The US Food and Drug Administration (FDA) has granted Fast Tack Designation for an immune medicine targeting triple-negative breast cancer. 

RPTR-1-201 is a novel T cell receptor (TCR) bispecific immune medicine, developed by biotechnology company Repertoire Immune Medicines, that is currently in a Phase I/II trial for the treatment of multiple advanced solid tumours. 

The treatment is comprised of an engineered TCR that binds with high affinity and precision to a tumour-selective epitope and an anti-CD3 moiety that engages and redirects T cells to kill tumour cells.  

RPTR-1-201 is derived from Repertoire’s DECODE platform, which maps the immune synapse to identify TCR-epitope pairs and translate these insights into T cell-targeted immune medicines. 

“RPTR-1-201 reflects our ability to discover tumour-selective epitopes and intentionally engineer TCR bispecifics designed to engage them with high affinity and specificity,” said Anthony Coyle, President and Head of Research and Development at Repertoire Immune Medicines.  

“Derived from our DECODE platform, RPTR-1-201 couples an epitope-specific TCR with an anti-CD3 domain to engage and redirect T cells. Fast Track Designation supports closer dialogue with the FDA as we advance the programme and continue its clinical evaluation.” 

“Patients with advanced TNBC often face limited options after progression on standard therapies,” added Robert Andtbacka, Chief Medical Officer of Repertoire Immune Medicines.  

“Fast Track Designation underscores the seriousness of this disease and the unmet needs for new treatment options. RPTR-1-201 is designed to redirect T cells by targeting a tumour-selective epitope on tumour cells in selected patients, and we appreciate the FDA’s engagement as we evaluate its potential in this population.”