BioNTech Adds Kite Production Platform and Facility

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

The agreement, financial details of which were not disclosed, provides for BioNTech’s acquisition of Gilead Sciences Kite Pharma‘s R&D technology on solid tumor neoantigen (TCR) T cell receptors. The deal will also see BioNTech take over the lease for the Gaithersburg manufacturing plant.

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

Image: iStock / alphaspirit

However, the firm is also targeting cell therapy. Its main candidate in the field of cell therapy is BNT221, a personal candidate for T cell therapy targeting neo-antigens, extracted from peripheral blood cells of patients and intended to treat solid tumors. The deal with Gilead will help support the candidate, the company said.

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

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

Through the acquisition, BioNTech will provide all Kite staff at the Gaithersburg facility with employment prior to the closing date and hire additional employees to support its growing cell therapy pipeline.

Kite network

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

Kite is one of the few companies to have obtained US Food and Drug Administration (FDA) approval for its CAR-T drugs, with the success of Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel).

And although Gilead hands over the keys to the Gaithersburg facility to BioNTech, it remains committed to its advanced therapy manufacturing network.

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

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