SAN DIEGO, Aug. 18, 2015 /PRNewswire/ -- OncoSec
Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company
developing DNA-based intratumoral cancer immunotherapies, today
announced enrollment of the first patient into the Phase II
Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to
assess the anti-tumor activity, safety, and tolerability of the
combination of OncoSec's investigational therapy, ImmunoPulse™
IL-12, and Merck's approved anti-PD-1 agent, KEYTRUDA®
(pembrolizumab), in patients with unresectable metastatic melanoma.
The primary endpoint is the best Overall Response Rate (bORR) of
the combination regimen in patients whose tumors are characterized
by low numbers of tumor-infiltrating lymphocytes (TILs).
"There is increasing evidence that tumors need to be inflamed
and have TILs in order for anti-PD-1 therapies to be most
effective," said Mai H. Le, MD,
Chief Medical Officer of OncoSec. "Both preclinical and clinical
evidence suggest that ImmunoPulse™ IL-12 can promote tumor
immunogenicity. We anticipate that ImmunoPulse™ IL-12 will increase
the proportion of patients who will respond to immune checkpoint
inhibitors like KEYTRUDA® and that the combination will
have synergistic anti-tumor activity."
"This is the first study in the field of immuno-oncology to
evaluate the combination of DNA-based interleukin-12 with
electroporation and an anti-PD-1/PD-L1 inhibitor," said
Punit Dhillon, CEO and President of
OncoSec. "We believe the combination of OncoSec's intratumoral
cancer immunotherapy and checkpoint inhibitors has the potential to
be a powerful approach in the fight against cancer."
This multi-center, open label, single-arm trial will enroll
approximately 42 patients with unresectable, "low-TIL" metastatic
melanoma. Alain Algazi, MD, a skin
cancer specialist in the Melanoma Center at the UCSF Helen Diller
Family Comprehensive Cancer Center, is the study's sponsor and
principal investigator. The key endpoints of the study include:
best Overall Response Rate by RECIST v1.1 and immune
related-Response Criteria (irRC); safety and tolerability; duration
of response; 24-week landmark progression-free survival; median
progression-free survival; and overall survival.
The treatment schedule for the trial follows the standard
schedule for pembrolizumab. Pembrolizumab will be administered
systematically once every three weeks and ImmunoPulse™ IL-12 will
be administered on three separate days every six weeks.
ImmunoPulse™ IL-12 employs intratumoral delivery of DNA-based IL-12
followed by electroporation. Merck will supply pembrolizumab, and
OncoSec will provide ImmunoPulse™ IL-12.
To learn more about the trial, visit www.oncosec.com. Additional
details can also be found at www.clinicaltrials.gov.
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 percent 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 63 percent
when the disease reaches the lymph nodes and 16 percent when the
disease metastasizes to distant organs.1
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.2 Two approaches – checkpoint
inhibitors and targeted kinase inhibitors – have demonstrated
improvement in overall survival of patients compared to
chemotherapy. 2
While immunotherapy can be extremely effective, the currently
approved regimens do not benefit the majority of patients. However,
early data of combination approaches with immunotherapies are
promising.2 Researchers also continue to focus efforts
on targeting pathways of T cell activation.3 The
presence of CD8+ T cells seems to correlate with improved prognosis
and long-term survival in solid malignancies, such as
melanoma,4,5 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
biopharmaceutical 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 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 Phase II development for several indications, including
metastatic melanoma, squamous cell carcinoma of the head and neck
(HNSCC), and triple-negative breast cancer (TNBC). 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.
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 "anticipate," "intend," "estimate,"
"believe," "expect," "future," "may," "should," "will," 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.
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.
References
1. American Cancer Society. Cancer Facts
& Figures 2015.
http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf.
Accessed July 22, 2015.
2. National Cancer Institute. Melanoma Treatment for Health
Professionals.
http://www.cancer.gov/types/skin/hp/melanoma-treatment-pdq#link/_876_toc.
Accessed July 22, 2015.
3. 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.
4. 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.
5. 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
Investor Relations:
Jordyn Kopin
OncoSec Medical Incorporated
855-662-6732
investors@oncosec.com
Media Relations:
Mary Marolla
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com
Logo -
http://photos.prnewswire.com/prnh/20120905/LA68078LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/oncosec-announces-first-patient-enrolled-in-phase-ii-clinical-trial-evaluating-combination-of-immunopulse-il-12-and-anti-pd-1-treatment-300129619.html
SOURCE OncoSec Medical Incorporated