How AFM13 works
HL is a type of blood cancer that is characterized by the development of abnormal large Reed Sternberg cells from a type of white blood cell called a B-cell. These cells tend to overexpress a protein called CD30 on their surface. This protein can also be expressed in some types of NHL, such as cutaneous T-cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL), and diffuse large B-cell lymphoma (DLBCL).
As a type of immunotherapy, AFM13 does not kill cancer cells directly but encourages the body’s own immune system to seek out and destroy the cells. It works by activating a type of immune cell, called a natural killer (NK) cell, and directing them to destroy the cancerous cells.
NK cells have receptors on the outside, which act to stimulate or inhibit their cell-killing ability when a particular protein binds to them.
AFM13 is a bispecific antibody, a protein designed to bind to two specific targets that Affimed calls a NK-cell TandAb. It consists of two parts. The first contains two binding sites for CD30, found on the cancerous cells. The second contains two binding sites for CD16A, the receptor to activate the NK cell.
When the natural killer cell is linked to the cancerous cell by AFM13 binding, its cell-killing ability is activated. This results in the body’s own immune cells destroying the cancer in a targeted manner.
AFM13 in clinical trials
A completed Phase 1 study (NCT01221571) assessed the safety, tolerability, and activity of AFM13 in 28 patients with HL that returned despite treatment or is resistant to standard treatment (relapsed/refractory). Results from the study were published in the scientific journal, Blood.
The maximum tolerated dose was not reached in the study, and the safety profile was positive with most adverse events being only mild or moderate. Of the 26 patients included in the analysis, 11.5 percent achieved partial remission, where the cancer was reduced, and 50 percent achieved stable disease, where the disease was no longer progressing.
Following these positive results, Affimed initiated a Phase 2 trial (NCT02321592), co-funded by the Leukemia and Lymphoma Society. The trial is being carried out at the University of Cologne, Germany, to test the safety and efficacy of AFM13 in 39 patients with relapsed/refractory HL.
A Phase 1b study (NCT02665650) called KEYNOTE-206 is assessing AFM13 in combination with Keytruda (pembrolizumab) in 33 patients with relapsed/refractory HL. This is being carried out as a collaboration between Affimed and Merck Sharp & Dohme, a subsidiary of Merck (MSD).
AFM13 was designated an orphan drug by the U.S. Food and Drug Administration (FDA) in September 2009.
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