1:30 PM
Oct 09, 2018
 |  BC Extra  |  Clinical News

Affimed sinks after placing clinical hold on bispecific T cell engager

Affimed N.V. (NASDAQ:AFMD) fell $1.13 (24%) to $3.50 Tuesday 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 Monday.

AFM 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.

Affimed said the SAEs occurred at the highest dose level tested in each trial. All three patients experienced neurotoxicities, Alland said. The patients had progressive disease and had received several lines of prior therapy.

The company said it will work with global health authorities, safety monitoring committees and clinical investigators to determine next steps for the program.

Safety events have been observed with other therapies targeting CD19 and CD3.

Blincyto blinatumomab, a bispecific T cell engager (BiTE) against CD19, from Amgen Inc. (NASDAQ:AMGN) carries a black box warning on its label for cytokine release syndrome and neurological toxicities. The therapy is approved to treat relapsed or refractory B cell precursor ALL and minimal residual disease (MRD)-positive B cell precursor ALL.

Affimed said the clinical hold will not affect another program targeting NK cells, AFM13, a bispecific human antibody targeting CD30 and Fcγ receptor IIIa (CD16a; FCGR3A; FcγRIIIa).

AFM13 has shown a favorable safety profile as a monotherapy and in combination with Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK), Alland said. Updated data from monotherapy and combination studies to treat blood cancers are expected at a medical conference this quarter.

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