Heidelberg, Germany, October 6, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the first patient was successfully dosed with allogeneic cord blood-derived natural killer (cbNK) cells preloaded with AFM13 and has moved on to the AFM13 monotherapy phase of the treatment cycle. This therapy was developed through a research collaboration with The University of Texas MD Anderson Cancer Center.
This is the first in human study to combine an NK cell product with an antibody whose primary mechanism is designed to specifically bind and activate NK cells and tumors cells in a bispecific fashion.
An NK cell armed with AFM13 is designed to direct NK cells to the tumor site in order to target cancer cells. Pursuant to the study design, after dosing with the preloaded NK cells, AFM13 is subsequently administered as monotherapy in order to maintain the activation of the infused cbNK cells and engage the patients’ own innate immune system (NK cells and macrophages), a distinct feature of Affimed’s ICE® products.
The Leukemia & Lymphoma Society Therapy Acceleration Program® (TAP) and Affimed formed a partnership in 2013 and co-funded phase 2 trials supporting AFM13, a novel tetravalent bispecific antibody directed against human CD30 and CD16A to treat Hodgkin lymphoma patients. LLS committed to investing up to $4.4 million to support the project.
AFM13 is Affimed’s most advanced ICE® clinical program, and it is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT). The study is actively recruiting and can be found at www.clinicaltrials.gov using the identifier NCT04101331.