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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Plug and Play, a global accelerator platform and one of the most active early-stage investors globally, has announced a strategic partnership with Gujarat International Finance Tec-City (GIFT City). Through the partnership, Plug and Play will establish and run the International Fintech Innovation Hub (IFIH), GIFT City’s FinTech Incubator and Accelerator, which aims to foster research and innovation in financial technology, reinforcing GIFT City’s role as a premier global fintech hub.
GIFT City’s MD and Group CEO, Mr. Tapan Ray, said, “Our vision at GIFT City is to drive fintech innovation by creating a climate-resilient, inclusive ecosystem that empowers diverse entrepreneurs and builds workforce competitiveness in emerging technologies. With the support of prominent partners in fintech education and incubation, we are committed to nurturing a new generation of talent that will be well-equipped to meet the needs of an evolving global economy.”
Manav Narang, Head of Financial Services for Plug and Play APAC and Program Lead for the GIFT Incubator and Accelerator added, “We are thrilled to bring Plug and Play’s global expertise to GIFT City. Our vision is to create India’s largest industry-wide fintech program – a collaborative platform where banks, payments corporations, venture capital and corporate venture capital firms, accelerators, and ecosystem partners unite. Together, we aim to catalyze transformative fintech solutions and nurture fintech unicorns that will shape the future of finance in India.”
The program will support fintech startups with resources, mentorship, capital, and networking to navigate and excel globally in the dynamic fintech landscape. The first batch of startups will be unveiled in January 2025.
The post Plug and Play and GIFT City Launch “IFIH,” a Global Fintech Incubator and Accelerator appeared first on .
Doo Group’s brokerage brand, Doo Financial is thrilled to announce its expansion into Indonesia by acquiring a reputable Indonesian broker to expand the business. This move brings its global investment services to local investors. Backed by the strength of Doo Group’s extensive international presence, cutting-edge technology, and 10 years of expertise, Doo Financial is well positioned to support investors at every level.
As a brand encompassing investment services offered by various legal entities within the Doo Group, Doo Financial provides a comprehensive range of global brokerage services. This wide range of products empowers investors to pursue their financial goals.
With a diversified portfolio, Doo Financial empowers investors to navigate various market conditions effectively, manage risks, and focus on long-term growth. This entry into the Indonesian market reflects Doo Financial’s commitment to supporting investors with flexible, high-quality investment options tailored to today’s dynamic financial landscape.
Supervision by International Regulatory Institutions to Ensure Top-Tier Safety
As a global leading finance group, Doo Group has licensed entities regulated by top regulatory authorities worldwide, ensuring a secure and reliable trading environment.
Our global credentials include licenses from the U.S. Securities and Exchange Commission (US SEC), the Financial Industry Regulatory Authority (US FINRA) in the U.S., the Financial Conduct Authority (UK FCA) in the UK, the Australian Securities and Investments Commission (ASIC), the Hong Kong Securities and Futures Commission (HK SFC), Badan Pengawas Perdagangan Berjangka Komoditi (BAPPEBTI) in Indonesia. These licenses enable us to provide secure and reliable financial services globally.
Dedication to Shape the Industry with Innovative Solutions
Doo Financial’s expansion into Indonesia brings advanced technology and a global perspective to empower local investors. As an international investment firm committed to secure and seamless trading, Doo Financial offers a diverse range of products and services to help diversify portfolios and open up new opportunities.
This growth elevates opportunities for Indonesian investors by offering seamless access to global markets and advanced trading platforms within a secure and regulated environment. It broadens investment choices and enhances the trading experience, aligning it with international standards and empowering local investors with comprehensive tools and resources for success.
Driven by unwavering commitment, this growth marks a significant milestone in Indonesia’s investment landscape, equipping our clients with the tools to navigate global markets. We remain dedicated to delivering exceptional service, exploring new opportunities, and driving future breakthroughs. With continued support from the FinTech community, we are excited to innovate and shape the future of finance.
Stay updated with the latest insights from Doo Financial. Join our community of empowered investors and let us be your trusted partner!
E-mail: [email protected]
The post Doo Financial Now in Indonesia: Offering Local Investors A Gateway to Global Markets appeared first on .
Fintech is on an accelerated trajectory of investment, collaboration, and innovation. This pulse tracks the most significant developments in the sector, from high-profile investments to global platform expansions. Each update in this briefing serves as a key indicator of where the industry is headed.
1. European Fintechs Face Regulatory Pressures Amid New Investment Surge
The European fintech sector finds itself at a crossroads with increasing scrutiny and rising costs due to stringent regulations. While investments continue to flow into the continent’s financial technology companies, challenges in meeting new compliance requirements, especially around data privacy and cybersecurity, create a complex landscape for scaling. This tension between opportunity and operational limitations might affect European fintechs’ growth strategies.
Source: Financial Times
2. Shopify, Slack Founders Join Peter Thiel in Fintech Investment Push
Tobi Lütke of Shopify and Stewart Butterfield of Slack, along with investor Peter Thiel, have co-invested in a new fintech initiative that aims to bolster small business access to capital. By merging technology with a streamlined funding model, this new initiative targets underserved SMBs, highlighting a broader trend of high-profile tech leaders pivoting to fintech investment. The participation of Lütke and Butterfield signals increased cross-sector collaboration in fintech, bringing expertise from e-commerce and communication technology into the financial arena.
Source: Yahoo Finance
3. Lean Technologies Raises $67.5 Million to Drive Fintech Innovation in the Middle East
Riyadh-based fintech platform Lean Technologies recently secured a $67.5 million Series B investment round, aiming to expand its operations across the Middle East. This funding reflects growing investor interest in emerging markets and the potential of Middle Eastern fintech to bridge regional gaps in financial services access. As Lean Technologies broadens its service offerings, the funding will support further technological integration and scalability across financial ecosystems in the region.
Source: Fintech Global
4. Apollo Global Management Invests in Fintech for Private Offerings Support
Apollo Global Management has taken steps to enhance its services for private offerings by investing in specialized fintech solutions. This development signifies a growing trend among private equity firms to adopt fintech as a core component in their service expansion, particularly for personalized client services. Apollo’s strategy of integrating fintech solutions into private offerings marks a strategic shift toward digitalization within traditional financial sectors.
Source: Bloomberg
5. Juniper Research Names 2025’s Future Leaders in Fintech
Juniper Research has revealed its picks for the top future leaders in fintech for 2025. This list emphasizes innovation in fields such as AI, open banking, and decentralized finance, highlighting startups that exhibit potential for reshaping industry standards. As these up-and-coming firms push the boundaries of traditional finance, they exemplify the rising tide of next-generation financial technology poised to become industry mainstays.
Source: Globe Newswire
Conclusion
The convergence of seasoned tech giants with fintech, new funding rounds for region-specific platforms, and the rise of future industry leaders underscore the momentum of the fintech sector. Each of these stories reflects a broader narrative: fintech is not only diversifying in services but also rapidly integrating into traditional finance and tech, paving the way for a transformative era.
The post Fintech Pulse: Evolving Fintech Investments and Partnerships Signal Industry Transformation appeared first on HIPTHER Alerts.
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