SAN DIEGO, Jan. 18, 2018 /PRNewswire/ -- OncoSec
Medical Incorporated ("OncoSec" or the "Company") (NASDAQ:ONCS), a
company developing intratumoral cancer immunotherapies, today
announced preliminary clinical observations related to its pilot
biomarker OMS-I140 clinical trial of ImmunoPulse® IL-12 in patients
with metastatic Triple Negative Breast Cancer (TNBC). The
study is designed to assess whether a single cycle of ImmunoPulse
IL-12 increases TNBC tumor immunogenicity by driving a
pro-inflammatory cascade of events including activation of
cytotoxic tumor-infiltrating lymphocytes (TILs).
To date, five patients with TNBC have been treated with a single
cycle of ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene
telseplasmid or "tavo"] with electroporation). Two of these
five patients were subsequently treated with single agent nivolumab
(Opdivo®) - an anti-PD-1 checkpoint inhibitor treatment - as their
immediate next therapy. Both of these patients, who were
heavily pretreated metastatic TNBC patients with chemotherapy
refractory disease, experienced robust objective responses in both
ImmunoPulse IL-12 treated and untreated lesions. These clinical
observations have prompted the Company to further commit to a more
definitive evaluation of the combined therapies.
"Metastatic TNBC is a heterogeneous cancer with a poor prognosis
where less than five percent of pre-treated patients achieve an
objective response to PD-1/PD-L1 checkpoint treatments," explained
Sharron Gargosky, Chief Clinical and Regulatory Officer of OncoSec.
"The marked synergy shown in these patients strongly suggests that
IL-12 may have primed the tumor microenvironment, impacting the
clinical result. The combination of ImmunoPulse IL-12 and
checkpoint inhibition represents a highly promising new therapeutic
approach for TNBC and warrants a formal evaluation given the
extremely low response rate in women who have failed multiple prior
therapies."
Previous studies have demonstrated that breast cancer patients
whose tumors are associated with markers of inflammation, such as
the presence of TILs, achieve better clinical outcomes. In
addition, the density of TILs is a key requirement for the
anti-tumor activity of immune checkpoint inhibitors like
anti-PD-1/PD-L1 antibodies. By augmenting the expansion of
CD8+ tumor infilatrating T cells, ImmunoPulse IL-12 may
be an ideal candidate to combine with checkpoint inhibitors, which
has demonstrated low and variable activity as a monotherapy in
TNBC.
Immunological examination of samples from all patients are
currently being analyzed. These data, along with the full
information regarding clinical observations and safety data, will
be submitted for presentation at an upcoming medical meeting in
2018.
To learn more about the trial, visit
www.oncosec.com. Additional details can also be found at
www.clinicaltrials.gov via NCT02531425.
OPDIVO® is a registered trademark of Bristol-Myers Squibb
Company.
ImmunoPulse® is a registered trademark of OncoSec Medical
Incorporated, San Diego, CA,
USA.
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 and in
the heavily pretreated population led to an objective overall
response in approximately 4-8% of patients; 6 the
anti-PD-L1 antibody, MPDL3280A, achieved an objective response in
33 percent of patients.7 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.8-13
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 plasmid encoded IL-12
(tavokinogene telseplasmid or "tavo"). In Phase 1 and 2 clinical
trials, ImmunoPulse® IL-12 has demonstrated a favorable
safety profile, evidence of anti-tumor activity in the treatment of
various solid tumors, and the potential to reach beyond the site of
local treatment to initiate a systemic immune response. OncoSec's
lead program, ImmunoPulse IL-12, is currently in clinical
development for metastatic melanoma and triple-negative breast
cancer. The program's current focus is on the significant unmet
medical need in patients with melanoma who are refractory or have
relapsed on anti-PD-1 therapies. In addition to tavo, 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, including statements about OncoSec's
business strategies, including advancement of its lead melanoma
program and its broader clinical portfolio and plans to pursue
collaborations with industry partners, as well as the potential
contributions and impact of new directors on these strategies. In
some cases, you can identify forward-looking statements by
terminology such as "may", "should", "expects", "plans",
"anticipates", "believes", "estimates", "predicts", "potential" or
"continue" or the negative of these terms or other comparable
terminology.
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 OncoSec's 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: the status, progress and results of clinical programs;
ability to obtain regulatory approvals for, and the level of market
opportunity for, OncoSec's product candidates; OncoSec's business
plans, strategies and objectives, including plans to pursue
collaboration, licensing or other similar arrangements or
transactions; expectations regarding OncoSec's liquidity and
performance, including expense levels, sources of capital and
ability to maintain operations as a going concern; the competitive
landscape of OncoSec's industry; and general market, economic and
political conditions; and the other factors discussed in OncoSec's
filings with the Securities and Exchange Commission, including its
annual report on Form 10-K for the year ended July 31, 2017.
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. Targetedonc.com. Checkpoint Inhibitors Moving Ahead in Breast
Cancer
http://www.targetedonc.com/conference/ibc-2017/checkpoint-inhibitors-moving-ahead-in-breast-cancer
7. 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.
8. Mahmoud SM, et al., "Tumor-infiltrating CD8+ lymphocytes predict
clinical outcome in breast cancer." Journal of Clinical Oncology,
2011. 29(15): p. 1949-55.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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:
Stern Investor Relations
Will O'Connor
Phone: (212) 362-1200
will@sternir.com
Media Relations:
Stern Strategy Group
Brian Hyland or Ashley Duvall
Phone: (908) 276-4344
OncoSecPR@sternstrategy.com
View original content with
multimedia:http://www.prnewswire.com/news-releases/oncosec-provides-encouraging-clinical-observations-related-to-triple-negative-breast-cancer-study-300584586.html
SOURCE OncoSec Medical Incorporated