SAN DIEGO, Jan. 3, 2018 /PRNewswire/ -- OncoSec Medical
Incorporated ("OncoSec" or the "Company") (NASDAQ:ONCS), a company
developing intratumoral cancer immunotherapies, announced its
anticipated operational milestones for 2018 and a review of
business highlights for year-end 2017.
"The momentum we achieved in late 2017 provides the foundation
for a transformational year in 2018," said Daniel J. O'Connor, Chief Executive Officer of
OncoSec. "The year ahead is critical for OncoSec with preliminary
data expected in key clinical programs; preliminary feedback
from regulators on an accelerated approval pathway for
ImmunoPulse® IL-12 in unresectable metastatic melanoma
patients who have progressed or are progressing on an anti-PD-1
therapy; and advances in our intratumoral delivery platform."
He continued, "Operational execution will dominate 2018, with a
focus on laying the groundwork for future BLA and IND filings. We
plan to conduct a second clinical trial in triple negative breast
cancer (TNBC), as well as two investigator sponsored trials in
squamous cell carcinoma of the head and neck (SCCHN) and in the
melanoma neoadjuvant setting. These trials will be in
combination with anti-PD-1 therapy. We look forward to sharing
progress toward our vision throughout the year: to have multiple
products that will make a dramatic patient impact and an innovative
pipeline driven by a sustainable product engine."
2018 OPERATIONAL MILESTONES
OncoSec anticipates the following
operational milestones in 2018:
Clinical Operations
ImmunoPulse IL-12 Melanoma
- Complete stage 1 enrollment of PISCES/KEYNOTE-695; a Phase
2b registration-directed clinical
trial of ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene
telseplasmid or "tavo"] with electroporation), in combination with
KEYTRUDA® (pembrolizumab) for patients with unresectable
metastatic melanoma who have progressed or are progressing on an
anti-PD-1 therapy
- Present preliminary data from PISCES/KEYNOTE-695 at a medical
meeting
- Seek preliminary FDA feedback on an accelerated approval
pathway for ImmunoPulse IL-12 Biologics License Application (BLA)
in patients with unresectable metastatic melanoma who have
progressed or are progressing on an approved anti-PD-1 therapy
- Apply for classification as an Advanced-Therapy Medicinal
Product (ATMP) for the treatment of unresectable metastatic
melanoma who have progressed or are progressing on an approved
anti-PD-1 therapy by the European Medicines Agency's Committee for
Advanced Therapies (CAT)
- Prepare to commercially launch ImmuoPulse IL-12 in the
U.S.
- Initiate a Phase 2 investigator-sponsored clinical trial in
combination with an anti-PD-1 therapy in the neoadjuvant
setting
ImmunoPulse IL-12 Triple Negative Brest Cancer
(TNBC)
- Provide update of preliminary clinical observations for
OMS-I140 TNBC pilot study conducted in collaboration with the
Stanford University Medical Center
- Present preliminary data for OMS-I140 TNBC study at a medical
meeting
- Initiate a Phase 2 clinical trial in combination with an
anti-PD-1 therapy in the recurrent and/or metastatic setting
ImmunoPulse IL-12 Squamous Cell Carcinoma of the
Head and Neck (SCCHN)
- Initiate a Phase 2 investigator-sponsored clinical study in
combination with two other immunotherapies in the recurrent and/or
metastatic setting
Business Development
- Seek partner for the development, registration and
commercialization of ImmunoPulse IL-12 in metastatic melanoma in
the U.S. and EU, as well as in other important regions
- Pursue multiple partnerships and collaborations for cancer
immunotherapy platform to enable additional research in combination
with other cancer therapies and novel immunotherapies
Expanding Clinical Pipeline
- Prepare an IND for a second product candidate utilizing our
proprietary, multi-gene expression Polycistronic Interleukin-12
Immune Modulator (PIIM) platform technology
Enhanced Platform Engineering and
Manufacturing
- Advance second-generation proprietary GENESIS™ generator to be
ready for introduction into the clinic
- Advance proprietary applicators in cancer indications beyond
cutaneous and subcutaneous tumors
- Undertake technology transfers with partners and install new
innovative technologies to improve the overall supply chain
2017 OPERATIONAL MILESTONE REVIEW
OncoSec achieved several important clinical, regulatory,
business and operational milestones during 2017.
Clinical Operations
ImmunoPulse IL-12 Metastatic Melanoma
- Presented updated positive long-term follow-up data from our
Phase 2 trial of ImmunoPulse IL-12 in combination with KEYTRUDA
(pembrolizumab) at the 2017 Society for Immunotherapy of Cancer
Annual Meeting
-
- Selected as a Late Breaking Abstract and Oral Poster
Presentation, OncoSec presented updated clinical and correlative
immune-focused biomarker data demonstrating a 57% progression free
survival (PFS) rate at 15 months with 100% (11/11) duration of
response, median PFS not yet reached, and a best overall response
rate (BORR) of 50% (41% complete response [CR] rate) in patients
selected to not respond to anti-PD-1 monotherapy
- Data indicate that ImmunoPulse IL-12 coordinates innate and
adaptive anti-tumor immune responses, converting "cold" tumors to
"hot," which drives adaptive resistance and strongly suggests a
synergistic relationship between ImmunoPulse IL-12 and anti-PD-1
combination.
- Presented preclinical data demonstrating multigene platform for
delivery of multiple cancer immunotherapies at the 2017 Society for
Immunotherapy of Cancer Annual Meeting
-
- Emerging data was presented from our novel, multi-gene (PIIM)
expression platform, demonstrating enhanced therapeutic
potential
- Announced the initiation of global, multi-center,
registration-directed open-label PISCES/KEYNOTE-695 Phase
2b clinical trial, evaluating the
combination of ImmunoPulse IL-12 and pembrolizumab in patients with
unresectable metastatic melanoma who have progressed or are
progressing on an approved anti-PD-1 therapy
-
- First patient dosed and multiple sites opened in the U.S. and
Australia
- Granted Orphan Drug Designation for ImmunoPulse IL-12 for the
treatment of unresectable metastatic melanoma from U.S. Food and
Drug Administration (FDA)
- Granted Fast Track designation from the FDA for ImmunoPulse
IL-12 in combination with pembrolizumab for stage III/IV melanoma
patients who are progressing or who have progressed on either
pembrolizumab or nivolumab treatment
Technology Access Program
- Established the OncoSec Technology Access Program (TAP) using
OncoSec's proprietary GENESIS™ research generator, which was
developed specifically for gene electro-transfer and features
customizable electroporation parameters for construct-specific
optimization of expression. It is the only in vivo
electroporation device enabled with TRACE™ Technology
(Tissue-Based, Real-Time Adaptive Control Electroporation)
-
- Entered into a preclinical agreement through TAP with Jounce
Therapeutics, Inc., InhibRx, LP, and others
Corporate
- Appointed Daniel J. O'Connor,
JD, as Chief Executive Officer and Director
- Expanded intellectual property estate for ImmunoPulse
Platform
- Completed two successful public offerings of common stock and
warrant exercise, raising net proceeds of $17.5 million
- Promoted Christopher G. Twitty,
Ph.D. to Chief Scientific Officer
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
ImmunoPulse® is a registered trademark of OncoSec Medical
Incorporated, San Diego, CA,
USA.
About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in skin cells
called melanocytes. As the cancer progresses and begins to spreads
beyond the skin, such as to the lymphatic system (metastatic
disease), melanoma becomes more difficult to treat. Given its
occurrence in young individuals, the potential years of life lost
to melanoma can be higher when compared with other cancers.
Although melanoma is a rare form of skin cancer, it accounts for
over 75% of skin cancer deaths. The American Cancer Society
estimates that approximately 87,000 new melanoma cases and 10,000
deaths from the disease will have occurred in the United States in 2017. Additionally, the
World Health Organization estimates that approximately 132,000 new
cases of melanoma are diagnosed around the world every year.
About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination
Electroporation Study)/KEYNOTE-695
PISCES/KEYNOTE-695 is a global, multicenter phase 2b, open-label trial of intratumoral
plasmid-encoded IL-12 (tavokinogene telseplasmid or "tavo")
delivered by electroporation in combination with intravenous
pembrolizumab in patients with stage III/IV melanoma who have
progressed or are progressing on either pembrolizumab or nivolumab
treatment. The Simon 2-stage study of intratumoral tavo plus
electroporation in combination with pembrolizumab will enroll
approximately 48 patients with histological diagnosis of melanoma
with progressive locally advanced or metastatic disease defined as
Stage III or Stage IV. The primary endpoint will be the Best
Overall Response Rate (BORR).
To learn more about the trial, visit
http://www.piscesclinicaltrial.com. Additional details can
also be found at www.clinicaltrials.gov via NCT03132675.
About OncoSec Technology Access Program
The OncoSec GENESIS™ research generator was developed
specifically for gene electro-transfer. It features customizable
electroporation parameters for construct-specific optimization of
expression, and it is the only in
vivo electroporation device enabled with TRACE™ Technology
(Tissue-Based, Real-Time Adaptive Control Electroporation.) TRACE™
technology incorporates an electrochemical tissue-sensing control
system to automatically adjust pulse width and treatment duration
in real time during the electroporation procedure. This feature
enables tissue- and therapeutic-specific delivery optimization,
maximizing uptake of the therapeutic while reducing unnecessary
cell ablation or damage. In research models, GENESIS™ with TRACE™
has yielded higher and more consistent in
vivo protein expression versus fixed-parameter
electroporation, even in heterogeneous tissues.
Potential advantages of using GENESIS™ with TRACE™ for the
objectives of animal immunization include cost savings versus
recombinant protein administration, a shortened pre-immunization
timeline relative to recombinant protein production, and display of
the immunizing antigen in its native conformation. The latter
benefit may be particularly relevant for certain therapeutic
indications, including immuno-oncology, in which many key targets
require functional agonism and/or structurally-complex therapeutic
modalities such as multimeric forms. To date, OncoSec has generated
multiple high-titer antibody libraries against immuno-therapeutic
targets.
The OncoSec Technology Access Program makes OncoSec's
electroporation technologies available to collaborators for
preclinical research. Devices are available for intratumoral,
intradermal, and intramuscular delivery. For more information,
please contact bd@oncosec.com.
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.
CONTACT:
Investor Relations
Stern IR
Will O'Connor l 212-362-1200
will@sternir.com
Media Relations:
Stern Strategy Group
Bryan Hyland l 908-325-3891
Ashley Duvall l 908-325-3865
oncosecPR@sternstrategy.com
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SOURCE OncoSec Medical Incorporated