Full Press Release Details
TScan Therapeutics to Present Updated Data from the Ongoing ALLOHA Phase
1 Heme Trial During Oral Session at the 66th American Society of
Annual Meeting and Exposition
To date, event-free survival strongly favors the treatment arm (HR=0.30; p=0.04), and
treatment-arm patients trend towards lower probability of relapse (HR=0.28; p=0.14)
No dose-limiting toxicities observed and infusions of TSC-100 and
tolerated across all three dose levels
Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December
10, 2024, at 8:00 a.m. ET
Mass., Dec. 9, 2024 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 updated results from the ongoing ALLOHA Phase 1 trial of TSC-100 and TSC-101 will be presented during an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.
TSC-100 and TSC-101 are designed to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and
myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) with reduced intensity conditioning.
is the leading cause of death in patients undergoing transplant following reduced intensity conditioning and represents a significant unmet medical need, said Chrystal U. Louis, M.D., Chief Medical Officer. As the majority of patients
enrolled in both the treatment and control arms were considered at very high risk for relapse, we are highly encouraged by the preliminary ALLOHA study results, which suggest that TSC-100 and TSC-101 have the potential to eliminate residual disease and prevent relapse in patients with AML, ALL, or MDS post-HCT.
We are very excited by these data and, based on these results, we intend to launch a pivotal trial in the second half of 2025, said Gavin
MacBeath, Ph.D., Chief Executive Officer. Following recent feedback from the FDA, we believe we have a clear development path and will share our plans at our KOL event tomorrow morning.
In the ongoing ALLOHA Phase 1 trial (NCT05473910), patients receive either TSC-100 or TSC-101 post-HCT, whereas control-arm patients receive HCT alone as per standard of care. To date, 38 patients have been enrolled in
the trial and undergone HCT, with 26 in the treatment arm and 12 in the control arm. The key endpoints in the trial are safety and efficacy, with exploratory endpoints including donor chimerism and minimal residual disease (MRD) status.
Key Presentation Highlights:
A copy of the presentation materials will be made available on the Publications section of the Company s website
at tscan.com once the presentation has concluded.
Virtual Key Opinion Leader (KOL) Event
The Company will host a virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December 10, 2024, at 8:00 a.m. ET to discuss the data presented
at ASH, updates with regards to a potential registrational path for the program following its initial meeting with the U.S. Food and Drug Administration, as well as future plans to expand the program, in addition to an update on the Company s PLEXI-T Phase 1 solid tumor trial.
Professor of Medicine and Director of the Cellular Immunotherapy Program at Columbia University Irving Medical Center. Details for attending the event can be found here.
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 candidates are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHATM Phase 1 heme trial). The Company has developed and continues to expand its ImmunoBank, the Company s repository of therapeutic TCRs that recognize diverse targets and are associated with
multiple HLA types, to provide customized multiplex TCR-T therapies for patients with a variety of cancers (the
PLEXI-TTM Phase 1 solid tumor trial). The Company is currently enrolling patients into both clinical programs.
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 hematologic malignancies program, including clinical updates of the ALLOHA Phase 1 heme trial, presentation of data, opening of expansion cohorts, and initiation of registrational trials; the Company s plans, progress, and timing
relating to the Company s solid tumor program, including, screening,
enrolling, and dosing patients, presentation of data, and submission of additional INDs to expand the ImmunoBank; the progress of the hematologic malignancies and solid tumor programs being
indicative or predictive of the success of each program; the engagement of CDMO being indicative of successful initiation or support of manufacturing activities or execution of definitive agreements; the Company s current and future research
and development plans or expectations; the structure, timing and success of the Company s planned preclinical development, submission of INDs, and clinical trials; the potential benefits of any of the Company s proprietary platforms,
multiplexing, or current or future product candidates in treating patients; the Company s ability to fund its operating plan with its existing cash, cash equivalents, and marketable securities; 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 candidates; TScan s expectations regarding its preclinical studies being predictive of clinical trial results;
TScan s recently 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 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 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.
TScan Therapeutics, Inc.
VP, Investor Relations