Clinical holds for Affimed's T cell bispecific following patient death

Affimed N.V. (NASDAQ:AFMD) fell $1.13 (24%) to $3.50 Oct. 9 after it placed a clinical hold on two studies of blood cancer candidate AFM11 following three treatment-related serious adverse events, including a patient death. The product is a tetravalent bispecific human antibody targeting CD19 and CD3. Affimed announced the hold late Oct. 8.

AFM11 is in two Phase I trials to treat relapsed or refractory B cell non-Hodgkin lymphoma (NHL) and B cell precursor acute lymphoblastic leukemia (ALL); the studies have enrolled a total of 33 patients. One patient in the European ALL study died after AMF11 treatment, and two patients in the international NHL study experienced life threatening SAEs. One of the two NHL patients recovered from the SAE but died following disease progression, Affimed CMO Leila Alland told BioCentury...