NIH, Genesis Biopharma enter Patent License Agreement for adoptive cell therapy

Oct 12 2011

Genesis Biopharma, Inc. (OTCBB: GNBP), a biotechnology company developing targeted cancer immunotherapies, today announced it has entered into a Patent License Agreement (the "License Agreement") with the National Institutes of Health, an agency of the United States Public Health Service within the Department of Health and Human Services ("NIH").  Pursuant to the License Agreement, NIH granted to the Company a non-exclusive worldwide license to 43 patents and patent applications, consisting of 9 issued United States patents, 13 United States patent applications, and 21 foreign corresponding patents and patent applications relating to adoptive cell therapy using autologous tumor infiltrating lymphocytes (TILs) for the treatment of certain cancers.  The Company also has rights to sublicense the intellectual property subject to the terms and conditions set forth in the License Agreement.  The License Agreement will expire on a product-by-product basis upon the expiration of the subject patent rights.  

These technologies were also the subject of the Cooperative Research and Development Agreement, effective August 5, 2011, as disclosed previously in the Company's Current Report on Form 8-K filed on August 11, 2011.  

In consideration for the License Agreement, the Company agreed to pay approximately $1.2 million in upfront licensing fees and expense reimbursements within 60 days of the effectiveness of the License Agreement, royalties based on a percentage of net sales (subject to certain annual minimum royalty payments), and a percentage of revenues from any sublicensing arrangements.  In addition, the Company will make additional payments on the achievement of certain clinical and regulatory milestones for each of the various indications.  

"We are very pleased to finalize this License Agreement as it will now allow us to move forward with the clinical development for Contego™, our ready-to-infuse adoptive cell therapy using TILs, to treat Stage IV metastatic melanoma.  We already have a process development and scale-up agreement for the manufacture of Contego with Lonza, one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries," stated Anthony J. Cataldo, Chairman and Chief Executive Officer of Genesis Biopharma.  

"Adoptive cell therapy using autologous TILs is presently being administered as a physician-sponsored investigational therapy to Stage IV metastatic melanoma patients at the National Cancer Institute (NCI), MD Anderson Cancer Center and H. Lee Moffitt Cancer Center & Research Institute.  The medical oncology community is very aware of this innovative work using adoptive cell therapy and autologous tumor infiltrating lymphocytes for the treatment of Stage IV metastatic melanoma," added Mr. Cataldo.