Inovio achieves positive results in Phase I PENNVAX-B study for HIV

February 22, 2016

67% (6 out of 9) of evaluated subjects receiving PENNVAX-B and 91% (20 of 22) of evaluated subjects receiving PENNVAX-B + IL-12 were observed to have generated antigen-specific T-cell responses (either CD4+ or CD8+). Antigen-specific CD4+ T-cell responses were generated by the vaccine in 70% of evaluated vaccine recipients (21 out of 30). Significantly strong antigen-specific, CD8+ T-cell responses were also generated by the vaccine in 55% of evaluated vaccine recipients (17 out of 31). Samples from eight placebo recipients and pre-vaccine samples from vaccine recipients were also tested and were negative for both CD4+ T-cell responses and CD8+ T-cell responses. PENNVAX-B delivered using the CELLECTRA? intramuscular electroporation delivery device with or without IL-12 was generally safe and well tolerated. There were no vaccine-related serious adverse events. Reported adverse events and injection site reactions were mild to moderate and required no treatment.

Dr. Kalams stated, "The preliminary immune response data from this novel DNA-based vaccine are indeed very encouraging. We look forward to our continuing work with Inovio to develop the potential of this promising vaccine candidate."

Dr. J. Joseph Kim, Inovio's President and CEO, said: "After recently announcing best-in-class immunogenicity data from our clinical trial for our cervical cancer DNA vaccine using the same technology platform, we are pleased to again see very strong T-cell immune responses from this vaccine platform for a different disease, and particularly a disease with unmet needs like HIV. They are amongst the highest immune responses seen in other HIV vaccine trials either with DNA or other vaccine platforms including proteins and viral vectors. However, unlike viral vectors, DNA vaccines do not induce unwanted immune responses against the carrier. Taken together 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 cancer and HIV."

In addition to the interim ICS results presented at the meeting, the complete immunogenicity data including data from the few remaining unanalyzed samples and additional antibody and T-cell results based on ELISpot assays as well as the end-of-study safety data are expected in 2Q 2011.

Source: Inovio Pharmaceuticals, Inc.