TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-200-A0201 Targeting HPV16 to Treat Solid Tumors

2023-06-06

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TSC-200-A0201 is TScan’s third cleared IND for the T-Plex solid tumor program supporting the use of multiple TCRs in combination to deliver customized, multiplexed TCR-T cell therapies based on target and HLA expression

WALTHAM, MA, USA I June 06, 2023 I TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-Ts) 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-200-A0201, a TCR-T targeting human papillomavirus 16 (HPV16). TSC-200-A0201 is the third TCR cleared for clinical development in the Company’s ImmunoBank following TSC-204-A0201 and TSC-204-C0702, which target MAGE-A1 presented on HLA types A*02:01 and C*07:02, respectively.

T-Plex serves as the primary IND for TScan’s solid tumor program, enabling customized combinations of enhanced TCR-Ts to be administered to patients based on the targets and HLAs expressed in their tumors. The specific TCRs for each patient will be chosen from the Company’s ImmunoBank, consisting of high-affinity, naturally occurring TCRs that recognize a variety of prevalent cancer-specific targets and are associated with various common HLA types.

TSC-200-A0201 targets HPV16, which is an oncogenic virus that is responsible for approximately 57% of cervical cancers and approximately 21% of head and neck squamous cell carcinomas.

“Our multiplexing strategy is unique in that it allows us to be more inclusive of patients with a variety of tumor types and supports combination therapy, the most successful approach to treating solid tumors,” said Debora Barton, M.D., Chief Medical Officer. “We believe that the delivery of customized treatments tailored to each patient’s tumor biology is critical for achieving durable responses in patients with solid tumors, by overcoming resistance due to tumor heterogeneity, and target and HLA loss. Clinical trial start-up activities are ongoing, and we anticipate initial data for the most advanced TCRs in this program by the end of this year.”

Gavin MacBeath, Ph.D., Chief Executive Officer, continued: “We now have three cleared INDs for TCR-Ts in our T-Plex solid tumor program, representing further progress in our drive to build the ImmunoBank and deliver multiplexed TCR-T to a broad patient population with a high unmet medical need. This IND clearance is further validation of the strength of our discovery platform to identify therapeutic TCRs suitable for clinical development. We are continuing to build our ImmunoBank and anticipate additional IND filings in 2023 and 2024.”

About TScan Therapeutics, Inc.

TScan is 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. The Company’s lead TCR-T therapy candidates, TSC-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. The Company is also developing multiplexed TCR-T therapy candidates for the treatment of various solid tumors. The Company has developed and continues to build its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplexed TCR-T therapies for patients with a variety of solid tumors.

SOURCE: TScan Therapeutics

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