Companies join forces in cell therapy applications and commercial-scale manufacturing
Shanghai, China,?February?3,?2021?-- JW Therapeutics, a leading cell therapy company in China, has signed an agreement with Thermo Fisher Scientific, the world leader in serving science, to ensure non-exclusive commercial access to Thermo Fisher’s Gibco CTS Dynabeads CD3/CD28.
The agreement will support the clinical development and commercial manufacturing of leading CAR-T (Chimeric Antigen Receptor T-Cells) therapies in China, including JW Therapeutics’ lead product relmacabtagene autoleucel (“relma-cel”). Relma-cel is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory (“r/r”) B-cell lymphoma. The therapy’s new drug application (NDA) has been accepted by China's National Medical Products Administration (NMPA). Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.
The CTS Dynabeads platform is part of Thermo Fisher’s proven Cell Therapy Systems (CTS) product portfolio designed to ease the transition from clinical development to commercial manufacturing of T-cell therapies. The CTS product line is a comprehensive portfolio of products designed to work together, from cell isolation/activation and gene transfer to cell expansion, to address cell therapy developers’ manufacturing workflow challenges. Thermo Fisher’s Gibco CTS Dynabeads provide a scalable platform to streamline therapy development and production while ensuring highly reproducible results.
“As JW Therapeutics progresses through the formal acceptance of a New Drug Application (NDA) for relma-cel, and its commercial plans accelerate, we’ll be alongside them ready to rapidly scale,” said Mark Stevenson, executive vice president and chief operating officer, Thermo Fisher Scientific. “Our strategy to support partners ‘in China for China’ ensures that we can provide reliable supply and technical expertise as they scale precision medicines.”
“This partnership is a natural extension of an already strong collaboration,” mentioned Dr. Harry Lam, executive vice president and chief technology officer, JW Therapeutics. “As we approach critical milestones in our commercialization strategy, this partnership will ensure we have the supply to scale up and meet the unmet medical needs of Chinese patients.”
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About JW Therapeutics
Co-founded by Juno Therapeutics and Wuxi AppTec, JW Therapeutics (HKEx: 2126) is a leading clinical and pre-clinical stage cell therapy company in China with an integrated platform focusing on developing, manufacturing and commercializing breakthrough cell-based immunotherapies for hematological cancers and solid tumors.
JW Therapeutics’ vision is to develop innovative cell therapies for the China market to transform the treatment of cancer for Chinese patients. The company has built a comprehensive and differentiated cell therapy pipeline covering both hematological cancers and solid tumors. Its lead product, Relmacabtagene autoleucel (“relma-cel”), an anti-CD19 CAR-T therapy for relapsed or refractory (“r/r”) B-cell lymphoma, is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.
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About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit?.