SAN DIEGO and PENNINGTON, N.J., Nov.
7, 2018 /PRNewswire/ -- OncoSec Medical Incorporated
(OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer
immunotherapies, today announced that the first patient has been
treated in KEYNOTE-890, a Phase 2 clinical trial for the treatment
of late-stage triple negative breast cancer (TNBC) with TAVO™
(intratumoral plasma encoded IL-12, or tavokinogene telseplasmid,
plus electroporation) in combination with Merck's
KEYTRUDA® (pembrolizumab).
KEYNOTE-890 is designed as a multicenter Phase 2 open-label
trial focusing on patients with a histologically confirmed
diagnosis of inoperable locally advanced or metastatic TNBC and at
least 1 prior line of approved systemic chemotherapy or
immunotherapy. 25 patients are expected to be enrolled.
Each patient will undergo 3-week treatment cycles with
pembrolizumab administered as a 30-minute IV infusion day 1 of
every cycle (flat dose of 200 mg) and treated with TAVO™ on days 1,
5 and 8 every six weeks.
"Treating the first patient in our KEYNOTE-890 clinical trial is
an important milestone for OncoSec as we seek to rapidly advance
this program," said Kellie Malloy
Foerter, Chief Clinical Development Officer of
OncoSec. "Additionally, this study is important for patients
with metastatic triple negative breast cancer given the lack of
treatment options currently available. Prior clinical
observations suggest that TAVO™ in combination with pembrolizumab
is a valid therapeutic approach for TNBC. Based on the
outcome of the study and feedback from FDA, we may choose to expand
the study and seek accelerated approval with the FDA for this
patient population."
Breast cancer cells that test negative for estrogen receptors
(ER-), progesterone receptors (PR-), and HER2 (HER2-) means the
cancer is triple negative.1 Approximately 10-20
percent of U.S. breast cancer cases are triple negative breast
cancer (TNBC),1 which disproportionately affects
younger women, as well as African-American
women,2 followed by Hispanic
women.3
TNBC remains a poor-prognosis breast cancer
subtype,2 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.5-8 Preliminary data from early-phase studies
demonstrated the anti-PD-1 antibody pembrolizumab led to an
objective response in 18 to 19 percent of TNBC
patients;5-7 and median overall survival was 8.9
months in a pretreated cohort.6 The anti-PD-L1
antibody atezolizumab (MPDL3280A) achieved an objective response in
25 percent of patients in the first-line and 11 percent of patients
in the second-line setting.8 There is increasing
evidence that tumors need TILs for anti-PD-1/PD-L1 therapies to be
most effective.9-12 Data also show TILs promote
better responses to chemotherapy and improve clinical outcomes in
breast cancer, including TNBC.13-17
To learn more about the trial, visit www.oncosec.com.
Additional details can also be found at www.clinicaltrials.gov
via NCT03567720.
About OncoSec Medical Incorporated
OncoSec is a
clinical-stage biotechnology company focused on developing
cytokine-based intratumoral immunotherapies to stimulate the body's
immune system to target and attack cancer. OncoSec's lead
immunotherapy platform – TAVO™ (tavokinogene telseplasmid) –
enables the intratumoral delivery of DNA-based interleukin-12
(IL-12), a naturally occurring protein with immune-stimulating
functions. The technology, which employs electroporation, is
designed to produce a controlled, localized expression of IL-12 in
the tumor microenvironment, enabling the immune system to target
and attack tumors throughout the body. OncoSec has built a
deep and diverse clinical pipeline utilizing TAVO™ as a potential
treatment for multiple cancer indications either as a monotherapy
or in combination with leading checkpoint inhibitors; with the
latter potentially enabling OncoSec to address a great unmet
medical need in oncology: anti-PD-1 non-responders. Results
from recently completed clinical studies of TAVO™ have demonstrated
a local immune response, and subsequently, a systemic effect as
either a monotherapy or combination treatment approach. In
addition to TAVO™, OncoSec is identifying and developing new
DNA-encoded therapeutic candidates and tumor indications for use
with its ImmunoPulse® platform. For more
information, please visit www.oncosec.com.
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme Corp., a subsidiary of Merck & Co., Inc.
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," "suggest," "look forward to,"
"potential," "understand," 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. 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:
David Schemelia/ Jason Rando
Tiberend Strategic Advisors, Inc.
Phone: 212-827-0020
dschemelia@tiberend.com
jrando@tiberend.com
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SOURCE OncoSec Medical Incorporated