Affimed V. announced that the FDA has granted fast track designation to the combination of its innate cell engager (ICE(R)) AFM13 with AlloNK(R) for the potential treatment of relapsed/refractory (r/r) Hodgkin lymphoma (HL). The FDA's decision is based on available data showing the potential of the AFM13 and AlloNK(R) combination therapy to overcome current limitations in the treatment of r/r HL. With the Fast Track Designation, the therapeutic development of the combination can benefit from more frequent engagement with the FDA, which will support the collection of appropriate data needed to accelerate its development.

LuminICE-203 builds on the clinical findings from the phase 1/2 AFM13-104 trial (NCT04074746), in which investigators assessed AFM13 in combination with cord blood-derived natural killer cells in heavily pretreated patients with CD30- positive Hodgkin lymphoma and non-Hodgkin lymphoma. Data presented to date from this trial have shown outstanding clinical results in late-stage, multi-refractory, patients with a 94% overall response rate (ORR), a 71% complete response (CR) rate and a well-managed safety profile at the recommended phase 2 dose (RP2D); specifically in the 31 r/r HL patients treated, the ORR and CR were 97% and 77% respectively.