Innovation is alive and well in the biotech industry. And while many of the giants focus on big diseases, there is a big arena filled with unmet medical needs that also needs attention. Why are niche markets profitable? Less competition.
Late-stage biopharmaceutical company Soligenix, Inc. (NASDAQ: SNGX) is focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.
The company’s specialized biotherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, the company’s 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).
The company’s public health solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, its vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of its 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 Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
Patient enrollment has recently been opened for the investigator-initiated study (IIS) at the University of Pennsylvania, supported by a $2.6 million Orphan Products Development grant award by the U.S. Food and Drug Administration (FDA)!
The IIS will evaluate the expanded treatment, including up to 12 months of treatment, with HyBryte™ (synthetic hypericin) in patients with early-stage cutaneous T-cell lymphoma (CTCL).
The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the recently published positive Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in the treatment of early-stage CTCL.
“"CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective treatment options. With the demonstration of statistical significance in the primary endpoint and continued improvement in treatment response with extended treatment in our published Phase 3 FLASH study, we are continuing discussions with FDA on the design of a second confirmatory Phase 3 study. This IIS has the potential to augment the expanding safety database for synthetic hypericin, as well as provide further real-world evidence into the practical use of HyBryte™ once commercially available."
HyBryte™ (research name SGX301) utilizes safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light approximately 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 plaques and 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.
Cutaneous T-Cell Lymphoma treatment for early stage CTCL lesions is complicated given the side effects of many commonly used approaches. HyBryte™ (synthetic hypericin or SGX301) may provide a safer, more convenient alternative. It is a topical ointment which is applied to the lesions and then activated by safe visible fluorescent light. HyBryte™ is being tested as a photodynamic light therapy with an enhanced safety profile and a treatment regimen that may be completed in as little as 6 weeks.
SNGX’s pivotal Phase 3 clinical study (the “FLASH” study) for CTCL has completed enrollment showing a statistically significant outcome after 6 weeks treatment (p=0.04) with continued improvement to 40% response rate after 12 weeks treatment (p<0.0001).
Background on Cutaneous T-Cell Lymphoma. The majority of patients with CTCL have early stage disease (called Mycosis Fungoides) which, with careful disease management, may never progress to later stages of disease. CTCL affects about 6% of non-Hodgkin’s lymphoma patients.
Approximately 20,000 patients in the US are believed to have this chronic disease with similar prevalence in Europe and significant incidence in Asia as well. CTCL is caused by the migration of malignant T-cells to the surface of the skin.
The characteristic lesions, tumors and plaques associated with CTCL can be extremely uncomfortable and treatment for cutaneous t-cell lymphoma is believed to slow disease progression.
There is NO FDA-approved first-line therapy for CTCL. Every potential treatment is either used off-label (i.e., it wasn’t specifically approved for use in CTCL) or is supposed to be used when other CTCL treatments fail. There is a high risk of serious side effects with most current therapies. Because early-stage CTCL is a disease which patients can live with for a long time, it is very important to prevent the accumulation of toxic side effects (such as the risk for melanoma) while maintaining effective treatment of the lesions. Living with CTCL means using a number of different therapies over a lifetime, while managing the accumulating toxic side effects.
HyBryte™ has demonstrated safety in a Phase 1 clinical study in healthy volunteers. In a Phase 2, placebo-controlled, clinical study in patients with CTCL, the drug was safe, well tolerated, and effective in ameliorating the skin lesions.
Synthetic hypericin may also be useful in psoriasis.
Psoriasis is characterized by the migration of T-cells to the skin surface. However, unlike in CTCL, the T-cells in psoriasis are not malignant. Psoriasis affects over 7 million adults in the US. Photodynamic therapy is a frequently employed initial therapy for psoriasis, despite the need for ultraviolet light exposure and its attendant risk of melanoma and non-melanoma skin cancer. The Phase 1/2 clinical study showed that hypericin and visible light phototherapy is also potentially effective in treating these lesions.
The company's ThermoVax® vaccine platform has been funded to date by government grants and contracts and centers around heat-stable freeze-dried vaccines, which only require water to be added prior to use and can be stored for at least 12 months at 40 degrees Celsius (104 degrees Fahrenheit), compared with many vaccines or vaccine candidates that require strict cold-chain storage of -60 degrees Celsius (-76 degrees Fahrenheit) or less.
Potential vaccine candidates being developed by Soligenix include RiVax®, a ricin toxin vaccine that is furthest along in the development pipeline, as well as a Marburg and Ebola filovirus vaccines, and a Covid-19 vaccine, all generating consistent protection.
Presently, the National Institutes of Health (NIH) ranks both the Ebola and Marburg filoviruses as category A priority pathogens, and Ebola, Marburg, ricin and Covid are all in the USDA's top 20 list of biological agents/toxins that could pose a severe health threat to both humans and animals, hence the critical importance of this category of work.
Chief Executive Officer
Wendy brings 25 years of success launching, relaunching and building organizations in diagnostic, surgical and capital sales, with a focus in Oncology and Women’s Health. She has achieved record revenue growth at a variety of organizations from early-stage start ups to Fortune 500 companies. Most recently, Wendy has served as CCO at Agendia, Animated Dynamics and Biodesix. Prior to Biodesix, Wendy served as VP of Sales with Integrated Oncology (LabCorp subsidiary) where she led the
successful integration of Genzyme Genetics following its acquisition for $925M. Before joining Integrated Oncology, she held several leadership roles with Cytyc Corporation prior to its $6.2B acquisition by Hologic.
Soligenix, Inc. (NASDAQ: SNGX)’s pipelines focus on orphan and unmet medical needs across a range of indications that could lead to substantial commercialization and revenues.
As detailed in the company’s corporate presentation, SNGX estimates the total addressable global market potential across both its business segments to be approximately $2 billion!
“When you look at our pipeline, current stock price and market cap, the potential upside is significant, in my opinion,” remarked CEO Christopher J. Schaber, PhD.
With FDA approval, HyBryte™ can be a potential game-changer in the treatment of CTCL.
THIS IS A PAID ADVERTISEMENT
NO INVESTMENT ADVICE
SCD Media LLC (d/b/a “Smallcaps Daily”), hereinafter referred to as “Smallcaps Daily,” and their affiliates and control persons (the “Publisher”) are in the business of publishing favorable information and/or advertisements (the “Information”) about the securities of publicly traded companies (each an “Issuer” or collectively the “Issuers”) in exchange for compensation (the “Campaigns”). Persons receiving the Information are referred to as the “Recipients.” The person or entity paying the Publisher for the Campaign is referred to herein as the “Paying Party”. The Paying Party may be an Issuer, an affiliated or non-affiliate shareholder of an Issuer, or another person hired by the Issuer or an affiliate or non-affiliate shareholder of the Issuer. The nature and amount of compensation paid to the Publisher for the Campaign and creating and/or publishing the Information about each Issuer is set forth below under the heading captioned, “Compensation”.
This website provides information about the stock market and other investments. This website does not provide investment advice and should not be used as a replacement for investment advice from a qualified professional. This website is for informational purposes only. The Author of this website is not a registered investment advisor and does not offer investment advice. You, the reader, bear responsibility for your own investment decisions and should seek the advice of a qualified securities professional before making any investment.
Nothing on this website should be considered personalized financial advice. Any investments recommended herein should be made only after consulting with your personal investment advisor and only after performing your own research and due diligence, including reviewing the prospectus or financial statements of the issuer of any security.
Smallcaps Daily, its managers, its employees, affiliates, and assigns (collectively the "Publisher") do not make any guarantee or warranty about the advice provided on this website or what is otherwise advertised above.
Release of Liability: through use of this website, viewing or using you agree to hold Smallcaps Daily, its operators, owners, and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources that we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. Smallcaps Daily encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the company profiled or is available from public sources and Smallcaps Daily makes no representations, warranties, or guarantees as to the accuracy or completeness of the disclosure by the profiled company. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provided herein. Instead, Smallcaps Daily strongly urges you to conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Smallcaps Daily’s full disclosure is to be read and fully understood before using Smallcaps Daily's website, or joining Smallcaps Daily's email or text list. From time to time, Smallcaps Daily will disseminate information about a company via website, email, sms, and other points of media. By viewing Smallcaps Daily's website and/or reading Smallcaps Daily's email or text newsletter you are agreeing to this ----> https://Smallcaps Daily.com/disclaimer/. All potential percentage gains discussed in any communications are based on calculations from the low to the high of the day. We are engaged in the business of marketing and advertising companies for monetary compensation.
If you have questions or concerns about a product you’ve seen in one of our emails, emails, text newsletters or SMS, we encourage you to reach out to that company directly.
Disclaimer – Always do your own research and consult with a licensed investment professional before investing. This communication is never to be used as the basis of making investment decisions and is for entertainment purposes only. At most, this communication should serve only as a starting point to do your own research and consult with a licensed professional regarding the companies profiled and discussed. Conduct your own research. This newsletter is a paid advertisement, not a recommendation nor an offer to buy or sell securities. This newsletter is owned, operated, and edited by the owner of Smallcaps Daily. Any wording found in this e-mail or disclaimer referencing to “I” or “we” or “our” refers to Smallcaps Daily. Our business model is to be financially compensated to market and promote small public companies. By reading our newsletter and our website you agree to the terms of our disclaimer, which are subject to change at any time. We are not registered or licensed in any jurisdiction whatsoever to provide investing advice or anything of an advisory or consultancy nature and are therefore unqualified to give investment recommendations. Companies with low prices per share are speculative and carry a high degree of risk, so only invest what you can afford to lose. By using our service, you agree not to hold our site, its editors, owners, or staff liable for any damages, financial or otherwise, that may occur due to any action you may take based on the information contained within our newsletters or on our website. We do not advise any reader to take any specific action. Losses can be larger than expected if the company experiences any problems with liquidity or wide spreads. Our website and newsletter are for entertainment purposes only. Never invest purely based on our alerts. Gains mentioned in our newsletter and on our website may be based on end-of-day or intraday data. This publication and its owners and affiliates may hold positions in the securities mentioned in our alerts, which we may sell at any time without notice to our subscribers, which may have a negative impact on share prices. If we own any shares, we will list the information relevant to the stock and the number of shares here.
In compliance with section 17(b) of the Securities Act we are disclosing that we have been compensated a fee pursuant to an agreement between Smallcaps Daily. Smallcaps Daily was hired by Silogenix, Inc for a period beginning August 2023 and ending September 2023 to publicly disseminate information about Silogenix, Inc., via website, email, and SMS. We were up to twenty five thousand USD via ACH. Subsequently, Smallcaps Daily was hired by Soligenix, inc for a period beginning September 2023 and ending September 2023 to publicly disseminate information about Silogenix, Inc., via website, and email. We were paid up to twenty-five thousand USD via ACH. Readers are advised to review SEC periodic reports: forms 10Q 10K, form 8K, insider reports, forms 3, 4, 5 schedule 13d. Smallcaps Daily is compliant with the CAN-SPAM Act of 2003. Smallcaps Daily does not offer investment advice or analysis, and Smallcaps Daily further urges you to consult your own independent tax, business, financial, and investment advisors. investing in micro-cap, small-cap, and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or impaired due to the speculative nature of the companies profiled. The private securities litigation reform act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events, or performance are not statements of historical fact but may be forward-looking statements. Forward-looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this action may be identified through the use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quotes; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results in preparing this publication. Smallcaps Daily has relied upon information supplied by its clients, as well as its clients’ publicly available information and press releases which it believes to be reliable; however, such reliability can not be guaranteed. Investors should not rely on the information contained on this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, Smallcaps Daily and its owners, affiliates, subsidiaries, officers, directors, representatives, and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of material facts from such advertisement. Smallcaps Daily is not responsible for any claims made by the companies advertised herein, nor is Smallcaps Daily responsible for any other promotional firm, its program, or its structure. Smallcaps Daily is not affiliated with any exchange, electronic quotation system, the Securities Exchange Commission, or FINRA.
Copyright © 2022 Smallcaps Daily. All rights reserved.