On March 9, 2022 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported financial results for the full year ended December 31, 2021, and outlined key 2022 priorities (Press release, TScan Therapeutics, MAR 9, 2022, View Source [SID1234609788]).
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"As we had guided throughout 2021, in December we filed two INDs for our liquid tumor program. We also completed construction of our now fully functional 7,000 square-foot GMP manufacturing facility. Both of these steps are instrumental in our transformation to a clinical-stage company," said David Southwell, President and Chief Executive Officer. "We also advanced our growing pipeline of solid tumor candidates and look forward to sharing further details around these programs in the coming months."
Recent Corporate Highlights
In January 2022, the Company announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate TSC-100 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation. The target of TSC-100 is the minor histocompatibility antigen HA-1, which is a lineage-specific antigen found on blood cells. The Company has now submitted the clinical protocol to Institutional Review Boards (IRBs) for the initial study sites and expects to initiate clinical trials in the first half of 2022.
In December 2021, the Company presented two posters related to its lead liquid tumor candidates TSC-100 and TSC-101 at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The posters highlighted the discovery of TSC-101, as well as the manufacturing process and clinical development plan for liquid tumor candidates TSC-100 and TSC-101.
During the fourth quarter of 2021, the Company completed the construction of a state-of-the-art good manufacturing practices (GMP) facility to manufacture Phase I/II TCR-T therapies. This facility will support the manufacturing of TSC-100 and TSC-101, as well as solid tumor candidates TSC-200, TSC-201, TSC-202, TSC-203, and TSC-204, designed to treat patients with solid tumors including head and neck, cervical, melanoma and non-small cell lung cancers.
The Company continues to strengthen its management team with the appointment of Ray Lockard as Vice President, Quality. Mr. Lockard brings over 25 years of experience in quality, validation, supply chain and manufacturing to TScan. Mr. Lockard most recently served as Executive Director, CMC QA and External Quality at Ultragenyx Pharmaceutical Inc. Prior to that, Mr. Lockard held positions of increasing responsibility for various biotechnology and life sciences companies including Biogen Inc., Alnylam Pharmaceuticals, Inc., Precision NanoSystems, Editas Medicine, Inc., and AveXis, Inc. (now Novartis Gene Therapies). Mr. Lockard holds a B.S. in Biology from Hampden-Sydney College and an M.B.A. from the University of North Carolina, Chapel Hill, Kenan-Flagler Business School.
Upcoming Expected Milestones and Key Priorities for 2022
Liquid Tumor Programs: TScan’s two lead liquid tumor TCR-T therapy candidates, TSC-100 and TSC-101, are designed to target HA-1 and HA-2, respectively, and treat patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation.
Initiate Phase 1 umbrella trial for TSC-100 following submission of clinical protocol to IRBs for the initial study sites, with plans to enroll patients in the first half of 2022.
As previously disclosed, the FDA placed a clinical hold on the IND for TSC-101 in January 2022. The Company has since received written communication from the FDA asking for additional assessment of the potential for off-tumor reactivity in certain tissues. TScan is working with the agency to resolve its questions as quickly as possible. The liquid tumor trial is based on an umbrella protocol, which will allow the Company to begin the TSC-100 and control arms in the near term and to open the TSC-101 arm of the ongoing trial upon clearance of the IND.
Present initial clinical data from the liquid tumor program at a medical meeting in the second half of 2022.
Solid Tumor Programs: TScan’s TSC-200 series of TCR-T therapy candidates include a combination of known targets, such as HPV16 for TSC-200, PRAME for TSC-203, and MAGE-A1 for TSC-204, as well as targets that are novel antigens for TCR-T therapy, such as those for TSC-201 and TSC-202.
Present initial preclinical data on the TSC-200 series at a medical meeting in the first half of 2022.
Progress IND-enabling studies for the TSC-200 series and submit two IND applications during the second half of 2022. These are expected to include TSC-200 for HPV and TSC-204 for MAGE-A1.
In 2023, the Company plans to release initial clinical data for the TSC-200 series TCRs, as well as file further INDs for additional programs in this series.
Infectious Disease Program
Research is continuing into potential T cell focused COVID-19 vaccine constructs utilizing TScan’s novel T cell target discoveries. The Company is currently conducting preclinical studies for this program.
Full Year 2021 Financial Results
As of December 31, 2021, TScan Therapeutics had cash and cash equivalents of $161.4 million excluding $5.0 million of restricted cash. Based on current operating plans, the Company believes that existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.
Revenue for the year ended December 31, 2021, was $10.1 million, compared to $1.1 million for the year ended December 31, 2020 (2020 Period). This increase is due to a full year of research activities related to TScan’s collaboration agreement with Novartis Institutes for Biomedical Research, on which work began in September 2020.
Research and development expenses for the year ended December 31, 2021, were $45.0 million, compared to $20.6 million for the 2020 Period. The increase of $24.4 million was primarily a result of increased personnel expenses and facility-related expenses, as well as expenses related to the progress of the Company’s liquid and solid tumor programs to IND filing.
General and administrative expenses for the year ended December 31, 2021, were $13.8 million, compared to $6.7 million for the 2020 Period. The increase of $7.1 million in general and administrative expenses was primarily a result of increased personnel expenses and other miscellaneous expenses, including expenses related to the IPO and status as a public company.
For the year ended December 31, 2021, TScan Therapeutics reported a net loss of $48.6 million, compared to a net loss of $26.1 million for the 2020 Period.
As of December 31, 2021, the company had issued and outstanding shares of 24,024,467 and 23,907,597, respectively.