OncoSec Medical Presents Positive Immune Response Data from Phase II Study at the 8th World Congress of Melanoma
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.
About Melanoma
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.
Copyright Business Wire 2013