TSC-100 / TSCan Therap - LARVOL DELTA

Initial Results of a Phase 1 Trial of TSC-100 and TSC-101, Engineered T Cell Therapies That Target Minor Histocompatibility Antigens to Prevent Relapse after Allogeneic Hematopoietic Cell Transplantation (ASH 2023) - P1 | "Targeting MiHAs HA-1 or HA-2 with TSC-100/ 101 following HCT shows early safety and biomarker evidence of efficacy by completing elimination of all detectable patient hematopoietic cells, normal or malignant, thereby reducing relapse risk. Updated results will be presented at the meeting."

IO biomarker • P1 data • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Myelodysplastic Syndrome • Oncology • Transplantation • CD33 • HLA-A • TP53

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 (ASH 2024) - P1 | "The data support the safety and potential of TSC-100/TSC-101 to reduce relapses and increase event-free and relapse-free survival in RIC HCT patients. Enrollment continues and updated data will be presented."

Clinical • IO biomarker • P1 data • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Myelodysplastic Syndrome • Oncology • Septic Shock • CD33 • HLA-A

TScan Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update (TScan Therap Press Release) - "Updates from the PLEXI-T solid tumor and ALLOHA heme Phase 1 clinical trials anticipated by end of year; On-track to file IND application for TSC-102-A0301 (CD45; HLA-A*03:01) to FDA in the second half of the year...Plans to present additional data from the ALLOHA Phase 1 trial by the end of the year, including two-year relapse data on the initial patients."

Commercial • IND • P1 data • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor

Upcoming Anticipated Milestones (GlobeNewswire) - "Plans to present updated clinical data on Phase 1 ALLOHA trial at ASH on December 6, 2025, in Orlando, Florida. Plans to submit INDs for two additional TCR-T product candidates to expand HLA coverage of the heme program in Q4 2025. Plans to launch pivotal trial for TSC-101 for patients with AML and MDS in Q2 2026."

IND • New trial • P1 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

TScan Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Heme Malignancies Program: TScan’s two lead TCR-T therapy candidates, TSC-100 and TSC-101...Opened expansion cohorts at dose level 3 to further characterize safety and evaluate translational and efficacy endpoints. Plans to continue development of TSC-101 only, as TSC-101 enables treatment of ~98% of patients with HLA type A*02:01. Initiate a registration trial for TSC-101, pending further feedback from regulatory authorities, in the second half of 2025. Plans to present additional data from the Phase 1 trial by the end of the year, including two-year relapse data on the initial patients. Plans to file an investigational new drug (IND) application for TSC-102-A0301, a TCR-T targeting CD45 on HLA-A*03:01, in the second half of 2025."

IND • New trial • P1 data • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

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 Hematopoietic Cell Transplantation (HCT) with Reduced Intensity Conditioning (RIC): Preliminary Results from the Phase 1 Alloha Trial (NCT05473910) (TCT-ASTCT-CIBMTR 2025) - P1 | "The data support the safety and potential of TSC-100/TSC-101 to reduce relapses and increase event-free and relapse-free survival in patients with AML, ALL and MDS undergoing RIC HCT. Enrollment continues and updated data will be presented."

Clinical • P1 data • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Infectious Disease • Myelodysplastic Syndrome • Transplantation

ALLOHA: A Study of TSC-100 and TSC-101 in AML, ALL and MDS Patients Undergoing Haploidentical Donor Transplantation (clinicaltrials.gov) - P1 | N=63 | Recruiting | Sponsor: TScan Therapeutics, Inc. | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Transplantation • HLA-A

TScan Therapeutics to Present Updated Data from the Ongoing ALLOHA Phase 1 Heme Trial During Oral Session at the 66th American Society of Hematology Annual Meeting and Exposition (GlobeNewswire) - P1 | N=63 | ALLOHA (NCT05473910) | Sponsor: TScan Therapeutics, Inc. | "To date, 38 patients have been enrolled in the trial and undergone HCT....To date, event-free survival strongly favors the treatment arm (HR=0.30; p=0.04) and early trends suggest a lower probability of relapse (HR=0.28; p=0.14). 2 of 26 (8%) treatment-arm patients relapsed compared to 4 of 12 (33%) control-arm patients. One treatment-arm relapse and subsequent mortality occurred in a very high-risk patient who was taken to transplant without first achieving complete remission, and the other was an extramedullary relapse in the patient’s central nervous system with no evidence of systemic relapse....8 of 38 (21%) patients in the study had TP53 mutations, with 6 cases in the treatment arm and 2 cases in the control arm....TSC-100 and TSC-101 infusions were well-tolerated at all three dose levels with no dose-limiting toxicities."

P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

TScan Therapeutics to Host Virtual KOL Event to Discuss Clinical Updates from the ALLOHA Phase 1 Trial and Heme Development Strategy (GlobeNewswire) - "TScan Therapeutics, Inc...announced the Company will host a virtual key opinion leader (KOL) event to discuss data from the ALLOHA Phase 1 heme trial presented at the ASH Annual Meeting and the clinical development strategy for the heme program. Additionally, the Company will provide an update on its PLEXI-T Phase 1 solid tumor trial. The virtual event will take place on Tuesday, December 10, at 8:00 a.m. ET. The event will provide an in-depth review of the oral presentation describing the preliminary results from TScan’s ongoing ALLOHA Phase 1 heme 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."

P1 data • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Myelodysplastic Syndrome • Solid Tumor

TScan Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Heme Malignancies Program: Plans to open expansion cohorts at the proposed recommended Phase 2 dose level to further characterize safety and evaluate translational and efficacy endpoints by the end of 2024; One-year clinical and translational data on initial patients to be reported by the end of 2024; Initiate a registration trial, pending feedback from regulatory authorities, and plans to report two-year clinical and translational data in 2025."

New trial • P1 data • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

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 (GlobeNewswire) - P1 | N=63 | ALLOHA (NCT05473910) | Sponsor: TScan Therapeutics, Inc. | "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...Enrollment in the ALLOHA Phase 1 trial continues and updated data will be presented at the meeting in December...The Company will host a virtual KOL event featuring Ran Reshef....on Tuesday, December 10, 2024, at 8:00 a.m. ET to discuss the data presented at ASH..."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TScan Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Research and development expenses for the second quarter of 2024 were $26.9 million, compared to $21.2 million for the second quarter of 2023. The increase of $5.7 million was primarily driven by an increase in clinical studies expense associated with the ongoing enrollment of our ALLOHA Phase 1 heme trial and start-up activities and initial enrollment in our Phase 1 solid tumor clinical trial, as well as an increase in personnel expenses due to additional headcount in support of our expanded research and development activities."

Commercial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Solid Tumor

A phase 1 trial of TSC-100 and TSC-101, engineered T cell therapies that target minor histocompatibility antigens to eliminate residual disease after hematopoietic cell transplantation. (ASCO 2024) - P1 | "MRD is measured before and after HCT using flow cytometry and NGS. Together, these assays measure elimination of residual patient hematopoietic cells, malignant or normal, and could provide early evidence of biological activity."

P1 data • Residual disease • Hematological Disorders • Hematological Malignancies • Oncology • Transplantation • HLA-A

TScan Therapeutics Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for its Two Lead TCR-T Therapy Candidates for the Treatment of Heme Malignancies (GlobeNewswire) - P1 | N=63 | NCT05473910 | Sponsor: TScan Therapeutics, Inc. | "On May 13, 2024, the Company provided an update on its Phase 1 heme malignancies program. The update included additional follow-up on all eight treatment-arm patients as well as data on two additional control-arm patients. With a median follow-up of >10 months, all eight patients treated with TSC-100 or TSC-101 remain relapse-free with no detectable disease. No dose-limiting toxicities were observed. In contrast, two of eight control-arm patients relapsed approximately six months post-transplant and one of these patients died approximately three months later."

P1 data • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

TScan Therapeutics Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for its Two Lead TCR-T Therapy Candidates for the Treatment of Heme Malignancies (GlobeNewswire) - "TScan Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to TSC-100 and TSC-101, the Company’s two lead TCR-T therapy candidates for the treatment of heme malignancies (NCT05473910). 'We are delighted to receive FDA RMAT designation for both candidates in our heme program designed to treat patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) with reduced intensity conditioning, based on encouraging initial data from the ALLOHA trial'..."

FDA event • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

TScan Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Heme Malignancies Program...Opening of expansion cohorts at the proposed recommended Phase 2 dose level to further characterize safety and evaluate translational and efficacy endpoints is planned for the third quarter of 2024. Completion of Phase 1 enrollment and reporting of one-year clinical and translational data on initial patients is anticipated in the second half of 2024. Expects to initiate registration trial pending feedback from regulatory authorities and report two-year clinical and translational data in 2025."

P1 data • Regulatory • Trial status • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

TScan Therapeutics Announces Upcoming Presentations at the 2024 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "TScan Therapeutics...announced the acceptance of two abstracts for poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 31 - June 4 in Chicago, IL as well as virtually."

P1 data • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor

Trial in Progress: A Phase 1 Trial of TSC-100 and TSC-101, Engineered T Cell Therapies That Target Minor Histocompatibility Antigens to Eliminate Residual Disease After Hematopoietic Cell Transplantation (ASGCT 2024) - P1 | "Our clinical trial is aiming to eliminate disease relapse by using genetically engineered immune cells that selectively attack the surviving cancer cells but leave any of the healthy transplanted blood cells intact. Patients are treated with these engineered immune cells immediately following transplant, when the number of surviving cancer cells should be at its lowest and easiest to eliminate, thus representing the best chance for achieving relapse-free survival."

P1 data • Residual disease • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation • HLA-A

TScan Therapeutics Announces Upcoming Presentations at the American Society of Gene and Cell Therapy 27th Annual Meeting (GlobeNewswire) - "TScan Therapeutics...announced the acceptance of one abstract for oral presentation and four abstracts for poster presentation at the upcoming American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting being held May 7-11 in Baltimore, MD as well as virtually."

Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor

TScan Therapeutics Provides Clinical Pipeline Update and Highlights Near-Term Priorities (GlobeNewswire) - P1 | N=63 | NCT05473910 | Sponsor: TScan Therapeutics, Inc. | "All eight patients treated with TSC-100 or TSC-101 remain MRD negative, relapse-free with no detectable cancer to date in either bone marrow biopsies or peripheral blood (median follow-up of >10 months)....To date, all but one patient has exhibited complete donor chimerism in all subsets of blood cells at all time-points, indicating that only donor-derived cells are present in these patients following treatment with either TSC-100 or TSC-101....Opening of expansion cohorts at the recommended Phase 2 dose level...is planned for the third quarter of 2024. Completion of Phase 1 enrollment and reporting of one-year clinical and translational data on initial patients is anticipated in the second half of 2024. Expects to initiate registration trial pending feedback from regulatory authorities and report two-year relapse data in 2025."

New trial • P1 data • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Trial in progress:A phase 1 trial of TSC-100 and TSC-101, engineered T cell therapies that target minor histocompatibility antigens to eliminate residual disease after hematopoietic cell transplantation (AACR 2024) - P1 | "Donor chimerism is measured by standard STR-based and novel high-sensitivity NGS-based assays to quantify residual patient-derived hematopoietic cells. Together, these assays measure elimination of residual patient hematopoietic cells, malignant or normal, and could provide early evidence of biological activity."

IO biomarker • P1 data • Residual disease • Hematological Malignancies • Oncology • HLA-A

TScan Therapeutics Presents Promising Updated Phase 1 Clinical Results on TSC-100 and TSC-101 at the 2024 Tandem Meetings of ASTCT and CIBMTR (GlobeNewswire) - P1 | N=63 | NCT05473910 | Sponsor: TScan Therapeutics, Inc. | "The oral presentation, selected for the plenary session as a Best Abstract, highlights updated data from the Phase 1 multi-arm clinical trial evaluating TSC-100 and TSC-101, designed to treat residual disease and prevent relapse following hematopoietic cell transplantation (HCT) in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or acute lymphocytic leukemia (ALL)....TSC-100 treatment arm (N=4: T-ALL, AML, AML, MDS): 4/4 patients treated with TSC-100 achieved complete donor chimerism with no relapse. TSC-101 treatment arm (N=4: TP53-mutated MDS, AML, B-ALL, B-ALL): 4/4 patients treated with TSC-101 achieved complete donor chimerism with no relapse, including a patient with high-risk, TP53-mutated MDS who has reached one year of follow-up."

P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

CareDx Showcases Digital Solutions and Pipeline in Cellular Transplant and Therapy Monitoring at the 2024 Tandem Meetings (Businesswire) - "CareDx, Inc...today announced that it will be showcasing the breadth of its specialized digital solutions and the latest advancements in its cellular therapy and transplant monitoring pipeline at the 2024 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, being held February 21-25 in San Antonio, Texas....Oral Presentation: TScan’s TSC-100 and TSC-101, TCR-T Cell Therapies That Target Residual Recipient Cells after Reduced Intensity Conditioning Transplantation, Induce Complete Donor Chimerism with Favorable Prognosis: Early Results of a Phase 1 Trial....Presenting interim data from the prospective multi-center ACROBAT study that supports the clinical utility of ultra-sensitive chimerism monitoring for detection of early relapse post allogeneic HCT."

Observational data • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Micro-Chimerism Detected By Highly Sensitive AlloHemeTM Solution Is Associated with Treatment Response and Relapse after Allogeneic Stem Cell Transplantation (TCT-ASTCT-CIBMTR 2024) - P=N/A, P1 | "Trial 2: NCT05473910 (TSCAN-001, TScan Inc.) is a multi-arm non-randomized controlled Phase 1 study evaluating the safety and efficacy of TScan's TSC100 and TSC101 - allogeneic T-cell receptor-engineered T cells that target haematopoietically restricted antigens HA-1 and HA-2 respectively, both presented on HLA-A*02:01, in mismatched reduced-intensity conditioning (RIC)-haplo donor HCT recipients. Additionally, where MRD results were available, AH CD33 iMC was associated with MRD (p=0.019, N=79) (Table 3). These interim results suggest a potential utility of MC measured by AlloHeme, an ultra-sensitive NGS-based chimerism monitoring solution, as a non-invasive predictive biomarker for treatment response and relapse in post allo-HCT patients."

IO biomarker • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation • CD33 • HLA-A

TSC-100 and TSC-101, TCR-T Cell Therapies That Target Residual Recipient Cells after Reduced Intensity Conditioning Transplantation, Induce Complete Donor Chimerism with Favorable Prognosis: Early Results of a Phase 1 Trial (TCT-ASTCT-CIBMTR 2024) - P=N/A, P1 | "The prognostic value of complete donor chimerism by AlloHeme was evaluated in the ACROBAT study (NCT04635384) in which 73 patients achieved >99.9% chimerism in CD33+ cells and, after median follow-up of 9 months/ 270 days (range 72-608 days), 3 relapsed (4%), comparing favorably with 18-20% 6-month relapse rates in CIBMTR data. In summary, TSC-100 and TSC-101 post-HCT induce MRD negativity and complete donor chimerism which may be associated with substantially reduced relapse rates."

P1 data • Acute Myelogenous Leukemia • Graft versus Host Disease • Immunology • Infectious Disease • Inflammation • Transplantation • CD33 • HLA-A