TCR² Therapeutics Establishes Commercial-Scale Cell Therapy Manufacturing Facility
TCR2 Therapeutics Inc. recently announced that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. 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 with a capacity to treat several thousand cancer patients annually. The facility is expected to accelerate the company’s commercial-scale manufacturing timelines with production anticipated 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, PhD, 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. We are very pleased to be building a world-class cell therapy production facility for gavo-cel that will bring new hope to cancer patients suffering from solid tumors.”
The 85,000-sq-ft facility constructed by Alexandria Real Estate Equities will provide space for commercial and clinical manufacturing, quality control laboratories, and offices upon completion. TCR2 is designing the state-of-the-art cell therapy facility to utilize semi-automated and functionally closed systems which aim to provide cGMP manufacturing while optimizing the reliability of our cell therapy products and reducing manufacturing costs and vein-to-vein time. The flexible layout will allow production of gavo-cel and other emerging cell therapies in the TRuC-T cell pipeline.
“The hiring of Aaron Vernon to head technical operations for the company comes at the right time as we expand our manufacturing capabilities in anticipation of commercial production. His prior leadership roles in building out commercial operations as well as his specific expertise in global supply chain management will offer vital insights to TCR2 as we continue to execute upon our clinical strategy for gavo-cel,” added Dr. Menzel.
Aaron Vernon joins TCR2 as Vice President of Technical Operations. Most recently, he held senior positions including Vice President of Global Technical Operations and Vice President of Engineering & Supply Chain at Autolus Therapeutics, a clinical stage autologous CAR-T cell therapy company, where he held numerous responsibilities, including manufacturing capacity expansion and overseeing internal and external manufacturing of plasmid, vector and cell therapy products. Previously, Aaron was Vice President of Global Supply Chain and Manufacturing at Sucampo Pharmaceuticals. Earlier in his career, served in various engineering and manufacturing operations roles at AstraZeneca, MedImmune and Johnson & Johnson.
TCR2 Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for patients suffering from solid tumors or hematological malignancies. TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC®-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while secreting lower levels of cytokine release. The Company’s lead TRuC-T cell product candidate targeting solid tumors, gavo-cel, is currently being studied 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. The Company’s lead TRuC-T cell product candidate targeting hematological malignancies, TC-110, is currently being studied in a Phase 1/2 clinical trial to treat patients with CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL). For more information, visit www.tcr2.com.
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