OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, today announced its melanoma development strategy. The company plans to continue forward in its development path to seek FDA approval for its ImmunoPulse therapy and outlines key activities in the melanoma program that the company expects to share more details about within the next 12 months.
Phase II Study Expansion
The company plans to move forward with an expansion study of its Phase II trial for metastatic melanoma. The effectiveness of an accelerated treatment cycle will be evaluated, where an additional 10 patients will be enrolled and will receive a second cycle of treatment after three weeks. OncoSec may amend the protocol depending on the study outcomes.
OncoSec’s Phase II melanoma study completed enrollment on June 18, 2013. Positive immune response data, confirming the systemic effects of DNA IL-12 administered locally with electroporation, was announced at the 8
World Congress of Melanoma meeting in July. Top-line interim clinical data detailing available objective response rates (complete and partial response rates at Day 180) is expected in the upcoming months.
OncoSec is conducting a research study with Old Dominion University to evaluate the effects of ImmunoPulse in combination with Anti-CTLA-4, Anti-PD-1 and Anti-PDL-1 in a melanoma mouse model. The research study supports the company’s strategy to investigate methods that can potentially improve response rates of front-line therapy. Moreover, a positive outcome from these preclinical studies may result in the ability to expand ImmunoPulse’s reach into a larger melanoma patient population, including those with unresectable metastatic melanoma. Data from this study is expected in early 2014.
Initiation of Phase IIb Study
While OncoSec’s current Phase II studies in metastatic melanoma and Merkel cell carcinoma are coming to a conclusion, the company is preparing for its next phase of development and is setting up for the initiation of a Phase IIb trial. The Phase IIb study will be a randomized, controlled study, providing the company with information for a key inflection point in the development of this program.