) for More Effective Anti-Cancer Immunotherapy

Description of Invention:
Scientists at NIH have developed a strategy to obtain large quantities of highly reactive tumor infiltrating lymphocytes (TIL) from patient tumor samples for anti-cancer immunotherapy by making use of gas permeable (GP) flasks. This advancement in personalized anti-cancer immunotherapy involves culturing a tumor sample in a series of GP containers to isolate and rapidly expand TIL. The process provides suitable quantities of TIL for adoptive transfer into the cancer patient more reliably than previous approaches.

Culturing and growing TIL in the GP containers permits efficient gas exchange between TIL cells and the air to promote optimal respiration, growth, and viability of the patient's TIL throughout the process. Using GP flasks in the TIL expansion process provides for better circulation of the growth media and larger surface area so more TIL can grow per unit volume. Therefore, less reagents and fewer numbers of culture containers are need to generate the required number of TIL for adoptive immunotherapy protocols to treat cancer patients. NIH researchers have demonstrated the advantages of this GP TIL growth process in comparison to their more established TIL expansion protocols using human patient tumor samples. This new TIL production method should enable TIL therapy to become more GMP compliant and allow it to become more standardized for widespread utilization as a cancer treatment option outside of NIH.

Applications:

• Adoptive cell transfer therapy (immunotherapy) for a variety of human cancers
• Growing TIL in gas permeable cultureware has the potential to become the new standard for obtaining suitable quantities of TIL for use in adoptive immunotherapy
• GMP grade TIL manufacture process to allow for regulatory approval of TIL therapy so that it can become a more widely available personalized cancer treatment option

Advantages:

• Simpler, faster, less laborious, less reagent intensive, and less equipment intensive TIL growth process compared to methods of obtaining TIL without gas permeable cultureware
• Reduces risks of microbial contamination versus comparable methodologies
• More GMP-compliant than other TIL growing processes
• Capable of producing larger quantities of TIL more reliably than other TIL methodologies
• Potential to expand the number of patients and types of cancers treatable by TIL

Development Status:

• Pre-clinical
• In vitro data available
• In vivo data available (human)

Inventors:
Mark E Dudley (NCI)
Steven A Rosenberg (NCI)
Robert P Somerville (NCI)
Jianjian Jin (CC)
Marianna V Sabatino (CC)
David F Stroncek (CC)


Patent Status:
HHS, Reference No. E-114-2011/0
US, Application No. 61/466,200 filed 22 Mar 2011


Related Technologies:
US, Application No. 10/526,697 filed 05 May 2005, Reference No. E-275-2002/1 (and foreign counterparts)
US, Application No. 12/869,390 filed 26 Aug 2010, Reference No. E-273-2009/0
US, Application No. 61/237,889 filed 28 Aug 2009, Reference No. E-273-2009/0


Collaborative Research Opportunity:
The National Cancer Institute Surgery Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize gas permeable flasks for cell and gene therapy applications and multicenter clinical trials. For collaboration opportunities, please contact John Hewes, Ph.D. at hewesj@mail.nih.gov .


For Licensing Information Please Contact:
Samuel Bish Ph.D.
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325,
Rockville, MD 20852
United States
Email: bishse@mail.nih.gov
Phone: 301-435-5282
Fax: 301-402-0220


Ref No: 2312

Updated: 08/2011