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.

About VGX-3100

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.

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