Affimed Presents Updated Clinical Data from Phase 1/2 Study of AFM13 Precomplexe… – Press Release


  • 100% objective response rate and improvement in the rate of complete responses (CR) from 38% to 62% after a second cycle in 13 patients treated at the recommended phase 2 dose (RP2D)
  • Patients enrolled were multi-refractory with a median of seven prior lines of treatment; all Hodgkin Lymphoma patients had failed brentuximab vedotin and PD-1 therapy in addition to failing multiple lines of chemotherapy
  • Of the eight patients who achieved a CR at the RP2D, seven remain in CR at median follow-up of 6.5 months, including 2 patients who remain in response after 10 months and two who received a consolidation autologous stem cell transplant (SCT)
  • Treatment was well tolerated; no instances of cytokine release syndrome, immune effector cell-associated neurotoxicity or graft versus host disease were observed
  • Data to be presented by Dr. Yago Nieto of The University of Texas MD Anderson Cancer Center, principal investigator of the study, as an oral presentation at AACR today, April 10, 1:00-3:00 p.m. CST during the Clinical Plenary Session

HEIDELBERG, Germany, April 10, 2022 (GLOBE NEWSWIRE) — Affimed N.V. AFMD (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today provided a data update from the ongoing study of the Company’s lead innate cell engager (ICE®) AFM13 precomplexed with cord blood-derived natural killer (cbNK) cells. AFM13 is currently being investigated at The University of Texas MD Anderson Cancer Center in a phase 1/2 study in patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas. The investigator-sponsored study is led by Yago Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson. The study shows a 100% objective response rate (ORR) and an improvement of complete response (CR) rate to 62% at the recommended phase 2 dose (RP2D) in 13 patients after 2 cycles of therapy. The results will be presented…