Inovio Product Pipeline: VGX™-3100: Therapeutic Vaccine for Cervical Cancer
Product & Indication
VGX™-3100 is a proprietary, therapeutic DNA vaccine candidate for the treatment of cervical intraepithelial neoplasias (CIN) caused by human papillomavirus (HPV) types 16 and 18. This vaccine includes plasmids targeting E6 and E7 proteins of both HPV subtypes 16 and 18. We have chosen to deliver our candidate vaccines via electroporation using the CELLECTRA® constant current device following intramuscular injection of the plasmids. Animal studies have shown that this delivery method increases the immune response to our DNA vaccine, leading to a decrease in the size of tumors caused by HPV 16 and 18.
Market Potential
Cervical cancer is caused by various types of human papillomavirus. Many people who have HPV may not show signs or symptoms. They can pass the virus to others without even knowing it. Prophylactic vaccines aimed at inducing natural immunity against HPV infection in non-infected individuals have been approved and are effective against HPV infection. However, once a person has an established infection, these vaccines are ineffective for preventing development of cervical cancer. There is a great need for an effective therapeutic vaccine to treat HPV-infected cervical tumor cells and potentially replace surgical procedures in young women - which can affect their reproductive potential.
Estimated impact of cervical cancer:
- Worldwide: 473,000 new cases of cervical cancer; 253,500 deaths per year.i
- US (2008): 11,000 new cases of cervical cancer; 3,870 deaths.ii
- Approximately $1.7 billion spent in the United States each year to treat cervical cancers.iii
Stage of Development
Phase: I, assessing safety and immunogenicity in subjects with history of surgically treated CIN2 or 3. Multi-center study in the U.S.
Purpose: To determine the safety/tolerability and immunogenicity of an experimental vaccine given as intramuscular injections followed by electroporation.
Study Type: Safety and immunogenicity
Study Design: Dose Escalating, Single Group Assignment, Safety Study
Study Start Date: November 2008
Status: Recruiting
For more information: www.clinicaltrials.gov Identifier: NCT00685412
Commercialization
Vaccine: licensed from The University of Pennsylvania.
Delivery technology: owned by Inovio.
Out-License Agreement: TBD.
Technical
Prophylactic vaccines already approved (Merck & GSK)
- Aimed at inducing protective immunity against HPV infection in naive individuals
- Generate serum-neutralizing antibodies
Therapeutic vaccines
- No therapeutic vaccine for HPV approved to date
- Focused on women with CIN 2 and 3
- Aimed at eradicating cervical cancer cells and replace surgical procedures for CIN
- Induction of strong cell-mediated response
- E6 and E7 proteins are expressed in most HPV-related (pre) cancerous tumors
- Therapeutic vaccine directed at HPV types 16 and 18 could potentially treat 71% of cervical cancers
Therapeutic Cervical Cancer DNA Vaccine (VGX™-3100)
(HPV types 16 )
Prophylactic Tumor Challenge in Mice
i "http://www.nccc-online.org". NCCC National Cervical Cancer Coalition. Retrieved on 2008-12-04.
ii "What Are the Key Statistics About Cervical Cancer?". American Cancer Society (Last Revised 2008-03-26). Retrieved on 2008-12-04.
iii "Cancer Trends Progress Report" (http://progressreport.cancer.gov), in 2004 dollars, based on methods described in Medical Care 2002 Aug; 40 (8 Suppl): IV-104-17. Last updated September 2008.