ONK Therapeutics Strengthens its Cell Therapy Manufacturing Process with License for EBV-LCL Feeder Cell Line from NIH to Enhance NK Cell Expansion

• License with NIH for intellectual property for a clinically-validated, GMP grade feeder cell line to enable robust natural killer (NK) cell expansion
• Enhances ONK Therapeutics’ evolving research efforts to scale up and support clinical trials

GALWAY, Ireland & SAN DIEGO--(BUSINESS WIRE)-- ONK Therapeutics Ltd, an innovative cell therapy company focused on engineered natural killer (NK) cell therapies, today announced it has entered into a license with the US National Institutes for Health (NIH) which provides rights to make and use a clinically-validated GMP-grade feeder cell line that will enable robust natural killer (NK) cell expansion, supporting scale-up of the company’s manufacturing process.

Engineered NK cell therapies are now emerging as an exciting cell therapy platform, that shows promise in overcoming challenges of earlier CAR-T cell therapies, offering alternative therapeutic options for patients with hematological malignancies and solid tumors. Successful ex-vivo expansion of cord-derived NK cells is key to developing large cell batch sizes required to produce truly off-the-shelf engineered NK cell therapy.

This proprietary, GMP grade Epstein Barr Virus-transformed lymphoblastoid cell line (EBV-LCL) has been proven as a method to expand NK cells as part of a clinical trial being led by Dr. Richard Childs at the NIH. The feeder layer enabled a robust expansion of NK cells with greatly enhanced cytotoxic potential and strong expression of Activating Receptors and Death Receptor ligands. Expansion of up to 1,000 fold over 2-3 weeks was demonstrated with the potential for continued exponential expansion over longer periods. This expansion provides a stable and consistent NK cell population that can be subsequently genetically modified and further expanded on a batch scale supportive of clinical trials of ONK’s NK cell therapy candidates.

Prof. Michael O’Dwyer, ONK Therapeutics’ founder and CSO said: “Extensive experience over many years in Dr. Childs’ group at the NIH indicate that co-culture with EBV-LCL cells enables ex-vivo activation and robust proliferation of highly functional NK cells, which can be safely administered to patients. Applying this technology to our cord-derived, dual-targeted NK cell platform will enable the manufacture of large quantities of optimized NK cells for off-the-shelf administration.”

ONK Therapeutics is accelerating the development of its NK cell engineering and manufacturing processes for its unique, proprietary dual-targeted NK cell platform that expresses both a chimeric antigen receptor (CAR) targeting a known tumor antigen and a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting the death receptor pathway (i.e. DR4 or DR5).

This agreement with the NIH follows quickly on the heels of a complementary license that ONK Therapeutics recently announced with Anthony Nolan Cell & Gene Therapy Services. This license provides a consistent supply of scalable and ethically-sourced umbilical cord blood and cord-derived NK cells which, in combination with the EBV-LCL feeder layer, will provide the critical starting material for its off-the-shelf cell therapy manufacturing process, to be used for both ONK Therapeutics’ research activities and continued process development work.

Chris Nowers, ONK Therapeutics’ CEO said: “This important license further enhances our manufacturing capability, taking us another step closer to our goal of creating a next generation of uniquely engineered NK cell therapies, with broad applicability across a wide range of targets and tumor types.”

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ONK Therapeutics – www.onktherapeutics.com
ONK Therapeutics Ltd is an innovative cell therapy company dedicated to developing the next generation of ‘off-the-shelf’, dual-targeted NK cell therapies targeting solid and hematological cancers.

The company was founded in 2015, by Prof. O’Dwyer MD, of NUI Galway, an expert in translational multiple myeloma research, the tumor microenvironment, and exploitation of NK cells as cellular immunotherapy. Its core proprietary off-the-shelf cell therapy platform is based on a dual-targeted NK cell expressing both a chimeric antigen receptor (CAR) targeting a known tumor antigen and a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting the death receptor pathway (i.e. DR4 or DR5). This unique approach has the potential to enhance efficacy by addressing both intrinsic (e.g. CAR engagement of a tumor-specific antigen) and extrinsic (e.g. signaling through the death receptor pathway) apoptotic pathways and to reduce the susceptibility to possible target antigen escape through the engagement of tumor antigen-independent TRAILv.

Its pre-clinical pipeline comprises four programs:

• The lead program, ONKT101, is a dual-targeted NK cell therapy incorporating a CD19 CAR and TRAILv targeting DR5, intended for the treatment of relapsed/refractory B cell malignancies. This program is partnered with Avectas, with the company having responsibility for development to Phase 1
• ONKT102 combines an optimized affinity CD38 CAR and a TRAILv targeting DR5, intended for the treatment of patients with relapsed/refractory multiple myeloma
• ONKT103 combines a TA-MUC1 CAR with a TRAILv targeting DR5, for the treatment of solid tumors
• ONKT104 combines a CLL-1 CAR with a TRAILv targeting DR4, for the treatment of AML

In addition to the unique off-the-shelf, dual-targeted NK cell therapy platform, the company has a strong focus on engineering strategies to enhance tumor homing and persistence in-vivo, and overcome exhaustion in the tumor microenvironment, including the exploration of proprietary gene edits, such as the deletion of checkpoint inhibitory receptors in NK cells.

ONK Therapeutics is headquartered in the med-tech hub of Galway, Ireland, with a wholly-owned US subsidiary, ONK Therapeutics, Inc. based at JLabs @ San Diego. Shareholders include Acorn Bioventures, ALSHC (principally Seamus Mulligan), and Enterprise Ireland.

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