TScan Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) applications for T-Plex, TSC-204-A0201, and TSC-204-C0702.
Serving as the primary IND for TScan’s solid tumour programme, T-Plex will enable customised combinations of T cell receptor (TCR)-engineered T cell therapies (TCR-T) to be given to patients based on the HLAs and targets expressed in their tumours.
The specific TCRs for each patient will be selected from TScan’s ImmunoBank.
The company noted that each unique TCR-T will be filed as a secondary IND and reference the primary IND for T-Plex.
TScan Therapeutics chief scientific and operations officer Gavin MacBeath said: “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 customised treatments tailored to each patient’s tumor biology.
“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.”
TScan also filed secondary INDs for TSC-204-A0201 and TSC-204-C0702, two initial TCR-T products.
With the clearances of these INDs, TScan is currently working to launch a multicenter Phase I clinical trial for establishing the preliminary efficacy, safety and feasibility of repeat dosing of multiplexed TCR-T.
This trial will have non-small cell lung cancer, melanoma, head and neck cancer, ovarian cancer, and cervical cancer patients.