TCR² Therapeutics establishes Maryland site for commercial-scale cell therapy manufacturing

By Rachel Arthur contact

- Last updated on GMT

Pic: getty/maksimtkachenko
Pic: getty/maksimtkachenko

Related tags: Cell therapy

TCR2 Therapeutics Inc, a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, has signed a lease for an 85,000 square foot cell therapy manufacturing facility in Rockville, Maryland: which is ready for Current Good Manufacturing Practice (cGMP) build-out.

The company has pledged to accelerate development of its lead program, gavo-cell, in 2021. The product candidate is currently in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. 

Preliminary safety, efficacy and translational data from gavo-cel Phase 1 trial is due to be presented at the American Association for Cancer Research’s Annual Meeting this month.

As part of the product’s development, TCR2​ Therapeutics is readying to increasing manufacturing capacity with the announcement of the Maryland facility this month.

The site will support clinical and commercial production of gavo-cel with a capacity to treat several thousand cancer patients annually. Production is expected to start in 2023.

“After observing the consistent early clinical benefit and manageable safety profile experienced by patients treated with gavo-cel, we committed to securing a dedicated US manufacturing facility as the first step in building a regional network to supply cancer patients with our therapies,”​ said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2​ Therapeutics.

“Leasing an existing manufacturing footprint is a substantial milestone for TCR2, saving us valuable time and capital so that we can be ready for commercial production in 2023. Our new state-of-the-art facility will allow us to directly leverage our cell therapy process development expertise and control our end-to-end production supply chain.”

The site will have space for commercial and clinical manufacturing, quality control laboratories and offices. It will use semi-automated and functionally closed systems which aim to provide cGMP manufacturing while optimizing the reliability of cell therapy products and reducing manufacturing costs and vein-to-vein time.

A flexible layout will allow production of both gavo-cel and other emerging cell therapies in the TRuC-T cell pipeline.

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