PRINCETON, N.J., Jan. 14, 2020 /PRNewswire/ -- Soligenix, Inc.
(Nasdaq: SNGX) (Soligenix or the Company), a late-stage
biopharmaceutical company focused on developing and commercializing
products to treat rare diseases where there is an unmet medical
need, today issued an update letter from its President and Chief
Executive Officer, Dr. Christopher J.
Schaber. The content of this letter is provided
below.
Dear Friends and Shareholders,
Let me start by wishing you a Healthy and Happy New Year!
I wanted to take this opportunity to provide a corporate update, as
well as some further guidance on our development programs moving
forward.
It is truly an exciting time for the Company. As many of
you are aware, we have a number of significant and potentially
transformational events ahead of us this quarter and over the next
six months. Most notably, top-line final results are imminent
from two pivotal Phase 3 clinical trials:
- SGX301 (synthetic hypericin) in the treatment of cutaneous
T-cell lymphoma (CTCL), where we have completed enrollment and
expect top-line results in Q1 2020; and
- SGX942 (dusquetide) for the treatment of oral mucositis in head
and neck cancer, where we expect to complete enrollment in Q1 2020
and report top-line results in Q2 2020.
In addition, we continue to advance the development of our heat
stable ricin toxin vaccine (RiVax®) with the financial
support of the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH),
while we also actively pursue additional non-dilutive funding to
support our rare disease pipeline.
Corporate Highlights
This past year we strengthened our commercial and business
expertise, both at the Board level and with our senior management
team, so that we may begin to position the company for the
potential success of our Phase 3 clinical trials.
In July 2019, we announced the
addition of Ms. Diane Parks to our
Board of Directors (access press release
here). Ms. Parks is an accomplished businesswoman and
commercial executive with an extensive record of driving profitable
growth for large pharmaceutical and biotech companies. With a
successful career spanning more than 30 years, she served as Senior
Vice President and Head of US Commercial for Kite Pharma, Inc.
(acquired by Gilead Sciences, Inc. for $11.9B), as Vice President and Head of Global
Marketing for Pharmacyclics, Inc. (acquired by Abbvie, Inc. for
$21B), as Vice President of Sales for
Amgen Inc., and as Senior Vice President, Specialty Biotherapeutics
for Genentech, Inc. (acquired by Roche Holdings AG for $46.8B). As we look forward to potential product
approval, we intend to leverage Ms. Park's extensive business and
commercialization experience in launching novel drug therapies in
orphan diseases and areas of high unmet medical need. We
believe her expertise adds significantly to our already diverse and
experienced Board of Directors and management team.
In September 2019, we announced
the additions of Jonathan Guarino,
CPA, as Senior Vice President and Chief Financial Officer (access
press release here) and Daniel Ring,
as Vice President, Business Development and Strategic Planning
(access press release here). Both Jonathan and Dan come with
extensive backgrounds in their respective disciplines, while also
having experience working for commercial life science
companies.
As we look forward to 2020, we continue to evaluate with
prospective partners a number of strategic alternatives including,
but not limited to, merger, acquisition, partnership, alliance,
co-development and/or co-commercialization licensing
agreements.
Specialized Biotherapeutics Business Segment
We continue to make good progress in advancing our two pivotal
Phase 3 clinical programs.
- We completed patient enrollment in our pivotal Phase 3
double-blind, placebo-controlled study in CTCL with SGX301
(synthetic hypericin) in December (access press release here)
following the positive recommendation received from the independent
Data Monitoring Committee (DMC) in October
2018 (access press release here). Everything remains on
track and our focus is now to complete the treatments for all
patients and to lock the study database shortly thereafter,
facilitating top-line results in Q1 2020.
We remain encouraged by this development program as a potential
front line treatment where there is currently an unmet medical
need. You may recall that this trial, referred to as the
"FLASH" study (Fluorescent Light Activated Synthetic Hypericin),
aims to evaluate the response to SGX301 as a skin directed therapy
to treat early stage CTCL. SGX301 has received Orphan Drug
designation as well as Fast Track designation from the United States (US) Food and Drug
Administration (FDA). Additionally, SGX301 was granted Orphan
Drug designation from the European Medicines Agency (EMA) and
Promising Innovative Medicine (PIM) designation from the Medicines
and Healthcare products Regulatory Agency (MHRA) in the
United Kingdom (UK).
Approximately 35 CTCL centers across the US, representing the major
Key Opinion Leaders (KOLs) in this indication, are participating in
this pivotal trial, which enrolled 169 subjects. Although the
trial begins with a double-blind, placebo-controlled portion
(referred to as Cycle 1), all participants in the trial eventually
receive active study drug (referred to as Cycle 2) and an optional
portion of the trial is available to them to continue with SGX301
treatment (referred to as Cycle 3). We remain encouraged that
the majority of patients have elected to continue with Cycle 3, the
optional open-label portion of the study. We also continue to
work closely with patient advocacy groups, such as the Cutaneous
Lymphoma Foundation and the National Organization for Rare
Disorders.
The CTCL development program has received partial funding of
approximately $1.5 million over two
years from a Small Business Innovative Research (SBIR) grant
awarded by the NIH's National Cancer Institute (NCI).
- We continue to actively enroll patients in a pivotal Phase 3
multinational, double-blind, placebo-controlled clinical trial of
SGX942 (dusquetide) for the treatment of oral mucositis in patients
with head and neck cancer (HNC) receiving chemoradiation therapy
(CRT). Since enrolling our first patient in December 2017 in a "controlled roll-out" of the
study in the US to assure site adherence with the protocol design,
we have expanded enrollment into Europe following the same controlled
process. As we announced in August
2019 (access press release here), the DMC conducted an
unblinded interim analysis with data from approximately 90 study
subjects, including assessment of the study's primary efficacy
endpoint. The DMC recommended that additional subjects be
randomized into the trial to maintain the rigorous assumption of
90% statistical power for the primary efficacy endpoint. No
safety concerns were reported by the DMC based on the interim
analysis. Although we do not typically give specific
enrollment numbers during the active conduct of our clinical
trials, I am happy to say that we currently have over 220 of the
260 subjects required to complete enrollment in this study.
Consistent with our public guidance, we currently expect to
complete enrollment in Q1 2020, with final topline results in Q2
2020.
This trial, referred to as the
"DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by
modulating INNATE immunity), aims to evaluate the response of
SGX942 in reducing the median duration of severe oral mucositis, in
addition to other clinically meaningful measures, and incorporates
feedback from the FDA as well as the EMA via the Scientific Advice
process. Scientific Advice from the EMA indicated that a single,
double-blind, placebo-controlled Phase 3 study, if successful, in
conjunction with the positive results from the Phase 2 dose-ranging
study, generally will be sufficient to support a marketing
authorization application for potential licensure in
Europe. SGX942 is the first Innate Defense Regulator in
development for oral mucositis and has previously demonstrated
positive results in a Phase 2 clinical trial.
Dusquetide is a new chemical
entity with a novel mechanism of action whereby it modulates the
body's reaction to both injury and infection towards an
anti-inflammatory and an anti-infective response. It also
accelerates resolution of tissue damage following exposure to a
variety of agents including bacterial pathogens, trauma and chemo-
and/or radiation therapy. The Phase 2 data demonstrated a
significant reduction in the duration of oral mucositis, as well as
reduced infection rates, as published in 2016 in the Journal of
Biotechnology (available here). Long-term follow-up data from
the Phase 2 trial, published in 2017 in Biotechnology Reports
(available here), further indicated the safety and tolerability of
SGX942 treatment, with a sustained trend towards reduced mortality
and increased tumor resolution compared to placebo. SGX942 has
received Fast Track designation from the FDA for the treatment of
oral mucositis as a result of CRT in HNC patients as well as PIM
designation from the MHRA in the UK.
Approximately 50 oncology centers
in the US and Europe are actively
participating in this pivotal, Phase 3 study, which is targeted to
enroll 260 subjects with squamous cell carcinoma of the oral cavity
and oropharynx who are scheduled to receive the standard treatment
regimen with a minimum total cumulative radiation dose of 55 Gy
fractionated as 2.0-2.2 Gy per day and concomitant cisplatin
chemotherapy given as a dose of 80-100 mg/m2 every third
week.
The oral mucositis development
program has received partial funding of approximately $1.5 million over two years from an SBIR grant
awarded by the NIH's National Institute of Dental and Craniofacial
Research (NIDCR).
Public Health Solutions Business Segment
We are advancing the development of our thermostabilized ricin
toxin vaccine, RiVax®, with the support of up to
$24.7 million over six years awarded
by NIAID, where we have successfully identified biomarkers for
RiVax® testing, as published in the journal Vaccine in
2018 (available here), facilitating potential approval under the
FDA Animal Rule. The FDA Animal Rule is applied to products
where testing in human clinical trials would be unethical, and in
the case of ricin toxin, fatal. The Animal Rule combines
safety studies in humans and efficacy testing in animals to
facilitate approval. Key to the application of the Animal Rule is
the requirement to establish a correlation between the immune
response observed in clinical trials in healthy volunteers with the
immune response demonstrated in animal efficacy studies.
We recently initiated a third Phase 1C vaccine immunogenicity
and safety study in healthy volunteers utilizing RiVax®
(access press release here). This study is building upon the
safety already demonstrated with the RiVax® antigen from
the two previous Phase 1 clinical trials, but will look to test the
product formulated with our proprietary heat stabilization
technology (ThermoVax®). In parallel, additional
efficacy studies in non-human primates are planned, enabling a
larger database of biomarkers for correlation with human clinical
results. In addition to being protective and thermostable,
RiVax® has demonstrated that a reduced number of
vaccinations may be required to establish protection, potentially
utilizing only two doses instead of three, and both vaccine
regimens are planned to be tested in future studies.
RiVax® has received Orphan Drug designations from
both the FDA and EMA, and as a new chemical entity, upon approval
in the US, has the potential to qualify for a biodefense Priority
Review Voucher (PRV). PRVs are transferable and can be sold,
with sales in recent years of approximately $100 million. Recent events, including the
news of an envelope addressed to President Trump that was thought
to contain this potent and potentially lethal toxin, as well as a
foiled bioattack with ricin in Germany, suggest that the RiVax®
vaccine may be of increasing interest to multiple countries.
Formulation development work with the University of Hawai'i on a
trivalent thermostabilized Ebola vaccine continues as planned with
the support of a $700,000 sub-award
over five years from NIAID. The subunit vaccine offers
broader coverage to different strains of Ebola, as well as Marburg
virus, and offers the potential for a simpler chain of custody with
no refrigerated conditions required. Previous work demonstrating
thermostabilization of the univalent vaccine has been recently
published in the European Journal of Pharmaceutics and
Biopharmaceutics (available here).
Additional funding for dusquetide (active ingredient in SGX942)
has also been obtained through a Defense Threat Reduction Agency
(DTRA) subaward of approximately $600,000 over 3 years (access press release
here). These studies will further elucidate the therapeutic
anti-infective action of dusquetide in animal models of
biodefense-related infectious agents.
Non-Dilutive Funding
As noted above, we aggressively pursue non-dilutive funding
sources to support our rare disease pipeline. We have received
two NIH SBIR grant awards totaling approximately $3 million for two of our biotherapeutics
development programs. We are also operating under NIAID grant
and contract awards of up to $25.4
million in our Public Health Solutions business segment to
support RiVax® development, our collaboration with the
University of Hawai'i at Manoa for the development of a trivalent
thermostabilized Ebola vaccine and the evaluation of dusquetide as
a broad spectrum therapeutic for the treatment of bacterial
infectious disease. This non-dilutive funding continues to
provide a meaningful offset to our development expenses while
better positioning us to effectively manage our overall cash burn.
Recently, we also received preliminary approval of a tax
credit under the New Jersey Economic Development Authority's
New Jersey Technology Business Tax Certificate Transfer program,
which we anticipate being able to sell for approximately
$850,000 in net proceeds (access
press release here).
Balance Sheet and Capital
As of January, we have over $6
million in cash. In addition to the non-dilutive funding
received and anticipated in 2019, we also have an At-The-Market
(ATM) instrument in place with B. Riley FBR, Inc. to judiciously
supplement cash if/when the need arises and stock volume and price
permit, such as to support the execution of certain CTCL
pre-commercialization activities to potentially support a new drug
application filing with the FDA. With this available funding,
we currently do not contemplate a larger capital raise, until at
the earliest, after final top-line CTCL results are disclosed. We
also continue to have ongoing business development discussions,
which may lead to more favorable capital inflows, including the
potential to receive additional non-dilutive funding. Overall,
we are mindful of dilution and will look at all future capital
inflow initiatives in the most efficient and shareholder friendly
manner as possible.
In closing, thank you for your interest and your continued
support of Soligenix. It is a very exciting time in our life cycle.
We look forward to a productive 2020 as we further advance our
development programs towards potential commercialization. Best
wishes!
Dr. Christopher J. Schaber
President and Chief Executive Officer
Soligenix, Inc.
January 14, 2020
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on
developing and commercializing products to treat rare diseases
where there is an unmet medical need. Our Specialized
BioTherapeutics business segment is developing SGX301 as a novel
photodynamic therapy utilizing safe visible light for the treatment
of cutaneous T-cell lymphoma, our first-in-class innate defense
regulator (IDR) technology, dusquetide (SGX942) for the treatment
of oral mucositis in head and neck cancer, and proprietary
formulations of oral beclomethasone 17,21-dipropionate (BDP) for
the prevention/treatment of gastrointestinal (GI) disorders
characterized by severe inflammation including pediatric Crohn's
disease (SGX203) and acute radiation enteritis (SGX201).
Our Public Health Solutions business segment includes active
development programs for RiVax®, our ricin toxin vaccine
candidate, OrbeShield®, our GI acute radiation syndrome
therapeutic candidate and SGX943, our therapeutic candidate for
antibiotic resistant and emerging infectious disease. The
development of our vaccine programs incorporates the use of our
proprietary heat stabilization platform technology, known as
ThermoVax®. To date, this business segment has been
supported with government grant and contract funding from the
National Institute of Allergy and Infectious Diseases (NIAID), the
Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced
Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit
the Company's website at www.soligenix.com.
This press release may contain forward-looking statements that
reflect Soligenix, Inc.'s current expectations about its future
results, performance, prospects and opportunities, including but
not limited to, potential market sizes, patient populations and
clinical trial enrollment. Statements that are not historical
facts, such as "anticipates," "estimates," "believes," "hopes,"
"intends," "plans," "expects," "goal," "may," "suggest," "will,"
"potential," or similar expressions, are forward-looking
statements. These statements are subject to a number of risks,
uncertainties and other factors that could cause actual events or
results in future periods to differ materially from what is
expressed in, or implied by, these statements. Soligenix
cannot assure you that it will be able to successfully develop,
achieve regulatory approval for or commercialize products based on
its technologies, particularly in light of the significant
uncertainty inherent in developing therapeutics and vaccines
against bioterror threats, conducting preclinical and clinical
trials of therapeutics and vaccines, obtaining regulatory approvals
and manufacturing therapeutics and vaccines, that product
development and commercialization efforts will not be reduced or
discontinued due to difficulties or delays in clinical trials or
due to lack of progress or positive results from research and
development efforts, that it will be able to successfully obtain
any further funding to support product development and
commercialization efforts, including grants and awards, maintain
its existing grants which are subject to performance requirements,
enter into any biodefense procurement contracts with the US
Government or other countries, that it will be able to compete with
larger and better financed competitors in the biotechnology
industry, that changes in health care practice, third party
reimbursement limitations and Federal and/or state health care
reform initiatives will not negatively affect its business, or that
the US Congress may not pass any legislation that would provide
additional funding for the Project BioShield program. In addition,
there can be no assurance as to timing or success of the Phase 3
clinical trial of SGX942 (dusquetide) as a treatment for oral
mucositis in patients with head and neck cancer receiving
chemoradiation therapy (including the outcome of the interim
analysis) or the Phase 3 clinical trial of SGX301 (synthetic
hypericin) for the treatment of cutaneous T-cell
lymphoma. Further, there can be no assurance that
RiVax® will qualify for a biodefense Priority Review
Voucher (PRV) or that the prior sales of PRVs will be indicative of
any potential sales price for a PRV for RiVax®. These
and other risk factors are described from time to time in filings
with the Securities and Exchange Commission, including, but not
limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless
required by law, Soligenix assumes no obligation to update or
revise any forward-looking statements as a result of new
information or future events.
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SOURCE Soligenix, Inc.