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.
Copyright Business Wire 2014