MBG453 is an immunotherapy that Novartis is developing to treat solid tumors and hematologic cancers, which form in the blood or immune system.

Immunotherapies use the body’s own immune system to fight cancer.

How MBG453 works

MBG453 inhibits TIM-3, a protein found on the surface of certain immune T-cells. Its full scientific name is T-cell immunoglobulin and mucin-domain-containing-3.

T-cells are crucial to the immune system performing its normal function of attacking and destroying cancer cells.

TIM-3 is an immune checkpoint, or protein that ensures that the immune system does not mistakenly attack healthy cells. Tumor cells have found a way to use checkpoints to prevent the immune system from attacking and destroying them. They apply a brake to the system to stop its normal functioning, including attacking cancer.

MBG453 binds to TIM-3 on the surface of T-cells, releasing the brakes that the tumor applied to the immune system. This allows it to function normally against cancer cells, reducing tumor growth.

MBG453 in clinical trials

Novartis is conducting Phase 1/2 clinical trials of MBB453 as a treatment for several types of cancer.

A Phase 1/2 trial (NCT02608268) is investigating the safety and effectiveness of MBG453, either alone or combined with another immunotherapy, in patients with solid tumors. The PDR001 study started in November 2015. It continues to recruit participants in the United States, Canada, Japan, Europe, China, and Singapore.

Novartis started another Phase 1 trial (NCT03066648) in July 2017. It is studying the safety of a combination of MBG453 and the chemotherapy Dacogen (decitabine) in patients with hematologic cancers, and patients’ ability to tolerate the treatment. One goal of the trial is to identify recommended doses for future studies. Researchers are recruiting participants in the United Kingdom, Spain and Australia.


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