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TScan Therapeutics has announced that the FDA has cleared its Investigational New Drug (IND) application for TSC-203-A0201, its fourth TCR-T cell product. The 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.
Clinical-stage biopharmaceutical company TScan Therapeutics, Inc., focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, announced the clearance of its IND application for TSC-203-A0201, a TCR-T targeting PReferentially expressed Antigen in Melanoma (PRAME).
Gavin MacBeath, Ph.D., Chief Executive Officer said:
“The IND clearance of TSC-203-A0201, the fourth TCR-T cell product cleared for our T-Plex solid tumor program, highlights the strength of our discovery platform and the potential of cell therapy to treat patients with a wide variety of solid tumors.”
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, SC-203-A0201 is the fourth TCR-T cleared for clinical development in TScan therapeutics’ solid tumor program. The 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. Specific combinations of TCR-T cell agents are administered to patients based on which targets and HLAs are expressed in their tumors. To establish safety, each agent will be tested first singly at two levels in the Phase I clinical trial; then will be eligible to be combined with any other TCR-T cell product.
“We are thrilled to have a multiplexing strategy that allows us to customize treatments tailored to each patient’s tumor biology, particularly utilizing targets that are expressed in prevalent cancers such as melanoma, lung, and head and neck cancers,” clarified Debora Barton, M.D., Chief Medical Officer.
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PRAME is expressed in approximately 90% of melanomas as well as frequently expressed in various other solid tumors. TSC-203-A0201 is specific for patients with HLA type A*02:01, representing over 40% of people in the U.S.
Macbeth added:
“PRAME is a particularly important target, as it is very frequently expressed in solid tumors and recent clinical trials targeting PRAME have shown promising results. In parallel, we are increasing our discovery efforts to further expand the number of therapeutic TCRs suitable for clinical development, and we anticipate additional IND filings for our solid tumor program this year and next.”
TScan’s lead TCR-T therapy candidates, TCS-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to eliminate residual disease and prevent relapse after allogeneic hematopoietic cell transplantation.
Source: TScan Therapeutics Press Release
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