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WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance’s AMTAGVI™ (lifileucel) for Advanced Melanoma

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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)

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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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Reshaping Finance: Huawei’s Commitment to 4-Zero and Resilient Infrastructure

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DUBAI, UAE, Oct. 15, 2024 /PRNewswire/ — On the first day of GITEX GLOBAL 2024, the Huawei Finance Forum was held under the theme of Boost Resilience, Reshaping Smarter Finance Together. This forum explored how to build resilient financial infrastructure for the future, as well as digital transformation and ecosystem development to help financial institutions gain a new competitive edge.

Over the past 15 years, China’s finance industry has undergone a significant transformation, largely driven by FinTech giants. As Chinese banks embarked on their digital transformation journey, Huawei developed an FSI solution framework, which focuses on reshaping customers’ resilience, agility, and intelligence.

“The value Huawei brings to our customers is not only in our products and solutions, but also in our unique capabilities, such as best practices worldwide, a global ecosystem, and an extensive digital talent system in China. These capabilities are crucial for customers’ successful transformation.” Shared by Alvin Feng, Director of Global Marketing and Solution Sales, Huawei Digital Finance BU.

Huawei has proposed reshaping resilient financial infrastructure with 4 Zeros: Zero Downtime, Zero Wait, Zero Touch, and Zero Trust. To achieve this, we need to coordinate cloud, network, storage, and computing infrastructure to develop an end-to-end resilient system.

Application modernization is vital for reshaping agility. Huawei has successfully supported many banks in transforming their legacy centralized architecture towards a cloud-native distributed architecture.

In terms of reshaping intelligence. Huawei supports banks in enhancing real-time data operations, a fundamental step for data intelligence. Meanwhile, we actively boost Generative AI adoption in banks through joint innovations in various scenarios.

Dr. Jassim Haji, President of the International Group of Artificial Intelligence, Executive Advisor of HH (His Highness) Nasser Artificial Intelligence Research and Development Center.

“Huawei is pioneering the future of intelligent finance, seamlessly blending AI innovation with enduring infrastructure. Their vision for All Intelligence and commitment to building resilient, secure, and efficient financial ecosystems is transforming the industry, creating smarter, more inclusive services for the AI era.” Said Dr. Jassim Haji, President of the International Group of Artificial Intelligence, Executive Advisor of HH (His Highness) Nasser Artificial Intelligence Research and Development Center.

Roger Wang, Director of Partner Development & Sales, Digital Finance BU, Huawei

“Huawei is continuously collaborating with global and local ecosystem partners to deliver value to customers by developing competitive scenario-based solutions”, stated by Roger Wang, Director of Partner Development & Sales, Digital Finance BU, Huawei. We consistently add value to our customers’ success through our global best practices, business and architecture innovation, and excellent service and support.

For more details, please visit: https://e.huawei.com/en/industries/finance 

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Qatari Diar Unveils Exclusive Waterfront Townhouses at The Seef Lusail

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Luxury Living Redefined with Attractive Investment Opportunities Starting from QAR 1.7 Million for apartments and QAR 3.4 Million for townhouses in Downtown Lusail

Flexible Payment Plans with 0% Interest and Direct Financing  

Freehold Ownership and Residency in Qatar

DOHA, Qatar, Oct. 15, 2024 /PRNewswire/ — Qatari Diar Real Estate Investment Company announced the launch of exclusive upscale waterfront townhouses at The Seef in Downtown Lusail, offering exceptional investment opportunities with 0% interest, direct financing, and flexible payment plans. Lusail represents a bold step forward in sustainable, smart urban living. Known for its state-of-the-art infrastructure and forward-thinking design, Lusail offers a mix of residential, commercial, and entertainment districts just minutes from Qatar’s newest community.

Situated in the heart of Lusail’s waterfront district, The Seef offers a limited collection of luxurious townhouses starting from QAR 3.4 million and apartments starting from QAR 1.7 million. These residences offer immediate occupancy and are designed to provide residents with a blend of modern elegance and comfort. With breathtaking sea views overlooking Qetaifan Islands and Lusail’s iconic skyline, the townhouses redefine modern living.

Lusail’s thriving real estate market presents significant growth potential for investors. The Seef offers freehold ownership, providing residency in Qatar for foreigners. With mortgage financing options from leading local banks, in addition to direct payment plans with 0% interest extending to 6 years for apartments and 4 years for townhouses, owning a luxury residence in The Seef is more accessible than ever. Situated in a location known for attracting substantial foreign investment, The Seef promises robust returns whether for resale or long-term residence.

Eng. Ali Mohamed Al-Ali, CEO of Qatari Diar, said: “The launch of our exclusive waterfront townhouses at The Seef marks a significant milestone in offering unparalleled luxury living in Qatar. Lusail represents more than just a place to live; it’s a lifestyle destination that combines convenience, sophistication and investment potential. With the recent advancements in the Qatari mortgage law, we are thrilled to extend flexible financing options in partnership with several Qatari banks that make owning a piece of this vibrant community achievable for a broader market.”

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The Seef’s townhouses are built to meet the diverse needs of residents, from professionals to families. Each townhouse features spacious layouts with high-end finishes, ensuring comfort and luxury at every turn. Residents will enjoy uninterrupted sea views, offering a tranquil escape within the city, and lush green landscapes that create a serene environment for relaxation. The prime location provides proximity to key attractions, including the Meryal Waterpark—the largest in Qatar—Lusail Marina, and Place Vendôme. Located near transit hubs, major highways, shopping centers, healthcare facilities, and educational institutions, The Seef offers residents unparalleled convenience, placing all the vibrant energy of Lusail right at their doorstep.

The Seef reflects Qatari Diar’s commitment to sustainability, with eco-friendly design elements that include energy-efficient infrastructure and green landscaping. The project’s unique architectural innovations, including sky bridge swimming pools and modern areas amenities, such as kids’ playgrounds, squash courts, gym facilities, retail outlets, and serene promenades, sets it apart from typical residential projects, creating a true lifestyle destination.

Prospective buyers and investors are invited to explore The Seef firsthand at the Cityscape Global in Riyadh, Saudi Arabia from 11 – 14 November. Attendees will have the opportunity to learn more about the development, view its luxury offerings, and discover how The Seef can become part of their future in Lusail, Qatar’s city of the future.

For more information, please visit Qatari Diar’s website to explore The Seef and view the full portfolio of investment opportunities.

About Qatari Diar
Qatari Diar Real Estate Company was established in 2005 by the Qatar Investment Authority, the sovereign wealth fund of the State of Qatar. Headquartered northeast of capital, Doha, in the City of Lusail, on the coast of the Arabian Gulf. Qatari Diar was entrusted to support Qatar’s growing economy and to coordinate the country’s real estate development priorities. For more information, visit qataridiar.com

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PharmaMar Announces Positive and Statistically Significant Overall Survival and Progression-Free Survival Results for Zepzelca® (lurbinectedin) and Atezolizumab Combination in First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

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  • Jazz plans to submit supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and PharmaMar will submit Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in first half of the year 2025 for this combination therapy as a first-line maintenance treatment for ES-SCLC. 

MADRID, Oct. 15, 2024 /PRNewswire/ — PharmaMar (MSE: PHM) and its partner Jazz Pharmaceuticals plc (Nasdaq: JAZZ)  have announced today positive top-line results from the Phase 3 clinical trial evaluating Zepzelca® (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Tecentriq®) compared to atezolizumab alone when administered as a maintenance treatment for adults with extensive-stage Small Cell Lung Cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab. The combination of lurbinectedin and atezolizumab demonstrated a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF), compared to treatment with atezolizumab alone.

“Each year, approximately 63,000 to 72,000 new cases of Small Cell Lung Cancer (SCLC) are reported in Europe. A majority of these patients are diagnosed with extensive stage disease, which is aggressive and often difficult to treat, with poor prognosis,[i],[ii],[iii]” said Luis Paz-Ares, M.D., Ph.D., head of medical oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and IMforte trial principal investigator. “These trial results demonstrate the efficacy of lurbinectedin, in combination with standard-of-care atezolizumab for patients in first-line maintenance treatment, a much-needed advancement for patients with extensive disease.”

The results of the Phase 3 IMforte trial are highly encouraging and showed a statistically significant benefit for the lurbinectedin and atezolizumab combination for extensive-stage small cell lung cancer patients receiving this treatment in the first-line maintenance setting. These results demonstrate the potential of this regimen to delay disease progression and extend survival for patients with this aggressive disease,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. “We are pleased with these clinically meaningful results and plan to submit an sNDA in the first half of 2025 to support this combination in the first-line maintenance setting. We thank the investigators and patients who are involved in this trial, along with our partners at Roche.

“Lurbinectedin monotherapy is currently the standard of care in 2L SCLC. In Europe, it is only approved in Switzerland and early access and compassionate use programs have already allowed some European patients to benefit from lurbinectedin,” said Javier Jiménez, Chief Medical Officer of PharmaMar.

The combination was generally well-tolerated. The preliminary safety data in the ongoing trial is consistent with the known safety profiles of lurbinectedin and atezolizumab with no new safety signals observed in the combination arm. 

Jazz and Roche plan to submit these data for presentation at a future medical meeting. 

PharmaMar will submit a marketing authorisation application (MAA) to the EMA in the first half of 2025 to request regulatory approval in the European Union (EU). Lurbinectedin is available for use in 16 territories around the world.

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This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

About PharmaMar

PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation.

PharmaMar has developed and now commercializes Yondelis® in Europe by itself, as well as Zepzelca® (lurbinectedin), in the US; and Aplidin® (plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: lurbinectedin, ecubectedin, PM534 and PM54. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland and The United States. PharmaMar also wholly owns Sylentis, a company dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.

About the IMforte Phase 3 Trial

IMforte (NCT05091567) is an ongoing Phase 3, randomized, multicenter maintenance trial evaluating the efficacy, safety and pharmacokinetics of lurbinectedin plus atezolizumab in adults (≥18 years) with ES-SCLC following induction therapy with carboplatin, etoposide and atezolizumab. The primary endpoints for this study are OS and IRF-assessed PFS.

The trial consists of two phases: an induction phase and a maintenance phase. Participants were required to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 after the induction phase of four cycles of carboplatin, etoposide, and atezolizumab to be considered for eligibility screening for the maintenance phase. Eligible participants were randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.

The trial is sponsored by Roche and co-funded by Jazz Pharmaceuticals. Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT05091567).

About Zepzelca®

Zepzelca® (lurbinectedin), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinascidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets. 

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please visit our website at www.pharmamar.com

[i] Cancer today. (s. f.). https://gco.iarc.who.int/today/en/fact-sheets-populations#regions

[ii] Alvarado-Lunda G, Morales-Espinosa D. Treatment for small cell lung cancer, where are we now? – A review. Transl Lung Cancer Res. 2016;5(1):26-38.

[iii] SEER Explorer Lung and Bronchus Cancer, Recent Trends in SEER Incidence Rates, 2000-2016, by Age, https://seer.cancer.gov/explorer Updated June 27, 2024. Accessed October 10, 2024.

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