Fintech
Soligenix’s HyBryte(TM) Treatment Now Within Reach for Rare Cancer Patients
HyBryte(TM) NDA Anticipated in H2 2022
New York, New York–(Newsfile Corp. – July 26, 2022) – PCG Digital — Late-stage biopharmaceutical company, Soligenix, Inc. (NASDAQ: SNGX), has completed the largest placebo controlled, randomized Phase 3 trial ever done in cutaneous T-cell lymphoma (CTCL) evaluating a novel topical treatment for early-stage CTCL and is preparing to submit a New Drug Application to the FDA to commercialize the product.
Soligenix, Inc.
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Cutaneous T-Cell lymphoma (CTCL) is a rare cancer that affects approximately 27,000 Americans. It has no cure and as a chronic condition must be managed by patients and their doctors over years, and sometimes decades. Today, most treatment options for CTCL are associated with significant safety concerns.
Soligenix’s treatment, HyBryte™, has been evaluated through Phase 1, 2 and 3 clinical trials and has been found to be safe and well-tolerated, and to significantly reduce CTCL lesion size. It also has an advantage over traditional phototherapy, which uses DNA-damaging ultraviolet (UV) light. HyBryte™ (topical synthetic hypericin), is applied directly to the cancerous skin lesions followed by activation with safe, visible fluorescent light, so the risk of developing actinic skin damage and skin cancers is not a concern as it is with UV light. Short term side effects are also less common and milder than those usually found in traditional phototherapy.
It is an exciting time for CTCL patients, who may soon have access to a safer and more effective treatment option. We caught up with Dr. Richard Straube, Soligenix’s Chief Medical Officer, to find out more about HyBryte and the clinical journey to date.
Q: Can you tell us about HyBryte™ and how it works?
A: HyBryte™ is an ointment that delivers a drug called synthetic hypericin. We apply it topically on the skin on the lesions that are seen in CTCL. After the drug is absorbed by the cancer cells, which takes about 24 hours, we shine a fluorescent light on the affected areas. That in turn kills the cancer cells.
Q: You’ve been involved in many clinical trials over the years. Is there anything about the HyBryte trials that stands out?
A: Certainly. The Phase 3 study undertaken by Soligenix to evaluate HyBryte™ as a treatment is the largest placebo randomized controlled trials ever done in CTCL, and it showed that treatment with this combination of drug and light reduced the size of patients’ tumors in six weeks. Importantly, the study showed that if you continue therapy, the mounted response and the duration of response continue to dramatically increase.
There are a number of new trials being done in CTCL, but the majority are evaluating treatments for late-stage disease. HyBryte™ is targeted to the vast majority of patients who have early-stage disease and who are likely to stay early-stage for years to decades.
Watch the recent interview with Dr. Straube.
Q: The results of the Phase 3 study have been published in JAMA Dermatology. What does this tell us about the study’s findings?
A: We are very pleased that the results of the study have been published in the JAMA Dermatology journal. It is one of the most prestigious journals in the field and the fact that they accepted this manuscript really underscores the importance of these results in treating CTCL patients. Additionally, the journal itself is targeted at those healthcare professionals that actually deal with these patients, and this article provides them with information directly, giving them the opportunity to discuss this treatment with their patients and make intelligent choices about whether or not this is the right therapy for them.
Q: Clinical trials are not possible without the patients involved. CTCL is a rare disease affecting approximately 27,000 Americans. How was Soligenix able to reach the patient population?
A: CTCL is an orphan disease and there are not a lot of patients out there. Finding these patients and making them aware of the trial was key in making the Phase 3 study possible. We’ve been very grateful to the Cutaneous Lymphoma Foundation (CLF) which reached out to its membership and provided information on the clinical trial, allowing patients to evaluate whether they were willing to participate. Involvement in a clinical trial like this is a huge commitment on the part of the patient. They knew that there was the potential that they would have absolutely no personal benefit from participating and yet they were willing to take part in a rigorous clinical trial in order to help determine whether HyBryte™ would become a real treatment option for other patients with this long-term cancer.
Q: How are CTCL experts responding to this potential treatment?
A: We’ve been really happy with the excitement of clinicians who have been involved in the study and also some that have just looked at the results. For many clinicians, HyBryte™ will potentially be the first new treatment they have seen in the past two decades, making it an important option for their patients in the future, provided the drug receives FDA approval.
Q: What’s next on the path to commercialization?
A: Soligenix is submitting a New Drug Application to the FDA later this year. We believe that the data we have is very solid and we look forward to presenting it and potentially having a promising new treatment to offer patients living with CTCL.
Disclaimer
This communication was produced by PCG Digital Holdings, LLC, an affiliate of PCG Advisory Inc., (together “PCG”). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its client’s securities. See www.pcgadvisory.com/disclosures.
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As we close out 2024, the fintech industry continues to deliver headlines that underscore its dynamism and innovation. From IPO aspirations to groundbreaking regulatory milestones, today’s updates highlight the transformative power of fintech partnerships, regulatory evolution, and disruptive technologies. Here’s what you need to know.
Chime’s Quiet Step Toward Public Markets
Chime, the U.S.-based financial technology startup best known for its digital banking services, has taken a significant step by filing confidential paperwork for an initial public offering (IPO). As one of the most valuable private fintechs in the U.S., Chime’s move could potentially signal a renewed appetite for fintech IPOs in a market that has been cautious following fluctuating valuations across the tech sector.
With a valuation that reportedly exceeded $25 billion in its last funding round, Chime’s IPO could set a new benchmark for the industry. Observers note that its strong customer base and revenue growth may make it an appealing choice for investors seeking to capitalize on the digital banking boom. However, the timing and success of the IPO will depend on broader market conditions and the regulatory landscape.
Source: Bloomberg
ZBD’s Pioneering Achievement: EU MiCA License Approval
ZBD, a fintech company specializing in Bitcoin Lightning network solutions, has made history by becoming the first to secure an EU MiCA (Markets in Crypto-Assets Regulation) license. This landmark approval by the Dutch regulator positions ZBD at the forefront of compliant crypto-fintech operations in Europe.
MiCA, which aims to harmonize the regulatory framework for crypto-assets across the EU, has been a focal point for industry players aiming to establish legitimacy and expand their offerings. ZBD’s achievement not only validates its operational rigor but also sets a precedent for other fintech firms navigating the evolving regulatory landscape.
Industry insiders view this as a strategic advantage for ZBD as it broadens its footprint in Europe. By leveraging its regulatory approval, the company can accelerate its product deployment and establish trust with institutional and retail users alike.
Source: Coindesk, PR Newswire
The Fintech-Credit Union Synergy: A Blueprint for Innovation
The convergence of fintechs and credit unions continues to reshape the financial services ecosystem. Collaborative initiatives, such as the one highlighted in the recent partnership between fintech innovators and credit unions, are proving to be a potent force in delivering tailored financial solutions.
This “dream team” approach allows credit unions to leverage fintech’s technological expertise while maintaining their community-focused ethos. Key areas of collaboration include digital payments, personalized financial management tools, and enhanced loan processing capabilities. These partnerships not only enhance member engagement but also enable credit unions to remain competitive in an increasingly digital-first financial environment.
Industry analysts emphasize that such collaborations underscore a broader trend of traditional financial institutions embracing fintech-driven solutions to bridge service gaps and foster innovation.
Source: PYMNTS
Tackling Student Loan Debt: A Fintech’s Mission
Student loan debt remains a pressing issue for millions of Americans, and a Rochester-based fintech aims to offer relief through its cloud-based platform. This innovative solution is designed to simplify loan management and provide borrowers with actionable insights to reduce their debt burden.
The platform’s features include repayment optimization tools, personalized financial education, and seamless integration with loan servicers. By addressing the complexities of student loan management, this fintech is empowering borrowers to make informed decisions and achieve financial stability.
As the student loan crisis continues to evolve, solutions like this highlight the critical role fintech can play in addressing systemic financial challenges while fostering financial literacy and inclusion.
Source: RBJ
Industry Implications and Takeaways
Today’s updates underscore several key themes shaping the fintech landscape:
- Regulatory Milestones: ZBD’s MiCA license approval exemplifies the importance of regulatory compliance in unlocking growth opportunities.
- Strategic Partnerships: The collaboration between fintechs and credit unions demonstrates the value of combining technological innovation with traditional financial models to drive customer-centric solutions.
- Market Opportunities: Chime’s IPO move reflects a potential revival in fintech public offerings, signaling confidence in the sector’s long-term prospects.
- Social Impact: Fintech’s ability to tackle systemic issues, such as student loan debt, showcases its role as a force for positive change.
The post Fintech Pulse: Your Daily Industry Brief (Chime, ZBD, MiCA) appeared first on News, Events, Advertising Options.
Leading global payments platform SPAYZ.io has confirmed it will be attending iFX EXPO Dubai 2025 on 14 to 16 January. Exhibiting at Stand 64 at Trade Centre Dubai, SPAYZ.io’s team of professionals will be on hand providing live demonstrations of its renowned payment services for payment providers. Attendees will also receive exclusive insight into SPAYZ.io’s plans for 2025 alongside early early access to its upcoming plans for the new year.
SPAYZ.io delivers a host of payment solutions that leverage the latest technological innovations and open access to the fastest growing emerging markets across Africa, Europe and Asia. Over the past year, there has been huge demand for its Open Banking and local payment method services, alongside bank transfers, mass payouts, online banking and e-wallets.
Yana Thakurta, Head of Business Development at SPAYZ.io commented: “We look forward to once again participating at iFX Dubai to expand our network of partners and clients. It’s a fantastic way to kick off the year, connecting with thousands of industry leaders from FOREX platforms to trading companies, and everything in between.
“Our key goal for iFX Dubai EXPO 2025 is to expand our portfolio of solutions and geographies. We’re using this as an opportunity to partner with like-minded entities who share our ambition to provide payment solutions that are truly global.”
Come meet SPAYZ.io’s team at the Trade Centre Dubai at Stand 64. You can also book a meeting slot with a member of a team.
The post SPAYZ.io prepares for iFX EXPO Dubai 2025 appeared first on News, Events, Advertising Options.
Airtm, the most connected digital dollar account in the world, is proud to announce the addition of two distinguished industry leaders to its Board of Directors: Rafael de la Vega, Global SVP of Partnerships at Auctane, and Shivani Siroya, CEO & Founder of Tala. These appointments reflect Airtm’s commitment to innovation and financial inclusion as the company enters its next phase of growth.
“We are thrilled to welcome Rafael and Shivani to Airtm’s Board of Directors,” said Ruben Galindo Steckel, Co-founder and CEO of Airtm. “Their unique perspectives and proven track records will be invaluable as we continue scaling our platform to empower individuals and businesses in emerging markets. Together, we’ll push the boundaries of financial inclusion and innovation to create a more connected and equitable global economy. Rafael and Shivani bring a wealth of experience and strategic insight that will strengthen Airtm’s mission to connect emerging economies with the global market.”
Rafael de la Vega, a seasoned leader in fintech global partnerships and technology innovation, is currently the Global SVP of Partnerships at Auctane. With a proven track record of delivering scalable, impactful solutions at the intersection of fintech, innovation, and commerce, Rafael’s expertise will be pivotal as Airtm continues to grow. “Airtm has built a platform that breaks down barriers and opens up opportunities for people in emerging economies to connect to global markets. I am excited to contribute to its growth and help further its mission of fostering financial inclusion on a global scale,” said Rafael.
Shivani Siroya, CEO and Founder of Tala, is a pioneer in financial technology, renowned for empowering underserved communities through access to credit and essential financial tools. Her leadership in leveraging data-driven innovation aligns seamlessly with Airtm’s vision of creating more equitable financial opportunities. “Empowering underserved communities has always been at the core of my work, and Airtm’s mission resonates deeply with me. I’m thrilled to join the Board and work alongside such a dynamic team to expand access to financial tools that truly make a difference in people’s lives,” said Shivani.
The post Airtm Enhances Its Board of Directors with Two Strategic Appointments appeared first on News, Events, Advertising Options.
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