In acquiring the facility from Kite-owner Gilead, BioNTech is both expanding its manufacturing footprint into North America, as well as expanding its work in individualized cell therapies.
BioNTech already has a cell therapy manufacturing facility in IdarOberstein, Germany: and the US facility will be used to support clinical trials stateside.
The deal will nalso 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.
Building an immunotherapy powerhouse
While BioNTech is now known for its mRNA COVID-19 vaccine developed with Pfizer, the company’s groundings have always been in cancer immunotherapy (it has set out ambitions to become a ‘global immunotherapy powerhouse’ as it looks into the future past COVID).
In January 2020 it announced the acquisition of Neon to grow its CAR-T and TCR therapy pipeline with the additional of neoantigen specific cell therapies, including a T cell therapy targeting shared RAS oncogenes. This also gave the German biotech a US hub for research and clinical development.
The company now highlights its ambitions to strengthen its cell therapy pipeline by accelerating individualized solid tumor neoantigen TCR cell therapy R&D, and adding a manufacturing footprint in North America, via this month’s deal with Kite.
TCR therapy
TCR therapy is a type of cellular immunotherapy designed to redirect the patient’s immune system in order to recognize and target tumors.
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 extracelluar antigens.
As a result, complex TCR therapies may be more effective in the treatment of solid tumors.
Neoantigens are immune targets derived from somatic mutations displayed by cancer cells offering the potential for more targeted anti-tumor 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 tumor. This program builds and further extends BioNTech’s work in individualized neoantigen targeting programs: in particular (iNeST) and BNT221 (NEOSTIM).
“The development of individualized cancer therapies is at the core of our work at BioNTech," said Ugur Sahin, M.D., CEO and Co-founder of 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 US and advance at the forefront of individualized cell therapies.
“It also strengthens our presence in the US, building on our successful integration of adoptive T-cell and neoantigen TCR therapies as part of our acquisition of Neon Therapeutics last year.”
Kite’s employees at the Gaithersburg facility will be offered employment with BioNTech, while BioNTech says it also plans to hire additional personnel in the future.
Kite will receive a one-time upfront payment from BioNTech for the discovery platform, the R&D site and clinical manufacturing facility: financial terms of which have not been disclosed.
From its side, Kite says the sale will allow it to focus its energies and investment on accelerating the reach of tis current CAR T-cell therapies and midterm pipeline. It will retain its new manufacturing facility in Frederick, MD, for commercial production of CAR T-cell therapy.
