Fintech PR
WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance’s AMTAGVI™ (lifileucel) for Advanced Melanoma
AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ — WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.
AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. AMTAGVI is also the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
With this announcement, WuXi ATU’s Philadelphia site becomes the first U.S. external manufacturing site and the first third-party contract testing, development, and manufacturing organization (CTDMO) to be approved by the FDA to support the commercial manufacturing and release of an individualized T cell therapy for a solid tumor cancer.
“We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma. WuXi ATU has partnered with Iovance since 2015, and we are thrilled to help them through each step of the drug development pipeline – from research to clinical manufacturing to FDA approval,” said Edward Hu, Chief Executive Officer of WuXi ATU and Vice Chairman of WuXi AppTec. “We are proud of our track record of enabling healthcare innovators to advance medical discoveries and deliver groundbreaking treatments to patients globally.”
Iovance, (NASDAQ: IOVA) is headquartered in San Carlos, California with an FDA-approved built-to-suit custom manufacturing facility, the Iovance Cell Therapy Center (iCTC), adjacent to WuXi ATU in the Navy Yard Philadelphia. The company is committed to innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies, including gene-edited cell therapies, for patients with cancer.
“The accelerated approval of AMTAGVI™ is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients. WuXi ATU has partnered with us to manufacture this cell therapy for close to a decade. It is a great benefit to both Iovance and the healthcare community to have a contract testing, development, and manufacturing partner adjacent to our facilities. Working together, our teams can make a meaningful difference for patients.”
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s AMTAGVI™ is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. For more information, please visit www.iovance.com.
About WuXi Advanced Therapies (WuXi ATU)
As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers advanced platforms and end-to-end solutions that enable the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world. For more information visit www.advancedtherapies.com.
About WuXi AppTec
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”
CONTACTS
WuXi Advanced Therapies
Amy Lamperti
Executive Director, Global Marketing
215-218-7100
[email protected]
WuXi AppTec
Davy Wu
Executive Director, Brand & Corporate Communications
[email protected]
Iovance Biotherapeutics, Inc:
Sara Pellegrino, IRC
Senior Vice President, Investor Relations & Corporate Communications
650-260-7120 ext. 264
[email protected]
Jen Saunders
Director, Investor Relations & Public Relations
267-485-3119
[email protected]
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Fintech PR
Strictly Money Launches Crowdcube Campaign, Inviting European Investors to Fuel its Growth Journey
LONDON, Dec. 27, 2024 /PRNewswire/ — Strictly Money Ltd, the London-based fintech, has launched a crowdfunding campaign on Crowdcube to invite European investors to fuel its next phase of growth. Crowdcube, Europe’s largest private market investment platform, has powered success stories like Revolut, Qonto, and Monzo. Regulated by the UK’s Financial Conduct Authority (FCA), Crowdcube provides a trusted and innovative platform for investors to participate in transformative ventures.
Strictly Money’s primary objective with this campaign is to accelerate its growth, fuel product development, and expand its shareholder base. The funding will enable Strictly Money to launch its payment card and banking app in early 2025 and to strengthen its market presence in Scandinavia, the UK, and Ireland. The company plans to introduce hedge fund returns products, broadening investment options for consumers by the end of 2025.
Discover how you can be part of Strictly Money’s growth journey by visiting our Crowdcube campaign at https://crowdcube.getstrictlymoney.com.
Will Povey, CEO and Co-Founder of Strictly Money, said: “At Strictly Money, our vision is to empower everyday investors with access to wealth-building tools and opportunities that were previously reserved for high-net-worth individuals. With this crowdfunding campaign, we aim to bring together a diverse community of investors who share our passion for financial innovation and inclusivity. This funding will not only help us launch our innovative debit card and app but also drive the development of new products that deliver real value to our users.”
About Strictly Money:
Strictly Money is a UK-based financial technology company set to launch a debit card and a cutting-edge banking app in early 2025. The company aims to democratize access to high-performing hedge fund returns, providing innovative investment strategies and financial solutions tailored to investors, savers, and entrepreneurs. Strictly Money’s mission is to open up premium investment opportunities traditionally limited to high-net-worth individuals (HNWIs). For more information, visit https://strictly-money.com.
For media inquiries contact:
Mary Prendergast
Email: [email protected]
Important Notice:
Investing in startups and early-stage businesses involves risks, including illiquidity, lack of dividends, loss of investment and dilution. It should be done only as part of a diversified portfolio. Crowdcube is targeted exclusively at investors who are sufficiently sophisticated to understand these risks and make their own investment decisions. Please read the full Risk Warning on Crowdcube’s website before deciding to invest.
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Fintech PR
Bybit Web3 Wallet Integrates Tonstakers: The First of Its TON Staking Offerings to Expand DeFi Opportunities
DUBAI, UAE, Dec. 27, 2024 /PRNewswire/ — Bybit, the world’s second-largest cryptocurrency exchange,is excited to announce the integration of Tonstakers, the leading liquid staking protocol on the TON blockchain, into its Web3 Wallet. This marks the first of Bybit Web3’s TON staking offerings, reinforcing its commitment to expanding decentralized finance (DeFi) opportunities for its users.
With this integration, Bybit Web3 Wallet users can now seamlessly stake Toncoin ($TON) and receive $tsTON (Tonstakers LST) in return. The value of $tsTON increases relative to $TON every 26 hours, ensuring competitive rewards while contributing to the growth and success of the TON ecosystem. The integration also opens the door for 130 million users in the TON ecosystem to access TON staking directly within the Bybit Web3 Wallet.
Bybit is dedicated to simplifying DeFi adoption by providing intuitive and user-friendly staking experiences. This milestone partnership with Tonstakers enables users to unlock annual returns estimated between 3% and 5% APY, with rewards automatically compounded, further cementing Bybit’s role as a leader in DeFi accessibility.
Why Tonstakers Matters: The First of Its Kind
Tonstakers is the inaugural partner in Bybit Web3’s TON staking initiative, setting a new standard for staking services. With a total value locked (TVL) exceeding $260 million and a significant market share in the liquid-staked TON sector, Tonstakers offers Bybit Web3 Wallet users unparalleled access to TON staking benefits:
- Effortless Staking: Securely stake $TON with ease, thanks to the user-friendly interface within the Bybit Web3 Wallet.
- Earn $tsTON Rewards: Receive tokenized staked Toncoin ($tsTON), which can be leveraged within DeFi applications across the TON ecosystem.
- Explore DeFi Liquidity: Engage with Tonstakers Earn to provide liquidity using $tsTON, unlocking diverse earning opportunities.
“Bybit Web3 is proud to deepen our integration with the TON blockchain, a crucial step in our mission to foster a thriving and interconnected Web3 ecosystem,” said Emily Bao, Head of Bybit Web3. “This integration empowers our users with seamless and trusted access to TON liquid staking pools and unlocks valuable earning opportunities. As a strong believer in DeFi adoption, Bybit Web3 is committed to bridging the gap between Web2 and Web3, creating simple, easy, and accessible solutions that bring the benefits of decentralized finance to a wider audience. We believe this integration will significantly contribute to the growth and success of the TON ecosystem.”
Start Staking Today To begin staking your $TON and earning with $tsTON, visit https://www.bybit.com/en/web3/staking and discover the power of Bybit Web3 Wallet’s integration with Tonstakers. Bybit Web3 Wallet currently supports a wide range of staking services beyond TON tokens, including ETH, USDT, USDC, bbSOL, SUI, and more.
#Bybit / #TheCryptoArk / #BybitWeb3
About Bybit Web3
Bybit Web3 is redefining openness in the decentralized world, creating a simpler, open, and equal ecosystem for everyone. We are committed to welcoming builders, creators, and partners in the blockchain space, extending an invitation to both crypto enthusiasts and the curious, with a community of over 130 million wallet addresses across over 30 major ecosystem partners, and counting.
Bybit Web3 provides a comprehensive suite of Web3 products designed to make accessing, swapping, collecting and growing Web3 assets as open and simple as possible. Our wallets, marketplaces and platforms are all backed by the security and expertise that define Bybit as the world’s second-largest cryptocurrency exchange by trading volume, trusted by over 60 million users globally.
Join the revolution now and open the door to your Web3 future with Bybit.
For more details about Bybit Web3, please visit Bybit Web3.
About Bybit
Bybit is the world’s second-largest cryptocurrency exchange by trading volume, serving a global community of over 60 million users. Founded in 2018, Bybit is redefining openness in the decentralized world by creating a simpler, open and equal ecosystem for everyone. With a strong focus on Web3, Bybit partners strategically with leading blockchain protocols to provide robust infrastructure and drive on-chain innovation. Renowned for its secure custody, diverse marketplaces, intuitive user experience, and advanced blockchain tools, Bybit bridges the gap between TradFi and DeFi, empowering builders, creators, and enthusiasts to unlock the full potential of Web3. Discover the future of decentralized finance at Bybit.com.
For more details about Bybit, please visit Bybit Press
For media inquiries, please contact: [email protected]
For updates, please follow: Bybit’s Communities and Social Media
Discord | Facebook | Instagram | LinkedIn | Reddit | Telegram | TikTok | X | Youtube
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LAS VEGAS, Dec. 27, 2024 /PRNewswire/ — Yaber reported a remarkable 100% year-over-year sales surge during Black Friday. The T2 outdoor projector, featuring a built-in battery and handle-to-stand design, ranked among Amazon’s Top 3 “Most Wished For” list. Meanwhile, the L2s projectors, available in exclusive Pantone colors, sold out shortly after launch.
Yaber T2 projector is currently available at Christmas sale on Amazon and the official Yaber website. Meanwhile, pre-orders for the L2s projectors in exclusive Pantone colors will reopen in mid-January 2025.
This year, Yaber further expanded its global retail presence, debuting at the iconic Selfridges in the UK and securing placements in MediaMarkt across EMEA, Canada’s London Drugs, Saudi Arabia’s EXTRA, Belgium’s FNAC, Greece’s PUBLIC, Czech Republic’s Datart, Japan’s Bic Camera and Yodobaxi, and Malaysia’s premier IOI City Mall and Plaza Low Yat.
Looking ahead, Yaber is set to unveil its first ultra-short-throw laser projector and a new Keith Haring-inspired entry-level model at CES 2025. The launch event will take place at 4:00 PM PST, January 6, 2025 at Caesars Palace, Las Vegas. Visit Yaber’s booth in South Hall 1-30808 at Las Vegas Convention and World Trade Center (LVCC) from January 7-10 to discover more.
About Yaber
Founded in 2018, Yaber redefined home entertainment by introducing the world’s first entertainment projector, pioneering a new category in the industry. Today, its innovative projectors have delivered immersive experiences to users in over 120 countries, making Yaber a trusted name in global home entertainment.
The letter “Y” in Yaber embodies the youthful vigor and innovative spirit of Generation Y. It’s not just a symbol, but a unique representation of youth identity and attitude towards life, infusing the brand with rich cultural connotations of youthfulness within simplicity.
Committed to excellence, Yaber has been pushing the boundaries of audiovisual innovation, crafting projectors that inspire richer, more vibrant lifestyles. Its achievements are recognised with prestigious accolades, including the Red Dot, IDEA, VGP, and CES Innovation Awards.
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