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HyBryte(TM): Addressing an Unmet Need for Rare Lymphoma

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Soligenix Demonstrates Clinical Success in First-in-Class Treatment for Cutaneous T-Cell Lymphoma

New York, New York–(Newsfile Corp. – July 22, 2021) – PCG Digital — Cutaneous T-cell lymphoma (CTCL) is a rare form of non-Hodgkin’s lymphoma that currently affects between 16,000 – 20,000 Americans, with approximately 1,000 new diagnoses each year. There is currently no FDA-approved first line treatment for CTCL, leaving clinicians and patients reliant on traditional phototherapy treatments.

Soligenix (NASDAQ: SNGX), a biopharmaceutical company specializing in treatments for rare diseases, is addressing this unmet need for those living with CTCL.

HyBryte™ (synthetic hypericin) offers a less invasive photodynamic therapy, using safe, visible light to treat early-stage CTCL. Soligenix recently conducted a Phase 3 FLASH trial of HyBryte™, demonstrating safety, tolerability and efficacy and positioning HyBryte™ as a safer short- and long-term treatment option for CTCL patients.

Dr. Ellen Kim, the Lead Principal Investigator for the study and Medical Director of the Dermatology Clinic for the Perelman Center for Advanced Medicine, presented at the United States Cutaneous Lymphoma Consortium (USCLC) Annual Meeting this month, summarizing the HyBryte™ FLASH trial.

Dr. Kim said, “We’re looking for treatment options with efficacy, but also short-term and long-term safety. Because there are no curable treatment options for CTCL, we manage this disease like we manage other chronic conditions. HyBryte™ is a safe and effective option for that.

“The response rate peaked at 49 percent which is quite typical for the sort of response for many skin-directed therapies currently approved for CTCL. What’s gratifying is that HyBryte™ has a really great safety profile.”

About the Phase 3 FLASH study for HyBryte:

  • The HyBryte study was a multi-center randomized control blinded trial held in the US.
  • HyBryte is a synthetic hypericin ointment that can be combined with visible light to treat early-stage mycosis fungoides CTCL.
  • The study was conducted in three cycles, with the first cycle randomizing patients in a blinded manner between placebo and the active drug. Cycle 2 was the crossover cycle where all patients received HyBryte™ and Cycle 3 was optional to treat all lesions. Response rate was measured at the end of each cycle.
  • Each cycle was six weeks long, with two treatments per week, followed by a two-week rest period before results were measured. 169 patients were enrolled in the study.
    • Cycle 1 produced a 16% response rate in active drug recipients
    • Cycle 2 produced a 40% response rate from patients who received two cycles of HyBryte™ (Cycle 1 and Cycle 2)
    • Cycle 3 produced a 49% response rate
  • The response rate is comparable to other skin-directed therapies studied and the safety profile was excellent, with responses seen in both patch and deeper plaque lesions. Other therapies have limitations with regards to short-term and long-term side effects.
  • Minimal adverse effects were seen in 16% of patients. 1.7% discontinued the trial due to adverse side effects, which included erythema, hyperpigmentation, and itching.
  • Due to the use of visible light that penetrates deeper versus traditional ultraviolet A or B phototherapy, there was no difference in response rate between dark and light-skinned patients.

Watch the full presentation here : HERE

To find out more, visit HyBryte.com.

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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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