Affimed scraps T-cell engager program, parts company with CSO

Affimed CEO Adi Hoess (left) and departing Chief Scientific Officer Martin Treder (Affimed)

Affimed has terminated its phase 1 bispecific T-cell engager program seven months after the FDA hit it with a clinical hold. The action shifts Affimed’s focus to innate cell engagers that it plans to combine with other modalities to treat cancers.

Germany’s Affimed made the CD19xCD3 T-cell engager, AFM11, its second clinical stage candidate in the belief the drug could improve on Amgen’s pioneering bispecific Blincyto, which hits the same two targets. But the program ran aground in October when Affimed, and then the FDA, put trials of the drug on hold in response to a death in one study and two life-threatening events in the other.

Affimed worked to get the trials restarted and filed information with the FDA as recently as April. But the company has now decided to walk away from AFM11, leaving it focused on the development of innate immune engagers.  

“In May, we received notification from the FDA that additional data would be needed to determine whether the AFM11 clinical hold may be lifted. We have informed the FDA of our intention to terminate the clinical program,” Affimed CEO Adi Hoess said on a conference call with investors. “This decision took into consideration the competitive landscape of T cell directed therapies currently in development and associated resources needed for further development of AFM11.”

Affimed thinks its R&D budget is better spent advancing its pipeline of innate cell engagers than generating the data needed to resuscitate AFM11. But the biotech is open to offloading the stalled program to a company that is willing to take the time to get it going again.

The decision frees up money for Affimed to invest in its innate cell engagers, AFM13 and AFM24. AFM13, which targets CD30 and CD16A, is heading toward a “registration-directed study” in peripheral T cell lymphoma and transformed mycosis fungoide, while AFM24 is on the cusp of entering clinical testing in patients with solid tumors.

Affimed plans to boost its pipeline by combining its innate cell engagers with other drugs and moving new assets into the clinic. But it will need to do so without the full-time involvement of Martin Treder, who is set to step down as chief scientific officer “to pursue new opportunities.”

The CSO seat may be vacant for a while. Affimed Chief Operating Officer Wolfgang Fischer will oversee operations on an interim basis. And with Treder providing support as a consultant, Hoess said “no quick reaction” to the departure is to be expected.