BioNTech halts cell therapy manufacturing at Maryland site, lays off dozens

With its oncology pipeline increasingly focused on bispecifics and antibody-drug conjugates, BioNTech has limited the scope of its sole CAR-T cell therapy programme. 

The company had planned last year to soon move BNT-211, a CLDN6-directed CAR-T, into a pivotal Phase II study for relapsed or refractory testicular cancer/germ cell tumours. Now, BioNTech is discontinuing the candidate's development in that indication after "a thorough assessment of data from a signal-seeking Phase I clinical trial," a company spokesperson told FirstWord.

As a result, BioNTech is shutting down CAR-T manufacturing at a site in Gaithersburg, Maryland, leading to a headcount reduction in the cell therapy technical operations team, the spokesperson said.

According to a state Work Adjustment and Retraining Notification (WARN), 63 employees at the Gaithersburg site have been let go. 

The development discontinuation will not affect the Phase I/II BNT211-01 study, which is evaluating the CAR-T in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

"We will reassess the clinical development strategy for this asset, including potentially considering evaluating the candidate in other indications," the spokesperson said.

The CAR-T setback is unlikely to affect BioNTech's current momentum. As excitement grows for the emerging class of PD-(L)1/VEGF-targeting bispecifics, BioNTech secured $1.5 billion upfront — and potentially $11 billion in milestones — from Bristol Myers Squibb in exchange for rights to co-develop its horse in the race, BNT327 (see – Spotlight On: BMS's bispecific deal with BioNTech — The key takeaways).

Last week, the drugmaker also agreed to buy up CureVac in an all-stock deal valued at around $1.25 billion, padding its portfolio of mRNA-based cancer immunotherapy candidates.