AFM13 is an investigational immunotherapy being developed by Affimed to treat patients with Hodgkin’s lymphoma (HL) who have not responded well to other treatments. It is considered a first-in-class drug because of its unique approach to harnessing the cancer-cell-destroying power of natural killer (NK) cells. NK cells are immune cells that specialize in attacking and destroying tumor cells or cells infected with a virus.
How AFM13 works
AFM13 is called a bispecific tandem antibody (TandAb) because it binds to two targets: CD30 on HL cancer cells, and CD16A on NK cells. CD30 is expressed in particularly high numbers on Reed Sternberg cells, the dominant malignant blood cells in HL, while CD16A is highly expressed on NK cells. AFM13 binds strongly and specifically to both CD30 and CD16A, which prevents AFM13 from binding to other targets on healthy cells.
By binding to both CD30 and NK targets, AFM13 activates the NK cells to destroy the CD30-positive HL cancer cells.
AFM13 in clinical trials
AFM13 was first tested in a Phase 1 clinical trial (NCT01221571) that explored its safety and effectiveness at escalating doses in patients with HL. Only patients with refractory or relapsing HL were included in the study, meaning that they either had not achieved remission (refractory) or their cancer had returned (relapsing) after standard cancer treatments, including chemotherapy, radiation therapy, and treatment with Adcetris (brentuximab vedotin), another type of immunotherapy.
The results of the study, published in a 2015 issue of the journal Blood, showed that AFM13 was safe at all of the doses tested and that its tumor-fighting effects increased as the dose increased (which is called being dose-dependent). Of the 26 patients who were evaluated, three achieved partial remission and 13 achieved stable disease, with an overall disease control rate of 61.5%.
Based on the results of the trial, AFM13 proceeded to a Phase 2 open-label, multicenter trial (NCT02321592) that also included only patients with refractory or relapsing HL. This trial, which began in May 2015 and is ongoing, is a collaboration between Affimed, the Leukemia and Lymphoma Society, and the University of Cologne in Germany.
Patients will be randomized to receive AFM13 either three times a week for eight weeks in a row, or three times a week for two weeks, followed by once a week for the next six consecutive weeks, to determine an optimum treatment schedule. The study began in May 2015 and is still recruiting participants.
A second Phase 1 study, called KEYNOTE-206 (NCT02665650), will evaluate the safety and effectiveness of AFM13 combined with Merck’s Keytruda (pembrolizumab), an immunotherapy that helps the immune system detect and fight tumor cells. Participants, who all have refractory or relapsing HL, will receive increasing doses of AFM13 for up to 25 weeks, along with fixed doses of Keytruda for up to 52 weeks.
Additional information
Because of the way AFM13 is cleared from the body, it does not require hours of continuous infusion. Rather, it can be given via a bolus injection into a standard vein.
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