IND Submissions Completed in Fourth Quarter 2021 for Lead Liquid Tumor TCR-T Candidates TSC-100 and TSC-101
Lead TCR Identified for Solid Tumor Program Targeting HPV16; Further TCRs Advancing into IND-Enabling Activities with IND Submissions Planned for Second Half of 2022
TScan Developing Multi-Target and Multi-HLA Solution for Non-Small-Cell Lung, Cervical, Head & Neck Cancers and Melanoma
Strong Financial Position to Support Pipeline Execution
WALTHAM, Mass., Jan. 10, 2022 (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, announced that the Company plans to begin its first clinical trials this year. As forecasted, in December 2021 TScan filed INDs for TSC-100 and TSC-101, its TCR-T programs to prevent relapse in leukemia patients following hematopoietic cell transplants. In addition, TScan is outlining here its priorities for 2022 across its pipeline of solid and liquid tumors as well as infectious disease.
“We are excited to enter the clinic this year with the first two TCR-T programs from our proprietary TCR discovery and development platform. Over the course of 2021 TScan made transformative strides in building the scientific, manufacturing and regulatory operations to support multiple clinical programs. Our long-term objective is to comprehensively treat the significant unmet needs in major cancer indications including non-small-cell lung, cervical, head & neck and melanoma. We plan to do this with a suite of TCR therapies that recognize a diverse set of targets and HLA types and can be combined together in a unique multi-target approach,” said David Southwell, President and Chief Executive Officer. “This year, our focus will be on demonstrating the clinical potential of our lead liquid tumor therapy candidates TSC-100 and TSC-101, which address unmet needs in myeloid hematologic malignancies that currently lack immunotherapy options. At the same time, we will progress towards multiple INDs for our solid tumor program in the second half of this year. We’re also continuing to progress our novel T cell-based SARS-CoV-2 vaccine and look forward to providing an update on this program in the near-term.”
2021 Accomplishments and 2022 Pipeline Objectives
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.
- During the fourth quarter of 2021, the Company completed investigational new drug (IND)-enabling studies and submitted IND applications to the U.S. Food and Drug Administration (FDA) for TSC-100 and TSC-101.
- Following the IND submissions and pending acceptance by the FDA, the Company expects to initiate Phase 1 clinical trials for TSC-100 and TSC-101 in the first half of 2022, with preliminary data expected in the second half of 2022.
- In December 2021, the Company shared clinical trial designs for TSC-100 and TSC-101 in a poster at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition. The Company provided further detail on the clinical rationale and trial design for the program in a virtual event with TScan management and Yi-Bin Chen, M.D., M.S., Director, Hematopoietic Cell Transplant and Cell Therapy Program, Allan B. Rogers, Jr. and Cara J. Rogers Endowed Chair, Massachusetts General Hospital, Associate Professor of Medicine, Harvard Medical School.
Solid Tumor Programs: TScan’s TSC-2xx 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.
- TScan plans to present initial preclinical data on the TSC-2xx series at a medical meeting in the first half of 2022.
- TScan plans to progress IND-enabling studies for the TSC-2xx series and submit multiple IND applications during the second half of 2022. Among these will be TSC-200 for HPV, which is a validated cancer target found in every cell of HPV-positive tumors, including many cases of head & neck and cervical cancer.
- Using its TargetScan platform, TScan discovered a novel HLA-C*07:02-restricted epitope encoded by the well-known cancer/testis gene MAGE-A1. This cancer-specific gene is frequently overexpressed in a wide variety of solid tumors, including as many as 45% of head & neck cancers, 50% of melanomas, 50% of cervical cancers and 50% of non-small cell lung cancers. In late 2021 TScan announced a new program, TSC-204, for MAGE-A1 that will include multiple TCRs for different HLA-restricted epitopes on this target. TScan believes that it is the only company with a disclosed TCR program in MAGE-A1 for HLA types other than A*02:01. The Company anticipates filing an IND for TSC-204 in the second half of 2022.
- In 2023, the Company plans to release initial clinical data for the TSC-2xx 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 IND-enabling activities for this program and will provide an update in 2022.
- In 2021, using its proprietary TargetScan discovery platform, TScan identified over 110 novel solid tumor targets in tumor samples from patients who have responded to immunotherapy. The Company has already developed an extensive library of known and novel solid tumor targets across different HLA types named ImmunoBank. In 2022, the Company will provide a further update on the progress of its ImmunoBank, which will include an even greater array of validated novel cancer targets across multiple HLA types. This will allow the Company to develop a pipeline of product candidates for highly prevalent solid tumor indications that allow for multiplexing across targets and HLAs to provide durable responses to a majority of patients.
- TScan completed the construction and validation of a 7,000 square-foot state-of-the-art GMP manufacturing facility to manufacture all necessary Phase I/II supply for its TCR-T therapies. This facility supported the Company’s first two IND filings and provides sufficient production capacity to supply product for all planned Phase I and II clinical studies for the liquid and solid tumor programs.
Strong Cash Position
As of September 30, 2021, the Company had cash and cash equivalents totaling $182.9 million. Based on the Company’s current operating plan, TScan expects that its cash and cash equivalents will enable it to fund its operating expenses into 2024.
TScan’s latest presentation is available on the “Events and Presentations” section of the Company’s website and can be accessed here.
About TScan Therapeutics, Inc.
TScan is 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. 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. The Company has developed and continues to build its ImmunoBank, the most extensive collection of known and novel solid tumor targets across different HLA types in the TCR field.
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.
TScan Therapeutics, Inc.
VP, Investor Relations
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