SC-203-A0201 is TScan’s fourth TCR-T cell product cleared for use in its solid tumor program, designed to enable customized, multiplexed TCR-T cell therapy
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 that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for TSC-203-A0201, a TCR-T targeting PReferentially expressed Antigen in Melanoma (PRAME). In addition to being expressed in ~90% of melanomas, PRAME is also frequently expressed in various other solid tumors, including ~90% of head & 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 U.S. TSC-203-A0201 is the fourth TCR-T cleared for clinical development in the Company’s solid tumor program, following TSC-200-A0201, TSC-204-A0201, and TSC-204-C0702, which target human papillomavirus 16 (HPV16) presented on HLA type A*02:01, and MAGE-A1 presented on HLA types A*02:01 and C*07:02, respectively.
All four TCR-T cell products are designed to be used in combination with each other and are being developed under a single master clinical trial protocol. Each agent is an enhanced, autologous T cell therapy product that includes the cancer antigen-specific TCR, along with CD8α/ß to engage helper T cells and a dominant negative form of TGFß receptor II to promote T-cell persistence. Patients are administered specific combinations of TCR-T cell agents based on which targets and HLAs are expressed in their tumors. In the Phase 1 clinical trial, each agent will first be tested singly at two dose levels to establish safety, and then will be eligible to be combined with any other TCR-T cell product.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.