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Soligenix’s HyBryte(TM) Treatment Now Within Reach for Rare Cancer Patients

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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.

PCG Digital
[email protected]
646-863-6341

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/131925

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Central banks and the FinTech sector unite to change global payments space

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The BIS, along with seven leading central banks and a cohort of private financial firms, has embarked on an ambitious venture known as Project Agorá.

Named after the Greek word for “marketplace,” this initiative stands at the forefront of exploring the potential of tokenisation to significantly enhance the operational efficiency of the monetary system worldwide.

Central to this pioneering project are the Bank of France (on behalf of the Eurosystem), the Bank of Japan, the Bank of Korea, the Bank of Mexico, the Swiss National Bank, the Bank of England, and the Federal Reserve Bank of New York. These institutions have joined forces under the banner of Project Agorá, in partnership with an extensive assembly of private financial entities convened by the Institute of International Finance (IIF).

At the heart of Project Agorá is the pursuit of integrating tokenised commercial bank deposits with tokenised wholesale central bank money within a unified, public-private programmable financial platform. By harnessing the advanced capabilities of smart contracts and programmability, the project aspires to unlock new transactional possibilities that were previously infeasible or impractical, thereby fostering novel opportunities that could benefit businesses and consumers alike.

The collaborative effort seeks to address and surmount a variety of structural inefficiencies that currently plague cross-border payments. These challenges include disparate legal, regulatory, and technical standards; varying operating hours and time zones; and the heightened complexity associated with conducting financial integrity checks (such as anti-money laundering and customer verification procedures), which are often redundantly executed across multiple stages of a single transaction due to the involvement of several intermediaries.

As a beacon of experimental and exploratory projects, the BIS Innovation Hub is committed to delivering public goods to the global central banking community through initiatives like Project Agorá. In line with this mission, the BIS will soon issue a call for expressions of interest from private financial institutions eager to contribute to this ground-breaking project. The IIF will facilitate the involvement of private sector participants, extending an invitation to regulated financial institutions representing each of the seven aforementioned currencies to partake in this transformative endeavour.

Source: fintech.globa

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TD Bank inks multi-year strategic partnership with Google Cloud

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TD Bank has inked a multi-year deal with Google Cloud as it looks to streamline the development and deployment of new products and services.

The deal will see the Canadian banking group integrate the vendor’s cloud services into a wider portion of its technology solutions portfolio, a move which TD expects will enable it “to respond quickly to changing customer expectations by rolling out new features, updates, or entirely new financial products at an accelerated pace”.

This marks an expansion of the already established relationship between TD Bank and Google Cloud after the group previously adopted the vendor’s Google Kubernetes Engine (GKE) for TD Securities Automated Trading (TDSAT), the Chicago-based subsidiary of its investment banking unit, TD Securities.

TDSAT uses GKE for process automation and quantitative modelling across fixed income markets, resulting in the development of a “data-driven research platform” capable of processing large research workloads in trading.

Dan Bosman, SVP and CIO of TD Securities, claims the infrastructure has so far supported TDSAT with “compute-intensive quantitative analysis” while expanding the subsidiary’s “trading volumes and portfolio size”.

TD’s new partnership with Google Cloud will see the group attempt to replicate the same level of success across its entire portfolio.

Source: fintechfutures.com

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MAS launches transformative platform to combat money laundering

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The MAS has unveiled Cosmic, an acronym for Collaborative Sharing of Money Laundering/Terrorism Financing Information and Cases, a new money laundering platform.

According to Business Times, launched on April 1, Cosmic stands out as the first centralised digital platform dedicated to combating money laundering, terrorism financing, and proliferation financing on a worldwide scale. This move follows the enactment of the Financial Services and Markets (Amendment) Act 2023, which, along with its subsidiary legislation, commenced on the same day to provide a solid legal foundation and safeguards for information sharing among financial institutions (FIs).

Cosmic enables participating FIs to exchange customer information when certain “red flags” indicate potential suspicious activities. The platform’s introduction is a testament to MAS’s commitment to ensuring the integrity of the financial sector, mandating participants to establish stringent policies and operational safeguards to maintain the confidentiality of the shared information. This strategic approach allows for the efficient exchange of intelligence on potential criminal activities while protecting legitimate customers.

Significantly, Cosmic was co-developed by MAS and six leading commercial banks in Singapore—OCBC, UOB, DBS, Citibank, HSBC, and Standard Chartered—which will serve as participant FIs during its initial phase. The initiative emphasizes voluntary information sharing focused on addressing key financial crime risks within the commercial banking sector, such as the misuse of legal persons, trade finance, and proliferation financing.

Loo Siew Yee, assistant managing director for policy, payments, and financial crime at MAS, highlighted that Cosmic enhances the existing collaboration between the industry and law enforcement authorities, fortifying Singapore’s reputation as a well-regulated and trusted financial hub. Similarly, Pua Xiao Wei of Citi Singapore and Loretta Yuen of OCBC have expressed their institutions’ support for Cosmic, noting its potential to ramp up anti-money laundering efforts and its significance as a development in the banking sector’s ability to combat financial crimes efficiently. DBS’ Lam Chee Kin also praised Cosmic as a “game changer,” emphasizing the careful balance between combating financial crime and ensuring legitimate customers’ access to financial services.

Source: fintech.global

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