USPTO Grants ONK Therapeutics’ Foundational Patent for CISH Knockout in NK Cells for Use in Cancer Therapies

  • The US Patent and Trademark Office (USPTO) has granted ONK Therapeutics’ patent for CISH knockout (KO) in Natural Killer (NK) cells based on the earliest scientific discoveries
  • The patent, under exclusive global license from WEHI, gives ONK key IP for CISH KO in human NK cells for their use in cancer therapies, irrespective of cell origin
  • The CISH IP adds to ONK’s broad and growing IP estate covering the optimization of persistence, metabolic profile and cytotoxic potential of its NK cell therapy platform

Galway, Ireland and San Diego, USA, 9 September 2021 – ONK Therapeutics Ltd, an innovative NK cell therapy company, today announced that the US Patent and Trademark Office (USPTO) has granted its licensed patent that covers CISH knockout (KO) in NK cells, irrespective of the source of the NK cells, including, for example, human cord blood-derived and human induced pluripotent stem cell (iPSC)-derived cells (Patent No. 11104735).

Earlier this year ONK entered into an exclusive global patent license agreement with Australia’s Walter and Eliza Hall Institute of Medical Research (WEHI) providing it rights to CISH KO in the field of human NK cells for the treatment of cancer, with the right to sublicence.

“We are excited to have this unparalleled opportunity to explore the potential of CISH KO in human NK cells. We believe this is the foundational patent, based on the earliest scientific discoveries which cover CISH KO NK cells from any source, and we intend to evaluate this edit in both umbilical cord blood and iPSC-derived NK cells,” said ONK Therapeutics’ CEO Chris Nowers.

CISH KO has been shown to improve the persistence, metabolic profile, and cytotoxic potential of NK cells. While several other companies and academic centers are exploring the potential of a CISH KO on NK cells, the research team at WEHI, in 2015, was the first to show the critical role CIS, the protein encoded by CISH, plays in negatively regulating the function of NK cells.

Prof. Michael O’Dwyer, founder and CSO of ONK Therapeutics said, “Editing of NK cells to knock out CISH has the potential to improve the potency of the NK cell-based therapies and provide greater benefit to patients.”

We are building an unrivaled and broad IP estate against multiple NK cell checkpoint receptors, including extracellular proteins CD96, TIGIT, Siglec-7 and PD-1 as part of our innovative strategy to engineer a highly differentiated NK cell therapy platform that has broad potential across both hematological malignancies and solid tumors.”

WEHI’s Head of Biotechnology and Commercialisation Dr Anne-Laure Puaux said, “Cell-based therapies have demonstrated their enormous potential as disease-modifying therapies in oncology.  By licensing our intellectual property to ONK Therapeutics we are supporting the opportunity to develop more potent cell-based therapies for the future benefit of cancer patients.”

In addition to this granted CISH KO US patent, ONK Therapeutics has filed a US continuation patent application. Parallel filings are also under review in the EU by the European Patent Office (EPO) as well as in China, Japan, Australia and New Zealand, thus providing excellent coverage for the company’s commercial interests.

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About CISH and the WEHI patent

CIS (encoded by the gene CISH) is a member of the suppressor of cytokine signaling (SOCS) family of proteins. When NK cells are stimulated with growth factors, such as interleukin 15 (IL-15), which encourage their growth, survival, and killing capability, there is an increase in the activity of CIS protein, which acts as a brake or checkpoint, on further NK cell growth and function.

The WEHI team found that when CIS was removed from NK cells by deleting the CISH gene, the NK cells were more responsive to growth factors and had improved survival and killing capacity(1). Improving the metabolic fitness of NK cells to enhance glycolysis and oxidative phosphorylation is important for optimizing the anti-tumor activity of NK cells, especially against solid tumors(2-3).

1. Delconte, R., Kolesnik, T., Dagley, L. et al. CIS is a potent checkpoint in NK cell–mediated tumor immunity. Nat Immunol 17, 816–824 (2016) https://www.nature.com/articles/ni.3470?proof=t

2. Daher et al., Targeting a cytokine checkpoint enhances the fitness of armored cord blood CAR-NK cells Blood Sept 9, 2020

3. Zhu et al., Metabolic Reprograming via Deletion of CISH in Human iPSC-Derived NK Cells Promotes In Vivo Persistence and Enhances Anti-tumor Activity Cell Stem Cell Sept 3, 2020

Caption: CISH gene knockout confers enhanced metabolic profile on NK cells, created with BioRender.com

Copyright: ONK Therapeutics Ltd

About 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:

  • 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 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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ONK Therapeutics’ CSO Prof. M O’Dwyer and his Academic Group Present New Data Showing the Benefit of Knocking Out the Inhibitory Receptor CD96 on Human NK Cells in the Context of Multiple Myeloma at EHA 2021

  • The checkpoint inhibitor CD96 was shown conclusively to be an inhibitory receptor on human NK cells in the presence of multiple myeloma (MM) cells expressing CD155
  • CD96 knock out (KO) using CRISPR/Cas9 gene editing enhanced both NK cell cytotoxicity and cytokine release
  • Efficient engineering of NK cells to genetically eliminate inhibitory receptor expression has the potential to overcome exhaustion and immune evasion in the tumor microenvironment

Galway, Ireland and San Diego, USA, 11 June 2021 – ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, welcomes new data presented by John Daly from the academic lab of CSO, Prof. Michael O’Dwyer at the Annual European Hematology Association 2021 Virtual Congress illustrating the merit of knocking out the checkpoint inhibitory receptor for CD96 on NK cells in the context of MM.

The data is based on research studies carried out at the National University of Ireland, Galway (NUI Galway), College of Medicine, Nursing and Health Sciences, by Prof. O’Dwyer’s academic research group.

Contradictory data had previously shown that CD96 could be both an activating and an inhibitory receptor on human NK cells, depending on the tumor type being examined.  The data presented during the poster presentation demonstrate conclusively that in the case of MM cells expressing CD155, CD96 is a human NK cell inhibitory receptor, regulating both cytotoxicity and cytokine release. Experiments using CRISPR/Cas9-mediated KO of CD96 in primary NK cells resulted in enhanced cytotoxicity and cytokine release compared to controls. Studies carried out in parallel also demonstrated a similar beneficial effect of CRISPR/Cas9-mediated KO of TIGIT in primary NK cells.

Furthermore, NK cells obtained from MM patient bone marrow had particularly high levels of CD96 expression, suggesting NK cells in the bone marrow of MM patients are more likely to be susceptible to CD155 mediated immune-evasion.

These new insights support knocking out inhibitory checkpoint receptors, including CD96 KO and TIGIT KO as a promising approach to improving the functionality of off-the-shelf engineered NK cell therapies for the treatment of cancer.

E-poster presentation title: Knockout of CD96 or TIGIT using CRISPR/Cas9 enhances NK induced
cytotoxicity and cytokine production in the presence of CD155 expressing myeloma cells.

Author(s)/Presenters: John Daly, Mark Gurney, Michael O’Dwyer.

Session title: Myeloma and other monoclonal gammopathies – Biology & Translational Research.

Abstract number: EP941

Date and Time: Available on the virtual platform as an e-poster Friday, June 11 at 9:00 CEST.

Download a copy HERE.

Chris Nowers, ONK Therapeutics’ CEO said, “The studies carried out by Prof. O’Dwyer’s academic research group are expanding our deep understanding of NK cell biology and are helping to confirm certain gene constructs and edits that will enhance NK cell cytotoxicity, cytokine production and persistence in the tumor microenvironment.  Gene edited NK cells lacking CD96 and/or TIGIT could therefore be beneficial for treating CD155 expressing malignancies, such as Multiple Myeloma.”

ONK Therapeutics was formed based on technology and intellectual property developed at NUI Galway by Prof. O’Dwyer. The Company is developing off-the-shelf, optimized NK cell therapies for cancer that utilize dual-targeting of the death receptor pathway in addition to incorporating a CAR, along with further strategies that utilize novel gene editing approaches to enhance persistence, metabolic profile, and cytotoxic potential. ONK has exclusive licenses to a broad intellectual property (IP) against a wide range of NK cell checkpoints, including CD96 and TIGIT.

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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

Follow us on Twitter and LinkedIn.

Media enquiries (for ONK Therapeutics)

International

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Ray Gordon, Gordon MRM – +353 87 2417373 ray@gordonmrm.ie

 

 

ONK Therapeutics and Trinity College Dublin Collaborate in an Enterprise Ireland Funded Project to Optimize Metabolism of NK Cells for Improved Cancer Therapies

  • Collaboration between ONK Therapeutics and Dr. David Finlay’s group at Trinity College Dublin, Ireland
  • Two-year Enterprise Ireland Innovation Partnership Programme (IPP) project grant of €373,295
  • Research to explore metabolic reprogramming and engineering of natural killer (NK) cells for improved cancer therapy

Galway, Ireland and San Diego, USA, 8 June  2021 – ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has been awarded an Innovation Partnership Programme (IPP) grant by Enterprise Ireland (EI) to fund collaborative research at Trinity College Dublin, Ireland, led by Dr. David Finlay to optimize the metabolism and engineering of NK cells for improved cancer therapies.

Dr. Finlay, Associate Prof. in Immunometabolism in the Schools of Biochemistry and Immunology, and Pharmacy and Pharmaceutical Sciences, at Trinity College Dublin is a world-leading expert in NK cell metabolism. His group was the first to characterize cellular metabolic pathways in NK cells (reviewed in (1)) and to demonstrate the importance of NK cellular metabolism for the cytotoxic anti-tumor functions of these cells (2).

Active research is ongoing to optimize the efficacy of NK cell therapies against solid tumors by addressing the immunosuppressive tumor microenvironment (TME), where NK cell metabolism is impaired due to low glucose levels, oxygen deprivation (hypoxia), presence of inhibitory cytokines, and the higher concentration of tumor-derived metabolic end products, such as lactate.

To date, such improvement strategies to boost the efficacy of NK cells in the tumor microenvironment of solid cancers have centred on adding cytokines and other factors.

“We are taking a completely novel approach by addressing NK cell metabolism from the inside out, fundamentally engineering NK cells to better treat cancer by increasing their resistance to the adverse metabolic conditions generated by tumors,” said Prof. Michael O’Dwyer, founder and CSO at ONK Therapeutics. “In working with Dr. Finlay, we are collaborating with the pioneering expert in the field of NK immunometabolism.”

Under the terms of the collaboration, Trinity College Dublin retains any intellectual property (IP) arising out of the research collaboration, with ONK Therapeutics having an exclusive option to license the IP.

“In order to understand why cellular cancer immunotherapies are not effective in all cancer patients, scientists are actively trying to identify why certain patients respond and some do not and why some types of cancer can be successfully treated while others cannot. One emerging reason is that tumors can create metabolically unfavorable environments that might impact the effectiveness of immune cell therapies. My laboratory has the foremost expertise in NK cell metabolism placing us in a very strong position to address this challenge,” said Dr. Finlay.

“Manipulating NK cell metabolism to enhance anti-cancer function is completely novel and is only possible based on our discoveries over the past five years,” he said. “Our goal is to discover new targets within NK cells to be edited through CRISPR deletion or overexpression strategies. Detailed evaluation of the resistance of these cells to the adverse environments generated by tumors should support the development of enhanced NK cell therapies. It is an innovative approach to developing improved cellular therapies to treat cancer, in particular solid tumors.”

Lawrence Lee, Manager, Innovation Partnership Programme Enterprise Ireland, said, “We are delighted to support this innovative research that has the potential to generate real and tangible benefits for cancer patients in Ireland and across the globe.  The project is aligned with Enterprise Ireland’s strategic goal of supporting world-leading research in Ireland and fostering relationships between industry and academic partners.  Research initiatives such as this have the capacity to further advance Ireland’s international research reputation and lay the foundations for the jobs of the future.

The Enterprise Ireland funding(3) covers 80% of the €373,295 project costs, with the industry partner, ONK Therapeutics providing €75,000 (20%) of the project costs. Trinity College Dublin will be recruiting two additional post-doctoral scientists into Dr. Finlay’s group over the two years of the project.

Chris Nowers, CEO of ONK Therapeutics, said, “We are highly ambitious in our goal to become a world-leading engineered NK cell therapy company that not only treats, but ultimately cures cancer. Our academic partnerships will deliver rich research insights and reinforce our own expertise as we aim to deliver new therapeutic options for patients in need.”

1. O’Brien KL., Finlay, DK. (2019) Immunometabolism and Natural Killer cell responses. Nature Reviews Immunology, May;19(5):282-290. doi: 10.1038/s41577-019-0139-2

2. Assmann N, O’Brien KL, Donnelly RP, Dyck L, Zaiatz-Bittencourt V, Loftus RM, Heinrich P, Oefner PJ, Lynch L, Gardiner CM, Dettmer K, Finlay DK. (2017) Srebp-controlled glucose metabolism is essential for NK cell functional responses. Nature Immunology. Sep 18. doi: 10.1038/ni.3838

3. IP 2021 0976 – ‘Metabolic reprogramming and engineering of NK cells for improved cancer therapy’

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Caption: Dr. David Finlay, Associate Professor, Trinity College Dublin, Ireland
Copyright: Dr. David Finlay
Profile: https://www.tcd.ie/Biochemistry/research/finlay/
Twitter: @DavidFinlayTCD
LinkedIn: www.linkedin.com/in/david-finlay-tcd/

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.

Follow us on Twitter and LinkedIn.

Enterprise Ireland – www.enterprise-ireland.com

Enterprise Ireland is the government organisation responsible for the development and growth of Irish enterprises in world markets. We work in partnership with Irish enterprises to help them start, grow, innovate and win export sales in global markets. In this way, we support sustainable economic growth, regional development and secure employment.

Innovation Partnership Programme (IPP0 grants are co-funded by the European Regional Development Fund (ERDF) under Ireland’s European Structural and Investment Funds (ESIF) Programmes 2014-2020.

 

Trinity College Dublin – www.tcd.ie

Trinity College Dublin, founded in 1592, is Ireland’s oldest university. Today it has a vibrant community of 19,000 students and is recognised internationally as Ireland’s premier university. Cutting-edge research, technology and innovation places the university at the forefront of higher education in Ireland and globally. It encompasses all major academic disciplines, and is committed to world-class teaching and research across a range of disciplines in the arts, humanities, engineering, science, social and health sciences.  Trinity College Dublin is Ireland’s leading university and is currently 101st in the QS World University Rankings.

Media enquiries 

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For Enterprise Ireland

Paul Daly, Press Office, Enterprise Ireland +353 87 2235197 paul.daly@enterprise-ireland.com

For Trinity College Dublin

Thomas Deane, Media Relations Officer, Communications – +353 1 896 4685 / 086 787 0748  deaneth@tcd.ie

ONK Therapeutics Secures Exclusive Global License to Patent for CISH Knockout in NK Cells for the Treatment of Cancer, from Australia’s WEHI

  • Cytokine Inducible SH2 containing protein (CIS; encoded by the gene CISH) is a potent checkpoint in NK cell-mediated tumor immunity
  • CISH knockout (KO) NK cells have been shown to be more efficient in eliminating cancer cells in in-vivo models
  • Exclusive global license to WEHI patent for CISH KO in the field of NK cells builds on and strengthens ONK Therapeutics’ broad intellectual property (IP) against a wide range of NK cell checkpoints
  • Will enable ONK Therapeutics to further optimize the persistence, metabolic profile and cytotoxic potential of its dual-targeted NK cell therapy platform

Galway, Ireland and San Diego, USA, 27 May 2021 – ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has entered into an exclusive global patent license agreement with Australia’s Walter and Eliza Hall Institute of Medical Research (WEHI) providing rights to CISH KO in the field of NK cells for the treatment of cancer.

“Deletion of CISH in NK cells leads to an improved metabolic profile, greatly enhancing their proliferation, cytotoxicity, and persistence. In-vivo models of cancer have shown that CISH KO NK cells are much more efficient in eliminating cancer cells, making such cells a very attractive prospect for future clinical development,” said Prof Michael O’Dwyer, CSO of ONK Therapeutics.

“This patent agreement builds on and strengthens the broad IP we have created at ONK Therapeutics against multiple NK cell checkpoints,” added Prof O’Dwyer.

CIS (encoded by the gene CISH) is a member of the suppressor of cytokine signaling (SOCS) family of proteins. The research team at WEHI, led at the time by Prof Nick Huntington and Assoc Prof Sandra Nicholson, was the first to show the critical role that CIS plays in negatively regulating the function of NK cells. When NK cells are stimulated with growth factors, such as interleukin 15 (IL-15), which encourage their growth, survival, and killing capability, there is an increase in the activity of CIS protein, which acts as a brake or checkpoint, on further NK cell growth and function.

The WEHI team found that when CIS was removed from NK cells by deleting the CISH gene, the NK cells were more responsive to growth factors and had improved survival and killing capacity(1). Improving the metabolic fitness of NK cells to enhance glycolysis and oxidative phosphorylation is important for optimizing the anti-tumor activity of NK cells, especially against solid tumors(2-3).

“Uncovering the role of CIS as an intracellular NK cell checkpoint has been an essential discovery to further the understanding of NK cell homeostasis and turnover,” said Dr. Anne-Laure Puaux, Head of Biotechnology and Commercialisation, WEHI. “We believe that our invention has the potential to improve the potency of the NK cell-based therapy platform developed by ONK Therapeutics and provide greater benefit to patients.”

Under the terms of the agreement, ONK Therapeutics has secured exclusive global rights to WEHI’s patent covering the use of human NK cells lacking CISH for the purposes of researching, developing, manufacturing and commercializing NK cell therapies. The financial terms of the agreement include milestone payments and royalties on sales, the specifics of which are not disclosed.

ONK Therapeutics’ CEO Chris Nowers said, “We are very pleased that via this agreement with WEHI we have the unique ability to produce therapeutic NK cells lacking CISH for the treatment of cancer. This is another example of our innovative strategy to engineer a highly differentiated NK cell therapy platform that has broad potential across both hematological malignancies and solid tumors.”

ONK Therapeutics is optimizing a unique off-the-shelf, dual-targeted NK cell therapy platform, combining the expression of a chimeric antigen receptor (CAR) and a TRAIL variant (TRAILv) and anticipates using CISH KO as a core feature of this platform. The pipeline currently has four programs in pre-clinical development across hematological malignancies and solid tumors. The Company is also exploring engineering strategies to enhance tumor homing, to optimize persistence and metabolism, and to overcome exhaustion in the tumor microenvironment, including the exploration of proprietary gene edits, such as the deletion of checkpoint receptors in NK cells, including extracellular proteins CD96, TIGIT, Siglec-7 and PD-1.

1. Delconte, R., Kolesnik, T., Dagley, L. et al. CIS is a potent checkpoint in NK cell–mediated tumor immunity. Nat Immunol 17, 816–824 (2016) https://www.nature.com/articles/ni.3470?proof=t

2. Daher et al., Targeting a cytokine checkpoint enhances the fitness of armored cord blood CAR-NK cells Blood Sept 9, 2020

3. Zhu et al., Metabolic Reprograming via Deletion of CISH in Human iPSC-Derived NK Cells Promotes In Vivo Persistence and Enhances Anti-tumor Activity Cell Stem Cell Sept 3, 2020″

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Caption: CISH gene knockout confers enhanced metabolic profile on NK cells, created with BioRender.com

Copyright: ONK Therapeutics Ltd

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 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.

Follow us on Twitter and LinkedIn.

International

Sue Charles, Charles Consultants – +44 7968 726585 sue.charles59@outlook.com

Ireland

Ray Gordon, Gordon MRM – +353 87 2417373 ray@gordonmrm.ie

 

ONK Therapeutics Enters into a Research Agreement with NUI Galway to Support Optimization of its Dual-Targeted NK Cell Therapy against AML

  • Agreement with the National University of Ireland, Galway (NUI Galway), supervised by leading expert in the cellular environment in Acute Myeloid Leukaemia (AML), Dr. Eva Szegezdi
  • Funded by ONK Therapeutics, the research will support engineering and optimization of its dual-targeted NK cell therapy candidate for AML (ONKT104)
  • Aims to explore the potential added benefit of certain gene edits to enhance NK cell cytotoxicity, cytokine production and persistence in the cancer microenvironment in the context of AML

Galway, Ireland and San Diego, USA, 17 May 2021 – ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has entered into a research collaboration with the National University of Ireland, Galway (NUI Galway) which provides access to unique expertise in evaluating the cancer cell microenvironment in Acute Myeloid Leukaemia (AML) and targeting of AML stem cells in models mimicking the bone marrow microenvironment. The research will support the optimization of ONK Therapeutics’ dual-targeted NK cell therapy program, ONKT104, being developed for the treatment of AML.

ONK Therapeutics will fund a year-long research program in the laboratory of Dr. Eva Szegezdi, lecturer in Biochemistry, NUI Galway, Head of the Blood Cancer Network Ireland. She has particular expertise in the AML microenvironment as well as cell death pathways, especially those initiated by ‘so-called’ death ligands (e.g. TRAIL) used by effector immune cells.

AML is the most common form of acute leukemia in adults. It is estimated that some 21,000 patients in the US and 18,000 in Europe are diagnosed with AML each year. It has a high unmet medical need having the lowest survival rate of all types of leukemia.

ONKT104 is a dual-targeted NK cell engineered to express a humanized scFv targeting the leukemic stem cell antigen CLL-1 (also known as CLEC12A) obtained through an option license agreement from Cellerant Therapeutics, together with ONK Therapeutics’ proprietary high-affinity TRAIL variant, targeting death receptor 4 (DR4). CLL-1 is selectively expressed on leukemic stem cells with no expression on normal hematopoietic stem cells, which ensures safer targeting and a lower risk of prolonged toxicity to normal bone marrow cells.  In pre-clinical research studies, a monoclonal antibody therapy targeting CLL-1 has revealed potential efficacy against AML cells and shown to be effective in reducing AML burden in a xenograft model. In addition, a CLL-1 CAR-T cell model has shown promising pre-clinical activity and has recently entered the clinic.

ONK Therapeutics believes its dual-targeted NK cell therapy approach may have several advantages over a CAR-T approach including shorter persistence of NK cells, reducing the risk of sustained neutropenia; proven inherent anti-AML activity of NK cells; the reduced likelihood of toxicity due to cytokine release syndrome or neurotoxicity; and the logistically simpler allogeneic, off-the-shelf nature of NK cells, reducing time to treatment once suitable patients are identified.

AML is a very challenging disease in which to achieve sustained, long term disease control due to the high plasticity and adaptability of AML stem cells, and the tendency for resistant cells to emerge and grow. In addition to targeting CLL-1, this project will evaluate multi-targeted approaches by combined targeting of other leukemia stem cell antigens.

ONK Therapeutics’ founder and CSO Prof Michael O’Dwyer said, “Alongside our in-house research, the project team at NUI Galway will explore construct design, as well as the potential added benefit of certain gene edits to enhance NK cell cytotoxicity, cytokine production and persistence in the context of AML strengthening our ONKT104 program. The aim is to select an optimized candidate to take forward into clinical development as a treatment for patients with relapsed/refractory AML.”

Dr. Eva Szegezdi said, “The project will evaluate different constructs that may be able to achieve synergistic killing of cancer cells and reduce the emergence of disease resistance. These include the co-expression of CARs targeting other AML antigens, in addition to CLL-1, such as CD96, TIM3, and CD38 alongside the TRAIL variant.”

ONK Therapeutics was formed based on technology and intellectual property developed at NUI Galway by Prof. Michael O’Dwyer, who retains his academic position as Professor of Haematology, Consultant Haematologist and HRB Clinician Scientist, alongside his role at the company. Over the past 12 months, ONK Therapeutics has expanded its team and operations at its headquarters and R&D facility in Ireland’s med-tech hub in Galway, where it now has 16 employees, with an additional 5 employees based in its US subsidiary in San Diego.

-Ends-

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.

Follow us on Twitter and LinkedIn.

Media enquiries (for ONK Therapeutics)

International

Sue Charles, Charles Consultants – +44 7968 726585 sue.charles59@outlook.com

Ireland

Ray Gordon, Gordon MRM – +353 87 2417373 ray@gordonmrm.ie

ONK Therapeutics Appoints Professor Philippe Moreau to its Scientific Advisory Board

  • Professor Philippe Moreau brings 20 years of experience in clinical hematology
  • Translational research head at University Hospital of Nantes, France
  • World-renowned expert in multiple myeloma, leading clinical trials
  • Joins US-based SAB members, Prof Malcolm Brenner MD, Ph.D. and Prof Jeffrey Miller MD 

Galway, Ireland, and San Diego, USA, 8 April 2021 – ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that Philippe Moreau MD, Professor of Clinical Hematology and Head of the Translational Research Program in Hematology and Oncology, at the University Hospital of Nantes, France, has been appointed to its Scientific Advisory Board (SAB).

Professor Moreau has over 20 years’ experience in clinical hematology and has led many pivotal clinical studies. His interests are focused on multiple myeloma (MM) and its treatment with high-dose therapy and novel agents. He has served as the Principal Investigator for many international randomized phase 3 clinical trials evaluating proteasome inhibitors, Immunomodulatory drugs (IMiDs), or CD38 antibodies. He participated in the study of Idecabtagene Vicleucel (Abecma) (1), that received FDA approval last month as the first genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and refractory MM.

Welcoming Professor Moreau to the SAB, ONK Therapeutics’ founder, CSO, and SAB Chair Professor Michael O’Dwyer MD said, “Philippe adds significant clinical and drug development experience to our SAB and we look forward to his insights guiding the clinical development pathway for our ONKT102 program, which combines an optimized affinity CD38 CAR and a TRAILv targeting DR5, intended for the treatment of patients with relapsed/refractory multiple myeloma.”

Currently Chairman of the Intergroupe Francophone du Myélome (IFM) since 2020 and Vice-President of the International Myeloma Society (IMS) since 2019, Professor Moreau has been a member of the steering committee of the International Myeloma Working Group since 2013. A world-recognized expert in his field, Professor Moreau has authored or coauthored more than 400 peer-reviewed publications. In 2018 he received the Robert A. Kyle lifetime achievement award.

ONK Therapeutics established its SAB in 2020, as it evolved into a more mature NK cell therapy company, with four pre-clinical programs. Other members of the SAB are Professor Malcolm Brenner MD, Ph.D. from Baylor College of Medicine, and Professor Jeffrey Miller MD from the University of Minnesota. Professor Brenner is a physician-scientist with expertise in the therapeutic use of T cell immunologic approaches and genetic engineering strategies, particularly in the treatment of cancer, whilst Professor Miller’s research is focused on the biology of NK cells and other immune effector cells and their use in clinical immunotherapy.

Full profiles of ONK Therapeutics’ scientific advisors are available HERE.

1. Munshi NC, et al Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021 Feb 25;384(8):705-716. doi: 10.1056/NEJMoa2024850. PMID: 33626253.

-Ends-

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.

Follow us on Twitter and LinkedIn.

Media enquiries (for ONK Therapeutics)

International

Sue Charles, Charles Consultants – +44 7968 726585 sue.charles59@outlook.com

Ireland

Ray Gordon, Gordon MRM – +353 87 2417373 ray@gordonmrm.ie

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, and San Diego, USA, 18 March  2021 – 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.”

-Ends-

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.

Follow us on Twitter and LinkedIn.

Media enquiries (for ONK Therapeutics)

International

Sue Charles, Charles Consultants – +44 7968 726585 sue.charles59@outlook.com

Ireland

Ray Gordon, Gordon MRM – +353 87 2417373 ray@gordonmrm.ie

Anthony Nolan Cell & Gene Therapy Services and ONK Therapeutics Announce Collaboration

  • Anthony Nolan Cell & Gene Therapy Services will provide umbilical cord blood and cord-derived NK cells to facilitate the development of ONK Therapeutics’ next-generation dual-targeted NK cell therapies
  • Collaboration supports a common mission to improve the lives of patients with hematological malignancies and solid tumors

London, UK and Galway, Ireland, and San Diego, USA 22 February 2021 – Cell therapy company ONK Therapeutics and blood cancer charity Anthony Nolan have entered into a collaboration to facilitate the development of the next-generation natural killer (NK) cell therapies to improve the lives of patients with hematological malignancies and solid tumors.

Anthony Nolan Cell & Gene Therapy Services will provide a consistent supply of umbilical cord blood and cord-derived NK cells as a choice of starting material for both ONK Therapeutics’ research activities and continued process development work. This source material is scalable and ethically-sourced from consenting donors.

The parties bring together their extensive experience in cell sourcing, cell processing, translational research, understanding of the tumor microenvironment, and exploration of NK cells as a foundation for cellular immunotherapy. In doing so they aim to expedite the development of much-needed new lifesaving cell therapies for patients with a broad range of cancers.

Diana Hernandez, Head of Immunotherapy at the Anthony Nolan Research Institute says: “Our innovative partnership with ONK Therapeutics will serve to accelerate vital research and development into hematological and solid cancer treatments.  We see this as an exciting opportunity which will ultimately lead to better treatments, improving the lives of many more cancer patients.”

Chris Nowers, CEO of ONK Therapeutics says: “Anthony Nolan has a rich heritage in stem cell therapy research, including an enviable understanding of the biology of NK Cells and their processing. We look forward to continuing to partner with their team and to benefiting from their extensive know-how as we drive our programs towards clinical trials and beyond.”

About Anthony Nolan Cell and Gene Therapy Services

Anthony Nolan is the pioneering charity that saves the lives of people with blood cancer and blood disorders who need a stem cell transplant. Anthony Nolan’s Cell and Gene Therapy Services aim to facilitate ethical research and development through the sourcing and supply of donor starting materials to researchers and developers. With a register of over 850,000 donors, a cord blood bank, and four decades of experience providing stem cells, Anthony Nolan has the infrastructure, the expertise, and the skills to support the needs of the cell and gene therapy industry.

Website: www.anthonynolan.org/clinicians-and-researchers/cell-and-gene-therapy-services

LinkedIn: www.linkedin.com/showcase/anthony-nolan-cell-&-gene-therapy-services/

Contact: katie.griffee@anthonynolan.org

About ONK Therapeutics

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 hematological malignancies and solid tumors.

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 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 research focus on strategies to enhance homing and persistence, and overcome exhaustion, 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.

Follow us on Twitter and LinkedIn.

Website: www.onktherapeutics.com

Ends

Media enquiries (for ONK Therapeutics)

International

Sue Charles, Charles Consultants – +44 7968 726585 sue.charles59@outlook.com

Ireland

Ray Gordon, Gordon MRM – +353 87 2417373 ray@gordonmrm.ie

Media enquiries (for Anthony Nolan)

For more information about the charity, please call the Anthony Nolan press office on 0207 424 1300 or email press@anthonynolan.org. For urgent out of hours media enquiries, call 07881 265 285.

NOTES TO EDITORS

About Anthony Nolan

Anthony Nolan saves the lives of people with blood cancer. The charity uses its register to match potential stem cell donors to blood cancer and blood disorder patients in need of stem cell transplants. It also carries out pioneering research to increase stem cell transplant success and supports patients through their transplant journeys. Every day Anthony Nolan gives three people a second chance at life. Find out more at www.anthonynolan.org

Note to sub-editors

Please note that Anthony Nolan changed its name in 2001 and is no longer known as Anthony Nolan Trust.

What is a stem cell transplant?

If a patient has a condition that affects their bone marrow or blood, then a stem cell transplant may be their best chance of survival. Doctors will give new, healthy stem cells to the patient via their bloodstream, where they begin to grow and create healthy red blood cells, white blood cells, and platelets.

Key statistics

  • About 2,000 people in the UK need a stem cell transplant from a donor every year
  • 90% of donors donate through PBSC (peripheral blood stem cell collection). This is a simple, outpatient procedure similar to giving blood
  • We need more young men to sign up, as they are most likely to be chosen to donate but make up just 18% of the register
  • We need more people from Black, Asian, and minority ethnic (BAME) backgrounds to sign up. Only 70% of transplant recipients receive the best match. This drops dramatically to around 37% if you’re from a Black, Asian, or ethnic minority background.
  • Blood cancer is the fifth most common type of cancer in the UK and the third biggest cancer killer. It accounts for 9% of all new cases of cancer diagnosed in the UK.
  • It costs £40 to add each new donor to the register so we always need financial support
  • To join the Anthony Nolan register, you must be 16-30 and healthy. Anthony Nolan’s world-leading Research Institute has shown younger donors offer better survival rates for patients.

ONK Therapeutics Appoints Mary Reilly as Chief Operating Officer

  • Mary Reilly joins as COO, to lead the company’s international operations and drive growth ambitions to transition from a pre-clinical to a clinical-stage company
  • 30 years’ experience in all aspects of global drug development and company operations
  • Prior experience as COO at Opsona Therapeuticsas well as at BioInvent International, Neuramedy, Elan Pharmaceuticals, and Taro Pharmaceuticals

Galway, Ireland and San Diego, USA, 18 January 2021 – ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has appointed Mary Reilly as Chief Operating Officer (COO). Based at the company’s headquarters in Galway, Ireland, she joins ONK Therapeutics’ Executive Leadership Team.

Mary is an accomplished, senior biopharma executive with over 30 years’ experience in all aspects of global drug development and company operations. Following its successful financing in October 2020, ONK Therapeutics has expanded its management and R&D teams significantly and opened state-of-the-art laboratories in both Galway, Ireland, and San Diego, USA. She will take on responsibility for the Company’s operations and will drive its organizational development as it transitions from a pre-clinical stage company through IND enabling studies.

Prior to joining ONK Therapeutics, Mary was consultant COO at both BioInvent International, a public Swedish company focused on the clinical development of antibody drugs for immunotherapy against cancer, and Neuramedy, a South Korean company developing drugs for neurodegenerative diseases. She was previously COO of Opsona Therapeutics, a biotech company focused on the development of an antibody targeting TLR2 in several disease areas. Earlier industry roles include senior leadership positions at Elan Pharmaceuticals and Taro Pharmaceuticals.

Mary has a first-class Masters in Pharmaceutical Science from the Royal College of Surgeons in Ireland (RCSI) and is eligible to act as a Qualified Person under EU clinical directive 2001/20/EC (Clinical Trials-Regulation EU No 536/2014) for the certification of medicinal products. She also has a Master’s degree in leadership from the Irish Management Institute (IMI) and a Diploma in Company Direction and Corporate Governance from the Institute of Directors (IOD).

Welcoming Mary to the team Chris Nowers, ONK Therapeutics’ CEO said, “As we continue our exciting growth trajectory, Mary’s breadth of experience and operational leadership across key aspects of our business will be invaluable and I look forward to working closely with her. Her broad experience in clinical development will be key as we continue to progress our best-in-class, off-the-shelf, dual-targeted NK cell therapy platform toward the clinic.”

Mary said, “Joining ONK Therapeutics during JPM week has provided a fast introduction to the company’s unique approach and the potential of its allogeneic NK cell therapy platform. I am looking forward to working with colleagues here in Ireland and in the USA, and our partners and collaborators worldwide, to help drive the company forward.”

-Ends-

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 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 CLEC12A 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 research focus on strategies to enhance homing and persistence, and overcome exhaustion, 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.

Follow us on Twitter and LinkedIn.

Media enquiries:

International

Sue Charles, Charles Consultants – +44 7968 726585 sue.charles59@outlook.com

Ireland

Ray Gordon, Gordon MRM – +353 87 2417373 ray@gordonmrm.ie

ONK Therapeutics Appoints Hugh O’Dowd as Independent Chairman

  • US-based Hugh O’Dowd joins the Board as independent Non-executive Chairman
  • Brings significant experience in commercialization of oncology drugs
  • Led Neon Therapeutics, Inc. for four years through to its acquisition by BioNTech SE
  • Twenty years of big pharma experience gained at Novartis, including as CCO of Novartis Oncology

Galway, Ireland and San Diego, USA, 14 January 2021 – ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has appointed Hugh O’Dowd as Director and independent Non-executive Chairman of its Board of Directors.

US-based Mr. O’Dowd brings significant experience and a background in the life sciences industry to the ONK Therapeutics’ Board in particular building organizations and commercialization of oncology therapeutics. His experience and strategic insights will be invaluable to ONK as it executes on its growth ambitions, progressing its novel, off-the-shelf, dual-targeted, natural killer (NK) cell therapy platform toward human clinical trials.

Mr. O’Dowd currently serves as Non-executive Director on the Board of oncology development and commercialization company Puma Biotechnology, Inc (NASDAQ: PBYI). Until its acquisition by BioNTech SE in May 2020, Mr. O’Dowd served for four years as President, Chief Executive Officer, and a member of the Board of Directors of Neon Therapeutics, Inc. (NASDAQ: NTGN), a clinical-stage immuno-oncology company that developed neoantigen-based therapeutics.

Prior to Neon Therapeutics, Mr. O’Dowd spent more than 20 years in a variety of senior leadership roles at Novartis Pharmaceuticals Corporation. While at Novartis, he served as Country President and General Manager of the United Kingdom and Ireland from 2015 to 2016, he was Senior Vice President and Chief Commercial Officer of Novartis Oncology from 2011 to 2015, and he served as Vice President, Latin America Region Head for the Oncology business unit from 2009 to 2011. During his time as Chief Commercial Officer Oncology, Mr. O’Dowd was responsible for the oncology portfolio strategy for the world’s then second-largest oncology/hematology organization, including global brand leadership, business development/licensing, and commercialization.

Mr. O’Dowd received an MBA from the Kellstadt Graduate School of Business at DePaul University in Chicago and a B.A. from Loyola University Chicago.

Mr. O’Dowd replaces founder and former Chairman Anthony Killarney, who remains on the ONK Therapeutics Board as Director, alongside newly appointed CEO Chris Nowers, Prof Michael O’Dwyer, MD, founder and CSO, and three additional directors – George Schlich, Eunan Maguire and Issac Manke, Ph.D.

Welcoming Hugh to the Board, Anthony Killarney said, “It has been a pleasure to be the Chairman of ONK Therapeutics through its early development. The company is now on a fast growth trajectory, with multiple exciting opportunities fordeveloping best-in-class, off-the-shelf, dual-targeted NK cell therapies. I welcome Hugh to the Board and know that his broad industry and leadership experience will be invaluable in helping steer the right path as we strive to develop life-changing medicines for patients.”

Hugh O’Dowd said, “ONK Therapeutics has the potential to establish global leadership in the allogeneic NK cell therapeutic area. It is at a very exciting stage in its development as it builds to become a multinational clinical-stage company, with a strong portfolio of product candidates and operations in both the USA and Europe. I look forward to working with the Board and Executive Team to help the company realize its ambitions.”

In October ONK Therapeutics closed a new financing round, led by US-based investor Acorn Bioventures and in November it announced expansion into the US, moving into JLABS @ San Diego, Johnson & Johnson Innovation’s flagship facility, at the heart of San Diego’s precision medicine and cell therapy cluster. Alongside expansion and recruitment in the USA, the company is also expanding its team and operations in Galway, Ireland.

-Ends-

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 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 CLEC12A 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 research focus on strategies to enhance homing and persistence, and overcome exhaustion, 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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International

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Ireland

Ray Gordon, Gordon MRM – +353 87 2417373 ray@gordonmrm.ie