Inovio Pharmaceuticals Cervical Dysplasia And Cancer Treatment Highlighted as One of 10 Promising Therapeutic Vaccines; Phase II Clinical Study Currently Enrolling
Fierce Vaccines Profiles Novel Synthetic Cancer Vaccine
BLUE BELL, Pa., Oct. 31, 2011 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), which is advancing synthetic vaccines to fight cancers and infectious diseases, announced today that VGX-3100, its investigational SynCon® vaccine for treating cervical dysplasia and cancer caused by human papillomavirus, was highlighted by Fierce Vaccines as one of 10 Promising Therapeutic Vaccines (see VGX-3100 – Cervical cancer). Inovio is currently enrolling patients with CIN 2/3 or CIN 3 cervical dysplasias in its Phase II clinical study being conducted in multiple centers around the US and sites in Canada, Korea, South Africa and Australia.
The article noted: "Fierce Vaccines spotlights 10 therapeutic vaccines now being tested in humans and generating buzz. Those for cancer get the most attention, in part because their anticipated gentleness stands in such stark contrast to the known toxicities of conventional chemotherapies….
"[Inovio's] VGX-3100 is a therapeutic DNA vaccine candidate, now in Phase II testing for the treatment of cervical dysplasia and cancer caused by human papillomavirus (HPV) types 16 and 18. These sexually transmitted strains are thought to cause up to 70% of cervical cancer cases. Inovio is conducting Phase II clinical trials of related vaccine candidates based on DNA associated with leukemia and hepatitis C virus, and Phase I studies for influenza and HIV. The company's vaccine candidates are similar to gene therapy, in that they are designed to insert into patients' cells a piece of DNA coding for an antigenic protein related to a particular disease. In theory, if enough DNA can get into cells even temporarily, those cells will produce the encoded antigenic protein and so trigger production of antibodies and T-cells against that target. In the case of VGX-3100, intramuscular injections deliver DNA for the proteins E6 and E7, which are known to inactivate two of the body's natural tumor suppressor proteins."
Inovio recently reported data demonstrating long-term durability of T cell immune responses of up to over two years in 87% (7 of 8) of evaluated patients following a fourth vaccination of VGX-3100. The data further highlighted the viability of using multiple booster vaccinations with a synthetic vaccine delivered using electroporation, in contrast to other non-replicating vaccine vectors that may induce unwanted immune responses against the vector after multiple vaccinations. The vaccine generated best-in-class T cell immune responses, which are widely believed to be important in clearing cancerous cells. VGX-3100 recently won the Edward Jenner Poster Award First Prize, a prestigious award that recognized the most promising research at the 5th Vaccine and ISV Global Congress.
Inovio's president and CEO, J. Joseph Kim, said, "We greatly appreciate recognition from a top-tier pharmaceutical publication for Inovio's leadership in developing a therapeutic vaccine against precancerous and cancerous cells of the cervix. Inovio's synthetic vaccine for cervical dysplasias/cancer answers an unmet need by providing a non-invasive and potentially more effective approach for treating women with this condition - there is neither a therapeutic live virus vaccine nor non-replicating vaccine available for cervical dysplasias and cancers."
Inovio is currently recruiting for its Phase II study, which is designed to enroll 148 patients with cervical dysplasia at approximately 25 study centers. This randomized, placebo-controlled study will assess regression of cervical lesions from CIN 2/3 or CIN 3 to CIN 1 or less and clearance of HPV 16 or 18. The secondary endpoint is to assess immune responses to VGX-3100. Subjects will also be monitored for tolerability and safety. See the HPV-003 clinical trial protocol.
About Fierce Vaccines
Fierce Vaccines is a weekly update on the vaccine industry with a special focus on the innovations revolutionizing the development and production of vaccines. Fierce Vaccines reaches corporate executives and R&D leaders at vaccine developers and pharmaceuticals of all sizes. Editorial topics include vaccine R&D, sales and marketing, research breakthroughs, vaccine production, disruptive technologies, and next-generation vaccine therapeutics. Fierce Vaccines is one of the publications offered by Fierce Markets, whose newsletters deliver crucial industry news and insightful analysis to over a million industry leaders each day. http://www.fiercevaccines.com.
Inovio's VGX-3100 is designed to raise immune responses against the E6 and E7 oncogenes common to HPV types 16 and 18, i.e. it targets four antigens. These oncogenes are responsible for transforming HPV-infected cells into pre-cancerous and cancerous cells. The goal is to stimulate a T-cell immune response strong enough to cause the rejection of these infected or transformed cells from the body. The potential of such a therapeutic vaccine would be to treat precancerous dysplasias (CINs), cervical cancers, as well as other anogenital and head and neck cancers caused by these HPV types.
About Cervical Dysplasias/Cancers
Human papillomavirus (HPV) is the causative agent responsible for most cases of cervical cancer. At any given time, approximately 10% of women worldwide are infected with HPV. While roughly 70% of HPV infections are cleared by the body on its own, persistent HPV can lead to dysplasia, or premalignant changes in cells, of the cervix. Researchers have estimated the global prevalence of clinically pre-cancerous HPV infections at between 28 and 40 million. Persistent dysplasias may then progress to cancer. Every year, 510,000 cases of cervical cancer are diagnosed worldwide, and about 288,000 of the afflicted women, primarily in developing countries, die.
Preventive vaccines such as GARDASIL® and CERVARIX® are playing an important role in limiting new HPV infections. However, preventive vaccines cannot provide protection for those already infected, which is a large population. In addition, a significant number of the girls and women eligible to be vaccinated are not receiving these preventive vaccines. There is no viable therapeutic vaccine or drug to treat HPV, nor dysplasias and cancers caused by HPV. Current ablative or surgical procedures to remove cervical dysplasias and cancers are unappealing due to their potential for disfigurement, the perceived negative impacts on childbirth, and the stress of the watch-and-wait approach that typically precedes these procedures.
HPV types 6, 11, 16 and 18 are responsible for 35% to 50% of the 1.4 million low-grade CIN 1 dysplasias diagnosed annually in the US. HPV types 16 and 18 are responsible for about 70% of the 300,000 high grade CIN 2/3 dysplasias and cervical cancer incidences.
About Inovio Pharmaceuticals, Inc.
Inovio is developing its revolutionary synthetic consensus immunogen technologies to extend the profound medical benefits of the 20th century's immune-system-stimulating vaccines by preventing and treating today's cancers and challenging infectious diseases. Its SynCon® vaccines are designed to provide universal cross-strain protection against unmatched known as well as newly emergent strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery method, have been shown in humans to be safe and generate best-in-class immune responses. Inovio's clinical programs include Phase II studies for cervical dysplasia/cancer, leukemia and hepatitis C virus and Phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company 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 the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2010, our Form 10-Q for the quarter ended June 30, 2011, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.
SOURCE Inovio Pharmaceuticals, Inc.
Web Site: http://www.inovio.com
Posted: October 2011