BioNTech SE and Kite, a Gilead Company announced the two companies have entered into a purchase agreement for BioNTech to acquire Kite’s solid tumour neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, MD. The acquired Gaithersburg facility will provide production capacity to support clinical trials in the United States and will complement BioNTech’s existing cell therapy manufacturing facility in Idar-Oberstein, Germany. The facility will support the development of BioNTech’s expanding pipeline of novel cell therapies, including cancer product candidates based on its CAR-T Cell amplifying mRNA vaccine (CARVac) and NEOSTIM platforms as well as the newly acquired individualized neoantigen TCR program.

“The development of individualized cancer therapies is at the core of our work at BioNTech. The acquisition of the Kite facility and its individualized TCR platform allows us to accelerate the clinical development of our cell therapies in the U.S. and advance at the forefront of individualized cell therapies,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “It also strengthens our presence in the U.S., building on our successful integration of adoptive T-cell and neoantigen TCR therapies as part of our acquisition of Neon Therapeutics last year.”

All Kite employees at the Gaithersburg facility will be offered employment with BioNTech prior to the date of closing. To support its growing cell therapy pipeline, BioNTech plans to further invest in the site including hiring additional personnel. Under the terms of the agreement, Kite will receive a one-time upfront payment from BioNTech to purchase Kite’s individualized solid tumour neoantigen TCR discovery platform as well as the Gaithersburg R&D and clinical manufacturing facility. Financial terms were not disclosed. Kite’s new manufacturing facility in Frederick, MD for commercial production of CAR T-cell therapy is not part of the purchase agreement.

“In order to serve more patients that need cell therapy today, Kite is rapidly growing both through global expansion and seeking new indications for our existing approved CAR T-cell therapies. This transaction will enable us to focus our energies and investment on accelerating the reach of our current CAR T-cell therapies and midterm pipeline,” said Christi Shaw, Chief Executive Officer of Kite. “As a company solely focused on cell therapy for over a decade, our approach to solid tumors and allogeneic cell therapy will progress through a combination of both internal research and external partnerships as we are an excellent partner for likeminded companies that share our vision of the power of CAR T-cell therapy to create better outcomes for patients.”

TCR therapy is a type of cellular immunotherapy designed to redirect the patient’s immune system in order to recognize and target tumours. In contrast to CARs that recognize antigens on the cell surface, TCR therapy involves engineering an individual’s T cells to express TCRs that can recognize peptide fragments from both intracellular and extracellular antigens. As a result, complex TCR therapies may be more effective in the treatment of solid tumours. Neoantigens are immune targets derived from somatic mutations displayed by cancer cells offering the potential for more targeted anti-tumour activity. Kite’s neoantigen TCR platform enables the development of individualized TCR therapies that are custom designed to target individual neoantigens on a patient’s tumour. This program builds and further extends BioNTech’s leadership in individualized neoantigen targeting programs such as BNT122 (iNeST) and BNT221 (NEOSTIM).