Robert Kneschke - stock.adobe.co
TCR2 Establishes Cell Therapy Manufacturing Facility in MD
TCR2 aims to treat several thousand cancer patients annually through its newly established cell therapy manufacturing facility.
TCR2 Therapeutics recently announced that it has signed a long-term, full-binding lease with Alexandra Real Estate Equities for an existing 85,000 square foot cell therapy manufacturing facility.
The facility formerly housed London-based Autolus Therapeutics, which intended to use the facility to bolster its oncology cell therapy assets. The company recently said it will focus its manufacturing facility strategy in the United Kingdom.
TCR2 is a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer. The manufacturing facility is located in Maryland and will support clinical and commercial production of gavo-cel with a capacity to treat several thousand cancer patients annually.
Leasing an existing manufacturing facility will allow TCR2 to save time so that the company can be ready for commercial production by 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 U.S. manufacturing facility as the first step in building a regional network to supply cancer patients with our therapies,” Garry Menzel, PhD, president and chief executive officer of TCR2 Therapeutics said in the announcement.
“The 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 continued.
The facility will provide space for both commercial and clinical manufacturing, quality control laboratories, and offices upon completion, a TCR2 spokesperson explained.
The company will utilize semi-automated and functionally closed systems, which intend to provide Current Good Manufacturing Practice (cGMP) manufacturing while also optimizing the reliability of its cell therapy pipeline and reducing manufacturing costs.
The layout of the 85,000 square foot facility will also allow production of gavo-cel and other emerging cell therapies in TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TruC-T cells) pipeline.
Last week, Aaron Vernon joined TCR2 as vice president of technical operations.
Previously, Vernon 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.
And earlier in his career, Vernon also served in various engineering and manufacturing operations roles at AstraZeneca, MedImmune, and Johnson & Johnson.
“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 Menzel.
Experts believe that the next generation of cell and gene therapies holds significant promise for patients because this alternative treatment option represents an advancement in personalized medicine.
In 2017, FDA approved the first gene therapy drug for the treatment of B-cell precursor acute lymphoblastic leukemia. The agency predicted that given the number of clinical trials in various stages, there may be more than 200 investigational new drug applications a year through 2025.
By the end of 2019, researchers estimated that there were more than 1,000 cell and gene therapy clinical trials globally. including 352 gene therapies, 452 gene-modified and cell-based immuno-oncology (IO), 216 cell therapies, and 46 tissue engineering.
Earlier this week, FDA approved Abecma, the first cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to or whose disease has returned after previous therapy.
FDA based its approval on a multicenter study of 127 patients with relapsed myeloma.
Of all patients studied, 28 percent showed a complete response or disappearance of all signs of multiple myeloma with Abecma, while 65 percent of this group remained in complete response to the treatment for nearly a year after the study ended.
