TScan Therapeutics, Inc. (NASDAQ:TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced its 2023 clinical pipeline plans and highlighted recent corporate achievements.
“We made significant progress and growth in 2022, positioning both our solid tumor and hematologic malignancies programs for important data readouts in 2023,” said David P. Southwell, President and Chief Executive Officer. “Our solid cash runway funds us well into 2024, seeing us through to multiple value-generating milestones. We believe that 2023 will be a pivotal year for TScan as we continue to advance our industry-leading clinical stage portfolio of TCR-T therapy candidates in both our solid tumor and hematologic malignancies programs.”
Debora Barton, M.D., Chief Medical Officer added, “We look forward to multiple clinical milestones next year. Specifically, we expect an interim data read out from our Phase 1 umbrella trial in prevention of relapse post-transplant for hematological malignancies as well as preliminary data for our most advanced solid tumor TCRs by the end of 2023.”
2022 Key Achievements and Recent Company Highlights
Hematologic Malignancies Program:
- FDA clearance of IND applications for TSC-100 and TSC-101 for the prevention of relapse following hematopoietic cell transplant (HCT) in acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and acute lymphocytic leukemia (ALL)
- Initiated multi-arm clinical trial with five clinical sites activated, with additional sites to be added in 2023
- Presented Phase 1 umbrella trial in progress poster on HA-1 (TSC-100) and HA-2 (TSC-101) at the 64th American Society of Hematology (ASH) annual meeting 2022
- Phase 1 trial design and translational assays designed to show early evidence of biological activity in residual leukemia after HCT
- Developed translational research program for early evaluation of efficacy
- Novel high-sensitivity next-generation sequencing assays to measure minimal residual disease and donor chimerism
Solid Tumor Programs
- FDA support for multiplexing clinical development plan through “T-plex” IND allowing simultaneous administration of multiple TCRs following singleplex dose escalation
- Filed initial three INDs for solid tumor program (T-plex, TSC-204-A0201, TSC-204-C0702) with four additional IND filings expected in 2023
- Built in-house in vivo pharmacology and in vitro toxicology capabilities to support rapid filing of additional TCR INDs to further expand the ImmunoBank
- Developed clinical trial assays to enable prospective patient selection through analysis of target and HLA status of tumor samples
- Presented preclinical data for solid tumor program at the 37th Society for Immunotherapy of Cancer (SITC) annual meeting 2022:
- TCR for an HLA-A*02:01 epitope of PRAME
- Multiplexing TCRs for MAGE-A1 and PRAME demonstrated synergistic cytotoxicity in vitro and in mouse xenograft models
- Presented preclinical data at the American Society of Gene and Cell Therapy (ASGCT) 25th annual meeting 2022
- Identified lead TCR-T cell therapy candidate, TCR-200-A0201, for the treatment of HPV-positive solid tumors
- Publication in Cell highlights the discovery of novel tumor antigens and high affinity TCRs for the treatment of solid tumors using TScan’s foundational screening technology
- TScan screening technology identified targets of expanded T cell clones in the tumors of patients with head and neck cancer responding to neoadjuvant immunotherapy, an indication for which the Company is developing potential new therapies
- Hosted virtual KOL events on solid tumor program and highlights from ASGCT and SITC annual meetings
Corporate
- Appointed Debora Barton, M.D. as Chief Medical Officer and Leiden Dworak, CPA, MBA, as Vice President, Finance
- Named highest-placed midsize biotechonology company in Top Places to Work for 2022 by The Boston Globe
Clinical Plans and Expected Milestones
- In the hematologic malignancies program, the Company expects to enroll the first two cohorts in the Phase 1 umbrella trial (NCT05473910) for TSC-100 and TSC-101 in the first half of 2023 and to report top-line data by the end of 2023. Additionally, the Company expects to share prevention of relapse data in 2024
- In the solid tumor program, the Company plans to file INDs for HPV (TSC-200-A0201) and PRAME (TSC-203-A0201) in the first half of 2023 with two additional INDs to be filed by the end of 2023; expects preliminary clinical data for the most advanced TCRs by the end of 2023. The Company expects to report initial multiplex therapy data for this program in 2024
