TScan Therapeutics Announces Upcoming Oral Presentation of Data from the ALLOHA™ Phase 1 Heme Trial at the 66th American Society of Hematology Annual Meeting and Exposition
TScan Therapeutics (NASDAQ: TCRX) announced preliminary results from the ALLOHA™ Phase 1 trial of TSC-100 and TSC-101 for blood cancers. The trial enrolled 27 patients, with 16 in the treatment arm and 11 in the control arm. Key findings showed no relapses in the treatment arm versus three relapses in the control arm, with a median time to relapse of 159 days in the control group. All five TSC-treated patients reaching one-year follow-up remained relapse-free and MRD negative. No dose-limiting toxicities were reported, and safety profiles were similar between treatment and control arms.
TScan Therapeutics (NASDAQ: TCRX) ha annunciato i risultati preliminari della sperimentazione clinica ALLOHA™ di Fase 1 per TSC-100 e TSC-101 nel trattamento dei tumori del sangue. Lo studio ha arruolato 27 pazienti, con 16 nel braccio di trattamento e 11 nel braccio di controllo. Risultati chiave hanno mostrato che non ci sono state recidive nel braccio di trattamento rispetto alle tre recidive registrate nel braccio di controllo, con un tempo mediano fino alla recidiva di 159 giorni nel gruppo di controllo. Tutti e cinque i pazienti trattati con TSC che hanno raggiunto il follow-up a un anno sono rimasti senza recidive e negativi per MRD. Non sono state riportate tossicità limitanti la dose e i profili di sicurezza sono stati simili tra i bracci di trattamento e di controllo.
TScan Therapeutics (NASDAQ: TCRX) anunció resultados preliminares del ensayo clínico ALLOHA™ de Fase 1 de TSC-100 y TSC-101 para cánceres de sangre. El ensayo inscribió a 27 pacientes, con 16 en el grupo de tratamiento y 11 en el grupo de control. Hallazgos clave mostraron que no hubo recaídas en el grupo de tratamiento frente a tres recaídas en el grupo de control, con un tiempo medio hasta la recaída de 159 días en el grupo de control. Los cinco pacientes tratados con TSC que alcanzaron el seguimiento de un año continuaron libres de recaídas y negativos para MRD. No se informaron toxicidades limitantes de la dosis, y los perfiles de seguridad fueron similares entre los grupos de tratamiento y control.
TScan Therapeutics (NASDAQ: TCRX)는 혈액암을 위한 TSC-100 및 TSC-101의 ALLOHA™ 1상 시험의 초기 결과를 발표했습니다. 이 시험에는 27명의 환자가 등록되었으며, 치료군에 16명, 대조군에 11명이 포함되었습니다. 주요 발견은 치료군에서 재발이 없었던 반면 대조군에서는 세 건의 재발이 있었고, 대조군에서의 재발까지의 중앙 시간은 159일로 나타났습니다. 1년 후 추적 관찰을 받은 TSC 치료 환자 5명 모두 재발 없이 MRD 음성이었습니다. 용량 제한 독성은 보고되지 않았으며, 치료군과 대조군 간의 안전성 프로파일은 유사했습니다.
TScan Therapeutics (NASDAQ: TCRX) a annoncé des résultats préliminaires de l'essai clinique ALLOHA™ de Phase 1 concernant TSC-100 et TSC-101 pour les cancers du sang. L'essai a recruté 27 patients, dont 16 dans le groupe de traitement et 11 dans le groupe de contrôle. Résultats clés ont montré qu'il n'y avait pas de rechutes dans le groupe de traitement contre trois rechutes dans le groupe de contrôle, avec un temps médian jusqu'à la rechute de 159 jours dans le groupe de contrôle. Les cinq patients traités avec TSC ayant atteint un suivi d'un an sont restés sans rechute et négatifs pour MRD. Aucune toxicité limitante de dose n'a été rapportée, et les profils de sécurité étaient similaires entre les bras de traitement et de contrôle.
TScan Therapeutics (NASDAQ: TCRX) gab vorläufige Ergebnisse der ALLOHA™ Phase-1-Studie zu TSC-100 und TSC-101 für Blutkrebs bekannt. Die Studie umfasste 27 Patienten, davon 16 in der Behandlungsgruppe und 11 in der Kontrollgruppe. Wichtige Ergebnisse zeigten, dass in der Behandlungsgruppe keine Rückfälle auftraten, während in der Kontrollgruppe drei Rückfälle verzeichnet wurden, mit einer medianen Zeit bis zum Rückfall von 159 Tagen in der Kontrollgruppe. Alle fünf Patienten, die mit TSC behandelt wurden und einjähriges Follow-up erhielten, blieben rückfallfrei und MRD-negativ. Es wurden keine dosislimitierenden Toxizitäten berichtet, und die Sicherheitsprofile waren zwischen der Behandlungs- und der Kontrollgruppe ähnlich.
- Zero relapses in treatment arm vs. three relapses in control arm
- All five TSC-treated patients reaching one-year follow-up remained relapse-free and MRD negative
- No dose-limiting toxicities reported in treatment arm
- Safety profile comparable to control arm
- None.
Insights
The preliminary Phase 1 ALLOHA trial results for TSC-100 and TSC-101 show remarkable promise in preventing disease relapse post-transplant. The data reveals zero relapses in the treatment arm (16 patients) compared to 3 relapses in the control arm (11 patients). Most notably, all five TSC-treated patients who reached one-year follow-up remained relapse-free and MRD negative, suggesting effective elimination of residual cancer cells.
The safety profile appears favorable with no dose-limiting toxicities reported for TSC-100/101 infusions. The adverse events observed were consistent with typical post-HCT complications. This early data suggests these therapies could potentially address a critical unmet need in transplant medicine, where disease relapse remains the leading cause of death in patients receiving reduced intensity conditioning.
These positive preliminary results could significantly strengthen TScan's market position in the cellular therapy space. With a market cap of
The upcoming ASH presentation and KOL event in December will be important catalysts for potential stock movement. If the updated data continues to show strong efficacy and safety profiles, it could accelerate the pathway to later-stage trials and potential commercialization, significantly impacting the company's valuation.
All TSC-treated patients were relapse-free and MRD negative as of data cutoff
TSC-100 and TSC-101 demonstrate the potential to reduce relapse rates and increase relapse-free survival in patients with AML, ALL, or MDS undergoing allogeneic HCT with reduced intensity conditioning
Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December 10, at 8:00 a.m. ET
WALTHAM, Mass., Nov. 05, 2024 (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 preliminary results from the ALLOHA™ Phase 1 trial of TSC-100 and TSC-101, 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, will be featured in an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 7 – 10 in San Diego, CA. A copy of the abstract is now available online via the ASH website at www.hematology.org.
“Disease relapse is the leading cause of death in patients undergoing transplant with reduced intensity conditioning,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “TSC-100 and TSC-101 were designed with this significant unmet need in mind, and preliminary clinical and translational data from the ALLOHA trial supports the safety and potential of TSC-100 and TSC-101 to reduce relapses and increase relapse-free survival. We look forward to providing additional data from the ongoing trial at the meeting in December.”
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. As of the July 8, 2024 data cut, 27 patients were enrolled in the trial and had undergone HCT, with 16 in the treatment arm and 11 in the control arm. No relapses occurred in the treatment arm versus three relapses in the control arm. Median time to relapse was not evaluable in TSC-treated patients, where no relapses occurred, versus 159 days in the control arm. All five TSC-treated patients that reached one-year follow-up remained relapse-free and MRD negative as of the data cutoff, consistent with effective elimination of residual cancer cells post-HCT. No dose limiting toxicities occurred following TSC-100 or TSC-101 infusions and safety was similar in the treatment and control arms, with expected post-HCT adverse events.
Enrollment in the ALLOHA Phase 1 trial continues and updated data will be presented at the meeting in December.
Oral Presentation Details:
Title: TSC-100 and TSC-101 Demonstrate the Potential to Reduce Relapse Rates and Increase Relapse-Free Survival in Patients with AML, ALL, or MDS Undergoing Allogeneic HCT with Reduced Intensity Conditioning (RIC): Preliminary Results from the Phase 1 ALLOHA Trial
Authors: Monzr M Al Malki, Alla Keyzner, Uday Popat, Yi-Bin Chen, Hyung C Suh, Tania Jain, Melhem M Solh, Anson Snow, Saar Gill, Lohith Gowda, Joseph Uberti, Erica Buonomo, Yun Wang, Nancy Nabilsi, Timothy White, Cuong Nguyen, Jim Murray, Gavin MacBeath, Chrystal Louis, Shrikanta Chattopadhyay, Michelle Matzko, Ran Reshef
Publication Number: 924
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Emerging Targeting Approaches of Cell Therapies for Hematologic Malignancies
Session Date & Time: Monday, December 9, 2024; 2:45 - 4:15 p.m. Pacific Time
Presentation Time: 4:00 p.m. Pacific Time
Location: San Diego Convention Center, Hall B
A copy of the presentation materials will be added to 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. Dr. Reshef is the 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, TSC-100 and TSC-101, 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 is also developing TCR-T therapy candidates for the treatment of various solid tumors. 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.
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 trial, presentation of data, and initiation of registrational trials; the progress of the hematologic malignancies program being indicative or predictive of the success of such program; the Company’s current and future research and development plans or expectations; the structure, timing and success of the Company’s planned preclinical development and clinical trials; 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 and strategy. 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.
Contacts
Heather Savelle
TScan Therapeutics, Inc.
VP, Investor Relations
857-399-9840
hsavelle@tscan.com
Maghan Meyers
Argot Partners
212-600-1902
TScan@argotpartners.com
FAQ
What are the preliminary results of TScan Therapeutics' (TCRX) ALLOHA Phase 1 trial?
How many patients were enrolled in TCRX's ALLOHA Phase 1 trial as of July 2024?
What was the safety profile of TSC-100 and TSC-101 in the ALLOHA trial?
