BioNTech to Cease Cell Therapy Manufacturing at Gaithersburg Site Following CAR-T Trial Setback

BioNTech is preparing to discontinue cell therapy production at its Gaithersburg, Maryland, facility, following underwhelming results from a Phase 1 study of its CAR-T candidate, BNT211, in testicular cancer. The company will begin laying off 63 employees later this summer, according to a recent Worker Adjustment and Retraining Notification (WARN) filing submitted to the state.

The decision affects the Gaithersburg cell therapy team and concludes the company’s operations at the facility by the end of 2025. BioNTech acquired the site from Gilead Sciences’ Kite Pharma division in 2021. At the time of purchase, BioNTech had extended employment offers to all 50 Kite employees based at the facility, which subsequently became the company’s first U.S.-based production center.
A BioNTech spokesperson explained that the termination of manufacturing operations at Gaithersburg was driven by the company’s choice to halt development of BNT211 in testicular cancer with germ cell tumors. “Following a thorough assessment of data from a signal-seeking Phase 1 clinical trial on BNT211 in testicular cancer/germ cell tumors, BioNTech has decided to discontinue future investigation of this candidate in this indication,” the spokesperson stated.
Despite this shift, BioNTech confirmed that it will continue the broader phase 1 BNT211-01 clinical trial in other patient populations, specifically those with relapsed or refractory solid tumors expressing CLDN6. The CLDN6 protein is known to be present in various solid tumors, including ovarian, gastric, sarcoma, endometrial, and testicular cancers. BioNTech noted that it would reevaluate the development strategy for BNT211 and may consider exploring its use in additional indications. The spokesperson also indicated that the company plans to reassign Gaithersburg’s capabilities to support other programs in its development portfolio.

Earlier this year, BioNTech made another adjustment to its CAR-T pipeline when it chose not to pursue a co-development option with Autolus Therapeutics. The candidate in question, AUTO1/22, is a dual-targeting CAR-T therapy. BioNTech had secured the option in a $250 million collaboration in 2023, which included access to Autolus’ clinical and manufacturing network in the United Kingdom. In March 2025, BioNTech decided not to exercise its product option for AUTO1/22, which Autolus attributed to a broader pipeline reprioritization effort that BioNTech had outlined earlier that month.
Though BioNTech became widely recognized for its COVID-19 mRNA vaccine developed in partnership with Pfizer, the company has since been shifting its focus toward cancer therapies. In May, BioNTech leadership shared plans to establish new “supply nodes” for its antibody-drug conjugate (ADC) BNT323, aiming to reduce reliance on suppliers based in China. The company intends to file BNT323 for FDA review within the year.

Additional expansion plans include up to £1 billion in investments over the next decade to strengthen research and development efforts in the U.K. This initiative will include two new research facilities and a new London headquarters. One of the upcoming research centers, to be based in Cambridge, will prioritize work in oncology, structural biology, genomics, and regenerative medicine.
Most recently, BioNTech completed a $1.25 billion all-stock acquisition of CureVac. In announcing the deal, BioNTech emphasized the strategic value of CureVac’s research and manufacturing infrastructure in Tübingen, rather than focusing on any specific mRNA vaccine candidates.