Inovio Product Pipeline: PSMA: Prostate Cancers
Product & Indication
This experimental plasmid prostate specific membrane antigen (PSMA) DNA vaccine is designed to target prostate cancers expressing the PSMA antigen. The vaccine is being delivered using Inovio's MedPulser® DNA Delivery System. The plasmid vaccine is delivered into muscle tissue with the assistance of electroporation with the goal of achieving expression of the PSMA antigen.
Market Potential
The most significant cancer in males, prostate cancer has an annual incidence of 219,000 in North America alone. An analysis of current treatments for prostate cancer suggests that potential pricing for a new DNA vaccine could be approximately $30,000 per treatment course, suggesting a potential market size in North America of US$6.5 billion.
Technical
This DNA vaccine consists of a PSMA27/pDom fusion gene given by intramuscular injection in HLA A2+ patients with prostate carcinomas, with or without electroporation.
As reported in May, 2007, an analysis of interim data from the first and partially from the second dose treatment groups demonstrated the following points:
- Electroporation appears safe and it is well tolerated.
- The number of patients with significant antibody responses was four of 10 in the patient groups treated without electroporation compared to nine of 10 in the patient groups treated with electroporation.
The magnitude of the antibody response was significantly higher in patients treated using electroporation.
As reported in January, 2008, a scientific paper, "DNA vaccines: precision tools for activating effective immunity against cancer," co-authored by two of the Southampton investigators conducting this clinical study and published in Nature Reviews Cancer, noted the following:
"...data from the two lowest dose levels already suggest that EP (electroporation) enhances antibody and CD4+ T-cell responses against the DOM 1 sequence. Preliminary analysis of CD8+ T-cell reactivity against the prostate-specific membrane antigen... indicates significant responses in 3 out of 3 patients so far (J.R., C.H.O. and F.K.S., unpublished observations)."
Stage of Development
Phase: I/II, treating HLA A2+ patients with prostate carcinomas. Investigator-sponsored, Southampton General Hospital, University of Southampton.
Purpose: Assess whether this DNA vaccine can stimulate patients to develop immune responses against prostate cancer and whether use of Inovio's electroporation system enhances this response.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Study Start Date: February 2005
Status: Enrolling
For more information: http://www.abedia.com/wiley/record_detail.php?ID=395
Commercialization
Vaccine: owned by University of Southampton.
Delivery technology: owned by Inovio.