Inovio Product Pipeline: IL-12: Metastatic Melanoma
Product & Indication
This experimental plasmid IL-2 DNA-based immunotherapy is a proprietary agent being developed by Vical. It is injected intratumorally into recurrent metastatic melanoma tumors. It is encoded to produce the IL-2 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
Interim study results reported in June 2007 showed that no serious adverse events related to the study drug or administration procedure had been reported and the treatment was well tolerated. The majority of related adverse events were localized to the treatment site, with the most frequent being mild injection site pain.
Objective tumor responses, defined as 50% tumor shrinkage or complete disappearance, were observed in 12 of 39 (31%) of the lesions that were targeted for observation. Of these observed lesions, seven of 18 treated tumors (38%) and five of 21 untreated tumors (24%) showed objective responses. The response of untreated tumor lesions suggests the possibility of a systemic effect of the treatment. Two subjects showed activity in untreated tumors distant from the site of administration of the therapy, including one subject showing shrinkage and disappearance of lung tumors.
Stage of Development
Phase: I, treating patients with recurrent metastatic melanoma. Conducted by Vical.
Purpose: Evaluate the safety of intratumorally injected VCL-1M01at escalating dosage levels, followed by electroporation.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Study Start Date: July 2005
Status: Enrolment completed
For more information: www.clinicaltrials.gov Identifier: NCT00223899
Commercialization
Vaccine: owned by Vical.
Delivery technology: owned by Inovio.