PRINCETON, N.J., Jan. 7, 2021 /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 it has signed an exclusive Supply,
Distribution and Services Agreement with Daavlin. Securing
long-term supply and distribution of a commercially ready light
device is an integral component of the regulatory and commercial
strategy for SGX301 (synthetic hypericin) for the treatment of
cutaneous T-cell lymphoma (CTCL).
Daavlin has a 40-year history of innovation and development in
the field of phototherapy, providing an extensive line of products
and services to health care providers and patients worldwide for
the purposes of treating photoresponsive skin disorders such as
psoriasis, vitiligo and now CTCL. The company's corporate
headquarters and manufacturing plant are located in Bryan, Ohio.
Pursuant to the Agreement, Daavlin will exclusively manufacture
the proprietary light device for use with SGX301 for the treatment
of CTCL. Upon approval of SGX301 by the US Food and Drug
Administration (FDA), Soligenix will promote SGX301 and the
companion light device, and facilitate the direct purchase of the
device from Daavlin; and Daavlin will exclusively distribute and
sell the SGX301 light device to Soligenix, physicians and
patients.
"We are pleased to be partnering with a company like Soligenix
that has such deep expertise in development of products for
treating rare diseases such as CTCL," said Dave Swanson, Founder and Chief Executive
Officer of Daavlin, "Our extensive history in the commercialization
of phototherapy medical devices in both the US and Europe complements Soligenix as they bring
SGX301 to CTCL patients in need."
"Daavlin brings technical, manufacturing and commercial
capabilities in both the US and Europe that will assist us in rapidly and
efficiently distributing the SGX301 companion light device upon
approval by FDA," stated Christopher J.
Schaber, PhD, President and Chief Executive Officer of
Soligenix. "Seamless integration of the drug product and companion
light device for physicians and patients is critical to the
commercial success of SGX301 and working with Daavlin will help us
achieve that operational excellence."
About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of
cancer of the white blood cells that are an integral part of the
immune system. Unlike most NHLs which generally involve
B-cell lymphocytes (involved in producing antibodies), CTCL is
caused by an expansion of malignant T-cell lymphocytes (involved in
cell-mediated immunity) normally programmed to migrate to the
skin. These malignant cells migrate to the skin where they
form various lesions, typically beginning as patches and may
progress to raised plaques and tumors. Mortality is related
to the stage of CTCL, with median survival generally ranging from
about 12 years in the early stages to only 2.5 years when the
disease has advanced. There is currently no cure for CTCL.
Typically, CTCL lesions are treated and regress but usually return
either in the same part of the body or in new areas.
CTCL constitutes a rare group of NHLs, occurring in about 4% of
the approximate 700,000 individuals living with the disease.
It is estimated, based upon review of historic published studies
and reports and an interpolation of data on the incidence of CTCL
that it affects over 25,000 individuals in the US, with
approximately 3,000 new cases seen annually.
About SGX301
SGX301 (synthetic hypericin) is a novel first-in-class
photodynamic therapy utilizing safe visible light for
activation. The active ingredient in SGX301 is synthetic
hypericin, a potent photosensitizer that is topically applied to
skin lesions, is taken up by the malignant T-cells, and then
activated by fluorescent light 16 to 24 hours later. The use
of visible light in the red-yellow spectrum has the advantage of
penetrating more deeply into the skin (much more so than
ultraviolet light) and therefore potentially treating deeper skin
disease and thicker lesions. This treatment approach avoids the
risk of secondary malignancies (including melanoma) inherent with
the frequently employed DNA-damaging drugs and other phototherapy
that are dependent on ultraviolet exposure. Combined with
photoactivation, hypericin has demonstrated significant
anti-proliferative effects on activated normal human lymphoid cells
and inhibited growth of malignant T-cells isolated from CTCL
patients. In a published Phase 2 clinical study in CTCL,
patients experienced a statistically significant (p=0.04)
improvement with topical hypericin treatment whereas the placebo
was ineffective. SGX301 has received orphan drug and fast
track designations from the FDA, as well as orphan designation from
the European Medicines Agency (EMA).
The Phase 3 FLASH trial enrolled a total of 169 patients (166
evaluable) with Stage IA, IB or IIA CTCL. The trial consists of
three treatment cycles. Treatments were administered twice weekly
for the first 6 weeks and treatment response was determined at the
end of the 8th week of each cycle. In the first double-blind
treatment cycle, 116 patients received SGX301 treatment (0.25%
synthetic hypericin) and 50 received placebo treatment of their
index lesions. A total of 16% of the patients receiving SGX301
achieved at least a 50% reduction in their lesions (graded using a
standard measurement of dermatologic lesions, the CAILS score)
compared to only 4% of patients in the placebo group at 8 weeks
(p=0.04) during the first treatment cycle (primary endpoint).
SGX301 treatment in the first cycle was safe and well
tolerated.
In the second open-label treatment cycle (Cycle 2), all patients
received SGX301 treatment of their index lesions. Evaluation of 155
patients in this cycle (110 receiving 12 weeks of SGX301 treatment
and 45 receiving 6 weeks of placebo treatment followed by 6 weeks
of SGX301 treatment), demonstrated that the response rate among the
12-week treatment group was 40% (p<0.0001 vs the placebo
treatment rate in Cycle 1). Comparison of the 12-week and 6-week
treatment groups also revealed a statistically significant
improvement (p<0.0001) between the two groups, indicating that
continued treatment results in better outcomes. SGX301
continued to be safe and well tolerated. Additional analyses also
indicated that SGX301 is equally effective in treating both plaque
(response 42%, p<0.0001 relative to placebo treatment in Cycle
1) and patch (response 37%, p=0.0009 relative to placebo treatment
in Cycle 1) lesions of CTCL, a particularly relevant finding given
the historical difficulty in treating plaque lesions in
particular.
The third (optional) treatment cycle (Cycle 3) was focused on
safety and all patients could elect to receive SGX301 treatment of
all their lesions. Of note, 66% of patients elected to continue
with this optional compassionate use / safety cycle of the study.
Of the subset of patients that received SGX301 throughout all 3
cycles of treatment, 49% of them demonstrated a treatment response
(p<0.0001 vs patients receiving placebo in Cycle 1). Moreover,
in a subset of patients evaluated in this cycle, it was
demonstrated that SGX301 is not systemically available, consistent
with the general safety of this topical product observed to date.
At the end of Cycle 3, SGX301 continued to be well tolerated
despite extended and increased use of the product to treat multiple
lesions. Follow-up visits were completed in Q4 2020, and data lock
and final analyses remain ongoing.
Overall safety of SGX301 is a critical attribute of this
treatment and was monitored throughout the three treatment cycles
(Cycles 1, 2 and 3) and the 6-month follow-up period.
SGX301's mechanism of action is not associated with DNA damage,
making it a safer alternative than currently available therapies,
all of which are associated with significant and sometimes fatal,
side effects. Predominantly these include the risk of
melanoma and other malignancies, as well as the risk of significant
skin damage and premature skin aging. Currently available
treatments are only approved in the context of previous treatment
failure with other modalities and there is no approved front-line
therapy available. Within this landscape, treatment of CTCL
is strongly motivated by the safety risk of each product.
SGX301 potentially represents the safest available efficacious
treatment for CTCL. With no systemic absorption, a compound
that is not mutagenic and a light source that is not carcinogenic,
there is no evidence to date of any potential safety
issues.
The Phase 3 CTCL clinical study was partially funded by the
National Cancer Institute via a Phase II SBIR grant
(#1R44CA210848-01A1) awarded to Soligenix, Inc.
About Daavlin
Daavlin is a privately held company founded in 1981 by
David Swanson, and has developed
into a leading manufacturer of phototherapeutic products with a
world-wide presence. The company's corporate headquarters and
manufacturing plant are located in Bryan,
Ohio. A network of international distributors offers Daavlin
products in more than sixty countries around the world. Daavlin has
a long tradition of development and innovation in the field of
phototherapy with an extensive line of products and services
offered in the field of dermatology. Daavlin products are used
world-wide by dermatologists and by patients in their homes to
treat photoresponsive skin disorders such as psoriasis, vitiligo,
and eczema (atopic dermatitis).
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 any of our 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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