Following a disappointing performance from the company’s CAR-T candidate in an early-stage cancer trial, BioNTech is winding down cell therapy manufacturing at its inaugural U.S. plant.
BioNTech will lay off 63 employees at its Gaithersburg, Maryland, cell therapy facility beginning later this summer, according to a Worker Adjustment and Retraining Notification (WARN) alert recently filed with the state.
The company has elected to end cell therapy manufacturing at the site—which it acquired from Gilead Sciences’ Kite Pharma in 2021—by the end of the year, a company spokesperson said in an emailed statement.
The move, expected to impact members of the Gaithersburg site’s cell therapy technical operations team, was influenced by BioNTech’s decision to stop development of its CLDN6-directed CAR-T asset BNT211 in testicular cancer with germ cell tumors, the spokesperson explained.
“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,” she said.
The discontinuation in testicular cancer won’t affect BioNTech’s ongoing phase 1 BNT211-01 study of the CAR-T prospect in patients with CLDN6-positive relapsed or refractory solid tumors, the spokesperson said.
CLDN6 is a protein target expressed on multiple solid tumors, including ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer.
“We will reassess the clinical development strategy for this asset, including potentially considering evaluating the candidate in other indications,” the spokesperson said, adding that BioNTech “will be realigning Gaithersburg capabilities to support the company’s pipeline” in the coming months.
The Gaithersburg cell therapy site became BioNTech’s first U.S. production facility when the German biotech purchased the plant from Gilead’s Kite Pharma unit in July 2021. At the time, BioNTech said it would extend job offers to all 50 Kite staffers who were then working at the facility.
While BioNTech will move forward with the development of BNT211 in other oncology indications, this isn’t the first time the company has adjusted its CAR-T priorities this year.
Back in March, BioNTech passed on an option to co-develop a dual-targeting CAR-T cell therapy with Autolus Therapeutics, one year after locking down the opportunity to work on the asset.
Autolus said that BioNTech declined to exercise its product option for the prospect, coded AUTO1/22, which the biotech attributed to a pipeline prioritization effort BioNTech unveiled earlier that same month.
BioNTech picked up the option last February in a $250 million upfront collaboration that also gave it access to Autolus’ manufacturing and clinical site network in the U.K. BioNTech noted at the time that it would use the new infrastructure to continue developing and producing BNT211 for pivotal trials in CLDN6+ tumors.
While BioNTech entered the limelight thanks to its Pfizer-partnered mRNA vaccine for COVID-19, the German drugmaker has increasingly turned its attention toward cancer as it seeks to become a “fully integrated immunotherapy powerhouse.”
To advance those ambitions, BioNTech executives said in May that the company plans to set up “supply nodes” for the antibody-drug conjugate (ADC) asset BNT323 to help curb its dependence on China suppliers. BioNTech has said it hopes to submit the ADC for FDA review sometime this year.
Meanwhile, BioNTech last month telegraphed plans to invest up to 1 billion pounds sterling over the next decade to bolster its R&D operations in the United Kingdom. The project covers the buildout of two new research centers in the country, plus a U.K. headquarters for the company in London.
One of the R&D centers, planned for Cambridge, will focus on projects around genomics, oncology, structural biology and regenerative medicine, BioNTech said.
And just last week, BioNTech bought out its German mRNA compatriot CureVac in an all-stock transaction worth $1.25 billion. In unveiling the deal, BioNTech glossed over plans to onboard any of CureVac’s mRNA vaccine candidates, instead focusing on the potential of CureVac’s cutting-edge research and manufacturing site in Tübingen, Germany.