Affimed (NASDAQ:AFMD) announced that the FDA has granted regenerative medicine advanced therapy (RMAT) designation to its combination therapy involving Affimed’s innate cell engager (ICE) acimtamig, and Artiva Biotherapeutic’s AlloNK (AB101) for the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL).
The combination therapy is currently being evaluated in the ongoing LuminICE-203 Phase 2 trial. Earlier this year, Affimed reported promising early efficacy data from 12 patients enrolled in the study.
“This is an important regulatory milestone demonstrating that the FDA acknowledges the critical need for new therapies in R/R HL, in particular for double refractory HL patients where there are no approved therapies,” said Dr. Shawn M. Leland, PharmD, RPh, CEO of Affimed.
“In addition, the RMAT designation validates the strength of our growing clinical data and the promise of our innovative treatment to bring hope to patients battling this rare and difficult-to-treat cancer,” Dr. Leland added.
