The FAD has granted primary IND clearance to the company’s T-Plex program and 2 initial TCR-T therapies.
The FDA has granted investigational new drug application (IND) clearance to 3 of TScan Therapeutics’ T-cell receptor (TCR) T cell therapy (TCR-T) programs, T-Plex, TSC-204-A0201, and TSC-204-C0702 for the potential treatment of solid tumors.
“With the clearance of these three INDs, we believe we are the only company in the cell therapy field to have a clear clinical and regulatory path to develop multiplexed TCR-T cell therapy, which we see as critical for achieving durable responses in patients with solid tumors by overcoming resistance due to target or HLA loss. We will continue to rapidly build out our ImmunoBank, allowing us to deliver customized treatments tailored to each patient’s tumor biology,” Gavin MacBeath, PhD, chief scientific and operations officer, said in a statement. “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.”
T-Plex is the primary IND in the company’s solid tumor programand includes the IND enables the use of multiple, customized, combinations of TCRs for each patient depending on targets and human leukocyte antigen expression. TCR-Ts are madefrom high-affinity, naturally occurring TCRs in TScan’sImmunoBankand each unique TCR-T will be filed as a secondary IND referencing the primary T-Plex IND.
TSC-204-A0201, and TSC-204-C0702 are 2 of these TCR-T products. They target melanoma-associated antigen 1 (MAGE-A1) on HLA types A*02:01 and C*07:02 and will be evaluated forsafety and tolerability in head and neck, melanoma, cervical, and non-small cell lung cancersin the soon-to-initiate phase 1 trial of singleplex and multiplexed TCR-Ts. TScan noted that, to their knowledge, TSC-204-C0702 is the first clinical program in MAGE-A1 for an HLA type other than A*02:01.
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The trial starts with a screening protocolto pre-identify patients with qualifying tumor targets and HLAs. The 3+3 designed trial will initial evaluate each TCR-T as singleplex therapy at 2 dose levels to establish safety, after which it becomes eligible for combination with other cleared TCR-Ts. The screening protocol is expected to initiate in the second quarter of 2023.
“Today marks the first three IND clearances for our solid tumor program and further validates the use of our proprietary platform to identify therapeutic TCRs suitable for clinical development. With the FDA clearance of T-Plex, along with two MAGE-targeting TCRs, we are now one step closer to bringing bespoke cell therapies to patients. We are continuing to build our ImmunoBank, with four more IND filings anticipated in 2023,” David P. Southwell, president and chief executive officer, TSCan Therapeutics, added to the statement.