LOS ANGELES, May 21, 2012 /PRNewswire/ -- Genesis Biopharma, Inc. (OTC/BB: GNBP), a biotechnology company developing targeted cancer immunotherapies, announces the posting of the following Letter to Shareholders to the Investors section of the Company's website at www.genesis-biopharma.com. In addition, on May 15, 2012, the Company filed with the U.S. Securities and Exchange Commission its Quarterly Report for the three months ended March 31, 2012 on Form 10-Q. The Form 10-Q includes unaudited interim consolidated financial statements containing the information highlighted below, as well as additional information regarding the Company. The Form 10-Q is available at www.sec.gov or www.genesis-biopharma.com.
The past months have been a productive and exciting time for Genesis Biopharma as we worked diligently to advance the clinical development of our targeted cancer immunotherapy, a ready-to-infuse autologous cell therapy ("ACT") utilizing tumor infiltrating lymphocytes ("TILs") for the treatment of patients with Stage IV metastatic melanoma. ACT is based on a physician-sponsored investigational therapy currently available at the National Cancer Institute ("NCI"), MD Anderson Cancer Center and the H. Lee Moffitt Cancer & Research Institute for this same indication.
During the fourth quarter of 2011, we were pleased to announce our Patent License Agreement with the National Institutes of Health ("NIH"), under which Genesis Biopharma was granted a non-exclusive worldwide license to 43 patents and patent applications. These include nine U.S. issued patents, 13 U.S. patent applications, and 21 foreign corresponding patents and patent applications relating to adoptive cell therapy using autologous TILs for the treatment of certain cancers.
We previously announced our entering into a Cooperative Research and Development Agreement (CRADA) with Dr. Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the National Cancer Institute for the further development of the NCI's proprietary adoptive cell transfer immunotherapy using tumor infiltrating lymphocytes in patients with metastatic melanoma. Dr. Rosenberg is the Principal Investigator for the CRADA, and the research effort will focus on (i) the in vitro development of improved methods of generation and selection of TILs with anti tumor reactivity; (ii) development of these approaches for large scale TIL generation that are in accord with Good Manufacturing Practice (GMP) procedures suitable for use in treating patients with metastatic melanoma; and (iii) development of clinical trials using these improved methods of large scale TIL generation as well as improved patient preparative regimens with the goal of commercializing the TIL therapy approach for treating patients with metastatic melanoma. Importantly, we have an exclusive option to negotiate an exclusive license to any new inventions developed jointly or solely by NCI scientists as a result of the research activities under the CRADA.
We have expanded our leadership with talented, experienced professionals. Earlier this year Hans Bishop, former Chief Operating Officer of Dendreon Corporation, joined our Board of Directors as Executive Chairman. Dendreon is the the first Company to obtain U.S. Food and Drug Administration ("FDA") approval for an autologous cell therapy in oncology. Hans' background makes him ideally suited to guide Genesis Biopharma as we advance our clinical programs, and he is a proven leader with an impressive track record of enhancing operational and financial results.
To support the commercial development plan for our ACT, we engaged four leading consultants to provide key services in cell therapy bioprocess engineering, clinical trial design, biostatistics, regulatory affairs and FDA compliance. This dynamic team has been instrumental in developing our clinical strategy to advance our ACT on a regulatory pathway toward approval.
One of the prerequisites for a successful IND filing is confirmation of our ability to manufacture our investigational ACT treatment in accordance with good clinical practice ("GCP"). Our goal is to ensure our GCP process will be consistent with the approach we propose to take for the manufacture of commercial product As previously reported we entered into a process development and scale-up agreement relating to the manufacture of Contego with Lonza, which is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Over the past months we have made significant progress in taking the Standard Operating Procedures (SOPs) currently used by the institutions conducting the physician-sponsored studies, and replicating them to build scaled-up bioprocesses that can support the commercial manufacture of Contego. Our goal is to complete the technology transfer to Lonza and obtain FDA certification for a commercial-scale TIL manufacturing processes to be ready to commence Registration trails in late 2013.
We are very satisfied with the progress we've made to date, and expect the remainder of 2012 to be an equally productive time. We are delighted to be working with several of the world's leading oncologists and clinical cancer-care institutions to bring our ACT through the regulatory process with the goal of expanding access to this life-saving therapy to the thousands of patients with late-stage melanoma who have no other treatment options.
On behalf of my colleagues and our Board of Directors, thank you for your continued interest in Genesis Biopharma.
Anthony J. Cataldo
Chief Executive Officer
About Genesis Biopharma, Inc.
Genesis Biopharma, Inc. is engaged in the development and commercialization of autologous cell therapies for the treatment of various cancers. The company's lead product candidate, Contego, is a ready-to-infuse autologous cell therapy that utilizes tumor infiltrating lymphocytes for the treatment of patients with Stage IV metastatic melanoma. Contego is based on a currently available physician-sponsored investigational therapy at the National Cancer Institute, MD Anderson Cancer Center and the H. Lee Moffitt Cancer & Research Institute for the treatment of Stage IV metastatic melanoma.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the proposed public offering and the intended use of proceeds from the offering. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including market conditions, risks associated with the cash requirements of the company's business and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission, and represent the company's views only as of the date they are made and should not be relied upon as representing the company's views as of any subsequent date. The company does not assume any obligation to update any forward-looking statements.
|SOURCE Genesis Biopharma, Inc.|
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