WALTHAM, Mass., July 29, 2026 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced that the first patient has been infused with TSC-101 in the pivotal Phase 3 ALLOHA-2™ trial (NCT07702578). The patient, who was enrolled in June, has now received their first infusion of TSC-101 following successful stem cell engraftment. The trial is investigating the efficacy and safety of TSC-101 for the treatment of residual disease to prevent relapse following allogeneic hematopoietic cell transplantation (allo-HCT) in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
“Dosing our first patient in the ALLOHA-2™ study is a significant milestone for TScan. Having been a part of TScan as we moved TSC-101 from an idea to Discovery, through Phase 1 clinical development, and now to a Phase 3 study, I want to acknowledge all the hard work that went into bringing TSC-101 to this integral step and congratulate all current and previous members of the TScan team,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “I would also like to thank the investigators, the patients, and their families for participating in our Phase 1 ALLOHA™ trial. In June, we reported initial data from Cohort C of that study, in which patients were treated with our commercial-ready manufacturing process. The strong clinical efficacy and positive safety profile observed in this cohort gives us added confidence in our Phase 3 trial and future clinical development plans.”
“TSC-101 has demonstrated a safety profile and clinical results that continue to excite the transplant community,” said Chrystal U. Louis, M.D., Chief Medical Officer. “The pace of Cohort C enrollment highlights the growing interest in TSC-101 as a potential therapeutic option for people with AML or MDS, and we look forward to working with our investigators to address residual disease and improve survival in patients after allo-HCT.”
The Phase 3 ALLOHA-2™ pivotal trial is a study evaluating TSC-101 administered after standard of care HCT vs HCT alone in patients with AML or MDS. Treatment is based on biological assignment (genetic randomization), with A*02:01-positive subjects with an appropriate donor assigned to the treatment arm, and A*02:01-negative subjects, or A*02:01-posititve subjects without an appropriate donor, assigned to the control arm. All subjects will receive HCT with reduced intensity conditioning. Subjects in the treatment arm will receive two infusions of TSC-101 following engraftment. The primary endpoint for the study is relapse-free survival, and key secondary endpoints include overall survival and event-free survival.
To learn more about the ALLOHA-2™ clinical trial, visit clinicaltrials.gov (identifier: NCT07702578).
About TScan Therapeutics, Inc.
TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidate, TSC-101, is in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHA-2™ Phase 3 pivotal trial). The Company is also in early stages of developing methods for in vivo engineering to treat solid tumors. In addition, the Company is applying its target discovery platform to discover novel targets in various T cell-mediated autoimmune disorders.
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 TScan Therapeutics, Inc.’s (“TScan” or the “Company”) plans, progress, expectations, and timing relating to the Company’s hematologic malignancies program, including clinical updates of the ALLOHA-2TM clinical trial, presentation of data, enrollment and dosing of patients, and market opportunities; the progress of the hematologic malignancies program being indicative or predictive of the success of such program; the structure, timing and success of the ALLOHA-2TM clinical trial; the potential benefits of any of the Company’s proprietary platforms or current or future product candidates in treating patients; and the Company’s goals, strategy and anticipated financial performance. 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 product candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; TScan’s approved INDs being indicative or predictive of bringing TScan closer to its goal of providing customized TCR-T therapies to treat patients with cancer; the timing of the launch, initiation, progress, expected results and announcements of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s ability to enroll patients for its clinical trials within its expected timeline; TScan’s plans relating to developing and commercializing its TCR-T therapy product candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy product 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 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.
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