SAN DIEGO, Oct. 29, 2015 /PRNewswire/ -- OncoSec Medical
Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing
DNA-based intratumoral cancer immunotherapies, announced today that
the Company has enrolled the first patient into a pilot biomarker
trial of ImmunoPulse™ IL-12 in patients with triple negative breast
cancer (TNBC). ImmunoPulse™ IL-12, which employs intratumoral
electroporation to enhance delivery of DNA-based interleukin-12
(IL-12), is designed to enhance tumor immunogenicity, leading to
increased tumor infiltrating lymphocytes (TILs) and
pro-inflammatory cytokines.
Previous studies have demonstrated that breast cancer patients
whose tumors are associated with markers of inflammation, such as
the presence of TILs, have better clinical outcomes. These data
have initiated an effort by an international consortium to develop
guidelines and recommendations for the routine evaluation of TILs
for breast cancer. Further, preliminary data reported at the 2014
San Antonio Breast Cancer Symposium indicate that TNBC is
responsive to cancer immunotherapies, such as anti-PD-1/PD-L1
checkpoint therapies. However, response rates in these TNBC
patients, who were selected for study participation based upon TIL
status, were only 18 to 33 percent.
"There is increasing evidence that breast cancer patients with
tumors characterized by a 'pro-inflammatory phenotype,' including
those with TNBC, have better responses to chemotherapy and
experience longer disease-free and overall survival rates," said
Mai H. Le, MD, Chief Medical Officer
at OncoSec. "We anticipate that ImmunoPulse™ IL-12 will drive a
tumor-specific inflammatory response in TNBC patients. The goal
with ImmunoPulse™ IL-12 is to increase the number of patients who
will benefit from anti-PD-1 therapy. We are very excited to be
working closely with our colleagues at Stanford University to evaluate the role of
ImmunoPulse™ IL-12 in promoting tumor immunogenicity."
Melinda L. Telli, MD, Assistant
Professor of Medicine (Oncology) and Irene
Wapnir, MD, Professor of Surgery (General Surgery), are
leading this clinical trial at Stanford
University Medical Center. Approximately 10 patients are
planned for enrollment into this trial. The primary objective of
the study is to evaluate the potential of ImmunoPulse™ IL-12 to
promote a pro-inflammatory molecular and histological signature in
tumor samples obtained from study participants. Secondary
objectives include: evaluation of safety and tolerability;
evaluation of local ablative effect (% necrosis); and description
of other evidence of anti-tumor activity.
To learn more about the trial, visit www.oncosec.com. Additional
details can also be found at www.clinicaltrials.gov.
About Triple Negative Breast Cancer (TNBC)
Breast
cancer cells that test negative for estrogen receptors (ER-),
progesterone receptors (PR-), and HER2 (HER2-) means the cancer is
triple negative.1 Approximately 15-20 percent of US
breast cancer cases are triple negative breast cancer
(TNBC),2 which disproportionately affects younger women
as well as African-American women, followed by Hispanic
women.3
TNBC remains a poor-prognosis breast cancer subtype, with
limited treatment options for patients with advanced, recurrent
disease. In the recurrent disease setting, chemotherapy remains the
standard of care, and median survival is approximately 13 months
from the time of disease recurrence.4
Emerging evidence shows immunotherapy options may play an
important role in the treatment paradigm for TNBC. Preliminary data
demonstrated the anti-PD-1 antibody, pembrolizumab, led to an
objective response in approximately 18 percent of TNBC
patients;5 the anti-PD-L1 antibody, MPDL3280A, achieved
an objective response in 33 percent of patients.6 There
is increasing evidence that tumors need TILs for anti-PD-1/PD-L1
therapies to be most effective. Data also show TILs promote better
responses to chemotherapy and improve clinical outcomes in breast
cancer, including TNBC.7-12
About OncoSec Medical Incorporated
OncoSec is a
biotechnology company developing DNA-based intratumoral
immunotherapies for the treatment of cancer. The Company's
investigational technology, 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, OncoSec's lead
program, 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. ImmunoPulse™ IL-12 is currently in Phase
II 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 seeking to identify and develop 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," "may," "will," "goal,"
"planned," 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. BreastCancer.org. Triple Negative Breast
Cancer. http://www.breastcancer.org/symptoms/diagnosis/trip_neg.
Accessed September 7, 2015.
2. Bauer KR, et al., "Descriptive analysis of estrogen receptor
(ER)-negative, progesterone receptor (PR)-negative, and
HER2-negative invasive breast cancer, the so-called triple-negative
phenotype: a population-based study from the California cancer Registry." Cancer.
2007 May 1; 109(9):1721-8.
3. BreastCancer.org. Who Gets Triple Negative Breast Cancer?
http://www.breastcancer.org/symptoms/diagnosis/trip_neg/who_gets.
Accessed September 7, 2015.
4. F Andre and CC Zielinski. "Optimal strategies for the treatment
of metastatic triple-negative breast cancer with currently approved
agents." Annals of Oncology, 2012. 23(6): vi46-vi51.
5. Nanda R, et al., "A phase Ib multicohort study of MK-3475 in
patients with advanced solid tumors." Journal of Clinical
Oncology, 2014. 32:5s (suppl; abstr PS3119).
6. Emens LA, et al., "Inhibition of PD-L1 by MPDL3280A leads to
clinical activity in patients with metastatic triple-negative
breast cancer." San Antonio Breast Cancer Symposium,
2014.
7. Mahmoud SM, et al., "Tumor-infiltrating CD8+ lymphocytes predict
clinical outcome in breast cancer." Journal of Clinical
Oncology, 2011. 29(15): p. 1949-55.
8. Adams S, et al., "Prognostic value of tumor-infiltrating
lymphocytes in triple-negative breast cancers from two phase III
randomized adjuvant breast cancer trials: ECOG 2197 and ECOG 1199."
Journal of Clinical Oncology, 2014. 32(27): p. 2959-66.
9. Loi S, et al., "Tumor infiltrating lymphocytes are prognostic in
triple negative breast cancer and predictive for trastuzumab
benefit in early breast cancer: results from the FinHER trial."
Annals of Oncology, 2014. 25(8): p. 1544-50.
10. Loi S, et al., "Prognostic and predictive value of
tumor-infiltrating lymphocytes in a phase III randomized adjuvant
breast cancer trial in node-positive breast cancer comparing the
addition of docetaxel to doxorubicin with doxorubicin-based
chemotherapy: BIG 02-98." Journal of Clinical Oncology,
2013. 31(7): p. 860-7.
11. Denkert C, et al., "Tumor-associated lymphocytes as an
independent predictor of response to neoadjuvant chemotherapy in
breast cancer." Journal of Clinical Oncology, 2010. 28(1):
p. 105-13.
12. Denkert C, et al., "Tumor-infiltrating lymphocytes and response
to neoadjuvant chemotherapy with or without carboplatin in human
epidermal growth factor receptor 2-positive and triple-negative
primary breast cancers." Journal of Clinical Oncology,
2014.58.1967.
Contact
Investor Relations:
Jordyn Kopin
OncoSec Medical Inc.
855-662-6732
investors@oncosec.com
Media Relations:
Mary Marolla
OncoSec Medical Inc.
855-662-6732
media@oncosec.com
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