PRINCETON, N.J., July 20, 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,
I hope this letter finds you and your families safe and
healthy. A great deal has changed in the World since my last
update earlier this year. We are now living through a
pandemic that is testing all of us both personally and
professionally. Like many life science companies, we are
confronted with the challenge of trying to predict the impact
COVID-19 may have on our operations and public guidance moving
forward. As many of you are aware, we had taken a
conservative approach with our Phase 3 clinical programs in order
to maintain their statistical integrity during these unprecedented
times; however, I am pleased to report that the negative impact
of the pandemic on our studies was much less significant than
initially anticipated and all timelines remain on-track.
Nonetheless, we will continue to remain vigilant and will report
any challenges caused by the COVID-19 pandemic that may have a
potential impact on our current guidance.
We continue to execute on our strategy with a number of positive
accomplishments. In March, we announced positive data in our
pivotal Phase 3 FLASH ("Fluorescent Light Activated Synthetic
Hypericin") study with SGX301 (synthetic hypericin) in the
treatment of cutaneous T-cell lymphoma (CTCL). In the
double-blind, placebo-controlled portion of the study (Cycle 1), a
statistically significant treatment response (p=0.04) was achieved
in the primary endpoint after 6 weeks of therapy (press release
available here). This positive treatment response continued
to dramatically improve with extended SGX301 treatment in the
open-label treatment cycle, referred to as Cycle 2, with an
additional 6 weeks of therapy (p<0.0001 compared to placebo and
p<0.0001 compared to 6-weeks treatment; press release available
here). Next up will be the extended safety results from the
optional, compassionate-use, treatment cycle (Cycle 3) and the
subsequent 6-month follow-up expected in the fourth quarter of
2020. In Cycle 3, subjects that completed Cycles 1 and 2 had
the option of continuing SGX301 treatment of up to all of their
lesions for another 6 weeks. I am happy to report that the
majority of patients enrolled have elected to continue with this
optional cycle of the study – a clear indication of their
satisfaction. This clinical trial success was a tremendous
accomplishment for the company, and we are eagerly anticipating
other important milestones during the remainder of 2020.
Our other pivotal Phase 3 clinical trial with SGX942
(dusquetide), referred to as the DOM-INNATE ("Dusquetide treatment
in Oral Mucositis – by modulating INNATE Immunity") study, treating
oral mucositis in patients with head and neck cancer, completed
patient enrollment in June (press release available here).
The study successfully enrolled 268 subjects, following positive
interim analysis, which included a prospectively defined, unblinded
assessment of the study's primary efficacy endpoint by an
independent Data Monitoring Committee (DMC). As you may recall, the
study enrollment was temporarily extended as we assessed the
potential impact of COVID-19 on the study (e.g., patient treatment
compliance and completion of necessary assessments). With
extra efforts by participating patients, physicians and clinical
staff, we successfully reported that the negative impact of the
pandemic on the overall study was much less than initially
anticipated. With enrollment now completed, top-line
results are expected in the fourth quarter of 2020.
Under our Public Health Solutions business segment, we continue
to advance our work with the University of Hawaiʻi at Mānoa (UH
Mānoa) and Hawaii Biotech Inc. (HBI) on filovirus vaccines
(protecting against viruses such as Ebola and Marburg). We
also extended this program to the development of vaccines to
potentially combat coronaviruses, including SARS-CoV-2, the cause
of COVID-19 (recent conference presentation available here).
We continue to support our FDA Fast Tracked (press release
available here) heat stable ricin vaccine, RiVax®, with
a National Institute of Allergy and Infectious Disease contract
award of $21.2 million.
With approximately $9 million in
cash, not including our non-dilutive government funding, along with
the at-the-market (ATM) sales issuance agreement with B. Riley FBR,
Inc. to judiciously supplement our cash runway as needed, we
anticipate having sufficient capital to achieve multiple inflection
points across our rare disease pipeline, including top-line results
in our SGX942 Phase 3 clinical trial in oral mucositis.
Corporate Highlights
Since our last update in January, we have continued to focus on
the quality execution of our multiple development programs in our
rare disease pipeline, where we currently anticipate achieving
multiple important milestones in the second half of
2020.
Specialized Biotherapeutics Business Segment
We continue to advance our two pivotal Phase 3 clinical
programs.
1. On March
19, 2020, we announced positive preliminary top-line
results for our pivotal Phase 3 FLASH trial evaluating SGX301 in
the treatment of Stages IA, IB and IIA CTCL. The study
enrolled 169 patients randomized 2:1 to receive either SGX301 or
placebo, demonstrating a statistically significant treatment
response (p=0.04) in the Composite Assessment of Index Lesion Score
(CAILS) primary endpoint assessment at 8 weeks for Cycle
1.
As Ellen
Kim, MD, Director of the Dermatology Clinic, Perelman Center
for Advanced Medicine and Lead Investigator of the FLASH study
stated in the announcement, "This is an important outcome for
patients suffering from CTCL. SGX301 has successfully
demonstrated efficacy in this challenging chronic cancer, with no
safety concerns, making it a potentially preferred first-line
option for the treatment of early stage CTCL, which is the large
majority of patients suffering from this disease. This
successfully proves that the drug has biologic activity in
combating this disease in a relatively short time window, with
preliminary data suggesting that the improvement continues to
increase with extended treatment. In addition to the efficacy
demonstrated, SGX301 was well-tolerated and its mechanism of action
is not associated with DNA damage like other currently available
therapies."
On April
30, 2020, we announced that continued treatment with SGX301
(synthetic hypericin) twice weekly for 12 weeks increased the
positive response rate to 40% (p<0.0001 compared to placebo and
p<0.0001 compared to 6-weeks treatment) in the open-label
treatment cycle (referred to as Cycle 2) of the pivotal Phase 3
study for the treatment of early-stage CTCL. These highly
statistically significant results confirm the benefit of continued
SGX301 treatment in CTCL patients.
As Ms. Susan Thornton, Chief Executive Officer of the
Cutaneous Lymphoma Foundation, the largest patient advocacy
organization for CTCL, noted in the announcement, "The availability
of a safe, rapid-acting, treatment for CTCL is extremely important
to patients. From the patient perspective, you want a
treatment that is safe and effective with the least amount of side
effects. Many of the therapies available today either don't
work for all patients, don't work for long-periods of time, can't
be used by some because of their concerning side effects, or are
used off-label creating access issues. As the leader of the
patient organization and a patient myself, I know first-hand the
importance of developing more therapies and options to support
people living with this rare cancer."
We are now awaiting the safety
data from the optional (compassionate use) treatment cycle (Cycle
3) of the trial, in which patients could receive SGX301 treatment
of up to all their lesions, as well as the 6-month safety follow-up
once all treatment has ended. Of note is that not only have
the majority of patients enrolled elected to continue with this
optional cycle of the study, but in an analysis of a subset of
patients in Cycle 3, it was demonstrated that SGX301 is not
systemically available, consistent with the general safety observed
with this topical product to date. Results from Cycle 3
and the subsequent 6-month follow-up are expected in the fourth
quarter of 2020.
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).
2. On June
24, 2020, we announced that we completed full enrollment of
268 patients randomized into the 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). With the positive interim analysis previously reported
(press release available here), we look forward to final
top-line results for the DOM-INNATE study in the fourth quarter of
2020.
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.
Public Health Solutions Business Segment
We most recently announced exciting developments in the area of
emerging infectious diseases. In collaboration with UH
Mānoa and HBI, we continue to advance development of filovirus
vaccines (protecting against viruses such as Ebola and
Marburg). Working with Axel
Lehrer, PhD of the Department of Tropical Medicine, Medical
Microbiology and Pharmacology, John A.
Burns School of Medicine (JABSOM), UH Mānoa, we have
demonstrated the feasibility of developing heat stable subunit
filovirus vaccines, including Ebola virus disease as well as
Marburg virus disease, with both monovalent and bivalent vaccine
combinations. Formulation conditions have been identified to
enable heat stabilization of each antigen, alone or in combination,
for at least 12 weeks at 40 degrees Celsius (104 degrees
Fahrenheit).
Formulation development work with the UH Mānoa on a
trivalent thermostabilized Ebola vaccine is currently supported by
a $700,000 sub-award over five years
from NIAID. The subunit vaccine offers broader coverage for
differing filoviruses, including Ebola, Marburg and Sudan, and offers the potential for a simpler
supply chain 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).
Expanding on our glycoprotein vaccine platform with UH Mānoa, we
have also recently announced efforts to develop a safe, broadly
applicable, subunit vaccine for treatment of COVID-19. Our COVID-19
vaccine candidate, CiVax™, utilizes a novel adjuvant, CoVaccine
HT™, which we have exclusively licensed from BTG Specialty
Pharmaceuticals ("BTG"), a division of Boston Scientific
Corporation (NYSE: BSX), in the fields of coronavirus and pandemic
flu (press release available here). Proof of concept studies in
mice with the platform have already demonstrated strong potential
COVID-19 immunogenicity. There are two components to the immune
response – the antibody response and the cell-mediated response
(involving T-cells); both of which can be activated by vaccines.
Typically, vaccines are characterized by their ability to generate
antibodies and particularly neutralizing antibodies (that is,
antibodies that can prevent virus binding and entry, as well as
marking the virus for destruction). Prototype studies with the
CoVaccine adjuvant with a SARS-CoV-2 antigen has indicated that
both types of immunity can be significantly enhanced.
Some of these results are available in a recent conference
presentation (available here). We will look to disclose more
data as it becomes available.
We continue to progress our heat stable ricin vaccine,
RiVax®, with the support of up to $21.2 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 and more recently 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.
RiVax® has received Orphan Drug designation as well
as Fast Track designation from the FDA, 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.
Additionally, RiVax® was granted Orphan Drug designation
from the EMA. 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.
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 government grant and contract awards of up to $22.5 million in our Public Health Solutions
business segment to support RiVax® development, our
collaboration with the UH Mānoa and HBI 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 to date has provided a meaningful offset to our development
expenses while better positioning us to effectively manage our
overall cash burn.
Balance Sheet and Capital
As of June, we had approximately $9
million in cash. In addition to the non-dilutive
funding received to date, we also have an 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 a solid balance sheet and the available resources,
we currently do not contemplate a larger capital raise until after
final top-line oral mucositis results are disclosed. We also
continue to have ongoing confidential 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.
One last note is our recent membership into the Russell
Microcap® Index, which remains in place for one year and
means automatic inclusion in the appropriate growth and value style
indexes. FTSE Russell determines membership for its Russell indexes
primarily by objective, market-capitalization rankings and style
attributes. Russell indexes are widely used by investment
managers and institutional investors for index funds and as
benchmarks for active investment strategies. Approximately
$9 trillion in assets are benchmarked
against Russell's US indexes. For more information on the
Russell Microcap® Index, go to the "Russell
Reconstitution" section on the FTSE Russell website here.
In closing, thank you for your interest and your ongoing support
of Soligenix. It continues to be a very exciting time in our
life cycle and late stage pipeline. We look forward to the
second half of 2020 being as productive as the first half, with the
potential for multiple near-term catalysts on the horizon as we
further advance our development programs towards
commercialization. Best wishes!
Dr. Christopher J. Schaber
President and Chief Executive Officer
Soligenix, Inc.
July 20, 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, SGX943, our therapeutic candidate for antibiotic
resistant and emerging infectious disease, and our research
programs to identify and develop novel vaccine candidates targeting
viral infection including Ebola, Marburg and SARS-CoV-2 (the cause
of COVID-19). 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, such as
experienced with the COVID-19 outbreak. 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 the
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, or any of
our other clinical/preclinical trials. Despite the
statistically significant result achieved in the SGX301 Phase 3
clinical trial for the treatment of cutaneous T-cell lymphoma,
there can be no assurance that a marketing authorization from the
FDA or EMA will be successful. 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®. Also, no
assurance can be provided that the Company will receive or continue
to receive non-dilutive government funding from grants and
contracts that have been or may be awarded or for which the Company
will apply in the future. 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.