TScan Therapeutics Presents Phase 1 Umbrella Trial in Progress on HA-1 (TSC-100) and HA-2 (TSC-101) at the 64th American Society of Hematology Annual Meeting 2022

Rhea-AI Summary

TScan Therapeutics, Inc. (Nasdaq: TCRX) announced the presentation of its Phase 1 trial design for TSC-100 and TSC-101, aimed at treating residual leukemia post-hematopoietic cell transplantation (HCT), at the 64th American Society of Hematology Annual Meeting 2022. The therapies target specific minor histocompatibility antigens and aim to reduce disease relapse. The company plans to enroll the first trial cohorts in H1 2023, with interim data expected by the end of 2023.

Positive

• Presenting Phase 1 trial design indicates progress in developing TCR-T therapies.
• Interim data report is expected by the end of 2023, signaling ongoing clinical advancement.
• Therapies aim to address significant relapse rates in residual leukemia post-HCT.

Negative

• Approximately 40% of patients with hematologic malignancies relapse within two years after RIC transplant, indicating a high unmet medical need.

Poster presents Phase 1 trial design and translational assays to generate early evidence of biological activity in residual leukemia after hematopoietic cell transplantation

WALTHAM, Mass., Dec. 12, 2022 (GLOBE NEWSWIRE) -- 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, today announced a poster presentation on the clinical trial design and trial in progress for the Phase 1 umbrella trial of TSC-100 and TSC-101 to treat residual leukemia and prevent relapse after hematopoietic cell transplantation (HCT) at the 64^th American Society of Hematology (ASH) Annual Meeting 2022.

TScan has developed two lead TCR-T therapy candidates, TSC-100 and TSC-101, that express TCRs targeting minor histocompatibility antigens (MiHA) HA-1 and HA-2, respectively, both presented by HLA-A*02:01. The goal is to select HCT patients who are HA-1 or HA-2 positive and donors who are mismatched on either the MiHA or HLA-A*02:01, whereby TSC-100 and TSC-101 can eliminate all recipient hematopoietic cells while leaving donor cells unaffected. Both products are being developed in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS) undergoing allogeneic haploidentical HCT with reduced intensity conditioning (RIC) to eliminate any residual recipient hematopoietic cells after HCT and prevent disease relapse. Approximately 40% of patients with these diseases relapse within two years after RIC transplant, at which point there are limited treatment options and poor prognosis. The longer-term objective is to enable more patients to maintain prolonged remission after HCT using RIC, which is a more tolerable chemotherapy than myeloablative conditioning, followed by TScan’s TCR-T.

“We continue to make meaningful progress across our pipeline and most notably with our lead hematologic malignancies Phase 1 trial of TSC-100 and TSC-101,” said David P. Southwell, President and Chief Executive Officer. “We remain on track to enroll the first two cohorts in this trial in the first half of next year with an interim data report by the end of 2023.”

Debora Barton, M.D., Chief Medical Officer added: “We are very excited that our Phase 1 trial design enables us to simultaneously assess TSC-100 and TSC-101 versus a control arm in a single umbrella study. We currently have five sites actively recruiting patients with more sites planned to open in the first half of 2023.”

A copy of the poster can be accessed on the “Publications” section of the Company’s website at www.tscan.com.

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 TCR-T therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to eliminate residual disease and prevent relapse after allogeneic hematopoietic 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 Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, in order to provide customized multiplexed TCR-T therapies for patients with a variety of solid tumors.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company’s plans, progress, and timing relating to the Company’s Phase 1 umbrella trial for TSC-100 and TSC-101 and the presentation of interim data, and the potential benefits of the Company’s proprietary platforms or current or future product candidates in treating patients. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of TScan’s TCR-T therapy candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; the timing of the initiation, progress and expected results of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s plans relating to developing and commercializing its TCR-T therapy candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and the effect of the COVID-19 pandemic, including mitigation efforts and political, economic, legal and social effects, on any of the foregoing or other aspects of TScan’s business or operations; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements.

Contacts

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

Joyce Allaire
LifeSci Advisors, LLC
Managing Director
617-435-6602
jallaire@lifesciadvisors.com

FAQ

What is the purpose of TScan Therapeutics' Phase 1 trial?

The Phase 1 trial aims to evaluate the efficacy of TSC-100 and TSC-101 therapies in treating residual leukemia and preventing relapse after hematopoietic cell transplantation.

When will interim data from the TCRX trial be available?

Interim data from the Phase 1 trial is expected to be reported by the end of 2023.

How does TSC-100 and TSC-101 work?

TSC-100 and TSC-101 are engineered T cell therapies targeting minor histocompatibility antigens to eliminate residual leukemia cells while preserving donor cells.

What are the main challenges facing the trial participants?

A significant challenge is that around 40% of patients with similar conditions relapsed within two years after reduced intensity conditioning transplant.

How many sites are currently recruiting for the TCRX trial?

Currently, five sites are actively recruiting patients for the TCRX Phase 1 trial, with plans to open more in the first half of 2023.