Inovio Product Pipeline: PENNVAX™-family of vaccines: Human Immunodeficiency Virus (HIV)
Product & Indication
Inovio is developing PENNVAX™, a family of DNA-based preventive and therapeutic vaccines for HIV. The underlying technology was developed by the University of Pennsylvania.
Inovio is presently testing the PENNVAX™-B vaccine against HIV clade B, the prevalent HIV strain in North America and Western Europe. This vaccine is in clinical research as a stand-alone entity or in combination with electroporation delivery and/or various cytokine and chemokine adjuvants.
Inovio has partnered with the HIV Vaccine Trials Network (HVTN) to conduct a clinical trial of the PENNVAX(tm)-B DNA vaccine in a prophylactic setting involving healthy adult volunteers.
In another collaboration, the University of Pennsylvania is conducting a clinical trial of the PENNVAX(tm)-B DNA vaccine in a therapeutic setting involving adult HIV-infected patients.
Inovio is also developing Synthetic Consensus (SynCon™) DNA vaccine constructs for HIV envelope clades A, C, and D for the developing regions of Africa and Asia (PENNVAX™-G, PENNVAX™-GP).
Market Potential
Refer to a brief by the International AIDS Vaccine Initiative called Assessing the Demand for an HIV Vaccine.
Stage of Development
Study One
Phase: I, treating healthy subjects at risk of HIV. Conducted by HIV Vaccines Trials Network (HVTN).
Purpose: To determine the safety, tolerability, and immune response to the DNA HIV vaccine, PENNVAX™-B, alone, in combination with IL-12, or with two different doses of IL-15.
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Study Start Date: October 2007
Status: Study ongoing
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)and HIV Vaccine Trials Network
For more information: www.clinicaltrials.gov Identifier: NCT00528489
Study Two
Phase: 1b, treating patients with HIV.
Purpose: To evaluate the safety and immunological effects of PENNVAX™-B with or without co-administration of constructs containing DNA encoding for the expression of either IL-12 or IL-15.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Study Start Date: September 2008
Status: Recruiting
Sponsors and Collaborators: University of Pennsylvania, Drexel University
For more information: www.clinicaltrials.gov Identifier: NCT00775424
Commercialization
PENNVAX™ DNA Vaccines: Licensed from The University of Pennsylvania ("Penn").
Delivery technology: owned by Inovio.
License agreement: Inovio has worldwide commercialization rights for vaccine and delivery technology. Financial terms of the license agreement with Penn for the DNA vaccine undisclosed, but deal terms include additional milestone payments and royalties.
Technical
DNA Vaccine Design for HIV-1 Infection- HIV Clade B: North America and Western Europe (PENNVAX™-B)
- HIV Clades A, C, and D: Developing regions of Africa and Asia (PENNVAX™-G, PENNVAX™-GP)
- Inovio Strategy for World AIDS Vaccine
- Develop SynCon™ DNA Vaccine Constructs for HIV Envelope Clades A, B, C, and D
- Develop SynCon™ DNA Vaccine Constructs for Gag and Pol Proteins
Inovio HIV Vaccine Trial Strategies
Conduct Clinical Testing with Clinical Partners
- Prophylactic Clade B Vaccine: Collaborations w/ HIV Vaccine Trials (PENNVAX™-B) Network (HVTN)
- PENNVAX™-B + Cytokine (IL-12 and IL-15) Genes (HVTN-070 Study) - Phase I initiated
- PENNVAX™-B + CELLECTRA® EP (HVTN-080 Study)
- Prophylactic Clades A, C, and D Vaccines:
- PENNVAX™-GP + CELLECTRA® EP
- Therapeutic Clade B Vaccine:
- PENNVAX™-B + CELLECTRA® EP
SynCon™ DNA Vaccines for HIV: Increased T Cell Immune Responses in Monkey Models
- HIV or SIV vaccines administered at 1 mg/construct + CELLECTRA® EP
- 10-30x improvement in immunogenicity compared to that observed via other vaccine methods*
- "Best" Cytotoxic T Lymphocyte (CTL) responses in Monkey Models for HIV
*Hirao LA, Wu L, Khan AS, Satishchandran A, Draghia-Akli R, Weiner DB. Vaccine. 2008 Jan 17;26(3):440-8. Epub 2007 Nov 8. Intradermal/subcutaneous immunization by electroporation improves plasmid vaccine delivery and potency in pigs and rhesus macaques.
Cristillo AD, Weiss D, Hudacik L, Restrepo S, Galmin L, Suschak J, Draghia-Akli R, Markham P, Pal R. Biochem Biophys Res Commun. 2008 Feb 1;366(1):29-35. Epub 2007 Nov 26. Persistent antibody and T cell responses induced by HIV-1 DNA vaccine delivered by electroporation.