FDA puts Affimed's T cell engager on official clinical hold

On Oct. 12, Affimed placed a voluntary hold on AFM11 due to a death and two life-threatening events in phase 1 trials. (FDA)

Just a week after Affimed decided to put its T cell engager for blood cancers on hold, the company reported that the FDA has “concurred with Affimed’s decision to stop recruitment” and placed the program on full clinical hold. 

The treatment, AFM11, targets CD19 and CD3 and is in phase 1 trials for non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). In total, 33 patients had been dosed in the trials.The FDA hold was just a matter of time, as Affimed had halted enrollment due to a death in the ALL trial and two life-threatening events in the NHL trial. The adverse events happened in patients taking the highest dose of AFM11, Affimed said. 

At the time, Heidelberg, Germany-based Affimed reported its decision to global health authorities and said it would buckle down with safety monitoring committees, health authorities and the studies’ investigators to work out the next steps for AFM11. 

Friday, the FDA told Affimed that it was placing a full clinical hold on AFM11, according to an SEC filing. 

“Affimed will continue to comply with FDA and other global health authorities’ requests for information as may be required to complete a full evaluation and resolve the clinical hold,” the company said in the filing. 

The news of the voluntary hold last week sent the company’s stock down by nearly one-third of its value, a dip Affimed has yet to recover from. 

Affimed has one other T cell engager program, AMV564, a CD33/CD3 bispecific in phase 1 for acute myeloid leukemia (AML) that is licensed to San Francisco-based Amphivena. And it has a handful of natural killer (NK) cell engagers, which, the company emphasized last week, are not affected by the clinical hold. Its lead NK cell engager, AFM13, is a bispecific antibody that binds to CD30 on tumor cells and to the NK cell receptor CD16A. It is furthest along in Hodgkin lymphoma and CD30-positive lymphoma. 

The NK cell engager platform is the basis of a deal Affimed struck with Genentech in August. Affimed picked up $96 million up front and could reap as much as $5 billion in milestone payments and royalties. 

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