PRINCETON, N.J., April 4, 2019 /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 US Patent Office will issue the
patent titled "Novel Peptides for Treating and Preventing
Immune-Related Disorders, Including Treating and Preventing
Infection by Modulating Innate Immunity" on April 9, 2019. The new patent (#10,253,068)
claims composition of matter for novel innate defense regulator
(IDR) analogs, expanding patent protection to more diverse analog
structures. Therapeutic use claims in oral mucositis, colitis,
and infectious disease, both alone and in conjunction with
antibiotics, will also issue.
Dusquetide (the active ingredient in SGX942) is a novel,
first-in-class IDR. It modulates the response of the innate
immune system in response to various stimuli, including infection,
tissue damage and inflammation. Dusquetide has demonstrated
efficacy in an extensive array of preclinical models emphasizing
all three aspects of its activity. SGX942 demonstrated
positive results in a Phase 2 study in the treatment of oral
mucositis in head and neck cancer (HNC) patients. SGX942 at a dose
of 1.5 mg/kg successfully reduced the median duration of severe
oral mucositis by 67% in patients receiving the most aggressive
chemoradiation therapy for treatment of their cancer. In
addition to the oral mucositis findings, an increased incidence of
"complete response" of tumor at the one month and 12-month
follow-up visits were observed. Decreases in infection rate
and an increase in the 12-month survival rate were also observed
with SGX942 treatment.
SGX942 is currently being evaluated in a pivotal, Phase 3,
randomized, double-blind, placebo-controlled, multinational
clinical study for the treatment of oral mucositis in HNC
patients. The ongoing Phase 3 trial, referred to as the
"DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by
modulating INNATE immunity), is actively enrolling patients in
the US and Europe.
"Soligenix continues to pursue broad patent coverage for
dusquetide and its library of related IDR analogs, first with
composition of matter claims followed by therapeutic use claims,
such as in oral mucositis," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "The composition of matter patents
are generally valid until 2028."
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 in a Phase 1 clinical study in 84
healthy human volunteers. Positive efficacy results were
demonstrated in an exploratory Phase 2 clinical study in 111
patients with oral mucositis due to chemoradiation therapy (CRT)
for HNC. 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 referred to as the "DOM–INNATE" study (Dusquetide
treatment in Oral Mucositis – by modulating INNATE immunity).
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.
Key nonclinical and clinical findings from the dusquetide
program can be found in the following publications:
- "Targeting Innate Immunity to Treat Disease: Potential
Therapeutic Applications" at
https://www.drugtargetreview.com/article/37410/targeting-innate-immunity/.
- "A novel approach for emerging and antibiotic resistant
infections: Innate defense regulators as an agnostic therapy" at
http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.
- "Dusquetide: A Novel Innate Defense Regulator Demonstrating a
Significant and Consistent Reduction in the Duration of Oral
Mucositis in Preclinical Data and a Randomized, Placebo-Controlled
Phase 2 Clinical Study" at
http://dx.doi.org/10.1016/j.jbiotec.2016.10.010.
- "Dusquetide: Reduction in Oral Mucositis associated with
Enduring Ancillary Benefits in Tumor Resolution and Decreased
Mortality in Head and Neck Cancer Patients" at
https://doi.org/10.1016/j.btre.2017.05.002.
In addition, a high level review of the dusquetide 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 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 Vaccines/BioDefense business segment includes active
development programs for RiVax®, our ricin toxin vaccine
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) 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 U.S.
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 U.S. 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 or the Phase 3 clinical trial of SGX301
(synthetic hypericin) for the treatment of cutaneous T-cell
lymphoma. There also can be no assurance as to timing or
success of the preclinical/clinical trials
of RiVax®,
that RiVax® will be approved for the
PRV program or the amount for which a PRV
for RiVax® can be sold.
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.