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 June, 2008, an analysis of interim data from the first and partially from the second dose treatment groups demonstrated the following points:
- 14 of 20 patients developed increases in anti-DOM (the immunostimulant sequence from tetanus) antibody. Of these increased responses, 5 of 10 were in the arm not using electroporation; 9 of 10 were in the electroporation arm. Antibody responses were generally higher in patients treated using electroporation compared to those treated with the DNA vaccine alone (without electroporation).
- In 9 of 10 patients in the low dose cohort, significant increases in CD4 responses were observed relative to pre-treatment. Of these increased responses, 4 of 5 were in the electroporation arm. Patients treated exclusively with electroporation produced a higher average CD4 response; patients initially treated without electroporation and later receiving a boost in conjunction with electroporation also displayed increased CD4 responses following the electroporation boost.
- In the lowest dose cohort, the PSMA27 antigen induced CD8+ cytotoxic T-cells (measured by cultured IFNg ELISPOT) not detected before vaccination in 6 of 10 subjects.
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.