TSC-203-A0201

TSC-203-A0201 is a T cell receptor (TCR)-engineered T cell therapy (TCR-T) targeting PReferentially expressed Antigen in MElanoma (PRAME). It is being developed by TScan Therapeutics for the treatment of various solid tumors, particularly those with high PRAME expression such as melanoma, head and neck cancers, and non-small cell lung cancer. ## Development Status TSC-203-A0201 received FDA clearance for its Investigational New Drug (IND) application in August 2023. The first patient with metastatic melanoma was dosed with TSC-203-A0201 in May 2024 as part of TScan's Phase 1 clinical trial for solid tumors. ## Mechanism and Target The therapy targets PRAME (PReferentially expressed Antigen in MElanoma), which is expressed in approximately 90% of melanomas, 90% of head and neck cancers, and 50% of non-small cell lung cancers. TSC-203-A0201 is specific for patients with HLA type A*02:01, which represents over 40% of people in the United States. ## Clinical Development TSC-203-A0201 is part of TScan's solid tumor program and is the fourth TCR-T cell product cleared for clinical development in this program, following TSC-200-A0201, TSC-204-A0201, and TSC-204-C0702. These TCR-T cell products are designed to be used in combination with each other (referred to as T-Plex combinations) and are being developed under a single master clinical trial protocol. The Phase 1 clinical trial is evaluating TSC-203-A0201 both as a monotherapy and in various combinations with other TCR-T therapies for the treatment of locally advanced, unresectable, or metastatic solid tumors. The company is on track to report initial data from this solid tumor clinical trial in 2024. ## Indications TSC-203-A0201 is being investigated for multiple indications including: - Metastatic melanoma - HPV positive oropharyngeal squamous cell carcinoma - Human Papillomavirus-Related Anal, Cervical, Penile, and Vulvar Squamous Cell Carcinoma - Locally Advanced Malignant Solid Neoplasm The multiplex TCR-T therapy approach has the potential to overcome tumor heterogeneity and HLA loss of heterozygosity, which are commonly observed resistance mechanisms in solid tumors.

Other names

TSC-203 (HLA-A*02:01)TSC203 (HLA-A*02:01)