TCR² Therapeutics Establishes Commercial-Scale Cell Therapy Manufacturing Facility

Rhea-AI Summary

TCR² Therapeutics Inc. (TCRR) has announced a long-term lease for an 85,000 square foot cell therapy manufacturing facility in Rockville, Maryland. This state-of-the-art facility is designed for commercial-scale production of gavo-cel, aimed at treating thousands of cancer patients annually, with operations expected to begin in 2023. The company has also appointed Aaron Vernon as Vice President of Technical Operations to enhance manufacturing capabilities. The new site will optimize production while reducing costs, allowing TCR² to effectively manage its supply chain.

Positive

• Lease signed for 85,000 sq. ft. state-of-the-art facility in Rockville, Maryland.
• Anticipation of commercial-scale production of gavo-cel in 2023.
• New facility expected to support treatment for thousands of cancer patients annually.
• Aaron Vernon hired to enhance manufacturing operations with relevant expertise.

Negative

• None.

• 85,000 square foot state-of-the-art facility being built in Rockville, Maryland
• Accelerates TCR²’s commercial-scale manufacturing timelines with production anticipated in 2023
• Aaron Vernon hired as Vice President of Technical Operations
  

CAMBRIDGE, Mass., March 29, 2021 (GLOBE NEWSWIRE) -- TCR² Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. (NYSE: ARE) for an existing 85,000 square foot cell therapy manufacturing facility in Rockville, Maryland 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 U.S. 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. 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 square foot 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.

About TCR² Therapeutics

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 about TCR², please visit www.tcr2.com.

Forward-looking Statements

This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding the therapeutic potential of gavo-cel, timing for interim updates for the Company’s clinical trials and announcement of additional preclinical data, timing for the certification and operation of our manufacturing facilities, including the new facility in Rockville, Maryland, manufacturing timing and capacity for clinical trials and commercial operations, increased clinical trial demand, timing of future IND filings and clinical development plans, the development of the Company’s TRuC-T cells, their potential characteristics, applications and clinical utility, and the potential therapeutic applications of the Company’s TRuC-T cell platform.

The expressed or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; TCR²’s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, including TCR²’s ability to secure additional manufacturing facilities; whether TCR²'s cash resources will be sufficient to fund TCR²'s foreseeable and unforeseeable operating expenses and capital expenditure requirements, the impact of the COVID-19 pandemic on TCR²’s ongoing operations; and other risks set forth under the caption "Risk Factors" in TCR²’s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR² believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.

Moreover, except as required by law, neither TCR² nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Investor and Media Contact:

Carl Mauch
Director, Investor Relations and Corporate Communications
TCR² Therapeutics Inc.
(617) 949-5667
carl.mauch@tcr2.com 

FAQ

What is TCRR's new manufacturing facility's location and size?

TCRR's new manufacturing facility is located in Rockville, Maryland and spans 85,000 square feet.

When is TCRR expecting to begin production at the new facility?

Production at the new facility is anticipated to begin in 2023.

Who has been hired as Vice President of Technical Operations at TCRR?

Aaron Vernon has been appointed as Vice President of Technical Operations at TCRR.

What is gavo-cel and its significance for TCRR?

Gavo-cel is TCRR's lead product candidate designed for treating cancer, with the facility supporting its commercial-scale production.

How will the new facility impact TCRR's manufacturing capabilities?

The new facility is expected to optimize manufacturing processes, reduce costs, and increase production capacity for gavo-cel and other therapies.