March 29, 2021 -- TCR2 Therapeutics has signed a long-term lease for an existing 85,000-sq-ft cell therapy manufacturing facility in Rockville, MD, which is ready for current good manufacturing practice (cGMP) build-out.
The site will support clinical and commercial production of gavo-cel, the company's lead T-cell receptor (TCR) fusion construct T cells (TRuC-T cells) product candidate targeting solid tumors. Gavo-cel is currently being studied in a phase I/II clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma.
The facility will have the capacity to treat several thousand cancer patients annually and is expected to begin commercial-scale production in 2023. The cell therapy space will provide commercial and clinical manufacturing, quality control laboratories, and offices once complete. It will also use semi-automated and functionally closed systems, while the layout will be flexible to allow for production of gavo-cel as well as other emerging TRuC-T cell pipeline products.
In conjunction with securing the manufacturing facility, the company has added Aaron Vernon as the vice president of technical operations to oversee commercial operations.
Financial details of the lease were not disclosed.