Fierce Vaccines highlights Inovio's VGX-3100 as one of 10 Promising Therapeutic Vaccines

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.