OncoSec Medical Presents Positive Immune Response Data from Phase II Study at the 8th World Congress
OncoSec Medical Presents Positive Immune Response Data from Phase II Study at the 8 th World Congress of Melanoma
Data Confirms the Systemic Effects of DNA IL-12 Administered Locally with Electroporation
SAN DIEGO--(BUSINESS WIRE)-- OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, announced interim immune response data from the company's Phase II study of ImmunoPulse in patients with metastatic melanoma. Findings showed that OncoSec's ImmunoPulse demonstrated a significant change in tumor immunity following treatment with DNA IL-12 and electroporation. Dr. Adil Daud, principal investigator at the University of California San Francisco, presented the data at the 8th World Congress of Melanoma in Hamburg, Germany.
Blood samples taken at baseline (Day 1) and Day 90 from subjects treated with ImmunoPulse were analyzed. Changes in activated T-cells and regulatory T-cells were quantified. At Day 90 following treatment, it was demonstrated that there was a significant decrease in circulating "exhausted" CD8/PD-1+ (p=0.0017) and CD8/CD69+ (p=0.008) T-cells. PD-1 is expressed in activated exhausted T cells, and blocking PD-1 is an emerging treatment modality for multiple cancers including melanoma. These results demonstrate that plasmid delivery of interleukin-12 (IL-12) can also result in a decrease in exhausted T-cells, which may lead to improvement in clinical outcomes for patients treated with ImmunoPulse.
In addition to changes in circulating T-cells, an increase in NK cell frequency and activation was also observed from baseline. It was also demonstrated that antigen-specific T-cell responses to melanoma were increased with DNA IL-12 while other antibody responses were modulated and appeared to narrow over time. These data confirm the systemic effects of DNA IL-12 administered locally with electroporation.
Punit Dhillon, President and CEO of OncoSec, said: "We are encouraged by these immune data, since they highlight a potential mechanism of action for ImmunoPulse, and demonstrate the biologic activity of this therapy after only a single cycle of treatment."
Dr. Daud commented: "The statistical significance of these data is impressive and confirms our understanding of the mechanism of action of IL-12. We look forward to understanding further if these changes in immune responses also correlate with positive clinical outcomes. These data will be shared later on this year."
OncoSec recently announced completion of enrollment for its Phase II melanoma trial. Previously, the company announced that ImmunoPulse demonstrated clinical benefit in both locally treated and untreated distant melanoma lesions, and that the therapy appeared to be safe and well-tolerated, after an interim analysis of safety and efficacy of the first 13 patients.
About the Phase II ImmunoPulse Study
A total of 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma have been enrolled in this Phase II, single-arm, open-label and multi-center study. The trial is designed to assess local and distant objective response following treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation with a primary endpoint of 24 weeks. One treatment cycle consists of three treatments applied to up to four lesions on days 1, 5 and 8 with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle. At 12 months, patients are moved to the follow-up phase of the study and will be followed for up to five years for safety.
Melanoma is the most serious form of skin cancer. If it is recognized and treated early, it is almost always curable, but if it is not, the cancer can advance and spread to other parts of the body, where it becomes hard to treat and can be fatal. While it is not the most common of the skin cancers, it causes the most deaths. The American Cancer Society estimates that at present, about 123,000 new cases of melanoma in the US are diagnosed in a year, resulting in approximately 10,000 deaths. Melanoma originates in melanocytes, the cells that produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown, but often they can also be skin-colored, pink, red, purple, blue or white. Currently, there remain few treatment options for patients with late-stage metastatic disease that can extend survival for the broad population.
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors. ImmunoPulse and NeoPulse therapies address an unmet medical need and represent a potential solution, for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec Medical's core technology is based upon its proprietary use of an electroporation platform to enhance the delivery and uptake of a locally delivered DNA-based immunocytokine (ImmunoPulse) or chemotherapeutic agent (NeoPulse). Treatment of various solid cancers using these targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while potentially sparing healthy normal tissues during early and late stage clinical trials. OncoSec's clinical programs include three Phase II clinical trials for ImmunoPulse targeting lethal skin cancers. More information is available at http://www.oncosec.com/.
This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward looking statements." Forward looking statements are based on management's current preliminary expectations and are subject to risks and uncertainties which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in OncoSec Medical's filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements which speak only as of the date they are made. OncoSec Medical disclaims any obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
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