AFM11 is an immunotherapy that Affimed is developing to treat non-Hodgkin lymphoma (NHL) and acute lymphocytic leukemia (ALL).

How AFM11 works

NHL and ALL are blood cancers characterized by the abnormal behavior and growth of white blood cells called B-cells. These cancerous B-cells commonly have a protein called CD19 on their surface.

The immune system normally kills infected or abnormal cells by directing a type of immune cell called a T-cell to destroy these abnormal cells. But many types of cancer cells find ways to evade the targeting.

It is an immunotherapy that does not kill cancer cells directly but encourages the immune system to recognize and destroy the cancer. AFM11 activates T-cells’ cytotoxic, or cell-killing, ability in the presence of cancer cells.

AFM11 uses Affimed’s T-cell TandAb technology, which involves the production of a bispecific antibody, or protein that can bind to two targets. AFM11 has two parts. The first part consists of two binding sites for the CD19 protein present on the surface of cancer cells. It links this to two binding sites for a protein called CD3, which is found on T-cells.

When AFM11 binds to both a T-cell and the cancer cell, it triggers a reaction to activate the cytotoxic activity of the T-cell, killing the cancer cell. Because AFM11 is specific to the cancer cell, it minimizes damage to healthy cells.

AFM11 in clinical trials

Preclinical-trial studies published in the journal mAbs indicated that AFM11 may be able to activate T-cells to kill cancer cells. The studies involved a lymphoma mouse model, human cancer cell lines, and human tumor samples.

The promising results prompted Affimed to start two Phase 1 clinical trials.

The first (NCT02106091) is assessing AFM11 in 50 patients with CD19-positive B-cell NHL that has come back after or is resistant to standard treatment.

The second (NCT02848911) is evaluating AFM11 in 50 patients with relapsed or refractory adult B-cell precursor ALL.

Both trials will increase doses to determine a maximum tolerated dose. The increases will occur over four weeks in NHL patients and two weeks in ALL patients. Researchers will monitor patients for their response to the therapy and for adverse effects for up to eight weeks.


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