SNGX Soligenix Inc.

2.24
-0.03  -1%
Previous Close 2.27
Open 2.32
52 Week Low 0.93
52 Week High 3.54
Market Cap $66,857,925
Shares 29,847,288
Float 29,744,572
Enterprise Value $57,088,985
Volume 380,488
Av. Daily Volume 454,715
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Upcoming Catalysts

Drug Stage Catalyst Date
SGX942 (dusquetide)
Oral Mucositis in Patients with Head & Neck Cancer
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
SGX301 (synthetic hypericin)
Cutaneous T-Cell Lymphoma (CTCL) cancer
Phase 3
Phase 3
Phase 3 top-line data met primary endpoint - March 19,2020.
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. Soligenix Inc. (NASDAQ:SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, where it has demonstrated positive […]

    Soligenix Inc. (NASDAQ:SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell…

    Soligenix Inc. (NASDAQ:SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, where it has demonstrated positive […]

    Soligenix Inc. (NASDAQ:SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, where it has demonstrated positive and statistically significant results in its pivotal Phase 3 FLASH ("Fluorescent Light Activated Synthetic Hypericin") study. Its first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, has completed patient enrollment in its pivotal Phase 3 clinical trial, referred to as the DOM-INNATE ("Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity") study, and the company expects top-line final results read out by end of this year.   For more information, visit the company's website at www.soligenix.com.

    To view IBN's virtual coverage of the Fall Investor Summit, visit https://ibn.fm/InvestorSummitFall2020

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  2. NEW YORK, NY / ACCESSWIRE / November 12, 2020 / Soligenix, Inc. (NASDAQ:SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, will be presenting at this year's virtual Fall Investor Summit on November 16th-18th.

    The Fall Investor Summit will take place virtually, featuring 75 companies and over 300 institutional and retail investors.

    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…

    NEW YORK, NY / ACCESSWIRE / November 12, 2020 / Soligenix, Inc. (NASDAQ:SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, will be presenting at this year's virtual Fall Investor Summit on November 16th-18th.

    The Fall Investor Summit will take place virtually, featuring 75 companies and over 300 institutional and retail investors.

    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.

    The Investor Summit (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors.

    To register as a presenting company: please contact Brittney Blocker ()

    To request complimentary investor registration: please visit our website at www.investorsummitgroup.com

    News Compliments of ACCESSWIRE

    FOR MORE INFORMATION

    Please visit: www.investorsummitgroup.com

    Or, contact Brittney Blocker at itgroup.com

    SOURCE: Soligenix, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/615982/Soligenix-Inc-to-Present-at-the-virtual-Fall-Investor-Summit-on-November-16th-18th

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  3. PRINCETON, N.J., Nov. 12, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended September 30, 2020.

    "We continue to look to the future with our Specialized BioTherapeutics business segment," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the recent successful completion of our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 has demonstrated the potential to be a significant new treatment for early-stage…

    PRINCETON, N.J., Nov. 12, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended September 30, 2020.

    "We continue to look to the future with our Specialized BioTherapeutics business segment," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the recent successful completion of our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 has demonstrated the potential to be a significant new treatment for early-stage cutaneous T-cell lymphoma (CTCL).  In the double-blind, placebo controlled Cycle 1 portion of the study, a statistically significant treatment response (p=0.04) was achieved in the primary endpoint after just 6 weeks of therapy.  This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycles at 12 weeks (Cycle 2) and 18 weeks (Cycle 3), reinforcing the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1.  With the study now concluded, we will begin preparing our new drug application for submission to the FDA.  We also continue to progress our pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) study for SGX942 (dusquetide), for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy.  With enrollment of 268 subjects completed, top-line final results continue to be expected before the end of the year."

    Dr. Schaber continued, "Under our Public Health Solutions business segment, supported by non-dilutive government funding, we continue to advance our work with the University of Hawaiʻi at Mānoa (UHM) and Hawaii Biotech Inc. on filovirus vaccines (protecting against viruses such as Ebola and Marburg) and the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19.  We recently announced publication of positive pre-clinical data from immunogenicity studies with CiVax™ (heat stable COVID-19 vaccine candidate), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the novel CoVaccine HT™ adjuvant in-licensed from BTG Specialty Pharmaceuticals (a division of Boston Scientific Corporation).  Our heat stable ricin vaccine, RiVax®, continues to be supported with a National Institute of Allergy and Infectious Disease contract award.  With over $11M in cash, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including final top-line results in our SGX942 Phase 3 clinical trial in oral mucositis."

    Soligenix Recent Accomplishments

    • On October 22, 2020, the Company announced the continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3), for a total of 6 months in the study, continued to significantly improve responses and remained safe and well-tolerated in its FLASH study. This data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further improved response rates, with 49% of patients electing to receive SGX301 for a total of 18 weeks demonstrating a 50% or greater reduction in their combined CAILS (Composite Assessment of Index Lesion Score) lesion score compared to 40% of patients demonstrating such a reduction after completing 12 weeks of SGX301 treatment in Cycle 2 (p=0.046). In addition, continued analysis of results has revealed that 12 weeks of SGX301 treatment (Cycle 2) is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p<0.0001) lesions of CTCL when compared to Cycle 1 placebo lesion responses. SGX301 continued to be very well tolerated, benefiting from the lack of hypericin circulation in the blood stream after targeted topical application to the lesions, as well as the use of visible light. To view this press release, please click here.



    • On September 15, 2020, the Company announced the publication of nonclinical results characterizing filovirus protein antigens (including for Ebola and Marburg viruses) and their thermostabilization. The article, authored by collaborators at the University of Colorado, University of Hawaiʻi at Mānoa (UHM) and Soligenix, is titled, "Preservation of Quaternary Structure in Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search for Stability-Indicating Assays" and has been accepted for publication in the Journal of Pharmaceutical Sciences. A copy of manuscript has been made available here. To view this press release, please click here.



    • On September 10, 2020, the Company conducted an Investor Webcast presentation on the use of its thermostabilized glycoprotein vaccine platform for the development of a COVID-19 vaccine, called CiVax™. To listen to this Webcast Event, please click here and to view the press release, please click here.

    Financial Results – Quarter Ended September 30, 2020

    Soligenix's revenues for the quarter ended September 30, 2020 were $0.6 million as compared to $1.3 million for the quarter ended September 30, 2019.  Revenues included payments on a contract in support of RiVax®, our ricin toxin vaccine candidate, grants received to support the development of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases, ThermoVax®, our thermostabilization technology, and the assessment of SGX942 safety in juvenile animals.

    Soligenix's basic net loss was $1.8 million, or ($0.06) per share, for the quarter ended September 30, 2020, as compared to $2.7 million, or ($0.14) per share, for the quarter ended September 30, 2019.  This decrease in net loss was primarily the result of decreased research and development spending due to the completion of the CTCL trial.

    Research and development expenses were $1.3 million as compared to $2.3 million for the quarters ended September 30, 2020 and 2019, respectively.  The decrease in research and development spending for the quarter ended September 30, 2020 was primarily attributable to the reduction in expense due to the completion of the CTCL trial.

    General and administrative expenses were $0.8 million for both the three months ended September 30, 2020 and 2019.

    As of September 30, 2020, the Company's cash position was approximately $11.3 million.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-recent-accomplishments-and-third-quarter-2020-financial-results-301171676.html

    SOURCE Soligenix, Inc.

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  4. PRINCETON, N.J., Nov. 10, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation at the upcoming virtual investor conferences below.

    • Virtual Fall Investor Summit held on November 16 through 18, 2020, with presentations, one-on-one meetings, round tables, and networking. The Soligenix presentation will be held on Tuesday, November 17 at 9:30AM ET. To view the live webcast, please visit https://www.webcaster4.com/Webcast/Page/2038/38404. For more…

    PRINCETON, N.J., Nov. 10, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation at the upcoming virtual investor conferences below.

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-invited-to-present-at-upcoming-virtual-investor-conferences-301169374.html

    SOURCE Soligenix, Inc.

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  5. PRINCETON, N.J., Oct. 22, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3), for a total of 6 months in the study, continued to significantly improve responses and remained safe and well-tolerated in its FLASH (Fluorescent Light Activated Synthetic Hypericin) study.  This data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further…

    PRINCETON, N.J., Oct. 22, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3), for a total of 6 months in the study, continued to significantly improve responses and remained safe and well-tolerated in its FLASH (Fluorescent Light Activated Synthetic Hypericin) study.  This data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further improved response rates, with 49% of patients electing to receive SGX301 for a total of 18 weeks demonstrating a 50% or greater reduction in their combined CAILS (Composite Assessment of Index Lesion Score) lesion score compared to 40% of patients demonstrating such a reduction after completing 12 weeks of SGX301 treatment in Cycle 2 (p=0.046).  In addition, continued analysis of results from the protocol mandated efficacy cycles (Cycles 1 and 2) of the study has revealed that 12 weeks of treatment (Cycle 2) with SGX301 is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p<0.0001) lesions of cutaneous T-cell lymphoma (CTCL) when compared to Cycle 1 placebo lesion responses, further demonstrating the unique benefits of the more deeply penetrating visible light activation of hypericin. SGX301 continued to be very well tolerated, benefiting from the lack of hypericin circulation in the blood stream after targeted topical application to the lesions, as well as the use of visible light.

    "Along with SGX301's rapid response time and safety profile, the patch and plaque data from the study are extremely compelling," stated Brian Poligone, MD, PhD, Lead Enrolling Investigator in the FLASH study and Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, USA.  "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."

    "On behalf of everyone at Soligenix, I would like to extend my sincere thanks to the patients, families, investigators, and advisors involved in the pivotal Phase 3 FLASH study," stated Richard Straube, MD, Chief Medical Officer of Soligenix.  "In treating CTCL, which is a chronic cancer with no cure, long-term safety is of paramount concern.  SGX301 treatment continues to demonstrate strong efficacy and a very benign safety profile, which is of significant benefit to patients living with this difficult disease.  Although the focus of the additional optional cycle was safety, we continue to see improvement in CTCL lesions with extended SGX301 treatment, building upon the robust efficacy signal in previous cycles.  The efficacy against both patch and plaque lesions, for example, is particularly encouraging and we believe provides another important differentiating feature from other therapies currently being used to treat early stage disease."

    "These results continue to strengthen our long-standing belief that SGX301 has the potential to be a valuable and life-changing therapy for patients suffering from CTCL, which is an orphan disease and area of unmet medical need," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "With the study now concluding, we continue to thoroughly assess commercialization and/or partnership of SGX301 while in parallel preparing for filing the New Drug Application with FDA.  Despite the challenges imposed by the COVID-19 pandemic, 2020 continues to be a very impactful year for us as we now focus on our next near-term and potentially transformational catalyst - the announcement of top-line final results by year-end from our other pivotal Phase 3 study of SGX942 (dusquetide) for the treatment of oral mucositis in head and neck cancer patients."

    Soligenix previously announced positive top-line results when the FLASH study achieved statistical significance (p=0.04) in its primary endpoint over the first 6-week double-blind treatment cycle (Cycle 1) (available here).  The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo in Cycle 1.  After the subsequent additional 6-week treatment in the open-label Cycle 2, the response rate in patients receiving a total of 12 weeks treatment increased two and a half-fold (40% with p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment).  These highly statistically significant results confirm the benefit of continued SGX301 treatment in CTCL patients (press release available here).  Treatment responses were assessed at Week 8 (after 6 weeks of treatment) and at Week 16 (after 12 weeks of treatment).  A positive response was defined as an improvement of at least 50% in the CAILS for three index lesions evaluated.  Further analysis of the patients receiving SGX301 through 12 weeks has revealed that treatment of both patch and plaque lesions was equally effective.  Similar to the overall findings, the responses of individual lesions were statistically significantly improved after 12 weeks treatment relative to 6 weeks treatment with SGX301 or placebo.  Importantly, this improvement was seen equally for both patches (response 37%, p=0.0009) and plaques (response 42%, p<0.0001), a differentiating feature of SGX301 relative to other treatment modalities in CTCL.

    Cycle 3 of the study was designed as a compassionate use, optional, cycle where patients could elect to continue SGX301 treatment for an additional 6 weeks (up to a total of 18 weeks) for all their lesions.  Sixty-six percent (66%) of patients elected to continue into Cycle 3.  During this cycle, SGX301 was applied to multiple cancerous skin lesions on the body, maximizing the exposure to the drug.  Including Cycle 3 in the study enabled a more rigorous safety assessment in the context of extended and increased exposure to SGX301.  Similar to the overall findings, the responses of individual lesions after three cycles of treatment with SGX301 was statistically significant after Cycle 3 relative to outcomes after Cycles 1 and 2 (49% of all lesions responded with a CAILS score reduction of at least 50%, with a statistically significant change from end of Cycle 2 [p=0.0009] and compared to patients receiving placebo only in Cycle 1 [p<0.0001]).  Further, no synthetic hypericin was detected in the bloodstream of patients, minimizing safety concerns of drug effects outside of the tumor area. All safety data continues to indicate that SGX301 treatment is safe and well tolerated, in marked contrast to other available second-line and off-label therapies for CTCL.   

    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 that may progress to more difficult to treat 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 and no FDA approved first-line treatment option.  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 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 are expected to be completed in 2020.   

    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 US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-phase-3-flash-study-continues-to-demonstrate-positive-benefits-in-patients-with-cutaneous-t-cell-lymphoma-301157831.html

    SOURCE Soligenix, Inc.

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