Advanced Cancer Therapeutics Licenses Technology to Develop Human Papillomavirus (HPV) Vaccine.

HPV is the Leading Cause of Cervical Cancer Worldwide

LOUISVILLE, Ky. -- Advanced Cancer Therapeutics (ACT), a for-profit private company dedicated to bringing new anti-cancer therapies to market, today announced the signing of two new collaborative agreements that will advance development of the Company's novel human papillomavirus (HPV) vaccine program.

The vaccine, to be produced in tobacco plants, targets the L2 protein, an integral part of the papillomavirus capsid. Preclinical research indicates that this development strategy may yield a vaccine that provides broader immune protection against a greater number of the approximate 200 HPV subtypes, as well as provide a more cost-effective alternative to the currently available options to patients. As such, the vaccine could have a significant impact on reducing the global incidence of HPV-linked cancers, including cervical cancer.

"There is a clear need for a lower cost HPV vaccine with broad spectrum immune protection against a greater number of the approximate 200 HPV subtypes and there are indications that a plant-produced L2 peptide based vaccine could provide a valuable treatment alternative," said Randall B. Riggs, President and CEO of Advanced Cancer Therapeutics. "These agreements are central to the timely and efficient development of a novel vaccine and we look forward to continuing our collaborations as we work towards this common goal."

The first agreement announced today is with the University of Louisville's James Graham Brown Cancer Center and grants ACT exclusive worldwide development and commercialization rights to monovalent vaccines derived from the minor capsid protein (L2) of human papillomavirus. The L2 protein, in combination with the L1 protein can assemble into virus-like particles (VLPs) in various expression systems. Immunization of laboratory animals with such VLP preparations or with inactivated virions from various animal papillomaviruses (PV) has been shown to protect animals from papillomavirus associated disease, indicating the potential of prophylactic PV vaccines based on PV capsids.

The intellectual property, licensed to ACT through University of Louisville's Office of Technology Transfer, is based on research by associate professor Kenneth Palmer, professor A. Bennett Jenson and their colleagues.

"The human papillomavirus is the leading cause of cervical cancer and is increasingly being implicated in other cancers, such as those of the head and neck," said professor Jenson. "As we learn more about the virus, it is becoming even more important to be able to protect people from preventable cancers by vaccinating them against this disease."

The current vaccine, Gardasil, costs approximately $350 for the three-dose series. According to the World Health Organization, about 80 percent of the world's 500,000 annual cases of cervical cancer occur in developing countries, where neither routine screening nor the vaccine are available or affordable.

"Our research to date indicates that the technology we are using to produce the vaccine protein in plants will be very cost-effective," said associate professor Palmer, a pharmacologist and plant bioscientist.

The second agreement announced today is with Kentucky BioProcessing, LLC (KBP), of Owensboro, Kentucky, for exclusive worldwide development and commercialization rights to KBP's GENEWARE[R] plant based gene expression system for development of an HPV vaccine. The GENEWARE system is widely recognized as one of the world's most potent, robust and effective plant-based gene expression systems and uses a specifically altered tobacco mosaic virus as a vehicle to carry a target protein. Once this altered virus is introduced into the tobacco plant, the natural growth of the plant causes the protein to be reproduced in larger quantities. Expression of antigens in plant systems offers the potential for products of appropriately-folded viral antigens under cost-effective and favorable agricultural scale conditions.

"Joining together on this exciting project allows ACT, KBP and the Brown Cancer Center to leverage the business, scientific and intellectual property capabilities of three Kentucky based entities to develop a solution to a very serious world health concern. KBP is proud to be a part of this collaboration," said KBP Chairman Hugh Haydon.

About Human Papillomavirus (HPV)

Human Papillomavirus (HPV) is a leading cause of cervical, anal and vaginal cancer, and approximately 20 million people are currently infected with this sexually transmitted disease (STD). According to the Centers for Disease Control and Prevention, at least 80 percent of women will have acquired genital HPV infection by age 50 with about 6.2 million Americans contracting a new genital HPV infection each year. The U.S. FDA recently approved the first HPV cervical cancer vaccine that includes a portion of the L1 capsid protein to guard against this terrible disease. Advanced Cancer Therapeutics is developing a novel HPV vaccine which targets the L2 capsid protein that we believe should provide broader immune protection to patients at risk of contracting cervical cancer. ACT intends to manufacture its novel HPV vaccine from tobacco mosaic plants, promising to be very cost effective for people at risk of contracting HPV in both developed and developing nations.

About Kentucky BioProcessing, LLC (KBP)

KBP (www.kbpllc.com) is located in Owensboro, Kentucky and is a world leader in the expression, extraction, purification and commercial scale production of proteins and other products from plants. KBP offers clients and collaborators access to controlled plant growth facilities along with bench, pilot and full scale processing facilities capable of production under cGMP conditions. In addition to its own capabilities KBP is able to leverage the experienced staff and facilities of the Owensboro Cancer Research Program and provides linkages to the considerable plant made product expertise of the Owensboro area agriculture community and to other services offered throughout the region designed to support research, development and growth of a plant made product business cluster.

About Advanced Cancer Therapeutics (ACT)

ACT is a for-profit private company dedicated to advancing novel therapeutics for the prevention and treatment of cancer. ACT has successfully established a unique and innovative business model with the University of Louisville's James Graham Brown Cancer Center (Brown Cancer Center) whereby ACT is able to obtain exclusive worldwide licenses to novel cancer therapeutics discovered at Brown Cancer Center under preset business terms. ACT then fast-tracks these discoveries, including the selection process for partnership, commercialization and manufacture, to the pharmaceutical industry, and ultimately to the patients who need them. Led by Dr. Don Miller, the Brown Cancer Center employs over fifty leading scientists focused on the discovery and advancement of breakthrough cancer therapeutics for patients suffering from cancer. For more information, please visit: http://www.advancedcancertherapeutics.com.

About James Graham Brown Cancer Center

The James Graham Brown Cancer Center is a key component of the University of Louisville's Health Sciences Center and UofL Health Care. As the region's leading academic, research, and teaching medical center, our patients benefit from the latest medical advances, often long before they become available in non-teaching settings. The Brown Cancer Center is affiliated with the Kentucky Cancer Program and the National Cancer Institute. It is the only cancer center in the region to use a unified approach to cancer care, with multidisciplinary teams of physicians working together to guide patients through diagnosis, treatment and recovery. For more information, please visit: http://www.browncancercenter.org.