OncoSec Medical Inc. (OTCQB: ONCS), a company developing its
ImmunoPulse DNA-based intratumoral cancer immunotherapy, today
issued the following letter from Punit Dhillon, President and CEO,
to the company’s shareholders:
2014
A Letter to Our Shareholders
This is an important moment in cancer immunotherapy and we
believe OncoSec is poised to make a real impact. During this
pivotal time, it is important that we outline the core fundamentals
of our company and our technology, so that you as shareholders will
understand why all of us here at OncoSec are excited for the
future.
So far, 2014 has been a year of unprecedented growth for the
company. As we continue to advance our technology and expand our
team, our goal is for all of our shareholders to know our company
as we know our company, and thus share our same confidence and
excitement moving forward.
A Revolutionary Platform
When we began our journey just three years ago, we knew that
intratumoral electroporation had the potential to be a
revolutionary drug delivery platform. Our original goal was to
demonstrate that this technology could be used to deliver potent
immune-stimulating proteins, such as DNA-based interleukin-12
(IL-12), in a safe and effective manner. We set out to develop
ImmunoPulse as a monotherapy, and soon realized that we had
something potentially bigger on our hands. ImmunoPulse has broad
applications and robust potential. Clinical results have been
extremely encouraging, and we now have the foundation to expand and
adapt this technology to address a wide variety of diseases, as
both a monotherapy and as a synergistic component of
combination-based approaches.
Near-final data from our Phase 2 metastatic melanoma study were
recently presented at the 2014 ASCO Annual Meeting, a significant
milestone for the company. Results demonstrated that, of evaluable
patients, 11 percent (3/28) achieved complete response, 32 percent
(9/28) achieved an objective response and 59 percent (13/22)
displayed the induction of a systemic anti-tumor immune response.
Correlative data were also presented for a subset of eight patients
that supported the hypothesis that IL-12 electroporation leads to
the induction of interferon-gamma and downstream
interferon-gamma-inducible genes, including key modulators of
antigen presentation and processing machinery and chemokines.
Our Chief Medical Officer, Dr. Robert Pierce, M.D., said of the
data, “Taken together, these data—the systemic clinical responses,
the gene expression pattern in the treated lesions in patients and
our analysis of treated and untreated tumors in B16 mouse
model—form a coherent picture of IL-12’s mechanism of action as a
potent enhancer of tumor immunogenicity. In summary, intratumoral
IL-12 appears to ‘de-cloak’ the tumor, allowing the immune system
to see the tumor as ‘foreign’ and generate the CD8 T cells needed
to mount an attack. These findings are incredibly important given
the emerging understanding that a prerequisite for response to T
cell checkpoint therapies such as anti-PD-1 mAbs is the presence of
the PD-1+ CD8 T cells.”
ImmunoPulse: A Team Player
The next step in our clinical development strategy for melanoma
is to initiate a Phase 2b trial that combines ImmunoPulse and a
checkpoint inhibitor, such as the anti-PD-1 or PD-L1 antibody. The
pairing of these two therapies represents a “natural” combination
from both a scientific rationale and business development
perspective. First, there is a well-defined correlation between
specific patient biomarkers and the effectiveness of anti-PD-1
therapy. Knowledge of this correlation and the distinction between
responders and non-responders exists because of the work done by
researchers like Dr. Robert Pierce, M.D., who prior to joining
OncoSec served as a key member of Merck’s PD-1 development team,
focusing on translational oncology research. As was discussed at
ASCO, our technology is demonstrating an ability to enhance these
specific biomarkers and convert anti-PD-1 non-responders into
responders. We believe this could be game-changing from a clinical
perspective, as the majority of late stage melanoma patients (60-80
percent) do not respond to this effective monoclonal antibody
treatment, which may soon become standard of care for a variety of
cancers. From a business development perspective, expanding the
responder population could lead to a significant market opportunity
for OncoSec. An important aspect to note is the highly immunogenic
nature of melanoma, meaning that the percentage of anti-PD-1
non-responders is likely to be even higher in other types of
cancer. As checkpoint inhibitors make their way into the market and
expand to other disease indications, the demand for a
transformative treatment will be even greater, and will constitute
a huge unmet medical need. Therefore, our goal with ImmunoPulse is
to close the gap between non-responders and responders, and let the
incredible successes of this class of monoclonal antibodies
resonate out to many more of those affected by these devastating
diseases.
A Robust Pipeline
Up until recently, we have been defined by our use of DNA IL-12
to treat cutaneous cancers. Although our work in this realm has
certainly laid a strong foundation for the future, we want to be
clear that OncoSec is not confined to DNA IL-12 or skin cancer. Our
goal is to be the premier intratumoral immunotherapy company, and
we believe that we have the technology, the team and the financial
backing to see this goal become a reality. In the past few months,
we have significantly ramped up our R&D and pre-clinical
capabilities to address the broad applications of our technology.
We expanded operations in Seattle and San Diego and tasked these
new teams with exploring and investigating new immune targets and
novel DNA plasmid constructs. As we continue to define the
mechanism of action of our ImmunoPulse treatment platform through
clinical and correlative analysis and related research efforts, our
engineering department is developing next-generation devices
capable of addressing a wide variety of indications.
A Spotlight on the Future
We hope that by gaining a better understanding of our technology
and business development strategy, our shareholders can similarly
understand that they are part of a company with a robust pipeline,
solid infrastructure and a clear path forward. The latest cash
raise was the largest financing in company history and involved
highly respected institutional biotechnology investors. Proceeds
from this offering give OncoSec a strengthened cash runway and the
ability to completely fund a Phase 2b program to completion.
Additionally, these capital resources will allow us to advance
our research and development activities by identifying new target
candidates, while continuing to move our DNA IL-12 program forward
toward commercialization. Our goal has always been to focus on
advancing our technology, product pipeline and people to push
our development strategy forward, and I believe that this financing
is a major step toward achieving these milestones. I’m thankful for
our wonderful team that continues to demonstrate resilience and a
determined focus toward achieving our corporate goals. We are not
only driven by knowing what is immediately possible, but also by
the knowledge that an open-mind can one day help us realize the
impossible. With more than 30 full-time employees and - at the time
of writing this letter - 12 open positions remaining, we are
building a team with the potential to position OncoSec as a leader
in intratumoral cancer immunotherapy.
As we continue to execute on our objectives for the year and
break new ground in cancer immunotherapy, I want to lend my sincere
thanks to all of our shareholders. I also want to thank our
patients, who motivate us to work tirelessly in advancing
innovative immunotherapies, and without whom we could never hope to
succeed. Because of your support, OncoSec is poised to deliver on
its promise to fundamentally impact the cancer treatment landscape
and bring much-needed relief to patients faced with unmet medical
needs. I appreciate your continued support, and look forward to
sharing our future success with you.
Thank You.
Punit Dhillon
President & CEO
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing
its ImmunoPulse immunotherapy to treat solid tumors. OncoSec
Medical's core technology leverages a proprietary electroporation
platform to enhance the local delivery and uptake of
IL-12 and other DNA-based immune-modulating agents. Clinical
studies of ImmunoPulse have demonstrated an acceptable safety
profile and preliminary evidence of anti-tumor activity in the
treatment of various skin cancers, as well as the potential to
initiate a systemic immune response without the systemic toxicities
associated with other treatments. OncoSec's clinical programs
currently include three Phase 2 trials targeting metastatic
melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. As
the company continues to evaluate ImmunoPulse in these indications,
it is also investigating additional indications and combination
therapeutic approaches. For more information, please
visit www.oncosec.com.
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this release that are not historical facts
may be considered such “forward-looking statements.”
Forward-looking statements 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. Some of the
potential risks and uncertainties that could cause actual results
to differ from those predicted include our ability to raise
additional funding, our ability to acquire, develop or
commercialize new products, uncertainties inherent in pre-clinical
studies and clinical trials, unexpected new data, safety and
technical issues, competition, and market conditions. These and
additional risks and uncertainties are more fully described in
OncoSec Medical’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
Medical 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.
OncoSec Medical Inc.Investor Relations:Veronica Vallejo,
CFO855-662-6732investors@oncosec.com
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