• Inovio expects to complete VGX-3100 Phase I trial immunogenicity and safety data to be reported in early Q1 2011. The company has reported previously that they are extremely pleased with the safety and tolerability profile of VGX-3100.
• During Q1 Inovio expects to announce Phase I data for VGX3400 for Bird Flu- in which The primary objectives are to assess safety and tolerability. The secondary objective is to measure antigen-specific antibody and cellular immune responses, in particular a measure of protection, against multiple strains of H5N1 influenza.
• During Q1 Inovio expects to begin Phase II studies for VGX3100 Cervical Intraepithelial Neoplasia

Inovio today announced that it has achieved high vaccine-induced response rates and strong magnitude of immune responses in its Phase I clinical study of PENNVAX™-B, a DNA vaccine for the prevention of HIV infection. Similar to recently 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 are significantly higher than those seen previously with other DNA vaccine trials. Dr. Spyros Kalams, principal investigator for the study and Immunology Director of the Vanderbilt Center for AIDS Research at Vanderbilt University Medical Center, presented the interim immune response and safety data at the Annual HIV Vaccine Trials Network (HVTN) Conference being held November 15-17 in Seattle, WA.

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In the study of 48 total volunteers, eight subjects received a placebo, 10 subjects received a 1 mg dose of PENNVAX™-B vaccine, and 30 subjects received a 1 mg dose of PENNVAX-B along with IL-12 DNA.

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.”

Here is a look at their chart:

Inovio's product categories include: Cancer DNA vaccines, Infectious disease DNA vaccines, Anti-Inflammatory drugs and Animal health. Its Cancer DNA vaccines include - V930 for breast, colorectal, ovarian and lung cancer; VGX(TM) 3100 therapeutic vaccine for cervical cancer; V934/V935 for breast, lung, prostate and other cancers; and PSMA for prostate cancer. Its Infectious disease DNA vaccines include - Pennvax(TM) family of vaccines for Human Immunodeficiency Virus (HIV), ChronVac-C for hepatitis C virus, etc. Its Anti-inflammatory drug includes - VGX(TM) - 1027 for the treatment of inflammatory diseases including rheumatoid arthritis (RA), Type 1 diabetes (T1D), uveitis and colitis.

Inovio owns a majority interest in VGX Animal Health, Inc., which is focused on the development of pharmaceutical products for animal health applications and markets LifeTide(TM) animal growth hormone for swine. The company has collaborations with, VGX Pharmaceuticals, Inc., Vaccine Research Center, University of Pennsylvania, U.S. Department of Defense, Vandalia Research, Inc, Advanced BioScience Laboratories, Inc, The National Cancer Institute, etc.

 

Disclosure: No Positions