TScan Therapeutics Establishes Facility to Manufacture T Cell Receptor Engineered T Cell Therapies

Rhea-AI Summary

TScan Therapeutics has completed the construction of a GMP manufacturing facility in Waltham, Massachusetts, aiming to support upcoming clinical milestones, including multiple IND filings for its TCR-engineered therapies TSC-100 and TSC-101 for liquid tumors. The 7,000 square-foot facility is operational and will provide early-stage production capacity. Additionally, TScan signed a ten-year lease for an extra 115,000 square feet to accommodate future growth. The company is expected to treat its first patient in the first half of 2022.

Positive

• Operational GMP manufacturing facility supports planned IND filings for TSC-100 and TSC-101.
• Expansion through a new 115,000 square-foot facility allows for increased production and R&D capacity.
• Potential to treat first patients in early 2022 enhances clinical timelines.

Negative

• None.

- Completion of facility supports upcoming clinical milestones including expected multiple fourth quarter IND filings -

WALTHAM, Mass., Dec. 02, 2021 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced that it has completed the construction of a state-of-the-art GMP manufacturing facility to manufacture Phase I/II TCR-T therapies. This facility will support the manufacturing of TScan’s two lead liquid tumor candidates, TSC-100 and TSC-101, designed to eliminate residual leukemia and prevent relapse after hematopoietic cell transplantation for patients with hematological malignancies, as well as solid tumor candidates TSC-200, TSC-201, TSC-202 and TSC-203, designed to treat patients with solid tumors including head and neck, cervical, anal, melanoma and non-small cell lung cancers.

“Manufacturing is critical to the success of cell therapy programs. We have developed T-Integrate, a non-viral transposon/transposase vector delivery system, that enables the rapid, cost-effective, and consistent manufacturing of TCRs. Our 7,000 square-foot GMP manufacturing facility is now operational and will provide us with sufficient early-stage production capacity to supply product for our planned Phase 1 clinical studies for our liquid and solid tumor programs and supports our pending IND submissions for TSC-100 and TSC-101,” said Warren Jaworowicz, Vice President, CMC and Head of Technical Development and Manufacturing.

This manufacturing facility is part of TScan’s existing footprint at 830 Winter Street in Waltham, Massachusetts. To accommodate the Company’s expansion of its manufacturing and research activities, TScan is also growing its footprint through the lease of an additional 115,000 square feet as the lead tenant in 880 Winter Street. TScan has signed a ten-year lease with extension options with leading biotechnology landlord Boston Properties (NYSE: BXP) for the new space, which will be built out for lab and office use to TScan’s specifications. The Company is preparing to take occupancy in the second half of 2022.

“It is a testament to our manufacturing and process development teams that we now have this state-of-the-art facility in place and will be ready to treat our first patient in the first half of 2022,” said David Southwell, President and Chief Executive Officer of TScan Therapeutics. “The additional space at 880 Winter Street will allow us to expand our footprint, support the growth of our team, and further advance our innovative platform as we work toward our mission of treating patients with cancer.”

About TScan Therapeutics, Inc.

TScan is a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer. The company’s lead liquid tumor TCR-T therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to eliminate residual leukemia and prevent relapse after hematopoietic stem cell transplantation. The company is also developing multiplexed TCR-T therapy candidates for the treatment of various solid tumors.

Forward-Looking Statements

This press release may contain 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. The express 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 risks set forth under the caption “Risk Factors” and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of TScan's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, which is on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at https://www.sec.gov/. 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 TScan 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 TScan 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.

Contacts

TScan Therapeutics
Heather Savelle
VP, Investor Relations
857-399-9840
hsavelle@tscan.com

Media Contact:
David Rosen
Argot Partners
212-600-1902
david.rosen@argotpartners.com

Investor Contact:
Sherri Spear
Argot Partners
212-600-1902
sherri@argotpartners.com

FAQ

What is the significance of TScan Therapeutics completing its GMP manufacturing facility?

The completion of the GMP manufacturing facility is crucial for TScan Therapeutics as it supports the upcoming IND filings for its TCR-engineered therapies, which are key to advancing its clinical trials.

What are the expected timelines for TScan Therapeutics' clinical trials?

TScan anticipates treating its first patient in the first half of 2022, following the completion of its GMP facility.

How does TScan Therapeutics plan to expand its operations?

TScan has signed a ten-year lease for an additional 115,000 square feet to support its expanding manufacturing and research activities.

What are the lead candidates being developed by TScan Therapeutics?

TScan is developing TSC-100 and TSC-101 for liquid tumors and several candidates (TSC-200, TSC-201, TSC-202, TSC-203) for various solid tumors.