Safety, Setbacks

One of Affimed’s new glass slippers cracks as a deadly incident forces halt to PhI cancer trials

Affimed’s Cinderella story has taken a deadly twist.

Just a few weeks after signing Genentech on to the platform for a collaboration using its NK cell tech for guiding an immune response against cancer, researchers for the biotech $AFMD have waved back patients in a Phase I program for their CD19/CD3-targeting T cell engager AFM11 after the death of one patient and a life-threatening reaction in two others.

The Phase I effort covers two types of cancer: CD19 positive B-cell non-Hodgkin lymphoma and acute lymphoblastic leukemia. Now the biotech has put the trials on hold and Affimed execs say they’ve informed regulators as they investigate what went wrong.

Its shares tanked, plunging 30% on the news.

Adi Hoess, Affimed CEO

There’s no word in the company’s statement what the reaction was, just that the three patients were on the high dose of a drug that targets CD3. Their more advanced work on an NK cell engagement strategy will proceed.

Affimed has been on a roller coaster ride over the last few months. Its stock was beaten up during the European Hematology Association meeting in June as the company offered up an early look at positive responses in their early study of AFM13, its lead NK cell engager candidate. 

Then, when Genentech stepped up with $96 million upfront and billions in potential milestones, the biotech world took a closer look at the NK tech that the big Roche subsidiary was most interested in — and the stock soared.

That deal combined Genentech’s deep experience with tumor biology with the biotech’s own know-how in activating NK cells while using a platform tech that the CEO described as a “simplified engineering system” that can create new therapeutics without the need for adding a lot of staff. The platform specializes in “tetravalent, multi-specific immune cell engagers,” with an antibody approach that applies to a variety of disease settings, bringing in the tumor cell killers needed to directly engage cancer.

A number of patients have been killed in trials during the last few years, most notably at Juno, which had to scrap its lead CAR-T and drop out of the race for the first approval in the field after a series of deadly incidents. 

The company, now a subsidiary of Celgene, as well as former CEO Hans Bishop, recently signed off on a $24 million payment to the stockholders who brought a class action suit against the biotech based on their claims that the company had misled investors by concealing the death of the first patient. 

That amounts to a speeding ticket after Celgene paid $9 billion for the group, which is now pursuing a new, safer lead program.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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