Balstilimab, also known as AGEN2034, is an immunotherapy that Agenus is developing to treat cervical cancer and other solid tumors.

How balstilimab works

As an immunotherapy, balstilimab does not act on a tumor directly. It helps the immune system do a better job of recognizing and fighting the cancer.

Most the time immune T-cells can identify cancer cells as abnormal and attack them. But some tumors develop ways to avoid T-cell detection.

Healthy cells produce proteins that help the body get rid of damaged cells. They are called programmed cell death pathway ligands 1 and 2, or PD-L1 and PD-L2. Ligands’ interaction with  a receptor called PD-1 on the surface of T-cells generates a signal that prevents the T-cells from go after the protein. By producing PD-L1, the tumor can trick the immune system into believing it is normal tissue, preventing it from being killed.

Balstilimab is an immune checkpoint inhibitor. It binds to PD-1 on T-cells, preventing ligands from interacting with the receptor. This prevents a tumor from sending signals that try to trick T-cells from attacking it. Instead, the T-cells recognize the tumor and try to kill it.

A downside of using an immune checkpoint inhibitor to fight cancer is that the abnormal immune system activation that the drug triggers can damage healthy as well as malignant tissue.

Balstilimab in clinical trials

Agenus is recruiting up to 75 people with cervical cancer or other advanced tumors for a Phase 1/2 clinical trial (NCT03104699) of AGEN2034. The Phase 1 portion of the trial is aimed at finding the maximum dose of the therapy that patients can tolerate.

The Phase 2 portion will evaluate the optimal dose’s ability to counter cervical cancer that returns after chemotherapy. Researchers will evaluate patients’ response to AGEN2034 for up to a year.

The first patient received AGEN2034 in April 2017. The trial is expected to be completed by September 2019.


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