Affimed hangs onto Genentech alliance after dropping stranded PhI program as CSO exits
Seven months into the full clinical hold the FDA slapped on its Phase I AFM11 program following a patient death, Affimed is scrapping the drug altogether to focus on two other early-stage innate cell engagers — and it will be doing so, for now, without a CSO.
The German biotech made the decision after hearing from regulators earlier this month that additional data would be required before they might resume work on the CD19/CD3-targeting T cell engager said CEO Adi Hoess on a conference call. Running a nimble small biotech operation, he explains, requires a commitment to the efficient allocation of time and resources.
That leaves AFM13 and AFM24 — both of which engage CD16A in immune cells — the stars of the show. The former targets CD30 in tumor cells, while the latter is designed to bind with EFGR.
Investors did not take the news well, sending shares $AFMD down 10% to $2.96.
As part of the same update, Affimed notified investors that CSO Martin Treder will be leaving his role for new opportunities but will remain as a consultant.
Hoess notes that he has a strong team and is in no rush, if ever, to replace Treder. In the meantime, COO Wolfgang Fischer will oversee the discovery and preclinical efforts.
These changes cap a tumultuous year for Affimed since Genentech signed up for a partnership with $96 million upfront, spiking the stock almost vertically. Not long after, the biotech documented the death of one patient and a life-threatening reaction in two others in a high-dose group of AFM11 and halted the trial before the FDA mandated a hold.
The partnership is still alive and well, Hoess said, highlighting recent milestone payments from the Big Biotech partner as they work to collect up to $5 billion in biobucks.