TSC-204-A0201 / TSCan Therap - LARVOL DELTA

TSCAN-002: A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=840 | Active, not recruiting | Sponsor: TScan Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Pan tumor • Anal Carcinoma • Cervical Adenocarcinoma • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • Head and Neck Cancer • Infectious Disease • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Ovarian Cancer • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Vaginal Cancer • Vulvar Cancer • HLA-A • HLA-C • PRAME

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

TSCAN-002: A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=840 | Recruiting | Sponsor: TScan Therapeutics, Inc. | N=100 ➔ 840

Enrollment change • Anal Carcinoma • Cervical Adenocarcinoma • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • Head and Neck Cancer • Infectious Disease • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Ovarian Cancer • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Vaginal Cancer • Vulvar Cancer • HLA-A • HLA-C • PRAME

TScan Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - Solid Tumor Program: Actively screening, enrolling, and dosing patients across the TCR-T therapy candidates; Update on solid tumor program expected by the end of 2024; Investigational new drug (IND) filing for TCR targeting MAGE-A4 on HLA-A*02:01 (TSC-202-A0201) planned by the end of the year; Response data for multiplex therapy anticipated in 2025."

IND • P1 data • Trial status • Oncology • Solid Tumor

TScan Therapeutics Provides Clinical Pipeline Update and Highlights Near-Term Priorities (GlobeNewswire) - "Phase 1 solid tumor clinical study has been initiated; first three patients expected to be dosed in early May 2024. More than 40 patients have completed all biomarker testing in the screening protocol across a broad array of tumor types. 60% of patients qualify for at least one TCR-T in the ImmunoBank and approximately 30% are eligible for multiplex therapy (T-Plex), potentially enabling rapid enrollment into the treatment protocol upon disease progression. Patients have been identified across all six TCR-T cohorts with dosing expected to commence early May. Initial data on patients from both singleplex and multiplex cohorts expected in the second half of 2024....Long-term duration of response data for multiplex therapy anticipated in 2025."

P1 data • Trial status • Solid Tumor

A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: TScan Therapeutics, Inc. | Initiation date: Nov 2023 ➔ Feb 2024

IO biomarker • Metastases • Pan tumor • Trial initiation date • Anal Carcinoma • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Head and Neck Cancer • Infectious Disease • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Ovarian Cancer • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Vaginal Cancer • Vulvar Cancer • HLA-A • HLA-C • PRAME

TScan Therapeutics Announces 2024 Clinical Plans and Highlights Recent Progress (GlobeNewswire) - "Upcoming Anticipated Milestones...Solid Tumor Program: (i) Initiated Phase 1 solid tumor clinical study and expects to dose the first patient in the first quarter of 2024; (ii) Expects to report initial multiplexed therapy data for its first combinations of TCR-Ts under T-Plex, as well as response data for singleplex cohorts, in 2024; (iii) Plans to continue to build ImmunoBank with additional IND filings throughout 2024; (iv) Long-term duration data for multiplexed therapy anticipated in 2025."

IND • P1 data • Trial status • Solid Tumor

A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: TScan Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Pan tumor • Anal Carcinoma • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Head and Neck Cancer • Infectious Disease • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Ovarian Cancer • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Vaginal Cancer • Vulvar Cancer • HLA-A • HLA-C • PRAME

A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: TScan Therapeutics, Inc.

Metastases • New P1 trial • Pan tumor • Anal Carcinoma • Cervical Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Head and Neck Cancer • Infectious Disease • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Ovarian Cancer • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Vaginal Cancer • Vulvar Cancer • HLA-A • HLA-C

TScan Therapeutics Announces FDA Clearance of Three Investigational New Drug Applications for the Treatment of Solid Tumors (GlobeNewswire) - "TScan Therapeutics, Inc....announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) applications for T-Plex, TSC-204-A0201, and TSC-204-C0702....With these INDs cleared, TScan is now working to open a multicenter Phase 1 clinical trial to establish the safety, preliminary efficacy, and feasibility of repeat dosing of multiplexed TCR-T. The trial will include patients with non-small cell lung cancer, melanoma, head and neck cancer, ovarian cancer, and cervical cancer....'We are now engaged in study start-up activities and look forward to sharing initial clinical data for the most advanced TCRs in this program by the end of 2023.'"

IND • New P1 trial • P1 data • Cervical Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Skin Cancer • Solid Tumor

TScan Therapeutics Announces FDA Clearance of Three Investigational New Drug Applications for the Treatment of Solid Tumors (GlobeNewswire) - "'We are continuing to build our ImmunoBank, with four more IND filings anticipated in 2023'....In the Phase 1 trial design, each TCR-T will initially be evaluated as singleplex therapy at two successive dose levels. Once single agent safety is established, each TCR becomes eligible for combination with any other TCR that has passed this threshold. The protocol has an interval 3+3 design, potentially allowing for a rapid path to multiplexing. The trial design also features a screening protocol, which pre-identifies patients whose tumors have a combination of targets and HLAs that would qualify them for the interventional study. The screening protocol is expected to initiate in Q2 2023."

Clinical protocol • IND • Cervical Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Skin Cancer • Solid Tumor

TScan Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "The Company plans to progress IND-enabling studies for its solid tumor programs and submit IND applications for two MAGE-A1 TCRs (TSC-204-A2 and TSC-204-C7) by the end of 2022; The Company plans to file INDs for HPV (TSC-200-A2) and PRAME (TSC-203-A2) in the first half of 2023 with two additional INDs to be filed by the end of 2023. The Company expects to release preliminary clinical safety data for the most advanced TCRs by the end of 2023."

IND • Oncology • Solid Tumor