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Inovio's License of Electroporation Intellectual Property Includes Skin Delivery Technology Used in Anthrax Collaboration

Posted on: Wednesday, 5 July 2006, 06:00 CDT

Inovio Biomedical Corporation (AMEX:INO) announced today that it has exercised an existing option with RMR, LLC to license certain patented technology relating to the delivery of gene-based therapeutics into skin. The license also includes other patents involving the delivery of genes or drugs via ex vivo, intratumoral, and intramuscular electroporation. As an example of potential applications, in the area of bioterrorism, RMR is currently employing its skin electroporation technology in the pre-clinical development of an anthrax vaccine under a Department of Defense Small Business Innovation Research (SBIR) Program grant. The technology may also be useful with respect to targets such as the Lassa fever virus currently being studied by the US Army in collaboration with Inovio. The ex-vivo patents are relevant to the delivery of genes to dendritic and stem cells.

Inovio has a number of ongoing clinical trials that involve delivering DNA vaccines into muscle tissue. Recent pre-clinical studies suggest that, for certain indications, needle-less skin electroporation of DNA plasmids encoding selected antigens may also be effective at inducing desired immune responses. The patented technology licensed from RMR covers various skin electroporation electrode designs and methods, including a needle-less design using a flexible material that conforms to the skin contour. Inovio and RMR have agreed to collaborate in an effort to develop research prototypes into commercial grade electrodes for skin delivery as well as other novel forms of electroporation-assisted DNA delivery. Inovio has agreed to provide RMR with other development expertise pertinent to projects such as RMR's SBIR-funded pre-clinical study using RMR's proprietary, conformable dermal electrodes to deliver a DNA vaccine against anthrax.

Inovio has also licensed from RMR patents that claim the intratumoral delivery method used in the ongoing clinical trial at the Moffitt Cancer Center & Research Institute, which is delivering the gene encoding interleukin-12 directly to melanoma lesions. RMR, Inovio, the University of South Florida and Moffitt Cancer Center have been collaborating in the development of this novel therapy for melanoma for the past two years.

Inovio has three proprietary gene and drug delivery platforms that may enable the development of numerous product candidates. These platforms encompass patents, technology, and other intellectual property encompassing intratumoral, intramuscular, and intradermal methods for delivering drugs and gene-based treatments in humans. The RMR patents complement Inovio's recently issued, seminal patent (US patent 6,972,013) claiming methods of delivery of any DNA plasmid to skin via electroporation and the company's recent licensing of Sphergen's muscle and tumor delivery intellectual property. Collectively, Inovio's patent portfolio places the company in a preeminent position with respect to patents and patent rights in the rapidly expanding field of electroporation-based delivery of gene-based treatments for cancers, infectious diseases and protein-proficiency diseases.

"Inovio has aggressively pursued consolidation of key intellectual property rights in the area of gene and drug delivery to any human tissue via in vivo electroporation," said Avtar Dhillon, MD, CEO of Inovio Biomedical. "We are pleased to strengthen our relationship with Drs. Richard Heller, Mark Jaroszeski and Richard Gilbert of RMR. Their scientific leadership contributed to the initiation of a pioneering clinical study using our proprietary electroporation delivery platform for a gene-based treatment. We anticipate that our collaboration with RMR may also enable other important applications of electroporation technology for DNA vaccines to counter bioterrorism agents and pandemics such as avian flu and HIV."

About RMR, LLC

RMR, LLC is a privately held biotechnology company dedicated to research and development of drug and gene delivery technology. The company was founded by Drs. Richard Heller, Mark Jaroszeski and Richard Gilbert of the University of South Florida and the Moffitt Cancer Center.

About University of South Florida

The University of South Florida is one of the nation's top 63 public research universities as designated by the Carnegie Foundation for the Advancement of Teaching. USF received more than $287 million in research contracts and grants last year, and it is ranked by the National Science Foundation as one of the nation's fastest growing universities in terms of federal research and development expenditures. The university has a $1.3 billion annual budget and serves nearly 43,250 students on campuses in Tampa, St. Petersburg, Sarasota/Manatee and Lakeland. USF is a member of the Big East athletic conference.

About Inovio Biomedical Corporation

Inovio Biomedical Corporation is a late stage biomedical company focused on commercializing its proprietary Selective Electrochemical Tumor Ablation (SECTA) therapy. SECTA is designed to target a significant unmet clinical need: a local treatment for solid tumors, with selective killing of cancer cells while preserving surrounding healthy tissue. Inovio is moving its lead product, the MedPulser(R), through pre-marketing studies for head and neck cancer and skin cancers in Europe, where it has CE Mark accreditation, a U.S. Phase III pivotal study for head and neck cancer, and Phase I trials for pancreatic and breast cancer. Merck, Vical, University of Southampton, and H. Lee Moffitt Cancer Center are using Inovio's gene delivery technology in clinical studies of novel DNA therapeutics delivered using electroporation. Inovio is a leader in developing human therapeutic applications of electroporation, with the industry's most extensive patent portfolio covering in vivo electroporation. More information is available at www.inovio.com.

This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio's technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in the our Annual Report on Form 10-K for the year ended December 31, 2005, our Form 10-Q for the three months ended March 31, 2006, and other regulatory filings. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products.

Source: Business Wire

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