Inovio Product Pipeline: IL-12: Malignant Melanoma
Product & Indication
This experimental plasmid IL-12 DNA-based immunotherapy is injected intratumorally into malignant melanoma tumors. It is encoded to produce the IL-12 protein and induce systemic immune responses to the tumor. The immunotherapy is being delivered using Inovio's MedPulser® DNA Delivery System.
Market Potential
One of the deadliest cancers, melanoma has an annual incidence of 60,000 in North America alone. An analysis of current treatments for melanoma suggests that potential pricing for a new DNA-based immunotherapy could be approximately $30,000 per treatment course, suggesting a potential market size in North America of US$1.8 billion.
Technical
Twenty four patients were treated at seven escalating dose levels. Interim results from this study, reported in March, 2008, include:
- No dose-limiting toxicity was noted
- The experimental regimen was safe and well tolerated
- There was a dose-dependent increase in IL-12 protein expression in
the treated lesions
- Electroporated tumors demonstrated marked lymphocytic infiltrates
- Clinical response:
- Of 19 patients with both treated and untreated distal
lesions, two (10%) showed complete regression of all lesions
(including distal untreated lesions), suggesting a systemic
effect of the therapy;
- 8 additional patients (42%) showed a systemic response
resulting in stable disease or objective regression of
untreated lesions.
Stage of Development
Phase: I, treating patients with malignant melanoma. Investigator-sponsored, H. Lee Moffitt Cancer Center and Research Institute (associated with University of South Florida)
Purpose: Determine the side effects and the correct dose of this type of treatment and also its effectiveness in treating melanoma.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Study Start Date: June 2004
Status: Enrolment completed
For more information: www.clinicaltrials.gov Identifier: NCT00323206
Commercialization
Vaccine: owned by Inovio.
Delivery technology: owned by Inovio.