Thermo Fisher Scientific has entered into a significant agreement with Chinese cell therapy leader JW Therapeutics, granting non-exclusive commercial access to its Gibco CTS Dynabeads CD3/CD28 technology. This collaboration is set to accelerate the clinical development and commercial manufacturing of CAR-T therapies in China, focusing on JW Therapeutics’ pioneering product, relmacabtagene autoleucel (relma-cel).

Enhancing CAR-T Therapy Development in China

Relma-cel, JW Therapeutics’ flagship anti-CD19 CAR-T therapy, is designed for patients with relapsed or refractory (r/r) B-cell lymphoma in the third-line setting. The therapy has recently seen its New Drug Application (NDA) accepted by China’s National Medical Products Administration (NMPA), positioning it to potentially become the first CAR-T therapy approved as a Category 1 biologics product in the country.

Dr. Harry Lam, Executive Vice President and Chief Technology Officer at JW Therapeutics, highlighted the strategic nature of this partnership: “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.”

Thermo Fisher’s Role and Commitment

The agreement utilizes the CTS Dynabeads platform, a component of Thermo Fisher’s Cell Therapy Systems (CTS) product portfolio, which is crucial for transitioning from clinical development to commercial-scale manufacturing of T-cell therapies. Thermo Fisher’s technology provides a scalable solution that optimizes therapy development and production, ensuring highly reproducible results.

Mark Stevenson, Executive Vice President and Chief Operating Officer at Thermo Fisher Scientific, elaborated on their support strategy: “As JW Therapeutics progresses through the formal acceptance of an 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.”

This partnership is a milestone in the advancement of CAR-T therapies in China, offering significant potential for transforming the treatment landscape for cancer patients. By combining JW Therapeutics’ clinical expertise and Thermo Fisher’s robust technological support, this collaboration is poised to lead significant developments in the field of personalized medicine, particularly in the treatment of complex cancers.

Further Developments and Innovations

As the partnership progresses, the focus will be on expanding access to cutting-edge treatments and enhancing the capabilities of both companies in the global and Chinese markets, thereby driving forward the field of cellular immunotherapy.

  CAR-T, CAR-T therapy, China, China biologics, Dr. Harry Lam, Gibco CTS Dynabeads, Gibco CTS Dynabeads CD3/CD28, JW Therapeutics, Lymphoma, Mark Stevenson, Relma-cel, relmacabtagene autoleucel, Thermo Fisher Scientific