Our lead candidate TCRT-ESO-A2 is an autologous T cell receptor (TCR)-T cell therapy targeting solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients. The U.S. FDA has recently allowed the IND application for this investigational agent, clearing our first T cell therapy product to advance to the first stage of clinical development in the U.S. Preclinical and early clinical findings indicate this TCR-T cell therapy technology could potentially be an effective treatment for multiple tumor types.
TCRT-ESO-A2 is similar to TAEST16001, an autologous cell-based therapy being developed simultaneously by our partner, XLifeSc, for clinical application in China, in that both therapies express the same affinity-enhanced TCR. China’s National Medical Products Association has allowed the IND application for TAEST16001 in early 2019 and XLifeSc has initiated a Phase I trial of TAEST16001 in China.
We are also developing high affinity TCRs using the TAEST technology selective for additional tumor associated antigens and restricted to several additional HLA alleles to extend the potential for treatment to a larger number of tumors and patients.