BioNTech ups its production capacity to support cell therapy clinical trials by acquiring Kite’s R&D platform and gaining a facility in Gaithersburg, Maryland.

The deal, of which financial details have not been disclosed, sees BioNTech acquire Gilead Sciences’ Kite Pharma’s solid tumor neoantigen T cell receptor (TCR) R&D technology. The deal will also see BioNTech take over the lease at the Gaithersburg manufacturing facility.

BioNTech became a household name after BNT162b2 became the first messenger RNA (mRNA) COVID-19 vaccine to receive emergency use approval in December 2020.

Image: iStock/alphaspirit

However, the firm also has a cell therapy in its sights. Its lead candidate in the cell therapy space is BNT221, a personal neoantigen-targeted T cell therapy candidate that is taken from patients’ peripheral blood cells that aims to treat solid tumors. The deal with Gilead will help support the candidate, the firm said.

“Upon closing the transaction, we add a state-of-the-art cGMP cell therapy manufacturing facility in the US to BioNTech’s global footprint,” the German firm told BioProcess Insider.

“The facility is sufficient to support planned clinical trials. The planned transaction could potentially accelerate our current TCR-T pipeline while the acquired assets would build and further extend our leadership in individualized neoantigen targeting programs such as BNT221 (NEOSTIM).”

Through the acquisition, BioNTech will offer all Kite members of staff at the Gaithersburg facility employment prior to the closing date and hire additional employees to support its increasing cell therapy pipeline.

Kite network

Kite’s manufacturing facility in Frederick, Maryland, which is used to support the production of its commercial chimeric antigen receptor (CAR-T) therapies is not part of the agreement.

Kite is one of only a handful of companies to have achieved US Food and Drug Administration (FDA) approval for its CAR-T drugs, with both Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) achieving success.

And though Gilead is handing over the keys to the Gaithersburg facility to BioNTech, it remains committed to its advanced therapy manufacturing network.

The firm announced its $150 million 204,514 square-foot facility in The Netherlands is fully operational and received approval from the European Medicine Agency (EMA) in June 2020 for the end-to-end manufacturing of Yescarta for up to 4,000 patients per year.