SNGX Soligenix Inc.

1.68
-0.14  -8%
Previous Close 1.82
Open 1.84
52 Week Low 1.21
52 Week High 3.1999
Market Cap $52,895,408
Shares 31,485,362
Float 31,382,646
Enterprise Value $43,805,318
Volume 2,441,047
Av. Daily Volume 4,627,850
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Upcoming Catalysts

Drug Stage Catalyst Date
SGX301 (synthetic hypericin)
Cutaneous T-Cell Lymphoma (CTCL) cancer
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
SGX942 (dusquetide)
Oral Mucositis in Patients with Head & Neck Cancer
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - December 22, 2020.
CiVax
COVID-19 vaccine
Phase 1
Phase 1
Currently pre-clinical. Intends to advance development.
RiVax
Ricin toxin vaccine
Phase 1b
Phase 1b
Phase 1c trial initiation announced December 12, 2019.
SGX203
Pediatric Crohn’s Disease
Phase 3
Phase 3
Phase 3 dependent on funding.

Latest News

  1. PRINCETON, N.J., Feb. 24, 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, 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 would like to start by thanking you for your continued support, and hope that you and your families are all healthy and well.  As 2020 recedes in the rearview mirror, we seem to be turning a corner on the challenges the COVID-19 pandemic has imposed on our everyday lives with promising coronavirus vaccines and…

    PRINCETON, N.J., Feb. 24, 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, 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 would like to start by thanking you for your continued support, and hope that you and your families are all healthy and well.  As 2020 recedes in the rearview mirror, we seem to be turning a corner on the challenges the COVID-19 pandemic has imposed on our everyday lives with promising coronavirus vaccines and a hope to return to a more normal existence in the not too distant future.  Hope and recovery appear to be the early theme of 2021, and we are energized by the promise of the coming year.  Last year posed a number of challenges and some disappointment for Soligenix, but more importantly a number of successes. Most notably, our positive Phase 3 study of SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL), allowing us to advance toward a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for marketing authorization in the not too distant future.  We also debuted new opportunities in our robust pipeline, such as our novel heat stable COVID-19 vaccine candidate, CiVax™, where we announced positive preclinical results and expect more data to follow shortly.  Additionally, we have followed through on our efficient and shareholder-friendly financing strategies, providing us with sufficient capital and cash runway to meet our goals through 2022 as we move towards U.S. commercialization of SGX301 in CTCL.  We expect peak annual net sales of SGX301 in the U.S. to exceed $90 million, with the total addressable worldwide market estimated at approximately $250 million annually.  Overall, we are excited about our near-term and future upcoming catalytic milestones.

    Corporate Highlights

    Since our last update, we have continued to advance our development programs across both the Specialized BioTherapeutics and Public Health Solutions business segments of our rare disease pipeline, where we currently anticipate achieving multiple important milestones in 2021 and 2022

    Specialized Biotherapeutics Business Segment

    In late October, we were very happy to announce completion of our pivotal Phase 3 FLASH ("Fluorescent Light Activated Synthetic Hypericin") study with SGX301 and share the continued positive benefits for our CTCL patients.  Compared to the currently approved CTCL therapies for early disease, the treatment response to SGX301 was very rapid, being detected in as little as 6 weeks of treatment (Cycle 1, p=0.0416).  Responses continued to improve through 12 weeks of treatment (Cycle 2, p<0.0001 vs end Cycle 1) and 18 weeks of treatment (Cycle 3, p<0.0001 vs end Cycle 1), ultimately enabling nearly half of patients who continued treatment to see sustained and significant improvement in their response rates. SGX301 also demonstrated statistically significant responses in both patch (Cycle 2 response 37%, p=0.0009) and plaque (Cycle 2 response 42%, p<0.0001) lesions, highlighting the unique benefits of the more deeply penetrating visible light activation of hypericin. Unlike other second line and off-label therapies for CTCL, SGX301 was both better tolerated with a reduced dropout rate and more broadly effective, with equal efficacy against both plaque and patch lesions. Further, no synthetic hypericin was detected in the bloodstream of patients, minimizing safety concerns of drug effects outside of the tumor area.

    As Brian Poligone, MD, PhD, Lead Enrolling Investigator in the FLASH study and Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, USA stated in the announcement, "Along with SGX301's rapid response time and safety profile, the patch and plaque data from the study are extremely compelling. Current treatments for CTCL are generally less effective against plaques and deeper lesions, very similar to the problem observed in psoriasis.  The ability of SGX301 to target both patches and thicker plaques in CTCL is an important feature for this therapy and, if approved, will be of benefit to patients, regardless of their presentation.  These results are consistent with the positive findings highlighted in a recently reported case study of folliculotropic mycosis fungoides, a hard to treat variant of CTCL where lesions are associated with the hair follicles deep in the skin and more resistant to phototherapy."

    With the study complete, we are now preparing to begin submission of the rolling NDA in 2Q 2021 for this first-in-class therapy.  SGX301 has received Orphan Drug and Fast Track designations from the FDA.  Additionally, SGX301 was granted Orphan Drug designation from the European Medicines Agency (EMA) and Promising Innovative Medicine designation from the Medicines and Healthcare products Regulatory Agency in the United Kingdom.

    January 2021 was a busy month for us.  We announced a strategic partnership with Daavlin, a leading manufacturer of phototherapy products used worldwide by dermatologists and patients, for supply and distribution of our SGX301 companion light device.  This exclusive supply, distribution and services agreement with Daavlin will secure long-term supply and distribution of a commercially ready light device that is an integral component of the regulatory and commercial strategy for SGX301 for the treatment of CTCL.  We also held an investor webcast event to discuss the unique U.S. commercialization opportunity for SGX301 in the treatment of CTCL.  During the webcast, we reviewed in some detail the disease, competitive landscape, and our intent to commercialize SGX301 ourselves in a cost efficient and most profitable manner.  As CTCL is a highly specialized orphan market with a discrete prescriber base, it presents a tailor-made market opportunity for us, where peak annual net sales in the U.S. are expected to exceed $90 million, with total U.S. revenues during the 10-year forecast period projected to be greater than $700 million.

    As Michael Young our acting Chief Marketing Officer and Principal, biomedwoRx: Life Sciences Consulting and a Board member of the Cutaneous Lymphoma Foundation stated,  "The value proposition for SGX301 is designed around maximizing the opportunity while minimizing the needed commercial investment, and represents a significant therapeutic opportunity in changing the landscape for treatment of early stage CTCL disease."

    During this webcast, we also discussed at a high level the analysis that went into our determination to ultimately commercialize in the U.S. versus partnership.  This decision was, in large part, based on maintaining 100% of SGX301's value with a very reasonable commercial build and launch expense of approximately $7 million compared to us retaining less than half of its value with partnering.  I would urge all those that want to better understand what a unique value proposition SGX301 in CTCL represents to listen to the full webcast here.

    We remain steadfast in our plans for partnership in the ex-U.S. markets and are in a number of active discussions with potential partners with similar reputation and expertise in this therapeutic area.  We anticipate receiving marketing approval in the U.S. first, and with this approval in hand we will aggressively pursue marketing authorizations in other key markets worldwide.  Given SGX301's success in CTCL, we are now evaluating other potential cutaneous oncology indications that might similarly benefit from the use of our first-in-class synthetic hypericin.

    As many of you know, in December, we announced preliminary top-line results for our pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) trial evaluating SGX942 (dusquetide) in the treatment of severe oral mucositis (SOM) in patients with head and neck cancer (HNC) receiving chemoradiation.  The study enrolled 268 patients randomized 1:1 to receive either SGX942 or placebo.  The primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was clearly observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group.  Other secondary endpoints supported the biological activity of dusquetide as well, including a statistically significant 50% reduction in the duration of SOM in the per-protocol population, which decreased from 18 days in the placebo group to 9 days in the SGX942 treatment group (p=0.049), consistent with the findings in the Phase 2 trial.

    As I noted during our investor call, we are very disappointed with this unanticipated outcome of the study.  Despite the fact that SGX942 demonstrated clinically meaningful reductions in oral mucositis consistent with the previous Phase 2 study, the Phase 3 trial did not achieve the statistically significant benefit we expected. We are continuing to analyze the full dataset to better understand why the study did not meet expectations.  Any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from SGX942 therapy, will be communicated to and discussed with the FDA and the EMA.

    Public Health Solutions Business Segment 

    We most recently announced a number of exciting developments in the area of emerging infectious diseases.  We were awarded a Direct to Phase II Small Business Innovation Research grant of approximately $1.5 million from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 (Coronavirus Disease 2019) and Ebola Virus Disease vaccine candidates in conjunction with our CoVaccine HT™ (CoVaccine) adjuvant.  This award also will support immune characterization of this novel, emulsified adjuvant that has unique potency and compatibility with lyophilization strategies to enable thermostabilization of subunit vaccines.

    Ongoing collaborations with Axel Lehrer, PhD, Associate Professor (Vaccinology) in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa (UHM), have demonstrated the feasibility of developing a highly immunogenic vaccine for COVID-19, the infection caused by SARS-CoV-2.  This heat stable subunit vaccine program, we call CiVax™, demonstrated immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity using the CoVaccine adjuvant in-licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation.  With significant research dedicated worldwide to the generation of COVID-19 vaccines, it is noteworthy that the essential attributes of a vaccine successful in controlling the ongoing pandemic are believed to include the ability to rapidly stimulate a Th1/Th2 balanced antibody response, raising significant virus neutralizing antibodies, as well as induce potent cell-mediated immunity.  Previous work with the CoVaccine adjuvant has indicated that it has these critical characteristics.  In addition, unlike other vaccines that have logistical challenges due to cold chain requirements (in some cases requiring maintenance of temperatures less than –70 degrees Celsius), the underlying technology platform has demonstrated the ability to produce single vial vaccines which are stable up to temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit). We expect to have proof of concept data in non-human primates (NHPs) no later than the end of Q2 this year.

    We followed this up with an announcement that we had demonstrated feasibility of developing heat stable subunit protein vaccine formulations for filovirus vaccines, including Ebola virus, Sudan virus, and Marburg virus.  Protective efficacy has been demonstrated in NHPs, the gold standard animal model, against infection with Ebola virus, Sudan virus, and Marburg virus.  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.  These most recent results demonstrate the thermostabilization of three virus glycoproteins (from Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus), and the identification of key stability-indicating assays to further support mono-, bi- and tri-valent vaccine formulations. 

    In December, we demonstrated extended protection with our heat stable ricin toxin vaccine candidate, RiVax®.  Mice, vaccinated twice on Days 1 and 21 were protected for at least 365 days against subsequent ricin challenge.  These results demonstrate that the thermostabilized vaccine formulation is capable of eliciting enduring protection in mice.  Coupled with previous demonstration of efficacy in mice and NHPs as well as long-term thermostability (at least 1 year at 40 degrees Celsius or 104 degrees Fahrenheit), these results reinforce the practicality of stockpiling and potentially utilizing the RiVax® vaccine in warfighters and civilian first responders without the complexities that arise for vaccines that require cold chain handling.  This same thermostabilization approach is also being advanced in the development of Soligenix's CiVax™ vaccine for COVID-19.

    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 bio attack with ricin in Germany, suggest that the RiVax® vaccine may be of increasing interest to multiple countries.

    Balance Sheet and Capital

    With more than $30 million in cash as of February 2021, not including our non-dilutive government funding, we are now sufficiently capitalized to achieve multiple key inflection points across our rare disease pipeline, including moving towards NDA and commercialization of SGX301.  This increase in capital was due to two important events. 

    1. A $20 million strategic partnership with Pontifax Medison, the healthcare-dedicated venture and debt fund of the Pontifax life science funds, in December. Under the terms of the partnership with Pontifax, Soligenix will have access to up to $20 million in convertible debt financing in three tranches, which will mature over a four-and-a-half-year period and have an interest-only period for the first two years.  Upon the closing of this transaction, we accessed the first tranche of $10 million, and have the option to draw the second tranche of $5 million at any time over the next 12 months and the third tranche of $5 million upon filing of the SGX301 NDA, subject to certain conditions.  Pontifax may elect to convert the outstanding loan drawn under the first two tranches into shares of Soligenix's common stock at any time prior to repayment at a conversion price of $4.10 per share.  We also have the ability to force the conversion of the loan into shares of our common stock at a conversion price of $4.92 per share, subject to certain conditions.
    2. The use of our at-the-market (ATM) sales issuance agreement with B. Riley Securities, Inc. over the last two months to supplement our cash runway.  Given the significant increase in both stock price and volume, with more than 186 million shares traded so far during 2021, we were able to add capital to our balance sheet judiciously while limiting sales to an extremely small percentage (approximately 4.6%) of the overall volume. 

    The combination of these two facilities provides significant cash runway through 2022.  With a solid balance sheet and other available resources at our disposal, such as non-dilutive government funding, we are well positioned to aggressively advance and expand our pipeline.  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 capital.  Overall, we continue to remain 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 ongoing support of Soligenix.  It continues to be a very exciting time in our life cycle and late stage pipeline.  We look forward to 2021 being even more productive than 2020, 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.

    February 24, 2021

    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 and commercializing SGX301 (synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With a successful Phase 3 study completed, regulatory approval and commercialization for this product is being advanced initially in the U.S.  Development programs in this business segment also include our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including 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 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 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.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-provides-important-highlights-and-upcoming-catalysts-in-corporate-update-letter-301234338.html

    SOURCE Soligenix, Inc.

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  2. PRINCETON, N.J., Feb. 11, 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 its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation at the BIO CEO & Investor Digital Conference taking place February 16-18, 2021.  The presentation will be available to registered conference attendees for on-demand viewing beginning February 15, 2021 at 9:00 AM EST via the virtual conference link. Alternatively, an audio webcast of the Soligenix corporate presentation is available on the Company's website via this…

    PRINCETON, N.J., Feb. 11, 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 its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation at the BIO CEO & Investor Digital Conference taking place February 16-18, 2021.  The presentation will be available to registered conference attendees for on-demand viewing beginning February 15, 2021 at 9:00 AM EST via the virtual conference link. Alternatively, an audio webcast of the Soligenix corporate presentation is available on the Company's website via this link

    Key members of Soligenix management will hold one-on-one meetings throughout the conference.  Registered conference attendees may schedule a meeting with Soligenix via the conference scheduling link.

    "On the heels of our recent SGX301 Commercialization Investor Webcast Event, the BIO CEO conference comes at an opportune time as we advance toward new drug application submission to the FDA, while continuing to highlight SGX301's unique commercial value proposition for the treatment of cutaneous T-cell lymphoma in the U.S.," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We remain focused on advancing our rare disease pipeline and look forward to meeting with high caliber investment funds and potential pharmaceutical partners during the conference."

    For more information about the BIO CEO & Investor Conference, please refer to the conference website at https://www.bio.org/events/bio-ceo-investor-digital-conference.

    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 and commercializing SGX301 (synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With a successful Phase 3 study completed, regulatory approval and commercialization for this product is being advanced initially in the U.S.  Development programs in this business segment also include our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including 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 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 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.

     

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-to-present-at-the-2021-bio-ceo--investor-digital-conference-301226650.html

    SOURCE Soligenix, Inc.

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  3. PRINCETON, N.J., Feb. 1, 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 the Hong Kong Registrar of Patents has granted a patent for the application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 16102842.8), published on January 29, 2021 under Publication No. 1214771 B.  The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of cutaneous T-cell lymphoma (CTCL), similar to those granted in Europe in 2020.  Synthetic hypericin is the active pharmaceutical ingredient in SGX301…

    PRINCETON, N.J., Feb. 1, 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 the Hong Kong Registrar of Patents has granted a patent for the application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 16102842.8), published on January 29, 2021 under Publication No. 1214771 B.  The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of cutaneous T-cell lymphoma (CTCL), similar to those granted in Europe in 2020.  Synthetic hypericin is the active pharmaceutical ingredient in SGX301, the Company's photodynamic therapy, for which positive primary endpoint results in a pivotal Phase 3 study for the treatment of CTCL were recently announced (available here).  This new patent is the first granted in Hong Kong and expands on Soligenix's comprehensive patent estate, which includes protection on the composition of the purified synthetic hypericin, methods of synthesis and therapeutic methods of use in both CTCL and psoriasis, and is being pursued worldwide. 

    SGX301 (synthetic hypericin) is a novel first-in-class photodynamic therapy for first-line treatment of early stage CTCL. In the recently completed pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 achieved a statistically significant treatment response rate (p=0.04) in the primary endpoint after just 6 weeks (Cycle 1) of therapy when compared to placebo.  This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycles after 12 weeks (Cycle 2) and 18 weeks (Cycle 3) total treatment, reinforcing the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1.  In addition, SGX301 has demonstrated a statistically significant response in both patch and plaque lesions through 12 weeks of treatment (Cycle 2), highlighting the unique benefit of using visible light with its deeper skin penetration.  SGX301 was well tolerated throughout the study and no mutagenic risks have been identified, unlike other second-line or off-label treatments, including other phototherapies, which utilize ultraviolet light. The Company believes SGX301 has compelling competitive advantages over existing therapies for early stage CTCL and represents a significant near-term commercial opportunity, as recently discussed (see webcast presentation here).

    "This recently issued patent continues to expand, strengthen and protect our worldwide synthetic hypericin patent estate," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "With the recently announced strategic financing with Pontifax and our partnership with Daavlin for supply and distribution of the SGX301 companion light device, as well as important contributions from key patient advocacy organizations, such as the Cutaneous Lymphoma Foundation, we are moving towards SGX301 marketing approval and commercialization in the U.S., while actively pursuing partnership opportunities to leverage ex-U.S. markets."

    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 U.S., 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 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 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 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.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-receives-hong-kong-patent-for-therapeutic-use-of-synthetic-hypericin-to-treat-cutaneous-t-cell-lymphoma-301218547.html

    SOURCE Soligenix

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  4. PRINCETON, N.J., Jan. 19, 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 will be hosting an Investor Webcast Event on Tuesday, January 26, 2021 from 2:30-4:00 PM Eastern Standard Time (EST) regarding United States (U.S) commercial planning for SGX301 in the treatment of Cutaneous T-Cell Lymphoma (CTCL).

    SGX301 (synthetic hypericin) is a novel first-in-class photodynamic therapy for first-line treatment of early stage CTCL. In the recently completed pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 achieved…

    PRINCETON, N.J., Jan. 19, 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 will be hosting an Investor Webcast Event on Tuesday, January 26, 2021 from 2:30-4:00 PM Eastern Standard Time (EST) regarding United States (U.S) commercial planning for SGX301 in the treatment of Cutaneous T-Cell Lymphoma (CTCL).

    SGX301 (synthetic hypericin) is a novel first-in-class photodynamic therapy for first-line treatment of early stage CTCL. In the recently completed pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 achieved a statistically significant treatment response rate (p=0.04) in the primary endpoint after just 6 weeks (Cycle 1) of therapy when compared to placebo.  This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycles after 12 weeks (Cycle 2) and 18 weeks (Cycle 3) total treatment, reinforcing the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. In addition, SGX301 has demonstrated a statistically significant response in both patch and plaque lesions through 12 weeks of treatment (Cycle 2), highlighting the unique benefit of using visible light with its deeper skin penetration.  SGX301 was well tolerated throughout the study and no mutagenic risks have been identified, unlike other second-line or off-label treatments, including other phototherapies, which utilize ultraviolet light. The Company believes SGX301 has compelling competitive advantages over existing therapies for early stage CTCL and represents a significant near-term commercial opportunity.

    Conference Call Tuesday, January 26, 2021 from 2:30-4:00 PM EST

    The Company will share information about its commercialization plans in the U.S. for SGX301 on Tuesday, January 26, 2021. A question and answer (Q&A) session with the featured experts and management will follow the presentations.  If you would like to ask a question during the Q&A, please submit your request via email to  at least 15 minutes prior to the scheduled start of the call.

    Live Event: https://sqps.onstreamsecure.com/origin/enliven/players/Soligenix.html

    An mp4 recording of the presentation will be archived for 30 days following the event.

    This Investor Event will include presentations from the following:

    Dr. Ellen Kim, Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study;

    Dr. Brian Poligone, Director, Rochester Skin Lymphoma Medical Group and lead enroller in the FLASH study;

    Mr. Michael Young, Principal, biomedwoRx: Life Sciences Consulting and member of the   Cutaneous Lymphoma Foundation Board of Directors; 

    Mr. Dan Ring, Vice President, Business Development & Strategic Planning of Soligenix; and

    Dr. Christopher J. Schaber, President and Chief Executive Officer of Soligenix.

    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 U.S., 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 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 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 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.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-investor-webcast-event-us-commercialization-of-sgx301-in-the-treatment-of-cutaneous-t-cell-lymphoma-301209662.html

    SOURCE Soligenix, Inc.

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  5. 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…

    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.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-strategic-partnership-with-daavlin-for-supply-and-distribution-of-the-sgx301-companion-light-device-in-the-treatment-of-cutaneous-t-cell-lymphoma-301202571.html

    SOURCE Soligenix, Inc.

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