Fintech
Soligenix Poised to Announce US Commercialization Plans of SGX301 in the Treatment of Cutaneous T-Cell Lymphoma
New York, New York–(Newsfile Corp. – January 25, 2021) – PCG Digital: Advancing health care innovation is a cornerstone of thorough public health policy. Researching and developing new treatments for unmet medical needs has become increasingly important as the world continues to battle through the worst pandemic in our lifetime. While the news and focus of health innovation continues to be largely on COVID-19, medical breakthroughs continue to progress across the board.
Soligenix, Inc. (NASDAQ: SNGX) is one such biopharmaceutical company that has made big strides against unmet medical needs. Recently, the company released data from the Phase 3 FLASH clinical trial of its SGX301 candidate for the treatment of cutaneous T-cell lymphoma (CTCL), which showed strong positive effects.
What is CTCL?
Cutaneous T-cell lymphoma (CTCL) is a rare form of non-Hodgkin’s lymphoma, which impacts a vital part of the immune system: white blood cells or T-cells. Patients with CTCL develop abnormalities within their T-cells, which makes the cells attack the skin. This leads to visible skin rashes, which feature redness and can be slightly raised, feature scaliness, and even form tumors.
There are two main types of CTCL: Mycosis fungoides (MF) and Sezary syndrome (SS). MF is the early-stage and most common version of CTCL, which features an 88% 5-year survival rate. On the other hand, SS is the more serious and advanced stage version of CTCL, which sees its 5-year survival rate plummet to 24%.
Over 40,000 non-Hodgkin’s lymphoma patients around the world currently suffer from some form of CTCL and there are no approved cures. According to the Cutaneous Lymphoma Foundation, there is an average of 3,000 new cases of CTCL reported in the U.S. every year and roughly 16,000-20,000 Americans currently suffer from mycosis fungoides. Soligenix notes that the total addressable global market for CTCL is around $250 million, with an estimated > $75 million coming from the United States.
SGX301 Phase 3 Data Shows Strong Efficacy
Soligenix’s SGX301 is a novel first-in-class photodynamic therapy for early-stage CTCL, known as mycosis fungoides. Synthetic hypericin is the key active ingredient in SGX301, which is a powerful photosensitizer that can be topically applied to areas on the skin impacted by CTCL. After the topical is absorbed by the impacted T-cells for 16-to-24 hours, it is activated by safe, visible fluorescent light.
Fluorescent lighting is used instead of ultraviolet for a couple of reasons. First, the visible light emitted by fluorescent can penetrate deeper into the skin compared to ultraviolet. Secondly, ultraviolet lighting has carcinogenic properties that can cause other more deadly skin cancers, such as melanoma.
During Soligenix’s Phase 3 FLASH trial for SGX301, a total of 169 patients with either Stage IA, IB, or IIA CTCL were enrolled in the clinical trial. The Phase 3 trial was a randomized, double-blind, and placebo-controlled study, which featured three treatment cycles. Treatments were delivered twice a week for the first six weeks of the trial, with a treatment response determination at the end of week eight of the trial.
After the first six weeks and completion of Cycle 1, SGX301 showed a statistically significant treatment response (p=0.04) compared to the patients that were administered the placebo. Thus, the Cycle 1 process reached its primary endpoint.
Soligenix noted that positive treatment responses only continued to show significant improvement during Cycle 2’s open-label treatment cycle after 12 weeks. It is important to note that SGX301 proved to be statistically significant through Cycle 2 in both patch and deeper plaque lesions. This further supports fluorescent lighting and its ability to deeply penetrate the skin. The same statistically significant improvements continued into the 18th week, which marked the completion of the optional Cycle 3 treatment.
Unlike other forms of phototherapies that use ultraviolet light, SGX301’s Phase 3 FLASH trial showed no mutagenic risks. This truly makes Soligenix’s SGX301 candidate a significant step in treating early-stage CTCL. Not only did the trial show a very clear and meaningful statistical benefit in treating CTCL, but its safety profile far exceeds second-line and off-label treatments.
SGX301 Commercialization: Daavlin-Soligenix Strategic Partnership
Now that SGX301 has shown to be a major potential gamechanger in the treatment against CTCL, Soligenix is preparing its US commercialization plans. On January 7, 2021, Soligenix made one of its biggest steps towards SGX301 commercialization after entering into a strategic partnership with Daavlin.
Daavlin is a 40-year-old, Bryan, Ohio-based company with a rich history of innovation and development within phototherapy. The company provides a rather extensive line of products and services to healthcare providers around the globe.
Under the terms of the agreement, Soligenix and Daavlin secured a long-term supply and distribution agreement of a commercially-ready light device that is critical to SGX301’s success in treating CTCL.
Once the U.S. FDA has approved SGX301, Soligenix will focus on promoting its SGX301 treatment and the Daavlin-supplied companion light device. Daavlin will exclusively sell the lighting device to Soligenix, physicians, and patients.
“Daavlin brings technical, manufacturing, and commercial capabilities in both the US and Europe that will assist us in rapidly and efficiently distributing the SGX301 companion light device upon approval by FDA,” stated Christopher J. Schaber, Ph.D., President, and Chief Executive Officer of Soligenix. “Seamless integration of the drug product and companion light device for physicians and patients is critical to the commercial success of SGX301 and working with Daavlin will help us achieve that operational excellence.”
SGX301 Commercialization Funding: Pontifax Financing Deal
Aside from qualified strategic partnerships, ample funding and capital allocation are required to successfully launch a new treatment. In December 2020, Soligenix announced a $20 million strategic convertible debt financing agreement with Pontifax Medison Debt Financing, a healthcare-focused venture, and debt fund.
Under the terms of the financing, Soligenix will have the ability to access up to $20 million in convertible debt financing broken up into three tranches. The funding is set to mature over a four-and-a-half-year period and will carry an interest-only period for the first two years of the deal.
Soligenix has accessed the first tranche of $10 million and will have the option to draw an additional $5 million in a second tranche any time over the next twelve months. The third tranche will also carry $5 million in funding and will be available upon the filing of the SGX301 new drug application (subject to conditions).
Pontifax has the option to convert outstanding drawn funds from the first two tranches into common shares of Soligenix at a conversion price of $4.10 per share. If certain conditions are met, Soligenix will have the ability to force the conversion at a price of $4.92 per share.
“The access to less dilutive capital provided by this facility is designed to increase our financial flexibility as we continue to advance our rare disease pipeline, and build toward commercialization in the United States with SGX301 for the treatment of cutaneous T-cell lymphoma (CTCL) and SGX942 for the treatment of oral mucositis in head and neck cancer patients,” stated Christopher J. Schaber, Ph.D., President and Chief Executive Officer of Soligenix.
Overall, Soligenix is continuing to show its expertise in the research and development of treatments for unmet medical needs. The company’s SGX301 candidate to treat early-stage CTCL is a gamechanger, as it provides several very clear advantages over the second-tier treatments available today. With primary endpoints being met throughout its successful Phase 3 FLASH trial, Soligenix has made the case for the FDA to approve SGX301. Considering the funding and strategic partnership deals with Pontifax and Daavlin respectively, Soligenix has established an ecosystem to successfully roll out SGX301 to the $75 million addressable US CCTL market.
Join the Soligenix investor webcast event scheduled for Tuesday, January 26, 2021 from 2:30-4:00 PM Eastern Standard Time (EST). Management plans to detail further information about their commercialization plans, and an opportunity for investors’ Q&A after the presentation. Check the link below to be a part of the investor webcast on Tuesday.
Live Event: https://sqps.onstreamsecure.com/origin/enliven/players/Soligenix.html
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Modern brands stake on influencer marketing, with 76% of users making a purchase after seeing a product on social media.The cryptocurrency industry is no exception to this trend. However, promoting crypto products through influencer marketing can be particularly challenging. Crypto influencers pose a significant risk to a brand’s reputation and ROI due to rampant scams. Approximately 80% of channels provide fake statistics, including followers counts and engagement metrics. Additionally, this niche is characterized by high CPMs, which can increase the risk of financial loss for brands.
In this article Nadia Bubennnikova, Head of agency Famesters, will explore the most important things to look for in crypto channels to find the perfect match for influencer marketing collaborations.
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Comments
There are several levels related to this point.
LEVEL 1
Analyze approximately 10 of the channel’s latest videos, looking through the comments to ensure they are not purchased from dubious sources. For example, such comments as “Yes sir, great video!”; “Thanks!”; “Love you man!”; “Quality content”, and others most certainly are bot-generated and should be avoided.
Just to compare:
LEVEL 2
Don’t rush to conclude that you’ve discovered the perfect crypto channel just because you’ve come across some logical comments that align with the video’s topic. This may seem controversial, but it’s important to dive deeper. When you encounter a channel with logical comments, ensure that they are unique and not duplicated under the description box. Some creators are smarter than just buying comments from the first link that Google shows you when you search “buy YouTube comments”. They generate topics, provide multiple examples, or upload lists of examples, all produced by AI. You can either manually review the comments or use a script to parse all the YouTube comments into an Excel file. Then, add a formula to highlight any duplicates.
LEVEL 3
It is also a must to check the names of the profiles that leave the comments: most of the bot-generated comments are easy to track: they will all have the usernames made of random symbols and numbers, random first and last name combinations, “Habibi”, etc. No profile pictures on all comments is also a red flag.
LEVEL 4
Another important factor to consider when assessing comment authenticity is the posting date. If all the comments were posted on the same day, it’s likely that the traffic was purchased.
2. Average views number per video
This is indeed one of the key metrics to consider when selecting an influencer for collaboration, regardless of the product type. What specific factors should we focus on?
First & foremost: the views dynamics on the channel. The most desirable type of YouTube channel in terms of views is one that maintains stable viewership across all of its videos. This stability serves as proof of an active and loyal audience genuinely interested in the creator’s content, unlike channels where views vary significantly from one video to another.
Many unauthentic crypto channels not only buy YouTube comments but also invest in increasing video views to create the impression of stability. So, what exactly should we look at in terms of views? Firstly, calculate the average number of views based on the ten latest videos. Then, compare this figure to the views of the most recent videos posted within the past week. If you notice that these new videos have nearly the same number of views as those posted a month or two ago, it’s a clear red flag. Typically, a YouTube channel experiences lower views on new videos, with the number increasing organically each day as the audience engages with the content. If you see a video posted just three days ago already garnering 30k views, matching the total views of older videos, it’s a sign of fraudulent traffic purchased to create the illusion of view stability.
3. Influencer’s channel statistics
The primary statistics of interest are region and demographic split, and sometimes the device types of the viewers.
LEVEL 1
When reviewing the shared statistics, the first step is to request a video screencast instead of a simple screenshot. This is because it takes more time to organically edit a video than a screenshot, making it harder to manipulate the statistics. If the creator refuses, step two (if only screenshots are provided) is to download them and check the file’s properties on your computer. Look for details such as whether it was created with Adobe Photoshop or the color profile, typically Adobe RGB, to determine if the screenshot has been edited.
LEVEL 2
After confirming the authenticity of the stats screenshot, it’s crucial to analyze the data. For instance, if you’re examining a channel conducted in Spanish with all videos filmed in the same language, it would raise concerns to find a significant audience from countries like India or Turkey. This discrepancy, where the audience doesn’t align with regions known for speaking the language, is a red flag.
If we’re considering an English-language crypto channel, it typically suggests an international audience, as English’s global use for quality educational content on niche topics like crypto. However, certain considerations apply. For instance, if an English-speaking channel shows a significant percentage of Polish viewers (15% to 30%) without any mention of the Polish language, it could indicate fake followers and views. However, if the channel’s creator is Polish, occasionally posts videos in Polish alongside English, and receives Polish comments, it’s important not to rush to conclusions.
Example of statistics
Wrapping up
These are the main factors to consider when selecting an influencer to promote your crypto product. Once you’ve launched the campaign, there are also some markers to show which creators did bring the authentic traffic and which used some tools to create the illusion of an active and engaged audience. While this may seem obvious, it’s still worth mentioning. After the video is posted, allow 5-7 days for it to accumulate a basic number of views, then check performance metrics such as views, clicks, click-through rate (CTR), signups, and conversion rate (CR) from clicks to signups.
If you overlooked some red flags when selecting crypto channels for your launch, you might find the following outcomes: channels with high views numbers and high CTRs, demonstrating the real interest of the audience, yet with remarkably low conversion rates. In the worst-case scenario, you might witness thousands of clicks resulting in zero to just a few signups. While this might suggest technical issues in other industries, in crypto campaigns it indicates that the creator engaged in the campaign not only bought fake views and comments but also link clicks. And this happens more often than you may realize.
Summing up, choosing the right crypto creator to promote your product is indeed a tricky job that requires a lot of resources to be put into the search process.
Author
Nadia Bubennikova, Head of agency at Famesters
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
The post Central banks and the FinTech sector unite to change global payments space appeared first on HIPTHER Alerts.
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
The post TD Bank inks multi-year strategic partnership with Google Cloud appeared first on HIPTHER Alerts.
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