Thermo Fisher Scientific has signed an agreement with Chinese cell therapy company JW Therapeutics to provide the latter non-exclusive commercial access to its Gibco CTS Dynabeads CD3/CD28.
The agreement will facilitate the clinical development and commercial manufacturing of CAR-T therapies in China, which includes JW Therapeutics’ lead product – relmacabtagene autoleucel (relma-cel).
Relma-cel is an anti-CD19 CAR-T therapy for relapsed or refractory (r/r) B-cell lymphoma in the third line setting.
Its new drug application (NDA) has been accepted by National Medical Products Administration (NMPA) in China.
Dr. Harry Lam – executive vice president and chief technology officer at JW Therapeutics said: “This partnership is a natural extension of an already strong collaboration.
“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.”
According to Thermo Fisher Scientific, Relma-cel is anticipated to become the first CAR-T therapy to get approval as a Category 1 biologics product in China.
The CTS Dynabeads platform is part of the Cell Therapy Systems (CTS) product portfolio of Thermo Fisher Scientific and has been designed to help in the transition from clinical development to manufacturing of T-cell therapies at a commercial scale.
Thermo Fisher Scientific said that its Gibco CTS Dynabeads offer a scalable platform to optimize therapy development and production while enabling highly reproducible results.
Mark Stevenson – executive vice president and chief operating officer at Thermo Fisher Scientific said: “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.
“Our strategy to support partners ‘in China for China’ ensures that we can provide reliable supply and technical expertise as they scale precision medicines.”