Genesis Biopharma Announces Letter to Shareholders Posted to Website
LOS ANGELES, Aug. 30, 2011 /PRNewswire/ — Genesis Biopharma, Inc. (OTC.BB: GNBP), a biotechnology company developing targeted cancer therapies, today announced that the following Letter to Shareholders will be posted today to the investor relations section of the Company’s website at www.genesis-biopharma.com. In addition, on August 22, 2011, the Company filed with the U.S. Securities and Exchange Commission its Quarterly Report for the three and six months ended June 30, 2011 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.
It is with great pleasure that I am providing this update on the progress Genesis Biopharma is making in developing autologous cell therapies for the treatment of various cancers. Importantly, in the past few months we have built the foundation upon which we will advance our lead product opportunity, Contego(TM) for the treatment of metastatic melanoma.
Contego is based on the standard therapy currently being administered to Stage IV metastatic melanoma patients at the National Cancer Institute (NCI), MD Anderson Cancer Center and H. Lee Moffitt Cancer Center & Research Institute. Previous studies conducted at the NCI and other major cancer centers have shown significantly higher Complete Response and Overall Response Rates using adoptive cell transfer-based immunotherapies (ACT) to treat metastatic melanoma in late stage patients. The published study can be accessed at http://www.ncbi.nlm.nih.gov/pubmed/21498393. In partnership with key scientists and clinicians at these cancer medical centers, Genesis Biopharma is developing commercial-scale manufacturing, quality and regulatory systems to allow Contego to be delivered to patients as the standard care autologous cell therapy.
We recently partnered with the NCI by entering into a cooperative research and development agreement (CRADA). The principal investigator is Steven A. Rosenberg, M.D., Ph.D., Chief, Surgery Branch, Center for Cancer Research of the NCI. While the ACT using tumor infiltrating lymphocytes (TIL) therapy approach is proprietary to the NCI, the principal goal of this CRADA is for Genesis and the NCI to collaborate on the development and evaluation of ACT/TIL for the treatment of patients with metastatic melanoma.
Specifically this CRADA addresses: (1) the in vitro development of improved methods for the large-scale generation and selection of TIL with anti-tumor reactivity from patients with metastatic melanoma based on ACT therapies developed by and proprietary to the NCI Surgery Branch; (2) the development of these approaches for large-scale TIL production that are in accord with Good Manufacturing Practice suitable for use in treating patients with metastatic melanoma; and, (3) the development of clinical trials using these improved methods of large-scale TIL production as well as improved patient preparative regimens with the goal of commercializing the ACT/TIL therapy approach for treating patients with metastatic melanoma.
Contego is a ready-to-infuse autologous cell therapy using tumor infiltrating lymphocytes that, following approval by the U.S. Food and Drug Administration, will be administered as an in-patient therapy at major cancer medical centers.
Our strategy of working in partnership with major cancer medical centers offers several economic advantages over alternative models. First, it is an efficient means to deliver Contego as it allows for centralized product manufacturing and distribution. Second, because the target market initially numbers approximately 20 cancer centers in the U.S. and a like number overseas, we can undertake a very focused and efficient marketing and sales operation. Third, delivery of Contego as an in-patient therapy places reimbursement in the hands of highly effective hospital reimbursement staff instead of community-based physicians and their office staff. Lastly, major cancer medical centers have the financial resources to accommodate the period of time between the purchase of Contego by their in-patient pharmacy and receipt of reimbursement. Conversely, community-based physicians and smaller clinics typically cannot weather the lengthy reimbursement payment schedule for a cell therapy product and its associated therapeutic regimen. Limiting the number of reimbursement stakeholders is a key element to our overall economic strategy.
Recently we entered into a process development and scale-up agreement relating to the manufacture of Contego with Lonza, one of the world’s leading suppliers to the pharmaceutical, healthcare and life science industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Most importantly, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. With this agreement we have secured critical constraints on our cost of goods for Contego.
Last but not least, we have assembled a Scientific and Medical Advisory Board that is comprised of world leading oncology scientists and clinicians, each of whom is renowned for their expertise in the treatment of metastatic melanoma using cell therapies. The clinical participation and guidance from these distinguished professionals is an invaluable asset for Genesis Biopharma. This Board includes:
- Cassian Yee, M.D., of the Fred Hutchinson Cancer Research Center
- James Mule, Ph.D. and Jeffrey Weber, M.D., Ph.D., of the H. Lee Moffitt Cancer Center & Research Institute
- Patrick Hwu, M.D. and Laszlo Radvanyi, Ph.D., of MD Anderson Cancer Center
- Daniel Powell, Ph.D., of the University of Pennsylvania School of Medicine
- Mario Sznol, M.D., of Yale University School of Medicine
- David DiGiusto, Ph.D., of the City of Hope
As we look forward to the remainder of 2011 and beyond, we believe Contego will continue to progress rapidly through manufacturing scale-up and the regulatory processes, and will become a life-saving therapy available to all metastatic melanoma patients at the major cancer medical centers in the U.S. and eventually, worldwide.
Thank you for your continued support as we work to bring life saving cancer treatments to patients worldwide.
Anthony J. Cataldo
Chairman and Chief Executive Officer
About Genesis Biopharma, Inc.
Genesis Biopharma, Inc. is engaged in the development and commercialization of a novel autologous cell therapy (ACT) for the treatment of various cancers. ACT using tumor infiltrating lymphocyte (TILs) is currently a standard therapy for treating Stage IV metastatic melanoma at the National Cancer Institute and leading institutions such as University of Texas MD Anderson Cancer Center in Houston and the H. Lee Moffitt Cancer Center in Tampa.
Within the next twelve months, Genesis Biopharma expects to initiate a pivotal clinical trial with its lead product candidate, Contego(TM), an autologous cell therapy using TILs as a second line treatment for Stage IV metastatic melanoma and thereafter to conduct a confirmatory trial for approval as a first line treatment in this indication. In addition, the Company plans to expand the development of this innovative platform technology with pilot studies using its ACT to treat breast, ovarian and colorectal cancers.
Genesis Biopharma is a led by a seasoned management team and world-class board of directors, with participation from a prestigious scientific and medical advisory board. For more information about the company, visit www.genesis-biopharma.com.
The foregoing announcement contains forward-looking statements that can be identified by such terminology as “expects”, “hopes”, “potential”, “suggests”, “bodes”, “may”, “should”, “could”, or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management’s expectations regarding future research, development and/or commercial results could be affected by, among other things, uncertainties relating to clinical trials and product development; availability of future financing; unexpected regulatory delays or government regulation generally; the company’s ability to obtain or maintain patent and other proprietary intellectual property protection; and competition in general. Forward-looking statements speak only as of the date they are made. The company does not undertake to update forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements are made.
SOURCE Genesis Biopharma, Inc.