PRINCETON, N.J., Feb. 3, 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, announced today that the Japanese Patent Office has granted
the patent titled "Novel Peptides and Analogs for Use in the
Treatment of Oral Mucositis." This allowance builds on
similar intellectual property in the
United States (US), New
Zealand, Australia and
Singapore and patent applications
pending in other jurisdictions worldwide. The new claims
cover therapeutic use of dusquetide (active ingredient in SGX942)
and related innate defense regulator (IDR) analogs, and add to
composition of matter claims for dusquetide and related analogs
that have been granted in the US and worldwide. Dusquetide
previously demonstrated positive results in a Phase 2 oral
mucositis clinical trial and a pivotal Phase 3 study is ongoing,
with a positive interim analysis completed in August 2019 and final topline results expected in
Q2 2020.
Based on the positive and previously published Phase 2 results,
the pivotal Phase 3 clinical trial is a highly powered,
double-blind, randomized, placebo-controlled, multinational
trial. The study, called DOM-INNATE (Dusquetide treatment in
Oral Mucositis – by modulating INNATE immunity), is enrolling
approximately 260 subjects with head and neck cancer (HNC)
undergoing standard chemoradiation therapy (CRT) and who are
therefore at high risk of developing severe oral mucositis.
Enrollment is ongoing in the US and across Europe with enrollment completion expected in
Q1 2020 and final topline primary endpoint results anticipated in
Q2 2020.
"Soligenix continues to pursue broad patent coverage for its IDR
technology, including dusquetide, first with composition of matter
claims followed by therapeutic use claims in oral mucositis,"
stated Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix. "Having
successfully pursued composition of matter claims in jurisdictions
worldwide, we continue to pursue therapeutic use claims like those
issued in the US previously and in Japan with this most recent patent. The
therapeutic use claims are expected to be generally valid until
2034, which provides significant patent protection and life to
dusquetide and our other IDRs. This allowance is timely as we
continue to have discussions with potential strategic partners and
pursue all options to advance our pipeline and plan for commercial
activities."
About Oral Mucositis
Mucositis is the clinical term for damage done to the mucosa by
anticancer therapies. It can occur in any mucosal region, but
is most commonly associated with the mouth, followed by the small
intestine. It is estimated, based upon review of historic
published studies and reports and an interpolation of data on the
incidence of mucositis, that mucositis affects approximately
500,000 people in the US per year and occurs in 40% of patients
receiving chemotherapy. Mucositis can be severely debilitating
and can lead to infection, sepsis, the need for parenteral
nutrition and narcotic analgesia. The gastrointestinal damage
causes severe diarrhea. These symptoms can limit the doses and
duration of cancer treatment, leading to sub-optimal treatment
outcomes.
The mechanisms of mucositis have been extensively studied and
have been recently linked to the interaction of chemotherapy and/or
radiation therapy with the innate defense system. Bacterial
infection of the ulcerative lesions is now regarded as a secondary
consequence of dysregulated local inflammation triggered by
therapy-induced cell death, rather than as the primary cause of the
lesions.
It is estimated, based upon review of historic published studies
and reports and an interpolation of data on the incidence of oral
mucositis, that oral mucositis in HNC is a subpopulation of
approximately 90,000 patients in the US, with a comparable number
in Europe. Oral mucositis almost always occurs in patients
with HNC treated with CRT and is severe, causing inability to eat
and/or drink, in >80% of patients. It is common (40-100%
incidence) in patients undergoing high dose chemotherapy and
hematopoietic cell transplantation, where the incidence and
severity of oral mucositis depends greatly on the nature of the
conditioning regimen used for myeloablation.
In the pediatric population, head and neck cancer is a rarer
occurrence and is caused by different underlying pathologies. The
major types of HNC in children are lymphoma, sarcomas (including
rhabdomyosarcomas), and neuroblastoma rather than squamous cell
carcinoma, the major type of adult HNC cancers. Hematopoietic
stem cell transplantation (HSCT), especially
allogeneic transplantation with higher risk of oral mucositis, is
more frequently used in the pediatric population than in adults
when treating a number of primary tumor types, as seen
in leukemia and lymphoma. Both treatment of HNC and
HSCT are associated with high risk of oral mucositis in the
pediatric population.
Oral mucositis remains an area of unmet medical need where there
are currently no approved drug therapies in the context of any
solid tissue tumors.
About Dusquetide
Dusquetide (the active ingredient in SGX942) is an IDR, a new
class of short, synthetic peptides. It has a novel mechanism
of action whereby it modulates the body's reaction to both injury
and infection towards an anti-inflammatory, anti-infective and
tissue healing response. IDRs have no direct antibiotic activity
but, by modulating the host's innate immune system responses,
increase survival after infections caused by a broad range of
bacterial Gram-negative and Gram-positive pathogens. It also
accelerates resolution of tissue damage following exposure to a
variety of agents including bacterial pathogens, trauma and chemo-
and/or radiation therapy. Preclinical efficacy and safety has
been demonstrated in numerous animal disease models including
mucositis, colitis, macrophage activation syndrome (MAS) as well as
bacterial infections, including melioidosis.
SGX942 has demonstrated safety and tolerability in a Phase 1
clinical study in 84 healthy human volunteers. Positive
efficacy results were demonstrated in an exploratory Phase 2
clinical study (Study IDR-OM-01) in 111 patients with oral
mucositis due to CRT for HNC, including potential long-term
ancillary benefits. Soligenix is working with leading oncology
centers in the US and Europe to advance SGX942 in oral
mucositis with the conduct of a pivotal Phase 3 clinical trial
(Study IDR-OM-02) referred to as the "DOM–INNATE" study (Dusquetide
treatment in Oral Mucositis – by modulating INNATE immunity). The
multinational, placebo-controlled, randomized Phase 3 study is
targeted to enroll approximately 260 subjects with squamous cell
carcinoma of the oral cavity and oropharynx, scheduled to receive a
minimum total cumulative radiation dose of 55 Gy fractionated as
2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as
a dose of 80-100 mg/m2 every third week. Subjects are
randomized to receive either 1.5 mg/kg SGX942 or placebo given
twice a week during and for two weeks following completion of CRT.
The primary endpoint for the study is the median duration of severe
oral mucositis, assessed by oral examination at each treatment
visit and then through six weeks following completion of CRT. Oral
mucositis is evaluated using the WHO (World Health Organization)
Grading system. Severe oral mucositis is defined as a WHO Grade of
≥3. Subjects are to be followed for an additional 12 months after
the completion of treatment. An interim analysis for this study has
been completed and identified a promising signal.
SGX942 has received Fast Track Designation from the FDA for the
treatment of oral mucositis as a result of radiation and/or
chemotherapy treatment in HNC patients, as well as Promising
Innovative Medicine designation in the United Kingdom by
the Medicines and Healthcare Products Regulatory Agency for the
treatment of severe oral mucositis in HNC patients receiving
CRT. In addition, products containing the same active
ingredient, dusquetide, have been granted Fast Track Designation as
an adjunctive therapy with other antibacterial drugs, for the
treatment of melioidosis and Orphan Drug Designations in the
treatment of MAS and the treatment of acute radiation
syndrome.
Soligenix has a strong intellectual property position in the IDR
technology platform, including composition of matter for dusquetide
and related analogs. Dusquetide was developed pursuant to
discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD
of the University of British
Columbia, Canada. Soligenix has received partial funding
from NIH for its oral mucositis clinical studies. The Phase 2
study was supported with a Phase I SBIR grant (#R43DE024032) award,
with the Phase 3 study being supported by a Phase II SBIR grant
(#R44DE024032) award.
In addition, a high level review of the IDR technology platform
is available here.
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.