TScan Therapeutics, Inc. (Nasdaq: TCRX) is thrilled to announce that the first patient has been successfully dosed as part of its Phase 1 umbrella trial of TSC-100 and TSC-101, T cell receptor (TCR)-engineered T cell therapies designed to target minor histocompatibility antigens (MiHA) HA-1 and HA-2 respectively. This cutting-edge trial aims to treat residual leukemia and prevent relapse following hematopoietic cell transplantation (HCT) using reduced intensity conditioning (RIC) in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or acute lymphocytic leukemia (ALL). The patient was treated with TSC-101, the first of its kind cell therapy product targeting MiHA HA-2. This breakthrough in cancer treatment is yet another step towards TScan Therapeutics’ mission to develop innovative therapeutics for cancer patients.
Today marks a major milestone for TScan and a new dawn for TCR-T cell therapy, as we dose the first patient in our hematologic malignancies program. Current HCT treatments in hematologic oncology have seen remarkable clinical outcomes, but the high relapse rates and mortality risk still remain. TSC-101 offers the potential to overcome the toxicity associated with myeloablative conditioning and maximize the potential of transplant therapy for hematologic cancers. We are thrilled by the enthusiasm of clinical investigators and the opening of additional clinical sites, and look forward to the possibilities that lie ahead.
At TSC, we are committed to helping patients with AML, ALL, and MDS who receive a reduced-intensity conditioning (RIC) regimen before their haploidentical hematopoietic cell transplant (HCT). Unfortunately, research has shown that roughly 40% of these patients relapse post-HCT, and there are few treatment options with a poor prognosis. We believe that TSC-100 and TSC-101 may be effective solutions to reduce the risk of relapse, allowing more patients to access the less toxic RIC regimen before HCT. We are on track to enroll patients in our study and expect to report preliminary safety and biomarker data in the middle of this year, with further updates by the end of 2023.
The Phase 1 umbrella trial is a groundbreaking multi-arm, i3+3 study that is set to revolutionize the field of hematopoietic cell transplantation (HCT). Through the evaluation of TSC-100, TSC-101, and standard of care HCT alone (control arm) in patients with AML, ALL or MDS, this study is set to revolutionize the treatment of these diseases. Treatment assignment is based on HLA and antigen expression, and the safety of repeated doses and efficacy of the TCR-T as compared to the control arm are the primary endpoints. Additionally, exploratory endpoints include cellular kinetics, minimal residual disease rates, percentage of donor chimerism, and persistence of TSC-100 and TSC-101, making this trial a potential game-changer for these life-threatening illnesses.
About TScan Therapeutics, Inc.
TScan is a clinical-stage biopharmaceutical company dedicated to developing revolutionary TCR-engineered T cell therapies (TCR-T) to treat cancer. Their leading TCR-T therapy candidates, TSC-100 and TSC-101, are designed to eradicate residual disease and reduce the risk of relapse after an allogeneic hematopoietic cell transplantation. Moreover, the company is also striving to create multiplexed TCR-T therapy options for various solid tumors. To make this possible, TScan has established the ImmunoBank, a repository of therapeutic TCRs that target a range of HLA types, to allow for personalized multiplexed TCR-T therapies for patients with solid tumors.