FDA grants Repertoire's cancer therapy Fast Track status

(CONNECT) The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Repertoire Immune Medicines ' novel bispecific immunotherapy RPTR-1-201 for the treatment of triple-negative breast cancer (TNBC). This has now been announced by the biotech company. It is headquartered in Cambridge in the US state of Massachusetts and is represented in Switzerland in the Bio-Technopark Schlieren-Zurich.

This particularly aggressive form of breast cancer occurs in around one in six patients, primarily in younger women. It is considered particularly difficult to treat because it lacks three characteristics for targeted therapies, which is why it is referred to as triple-negative breast cancer.

"Patients with advanced TNBC often have few treatment options left after the disease has progressed with standard therapies," Repertoire's Medical Director Robert Andtbacka is quoted as saying in the press release. "The fast track approval underlines the severity of this disease and the unmet need for new treatment options." This status enables an accelerated procedure with shortened processes, reduced waiting times and faster development, also by means of an accompanying intensive exchange with the FDA.

RPTR-1-201 was discovered using Repertoire's DECODE platform. This is a T-cell receptor-specific therapy. It redirects the body's own T cells of a sick person, directs them towards a common, tumor-specific target and kills the tumor cells in this way. In contrast to many other T cell-targeted therapies, which focus on known antigens specific to a single tumor type, the new drug binds to a molecular segment (epitope) that is present in various solid tumors and could therefore be used against several tumors.

RPTR-1-201 is currently being investigated in a Phase 1/2 clinical trial in people with advanced solid tumors - as a monotherapy and in combination with a treatment that blocks the PD-1 protein on T cells. The study takes place in Europe and the USA. ce/mm