SAN DIEGO, April 19, 2016 /PRNewswire/ -- OncoSec
Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company
developing DNA-based intratumoral cancer immunotherapies, today
presented long-term, follow-up data of patients who were treated
with its investigational therapy ImmunoPulse™ IL-12 and later went
on to receive an anti-PD-1/PD-L1 therapy. These data suggest that
ImmunoPulse™ IL-12 may prime and enhance response rates to
PD-1/PD-L1 blockade. Alain Algazi,
MD, skin cancer specialist in the Melanoma Center at the UCSF Helen
Diller Family Comprehensive Cancer Center, presented the findings
in an oral presentation entitled "Intratumoral electroporation of
plasmid IL-12 can prime response to anti-PD1/PD-L1 blockade in
patients with Stage III/IV-M1a melanoma" (Abstract #CT134) at the
American Association of Cancer Research (AACR) Annual Meeting in
New Orleans, LA.
"We are encouraged by the data from this analysis, which show
that intratumoral IL-12 DNA with electroporation can prime the
immune system and help improve patient response to anti-PD-1," said
Dr. Algazi. "These results are being validated prospectively in a
Phase II clinical trial and they could make a clinically meaningful
impact on patient outcomes and address a great unmet need in
immuno-oncology."
These new data were generated from a single-site retrospective
analysis of the Company's Phase II monotherapy clinical study of
ImmunoPulse™ IL-12, which employs intratumoral electroporation to
enhance delivery of DNA-based interleukin-12 (IL-12), in patients
with advanced melanoma. After completing treatment with
ImmunoPulse™ IL-12, a subset of patients subsequently received an
anti-PD-1/PD-L1 therapy either as their next line of treatment or a
later line of treatment. Patients with documented follow-up history
and evaluable for anti-PD-1/PD-L1 response were included in this
analysis.
In this study, 34 patients were enrolled and treated with
ImmunoPulse™ IL-12 alone. Fourteen of these 34 patients went on to
receive a systemic anti-PD-1/PD-L1 therapy and were evaluable for
PD-1/PD-L1 overall response rate ("ORR") using immune-related
response criteria. The PD-1/PD-L1-associated ORR among patients was
64% (9/14). The analysis showed 36% of patients (5/14) had a
complete response (CR), 29% of patients (4/14) had a partial
response (PR), 14% percent of patients (2/14) experienced stable
disease, and 21% of patients (3/14) had progressive disease.
Furthermore, 8 of these 14 evaluable patients received a systemic
anti-PD-1/PD-L1 antibody with no intervening therapy after
treatment with ImmunoPulse™ IL-12. Of these 8 patients, an ORR of
75% was observed (50% CR and 25% PR).
Additionally, multiple biomarker analyses demonstrate that
ImmunoPulse™ IL-12 therapy promotes the generation of activated
natural killer and functional T cell immune subsets in the
periphery as well as CD8+ tumor infiltrating lymphocytes
(TIL), which may help trigger the PD-1 immune checkpoint (i.e.
"adaptive immune resistance") to provide the "substrate" for
effective anti-PD-1/PD-L1 therapy.
"Although one always needs to be cautious regarding the
interpretation of retrospective analyses, these data are consistent
with our hypothesis that ImmunoPulse™ IL-12 is driving a specific
anti-tumor TIL response, which primes the patient for an enhanced
response to PD-1 blockade," said Robert H.
Pierce, MD, Chief Scientific Officer. "We look forward to
following up on these observations with interim data from our
ongoing combination trial in patients with melanoma investigating
ImmunoPulse™ IL-12 and the anti-PD-1 therapy, pembrolizumab, later
this year."
The full-text abstract is available and can be viewed on AACR's
website at www.aacr.org. The presentation is available in the
Publications section of OncoSec's website.
About Melanoma
Melanoma is one of the most dangerous
forms of skin cancer and accounts for the vast majority of skin
cancer deaths.1 When melanoma is caught early enough,
surgical excision can be curative in the majority of Stage I and II
melanomas. The overall 5-year survival rate for patients with
localized melanoma is 98% in the United
States.1 At later stages, malignant melanoma
remains a deadly and frequently difficult to treat cancer. The
overall 5-year survival rate for patients falls to 17% when the
disease metastasizes to distant sites or organs.1
Approximately 8,780 patients are diagnosed with Stage III and IV
melanoma in the United States each
year.2
Melanoma that has spread to distant sites may be treated with
surgery, immunotherapy, chemotherapy and/or radiation
therapy.1 Numerous chemotherapy regimens have been
tested in melanoma with only modest success and limited overall
survival benefit.3 Immunotherapies, such as checkpoint
inhibitors, have demonstrated improvement in overall survival of
patients compared to chemotherapy.3
While immunotherapy can be extremely effective, the majority of
patients will not respond to anti-PD-1 therapy alone, representing
a great unmet need in oncology. However, researchers are focusing
efforts on targeting pathways of T cell activation.4 The
presence of CD8+ T cells seems to correlate with
improved prognosis and long-term survival in solid malignancies,
such as melanoma,5,6 thus many emerging experimental
immunotherapies seek to enhance the tumor's immunogenicity and
increase the anti-tumor CD8+ T cell response.
About OncoSec Medical Incorporated
OncoSec is a
biotechnology company developing DNA-based intratumoral
immunotherapies with an investigational technology, ImmunoPulse™,
for the treatment of cancer. ImmunoPulse™ is designed to
enhance the local delivery and uptake of DNA-based immune-targeting
agents, such as IL-12. In Phase I and II clinical trials,
ImmunoPulse™ IL-12 has demonstrated a favorable safety profile and
evidence of anti-tumor activity in the treatment of various skin
cancers as well as the potential to initiate a systemic immune
response. OncoSec's lead program, ImmunoPulse™ IL-12, is currently
in clinical development for several indications, including
metastatic melanoma, squamous cell carcinoma of the head and neck,
and triple-negative breast cancer. In addition to ImmunoPulse™
IL-12, the Company is also identifying and developing new
immune-targeting agents for use with the ImmunoPulse™ platform. For
more information, please visit www.oncosec.com.
University of California
Disclaimer
The information stated above was prepared by
OncoSec Medical Incorporated and reflects solely the opinion of the
corporation. Nothing in this statement shall be construed to imply
any support or endorsement of OncoSec, or any of its products, by
The Regents of the University of
California, its officers, agents and employees.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains "forward-looking
statements" within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995. Forward-looking statements can be
identified by words such as "can," "may," "will," "hypothesis,"
"look forward to," "potential," and similar references to future
periods.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they 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.
Potential risks and uncertainties that could cause actual results
to differ from those predicted include, among others, the
following: uncertainties inherent in pre-clinical studies and
clinical trials, such as the ability to enroll patients in clinical
trials and the risk of adverse events; unexpected new data,
safety and technical issues; our ability to raise additional
funding necessary to fund continued operations; and the other
factors discussed in OncoSec'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
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.
References
1. American Cancer Society. "Cancer Facts
& Figures 2016."
http://www.cancer.org/acs/groups/content/@research/documents/document/acspc-047079.pdf.
Accessed April 2016.
2. DataMonitor Healthcare. "Malignant Melanoma Epidemiology."
October 2014. Reference Code
DMKC0130291.
3. National Cancer Institute. "Melanoma Treatment for Health
Professionals."
http://www.cancer.gov/types/skin/hp/melanoma-treatment-pdq#link/_876_toc.
Accessed April 2016.
4. Thomas, N. E., et al. (2013). "Tumor-infiltrating lymphocyte
grade in primary melanomas is independently associated with
melanoma-specific survival in the population-based genes,
environment and melanoma study." J Clin Oncol 31(33):
4252-4259.
5. Dudley, M. E., et al. (2005). "Adoptive cell transfer therapy
following non-myeloablative but lymphodepleting chemotherapy for
the treatment of patients with refractory metastatic melanoma." J
Clin Oncol 23(10): 2346-2357.
6. Hunder, N. N., et al. (2008). "Treatment of metastatic melanoma
with autologous CD4+ T cells against NY-ESO-1." N Engl J Med
358(25): 2698-2703.
Contact
Mary
Marolla
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com
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