March 18, 2021 -- ONK Therapeutics has entered into a license agreement with the U.S. National Institutes of Health (NIH) to gain rights to make and use clinically validated good manufacturing practice (GMP)-grade feeder cell lines that will enable robust natural killer (NK) cell expansion to support the scale up of the company's manufacturing process.
The proprietary, GMP-grade Epstein Barr Virus-transformed lymphoblastoid cell line has been proven to expand NK cells as part of a clinical trial conducted at the NIH. The feeder layer enables expansion of up to 1,000-fold over a period of two to three weeks. The expansion produces a stable and consistent NK cell population that can be subsequently genetically modified and further expanded on a batch scale to support clinical trials of ONK's NK cell therapy candidates.
The company's proprietary dual-targeted NK cell platform expresses both a chimeric antigen receptor (CAR) targeting a known tumor antigen and a tumor necrosis factor (TNF)-related apoptosis-inducing ligand variant (TRAILv) targeting the death receptor pathway (e.g., DR4 or DR5).
In conjunction with ONK's recent license with Anthony Nolan Cell & Gene Therapy Services, the company should provide the critical starting materials for its off-the-shelf cell therapy manufacturing process to support researchers and process development work.