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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DUBAI, UAE, Sept. 6, 2024 /PRNewswire/ — Bybit, the world’s second-largest cryptocurrency exchange by trading volume, set out to make the community’s TOKEN2049 journey more rewarding. Gearing up for the most anticipated blockchain and Web3 event in the region, Bybit is thrilled to announce three bonus events to enable both attendees and remote fans to both be part of the experience.
The winning opportunities are open to both attendees of TOKEN2049 and followers from afar. Through trading and offline events, participants stand to get free tickets, a share of the $80,000 prize pool in airdrops and coupons, and Bybit merchandise.
Event 1: TOKEN2049 Treasure Express
From now to Sep. 26, 2024, Bybit users may register for the event and complete tasks by depositing and trading assets to earn lucky draw tickets. The wheel of fortune will turn to one of the three prizes:
1. A pair of tickets to TOKEN2049;
2. A share of the airdrop prize pool valued at $50,000 featuring the hottest tokens, including DOGS, PEPE, SOL, XRP, TON and USDT; or
3. Up to 50 USDT in spot coupons.
Even more rewards await in referrals and social media giveaways. For details, visit: TOKEN2049 Treasure Express
Event 2: Share and Unlock
From now to Sep. 30, 2024, unleash your social media magic for a chance to win a 10 USDT spot trading coupon. Share a Bybit blog link and your thoughts on Bybit and Web3. Remember to tag @Bybit_Official and use the hashtag #UnlockWeb3Future and submit the form with us here: #UnlockWeb3Future at TOKEN2049 with Bybit
Event 3: Meet us offline at TOKEN2049
Spot our logo at TOKEN2049 and capture a photo at the Bybit booth (M50) to win Bybit merchandise. Remember to share to your social media channels and use the right hashtag. For details, visit: #UnlockWeb3Future at TOKEN2049 with Bybit
An advocate for a sustainable Web3 ecosystem, Bybit will be featured prominently at TOKEN2049 on a series of keynote panels, thought leadership and community events, and booth M50.
#Bybit / #TheCryptoArk
About Bybit
Bybit is the world’s second-largest cryptocurrency exchange by trading volume, serving over 40 million users. Established in 2018, Bybit provides a professional platform where crypto investors and traders can find an ultra-fast matching engine, 24/7 customer service, and multilingual community support. Bybit is a proud partner of Formula One’s reigning Constructors’ and Drivers’ champions: the Oracle Red Bull Racing team.
For more details about Bybit, please visit Bybit Press.
For media inquiries, please contact: [email protected]
For more information, please visit: https://www.bybit.com
For updates, please follow: Bybit’s Communities and Social Media
Discord | Facebook | Instagram | LinkedIn | Reddit | Telegram | TikTok | X | Youtube
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View original content:https://www.prnewswire.co.uk/news-releases/board-the-token2049-treasure-express-with-bybit-and-dive-into-an-80-000-prize-pool-302240594.html
DUBAI, UAE, Sept. 6, 2024 /PRNewswire/ — Bybit, the world’s second-largest cryptocurrency exchange by trading volume, is excited to announce it’s among the first to be granted consent to a full authorization by the Astana Financial Service Authority (AFSA). This milestone brings Bybit closer to becoming a fully regulated Digital Asset Trading Facility (DATF).
As part of a rigorous process, Bybit Kazakhstan has passed a full AML check, business conduct audit, and detailed compliance inspections. This is part of Bybit’s focus on securing new user opportunities in Kazakhstan and the broader Commonwealth of Independent States (CIS) region.
“Kazakhstan has become a key player in the global crypto ecosystem, and we are thrilled to be expanding our services in such a dynamic market,” said Ben Zhou, co-founder and CEO of Bybit. “We are committed to bringing our cutting-edge technology, security, and transparency to crypto traders in Kazakhstan, ensuring they can access the best possible tools and services to thrive in this fast-growing industry.”
Once the full license is in place, Bybit Kazakhstan will offer various digital assets related products and services. The expansion into Kazakhstan aligns with Bybit’s mission to provide reliable and transparent services, catering to the unique needs of crypto traders and investors in the region.
This development follows Bybit’s receipt of its initial operating and custody licenses from AFSA in June 2023, reinforcing its commitment to local regulatory requirements. Bybit’s ongoing efforts to strengthen its presence in Kazakhstan underscore its belief in responsible growth and ensuring a compliant and secure trading environment.
Kazakhstan has quickly emerged as a hub for crypto innovation, and Bybit is proud to play a leading role in fostering this development. For example, Bybit hosted a “Foundations of Blockchain, Web3 and Crypto Exchange Activities” course for Banks of Kazakhstan in 2024. This event was part of Bybit’s drive to make blockchain education more accessible in the CIS region.
By securing this full authorization, Bybit is poised to enhance crypto adoption, provide institutional-grade security, and offer advanced trading features to its growing regional user base.
#Bybit / #TheCryptoArk
About Bybit
Bybit is the world’s second-largest cryptocurrency exchange by trading volume, serving over 40 million users. Established in 2018, Bybit provides a professional platform where crypto investors and traders can find an ultra-fast matching engine, 24/7 customer service, and multilingual community support. Bybit is a proud partner of Formula One’s reigning Constructors’ and Drivers’ champions: the Oracle Red Bull Racing team.
For more details about Bybit, please visit Bybit Press.
For media inquiries, please contact: [email protected]
For more information, please visit: https://www.bybit.com
For updates, please follow: Bybit’s Communities and Social Media
Discord | Facebook | Instagram | LinkedIn | Reddit | Telegram | TikTok | X | Youtube
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View original content:https://www.prnewswire.co.uk/news-releases/bybit-expands-global-reach-receives-formal-consent-for-full-authorization-in-kazakhstan-302240634.html
Fintech PR
Integrum ESG and CSRHub enable fund managers to monitor both long-term trends and short-term movements in ESG ratings for companies, across a 10-year time series
LONDON, Sept. 6, 2024 /PRNewswire/ — Integrum ESG, the leading alternative ESG data provider, has today announced the launch of their Consensus ESG Ratings module.
Just as investors monitor movements in consensus earnings estimates or credit ratings, investors now are aware of the demand for the ability to monitor long-term trends and short-term movements in consensus ESG ratings.
This new feature enables Integrum ESG’s asset manager clients to now see the consensus ESG score for any company, either as an absolute rating or a relative percentile ranking, across a 10-year time series.
These scores will indicate to any investor what the capital markets have ‘priced in’ for a company’s ESG performance, allowing users to quickly understand the market’s view on a company and easily conduct relative ESG analysis on the positions they hold within their Portfolio.
This regularly updated data is provided by CSRHub, the world’s leading provider of consensus ESG ratings. CSRHub has spent years aggregating and normalising a vast range of licensed sources – from large ESG ratings firms such as MSCI, ISS, S&P Global, and Sustainalytics to specialists such as CDP and Better World Companies.
Shai Hill, Founder and CEO of Integrum ESG, commented: “Many investors have told us they want a sense of ‘what is priced in’ in terms of a company’s ESG performance, so they can compare this to what anyone ESG ratings firm is saying. CSRHub is the only firm to have credibly achieved this, thanks to a model refined over years and a vast data lake – so we are delighted to be partnering with them.”
Bahar Gidwani, Co-Founder of CSRHub, added: “Investors need to fine tune their ESG-related investment strategies to improve their returns and better match the preferences of their clients. Combining CSRHub’s expert outside-in, consensus view of ESG with Integrum ESG’s detailed real-time data stream provides a strong solution for these needs.”
About Integrum ESG
Integrum ESG is the leading alternative ESG data and ratings platform for investors, blending human analysis and award-winning artificial intelligence models to capture, verify and display granular and relevant ESG data for analysis and assessment. Their Platform allows clients to dissect ESG scores, real-time sentiment, and more with a variety of unique-to-market features, empowering industry professionals and investors and giving them complete oversight of ESG risk across their portfolio.
For more information, visit www.integrumesg.com
About CSRHub
CSRHub offers the most comprehensive global set of Consensus ESG (Environmental, Social, and Governance) ratings, information, and tools. CSRHub’s business intelligence system measures the ESG business impact that drives corporate and investor sustainability decisions. Founded in 2007, CSRHub covers 56,545 public and private companies, and provides ESG performance scores on over 37,899 companies from 135 industries in 210 countries. Our Big Data platform uses algorithms to aggregate, normalize and weight ESG metrics from 957 sources to produce a strong consensus signal on corporate sustainability performance.
For more information, visit www.csrhub.com
Media Contact
Harish Karunalingam
Integrum ESG
[email protected]
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