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Wednesday, June 12, 2024

Affimed Q1 Update

 Program Updates

Acimtamig (AFM13; CD30 / CD16A)
Independent read data from the first 7 patients show an ORR of 85.7 % with 4 CRs and 2 PRs.

  • All patients were heavily pretreated with a median of 4 lines of prior treatment including combination chemotherapy, brentuximab vedotin and checkpoint inhibitors; 71 % (5/7 patients) had also failed after prior autologous stem cell transplantation (ASCT).
  • Treatment related adverse events were consistent with previous experience and were mainly mild to moderate IRR/CRS in nearly two thirds of the patients (4/7). One patient developed a short-lasting grade 3 CRS but was also diagnosed to have acute cytomegalovirus infection. All side effects were well manageable with standard of care treatment and there were no treatment discontinuations due to acimtamig or AlloNK® related adverse events. No cases of bleeding, immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease were observed. Enrollment in cohorts 1 and 2 is completed; cohorts 3 and 4 are now open and enrolling.
  • Continued updates from the study to be provided on upcoming earnings calls and scientific conferences.

Upcoming Milestones:

  • Data readout from the 12 patients in cohorts 1 and 2 of the LuminICE-203 (AFM13 combination with AlloNK® cells) study in Q3 2024.
  • ORR and PFS data from the 25 patients in the EGFRmut cohort of the AFM24-102 study in Q3 2024.
  • ORR and PFS data from the 40 patients in the EGFRwt cohort of the AFM24-102 study in Q4 2024.

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