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Affimed Down After Clinical Hold on Two Early-Stage Studies

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Affimed N.V. (AFMD - Free Report) announced that it has placed two phase I studies evaluating its CD19/CD3-targeting T cell engager, AFM11, on clinical hold. The studies were evaluating the candidate in patients with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL). The company has notified global health authorities about its decision.

The decision was taken due to occurrence of serious adverse events (SAEs), which included death of one ALL patient and two life-threatening events in the NHL study in the respective highest dose cohorts.

Shares of the company declined 25.1% in after-hours trading on Oct 8, following the announcement. However, Affimed’s shares have witnessed a significant rally of 256.1% so far this year against the industry’s decrease of 0.5%.

Affimed is a Germany-based clinical stage biopharmaceutical company, which is focused on developing highly targeted cancer immunotherapies by engaging NK and T cells.

The company intends to further analyze the data from the study in collaboration with various global health authorities, the safety monitoring committees, and the studies' clinical investigators. Any decision on future development will be taken upon the completion of the evaluation.

Apart from AFM11, the company also has other NK cell engager programs, which target a different protein, CD16A, instead of AFM11’s target, CD3. These studies will not be impacted by the clinical hold and will continue as expected.

We remind investors that Affimed had signed a collaboration agreement with Roche Holding (RHHBY - Free Report) in August for development and commercialization of a host of immunotherapeutic treatments for multiple cancers. The deal is a major boon for Affimed as it received $96 million in upfront fees. It also has the potential to generate future cash flow of about $5 billion in milestone and royalty payments.

 Zacks Rank & Key Picks

Affimed currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the same space are Champions Oncology, Inc. (CSBR - Free Report) and BioSpecifics Technologies Corp (BSTC - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Champions Oncology’s earnings estimates have been raised 240% for 2018 and 25% for 2019 over the past 60 days. The company delivered an average positive earnings surprise in the trailing four quarters of 200%. The stock has soared 249% so far this year.

BioSpecifics earnings estimates have moved 9.1% north for 2018 and 11.7% for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 11.37%. The stock has gained 37.9% year to date.

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