TCR2 Therapeutics Leases Manufacturing Space in Maryland, Autolus Backs Out of U.S. Expansion

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After Autolus Therapeutics’ backed out of its plan to establish a manufacturing center in Rockville, Maryland, Massachusetts-based TCR2 Therapeutics has stepped up to the plate to build an 85,000 square-foot cell therapy manufacturing facility in Rockville.

London-based Autolus announced Monday that it opted to expand its manufacturing footprint in the U.K. instead of taking over the lease of a manufacturing and office facility in Rockville. The company said instead, it will establish a commercial manufacturing facility in the U.K. to develop its oncology cell therapy assets. Autolus said the revised strategy aims to deliver a less capital-intensive commercial manufacturing infrastructure at a lower cost base.

The potential loss to Maryland’s fast-growing cell therapy manufacturing ecosystem has been offset by TCR2’s decision. The company will lease the space from Alexandria Real Estate Equities. 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.

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 the production of gavo-cel and other emerging cell therapies in the TRuC-T cell pipeline, the company said.

TCR2 is developing novel T-cell therapies for solid tumors and hematological cancers. Its T-cell receptor (TCR) Fusion Construct T cells (TRuC-T cells) recognize and kill cancer cells by leveraging signaling from the entire TCR. The company’s lead TRuC-T cell product candidate targeting solid tumors, gavo-cel, is currently being studied in a Phase I/II clinical trial as a treatment for 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 being studied in a Phase I/II trial to treat patients with CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL

Garry Menzel, president and chief executive officer of TCR2, said after observing the consistent early clinical benefit and manageable safety profile experienced by patients treated with gavo-cel, TCR2 committed to securing a dedicated U.S. manufacturing facility as the first step in building a regional network to supply cancer patients with its therapies.

“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,” Menzel said in a statement.

In addition to the leasing of the manufacturing space, TCR2 also tapped former Autolus executive Aaron Vernon as the new Vice President of Technical Operations. Vernon most recently served as Vice President of Global Technical Operations and Vice President of Engineering & Supply Chain at Autolus.

“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,” Menzel added.

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