Positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C virus

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today the publication of a scientific paper highlighting positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C viruses in the journal Vaccine. Clade C is the predominant HIV-1 strain infecting people in sub-Saharan Africa, India, and China, and there is a critical need for a vaccine targeted to these areas.

“High antibody and cellular responses induced to HIV-1 clade C envelope following DNA vaccines delivered by electroporation.”

The study, conducted by Inovio scientists and their collaborators, is described in the published paper, entitled "High antibody and cellular responses induced to HIV-1 clade C envelope following DNA vaccines delivered by electroporation." In this study, the vaccine induced strong antibody and T-cell immune responses in rhesus monkeys. Furthermore, the vaccinated monkeys displayed protective effects against a subsequent challenge with an infectious dose of SHIV virus (chimeric HIV/SIV virus) compared to the placebo control animals. These results further support the proof of concept for Inovio's global DNA vaccine candidates, PENNVAX™-G (vaccine against HIV Clades A, C, and D) and PENNVAX™-GP (vaccine against HIV Clades A, B, and C) in a relevant preclinical model. PENNVAX™-G is currently being tested in a 92-patient global Phase I clinical study (RV-262) conducted by the U.S. Military HIV Vaccine Research Program (MHRP). PENNVAX-GP is being developed using a multi-year $23.5 million NIAID HIV vaccine development contract awarded to Inovio.

Inovio recently announced interim immunogenicity and safety data from its Phase I clinical study of PENNVAX™-B, a DNA vaccine for the prevention of HIV Clade B infection. PENNVAX-B achieved high vaccine-induced response rates and strong magnitude of T-cell immune responses in vaccinated subjects. Similar to reported results from a Phase I clinical study of Inovio's therapeutic DNA vaccine for cervical cancer, the response rates and magnitude of responses achieved in this study were significantly higher than those seen previously with other DNA vaccine trials. Complete immunogenicity data as well as end-of-study safety data from the PENNVAX-B study are expected in 2Q 2011.

Dr. J. Joseph Kim, Inovio's president and CEO, said: "In the past year, we were able to demonstrate best-in-class clinical immunogenicity data from our DNA vaccines for cervical cancer and HIV. We look forward to advancing our cervical cancer candidate into Phase II studies this quarter and completing the preventive HIV study in the next quarter. The data from this study is supportive of the ongoing Phase I clinical program, under the RV-262 protocol, and we are excited about the significant preclinical progress of our PENNVAX-GP global HIV vaccine program. These results further support the prospect that Inovio's DNA vaccine and delivery platform could play an important role in developing new vaccines and therapies for major diseases like HIV."

Inovio's PENNVAX-G vaccine is currently being tested in 12 HIV-uninfected participants in the U.S. Once the vaccine has been assessed as safe and acceptable, the study will expand to three additional global MHRP sites: Kericho, Kenya; Kampala, Uganda; Mbeya, Tanzania. Healthy, HIV-uninfected participants will be enrolled at each of these sites for a total of 80 international participants.

IND-enabling preclinical work for PENNVAX-GP will be conducted in 2011 and the Phase I study is planned to be initiated in 2012.