TSR-022 is an experimental immuno-oncology treatment being developed by Tesaro in collaboration with AnaptysBio.

How TSR-022 works

TSR-022 is a monoclonal antibody against TIM-3 (also called HAVCR2), an immune checkpoint receptor. Immune checkpoint proteins are molecules that help to regulate the immune system so it does not mistakenly attack healthy cells. However, they can also keep immune cells from recognizing and killing cancer cells.

TIM-3 is found on the surface of certain T-cells, including tumor-infiltrating T-cells, that have left the bloodstream and migrated into the tumor environment. By binding to and blocking TIM-3, TRS-022 allows for T-cells to become activated so as to enhance T-cell-mediated attacks on tumors. These attacks reduce their growth.


TSR-022 in clinical trials

TSR-022 was first evaluated in preclinical studies in mice and monkey models as well as human cell lines. These studies showed that TSR-022 specifically binds to human and monkey TIM-3 but not to mouse TIM-3. More importantly, they showed that TSR-022 increases T-cell activation without being toxic, being well-tolerated in both monkey studies and human cells assays.

The safety, tolerability, and efficacy of TSR-022, alone or in combination with Tesaro’s investigative anti-PD-1 antibody, TSR-042, are being evaluated in a multicenter, open-label Phase 1 trial (NCT02817633). The study, which is now recruiting  627 patients with advanced solid tumors in nine locations in the U.S., will be conducted in two parts: a dose escalation and cohort expansion phase.

The dose escalation part will determine the ideal, recommended dose of TSR-022 — one with good anti-tumor activity but limited side effects. The second part will  explore the safety and clinical activity of the recommended dose of TSR-022 as monotherapy and in combination with TSR-042.

The trial is expected to run through June 2020.


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