Healthcare Business

Can This Clinical Hold Stop Affimed's Momentum?

Affimed N.V. (NASDAQ: AFMD) shares took a big step back early on Tuesday after the company announced that it has placed its AFM11 (CD19/CD3-targeting T cell engager) on clinical hold, and has notified the global health authorities of its decision.

While this clinical hold may be temporary, Affimed has made some incredible gains this year. Excluding Tuesday’s move, Affimed has outperformed the broad markets with the stock up about 107% in the past 52 weeks. In just 2018 alone, the stock is down 256%.

For some quick background: AFM11 is being evaluated in two Phase 1 clinical studies for the treatment of patients with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). The clinical hold was initiated after the occurrence of serious adverse events in three patients, which included a death in the ALL study and two life-threatening events in the NHL study.

Affimed will be working closely with the global health authorities, the Safety Monitoring Committee and the studies’ clinical investigators to review the events, carefully assess all the data and determine next steps for the AFM11 program. The company intends to provide an update on AFM11 upon completion of the evaluation.

The clinical hold does not affect the ongoing development of Affimed’s NK cell engager programs, which are based on targeting the NK cell receptor CD16A, a different approach than used for AFM11, which targets T cells through CD3.

Shares of Affimed closed Monday at $4.63, with a consensus analyst price target of $7.19 and a 52-week trading range of $1.15 to $7.35. Following the announcement, the stock was down 25% at $3.45 in early trading indications Tuesday.