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.

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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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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.”

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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

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

Ireland

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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.”

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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 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.

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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 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 Announces Three Exclusive Option License Agreements, Which Extend and Strengthen its Dual-Targeted NK Cell Therapy Pipeline

  • Three new exclusive option license agreements expand the depth and breadth of ONK’s pre-clinical pipeline
  • A humanized scFv targeting CLEC12A licensed from Cellerant Therapeutics, creates a fourth pre-clinical program, ONKT104, for the treatment of acute myeloid leukemia (AML)
  • A humanized scFv targeting a novel tumor-specific MUC1 glycopeptide epitope licensed from Glycotope GmbH, strengthens pre-clinical program ONKT103, for solid tumors
  • A CCR7 homing receptor licensed from the National Institute of Health (NIH), for use in the pre-clinical ONKT101 program, for relapsed/refractory B cell malignancies

Galway, Ireland, and San Diego, USA, 17 December 2020 … ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has secured three new exclusive option license agreements which strengthen its off-the-shelf, dual-targeted natural killer (NK) cell therapy platform and extend its pre-clinical pipeline to four programs across both hematological and solid tumors.

The first option agreement, with Cellerant Therapeutics, gives exclusive rights to a humanized CLEC12A scFv binder. CLEC12A is strongly expressed by blasts in the majority of AML patients. The option to license has enabled ONK to expand its pre-clinical product portfolio, launching a fourth program (ONKT104). This dual-targeted approach combines the CLEC12A CAR with a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting death receptor 4 (DR4).

“While expressed on leukemic stem cells, CLEC12A is absent from normal hematopoietic stem cells and we thus expect that our dual-targeted NK cell therapy approach should enable safe targeting, with a reduced risk of prolonged aplasia in AML,” said Prof Michael O’Dwyer MD, ONK Therapeutics’ co-founder, and CSO.

The second agreement in-licenses a humanized, tumor-specific antibody targeting an aberrantly glycosylated tumor-associated form of MUC1 (TA-MUC1) from Glycotope GmbH. Multiple solid tumor types express the mucin MUC1, including non-small cell lung cancer, breast cancer, and ovarian cancer. This antibody will be integrated into ONK’s pre-clinical program ONKT103, for solid tumors.

Non-selective targeting of MUC1 could be problematic since the target is also expressed by healthy tissues, but O’Dwyer explains how ONK’s dual-targeted approach can be used to address this. “We have designed a CAR tailored to the glycosylation pattern distinct to tumor-associated MUC1 with specific recognition of the carbohydrate antigens Tn and T on MUC1, the expression of which is restricted to cancer cells. Glycotope has identified the glycosylation pattern as a way to unlock the potential of TA-MUC1 as a solid tumor target. ONK is thus set to bring the natural benefits of NK cells over T cells to bear on TA-MUC1, in a tumor-specific fashion, while also further boosting efficacy and countering resistance through the use of our TRAIL variant targeting DR5,” he said.

ONK’s unique platform approach combines the expression of a chimeric antigen receptor (CAR) and a high affinity, membrane-bound TRAILv. The incorporation of these two humanized scFvs has the potential to minimize the risk of immunogenicity in the allogeneic setting.

ONK is also exploring several innovative strategies to improve the homing of NK cells. This is an important consideration as ex-vivo expansion can lead to changes in chemokine receptor expression. Through this new license agreement with the NIH, ONK plans to enforce the expression of CCR7, which is downregulated on NK cell expansion. This may improve the homing of NK cells to lymph nodes and is expected to be particularly useful for ONK’s off-the-shelf CD19 program targeting B cell lymphoma, ONKT101, which is partnered with Avectas.

ONK is making rapid progress since it announced its most recent financing in October. Chris Nowers, ex Kite Pharma Head of Europe, who joined at that time as Chief Executive Officer, said: “The recent American Society of Hematology meeting highlighted the NK cell therapy area as offering great hope as the next generation of advanced cell therapies. We believe our best-in-class off-the-shelf, dual-targeted NK cell therapy platform has the potential to improve performance and overcome some of the shortcomings seen with earlier approaches. These new licensing activities strengthen and expand our programs and illustrate our ambition and strategy to become a leader in this exciting field.”

The company recently expanded its operations into the USA, moving into JLABS @ San Diego, Johnson & Johnson Innovation’s flagship facility, at the heart of San Diego’s precision medicine and cell therapy cluster. This represents a second facility that complements its main R&D team and operations in Galway, Ireland. The company’s recruitment drive across both facilities has been rapid and the company continues to expand its capability in key areas, including NK cell biology, construct design, gene editing, and process development.

-Ends-

ONK Therapeuticswww.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 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 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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About Avectaswww.avectas.com

Avectas is a cell engineering technology business that has developed a unique delivery platform, Solupore® to enable the ex vivo manufacture of cell therapy products, which have high in-vivo functionality.

Glycotopewww.glycotope.com

Glycotope is a biotechnology company utilizing a proprietary technology platform to develop highly tumor-specific monoclonal antibodies called GlycoBodies. GlycoBodies bind to targets (GlycoTargets) tumor-specific carbohydrate structure dependent, enabling the development of highly-specific immunotherapies across a broad range of cancer indications. Glycotope has to date discovered in excess of 150 GlycoTargets with GlycoBodies against eight of these targets currently under development.

Each GlycoBody can be developed in an array of modalities with different modes of action providing a unique offering in the (immuno) oncology space. Currently, six clinical and pre-clinical programs based on the GlycoBody technology are under development by Glycotope or its licensing partners.

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 Opens US R&D Operations and Appoints Head of R&D, USA

  • ONK opens US operations and becomes a resident of Johnson & Johnson Innovation JLABS @ San Diego
  • Rohit Duggal Ph.D. appointed as Head of R&D, USA
  • ONK Therapeutics, Inc. formed, to facilitate the expansion of operations in the USA, alongside its growing hub in Galway, Ireland

Galway, Ireland and San Diego, USA, 12 November 2020

ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has been accepted to become a resident at Johnson & Johnson Innovation – JLABS @ San Diego. It is also pleased to announce that it has appointed Rohit Duggal Ph.D. to Head of R&D, USA, as its first employee based at its San Diego operations and has incorporated a US subsidiary, ONK Therapeutics, Inc.

ONK is growing rapidly, expanding its pre-clinical R&D and manufacturing capabilities, to progress its novel, dual-targeted, natural killer (NK) cell therapy platform towards human clinical trials. In October the company closed a new financing round, led by US-based investor Acorn Bioventures.

Located in the heart of the Torrey Pines Mesa alongside world-class research institutes, JLABS @ San Diego is Johnson & Johnson Innovation’s flagship facility, opened in 2012. It is home to over 50 resident biotech startup companies and has over 90 alumni companies within its network. JLABS @ San Diego’s life science lab space reflects the region’s leadership in the fields of genomics, precision medicine, cell therapy, and the microbiome – with about 70% of resident biotech companies developing therapeutic potential solutions in these areas.

Rohit Duggal Ph.D. joins as Head of R&D, USA from NantKwest, an innovative clinical-stage cellular-immunotherapy company, where he led the primary lymphocyte product development program. He is an experienced industry-research leader who specializes in establishing and advancing cell therapy and immuno-oncology platforms for product development. He has 22 years of industry experience that spans cellular immunotherapy, immuno-oncology, oncolytic virotherapy, translational oncology, and antiviral drug discovery. Previous experience includes Sorrento Therapeutics, where he played a role in developing the immuno-oncology franchise that included next-generation NK cell product development. He started his industry career at Agouron Pharmaceuticals, Inc. now a subsidiary of Pfizer where he was responsible for working on antiviral and oncology programs from drug discovery and translational research through to delivering clinical candidates. Rohit received his Ph.D. from Texas A&M University, College Station, Texas, USA.

Rohit will report to ONK Therapeutics’ founder and CSO, Prof. Michael O’Dwyer, MD. Welcoming Rohit to the team, Prof. O’Dwyer said, “I am delighted to welcome Rohit to support our goal of developing best-in-class, off-the-shelf, dual-targeted NK cell therapies targeting solid and hematological cancers. His expertise in cell therapy approaches for immuno-oncology treatments and industry-research will be invaluable. We will be expanding our US-based operations and team rapidly under Rohit’s leadership and expect to recruit several R&D specialists to the team in the weeks ahead. JLabs @ San Diego is a perfect location and we are very pleased to have been accepted into the facility, as the area is a hot-bed for NK cell therapy companies and expertise, with the University of California San Diego (UCSD), Fate Therapeutics, Artiva, and Nantkwest all located in the cluster.”

Rohit Duggal Ph.D. said, “It’s an exciting time to be joining ONK, as it transitions to become a clinical-stage company and progresses several of its unique dual-targeted NK cell therapy programs through IND enabling studies. I am confident that being based at the impressive JLABS @ San Diego will facilitate cutting-edge work, recruitment and support our US expansion.”

To facilitate its US expansion, the company has incorporated ONK Therapeutics, Inc., a wholly-owned subsidiary of ONK Therapeutics Ltd.  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 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.

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. The company’s second program, ONKT102, combines an optimized affinity CD38 CAR and a TRAILv targeting DR5, intended for the treatment of patients with relapsed/refractory multiple myeloma.

In addition to the unique 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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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 Closes New Financing and Appoints Chris Nowers as CEO

  • Off-the-shelf natural killer cell therapy company, targeting solid and hematological cancers
  • Raises US$8M from US-based investor Acorn Bioventures and current shareholders, bringing total raised in last six months to US$14.6M
  • Funding will enable expansion of R&D and manufacturing capabilities, and progression of its two lead programs towards the clinic:
    • ONKT101 a dual-targeted NK cell therapy incorporating a CD19 CAR and TRAILv intended for the treatment of relapsed/refractory B cell malignancies
    • ONKT102 combining an optimized CD38 CAR NK and TRAILv intended for the treatment of patients with relapsed/refractory multiple myeloma
  • Chris Nowers, an experienced biopharma executive, with significant cell therapy expertise, appointed as CEO

 

Galway, Ireland, 19 October 2020 … ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has raised US$8M in a financing from new and existing investors. This brings the total raised in the last six months to US$14.6M. It also announces the appointment of Chris Nowers as Chief Executive Officer (CEO).

The new financing round was led by New York-based investor Acorn Bioventures, and current shareholders, principally Seamus Mulligan, an experienced biopharmaceutical executive. The new investment will be used to expand the company’s team, its pre-clinical R&D and its manufacturing capabilities, in order to progress its novel, dual-targeted, natural killer (NK) cell therapy platform towards human clinical trials.

Founded in 2015, by Chief Scientific Officer (CSO) Prof. Michael O’Dwyer, ONK Therapeutics is a pre-clinical stage company dedicated to the development of a best-in-class, off-the-shelf, dual-targeted NK cell therapy platform, targeting solid and hematological cancers. This unique approach combines the expression of a chimeric antigen receptor (CAR) and a high affinity, membrane-bound TNF related apoptosis inducing ligand variant (TRAILv). This is coupled with a strong research focus on strategies to enhance homing and persistence as well as to overcome exhaustion, including the exploration of proprietary gene edits, such as the deletion of checkpoint inhibitory receptors in NK cells. The company is advancing an expanding portfolio of product candidates based on this unique platform.

Chris Nowers joins as CEO to lead the company’s expansion and development. Chris is an experienced biopharma executive, with significant cell therapy expertise from his tenure at both Kite Pharma (Head of Europe) and Cell Medica (CEO).  Additional roles spanning more than 25 years in the biopharma industry include senior leadership positions as CEO of Avantogen Oncology, General Management roles at Amgen, and senior global and regional commercial leadership roles in the field of immunology at Bristol-Myers Squibb (BMS).

The company’s lead research program, ONKT101, is a dual-targeted NK cell therapy incorporating a CD19 CAR and TRAILv targeting the death receptor pathway (DR5) intended for the treatment of relapsed/refractory B cell malignancies. This program is partnered with Avectas and will utilize its proprietary SOLUPORETM technology as a means of non-viral genetic modification. The second program, ONKT102, combines an optimized affinity CD38 CAR and a TRAILv targeting DR5 intended for the treatment of patients with relapsed/refractory multiple myeloma.

Chris Nowers, CEO, said “I was attracted to the company’s innovative and unique approaches, which harness the natural biology of NK cells, and further optimize them through genetic modifications to improve both their cytotoxicity and functionality. This exciting off-the-shelf platform has the potential to produce a next-generation of cell therapies, which could improve performance and overcome some of the shortcomings seen with earlier approaches.”

Commenting on the investment, Isaac Manke, PhD, Partner at Acorn Bioventures said “ONK Therapeutics is a highly innovative next-generation NK cell therapy company with an exciting portfolio of research stage assets targeting both hematological and solid tumors. It is anticipated that this financing will enable the company to progress multiple programs through IND enabling work and towards clinical studies.”

Following the investment, Dr Manke and Mr Nowers will join the board of directors.

 

– Ends –

 

ONK Therapeutics www.onktherapeutics.com

ONK Therapeutics Ltd, is an innovative cell therapy company dedicated to developing a 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 tumour microenvironment, and exploitation of NK cells as cellular immunotherapy. Its core proprietary platform is based on a dual-targeted NK cell expressing both a chimeric antigen receptor (CAR) targeting a known tumour 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. signalling 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.

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. The company’s second program ONKT102, combines an optimized affinity CD38 CAR and a TRAILv targeting DR5, intended for the treatment of patients with relapsed/refractory multiple myeloma.

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

Based in the med-tech hub of Galway, Ireland, ONK Therapeutics shareholders include Acorn Bioventures, ALSHC (principally Seamus Mulligan) and Enterprise Ireland.

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Avectas – www.avectas.com

Avectas is a cell engineering technology business developing a unique delivery platform to enable the ex vivomanufacture of gene-modified cell therapy products, which have high in vivo functionality. Their vision is to be a leading non-viral cell engineering technology enabler, integrated into manufacturing processes for multiple autologous and allogeneic therapies, commercialized through development and license agreements. SOLUPORETM is a trademark of Avectas.

Acorn Bioventures www.acornbioventures.com

Acorn Bioventures invests across stages in small-cap public and private biotechnology companies focused on bringing novel innovative medicines to patients. Their investment flexibility allows them to provide value across the entire spectrum from seed financings, cross-over financings, IPOs, registered direct offerings, PIPEs, open market purchases, etc. Acorn Bioventures’ investment process is based on fundamental research. They look for paradigm changing medical therapies, undiscovered or underappreciated assets, backed by outstanding teams.

 

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

Avectas and ONK Therapeutics to Develop Off-the-Shelf Cancer Therapy

Avectas announced that it has exclusively licenced from ONK Therapeutics (ONK) a Chimeric Antigen Receptor-directed Natural Killer (CAR NK) cell therapy incorporating ONK’s proprietary Death Receptor (DR5) TRAIL variant for the treatment of B-cell malignancies.  Under the collaboration, ONK will be responsible for rapidly progressing the potential therapy to a Phase I clinical trial.  The potential therapy will be engineered using Avectas’ proprietary non-viral cell engineering platform (Solupore®).  Avectas will retain worldwide development and commercialization rights to the therapy.

Avectas has also, through a holding company, acquired a minority shareholding in ONK.

The collaboration between the two companies will target the development of a CAR that uses NK cells, optimally engineered (using Avectas’ Solupore technology) to both enhance targeting of specific cancer cells and increase therapeutic potency by adding a secondary cancer cell killing mechanism using the DR5 TRAIL variant.  If successful, the therapy would be allogeneic – allowing for an off-the-shelf solution – and its cell-killing effects would be transient to enhance dose control.

Michael Maguire, PhD, CEO of Avectas, commented: “We are excited to collaborate with ONK and its expert team to develop this potentially breakthrough immuno-oncology therapy which seeks to improve on the challenges of scale and potency seen with first generation CAR therapies.” He continued, “Solupore was developed to address the urgent need for non-viral cell engineering solutions to support advanced therapies and so this collaboration is a natural next step for our business.”

Professor Michael O’Dwyer, CSO of ONK Therapeutics commented: “This exciting collaboration enables us to exploit Avectas’ expertise in non-viral gene engineering and will greatly accelerate our efforts to move novel CAR NK cells into the clinic.  While early clinical data with CAR NK cells appear promising, resistance is still an issue.  Incorporation of our unique proprietary DR5 TRAIL variant into CAR-NK cells provides a powerful, complementary killing mechanism to overcome resistance, which may have applicability in a broad range of cancers.”

Terms:

Under the terms of the transaction, ONK will receive upfront fees, development and commercial milestones and royalties.  Avectas has also, through a holding company, acquired a minority shareholding in ONK.

This collaboration builds on Avectas’ recent developments including a Series C funding, the issuance of a key US patent covering Soluporation and new collaborations with Vycellix of Florida, USA, the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto, Canada and entering the new NK Cell Centre of Excellence at Karolinska Institute, Sweden, as a partner.

The collaboration also builds on ONK Therapeutics’ success in securing funding under the Irish Government’s Disruptive Technology Innovation Fund (DTIF) call in partnership with the Centre for Cell Manufacturing Ireland, based at NUI Galway.

About Avectas:

Avectas is a cell engineering technology business developing a unique delivery platform to enable the ex-vivo manufacture of gene-modified cell therapy products, which will retain high in-vivo functionality. Our vision is to be a leading non-viral cell engineering technology provider, integrated into manufacturing processes for multiple autologous and allogeneic therapies, commercialized through development and license agreements. For more information, please visit http://www.avectas.com

About ONK Therapeutics:

ONK Therapeutics was founded in 2015 with the goal of developing novel anti-cancer therapies using Natural Killer (NK) cells.  NK cells are one of the body’s strongest defences against cancer, being one of the most tumour cytotoxic components of the human immune system. The company’s strategy is to develop novel, off the shelf, NK cell-based therapies for cancer. Further, the company is seeking to enhance these NK cells through the introduction of a series of genetic modifications, creating a technology platform that can be tailored to multiple cancers. For more information, please visit www.onktherapeutics.com

NOTE:

NK cells kill targetted cancer cells, primarily by releasing toxic granules into the cancer cell.  TRAIL, a protein expressed on the NK cell also contributes to killing by binding to death receptors (e.g. DR5) on the cell surface.  TRAIL variants bind more tightly than natural TRAIL, generating a much stronger killing signal. Since TRAIL killing does not rely on recognition of a target antigen, TRAIL variants can help prevent the emergence of resistance to CARs.

ONK Therapeutics announced as one of the 27 ground breaking projects to receive funding Under Disruptive Technologies Innovation Fund

Today, The Department for Business, Enterprise and Innovation through the Disruptive Technologies Innovation Fund announced that Galway based ONK Therapeutics Ltd, together with it’s consortium partners Janssen Sciences Ireland UC based in Cork and the Centre for Cell Manufacturing Ireland based at NUI Galway, are one of it’s 27 chosen projects to receive funding in order to further develop it’s research into the treatment of cancer, the second biggest killer of humans globally.

ONK Therapeutics is an NK cell therapy company focused on cancer treatment.  NK cells are one of the body’s strongest defences against cancer, being one of the most tumour cytotoxic components of the human immune system. ONK Therapeutics’s strategy is to develop novel, off the shelf, NK cell-based therapies for cancer. Further, the company is seeking to enhance these NK cells through the introduction of a series of genetic modifications, creating a technology platform that can be tailored to multiple cancers.

Following this morning’s announcement by An Taoiseach, Leo Varadkar TD and Minister for Business, Enterprise and Innovation, Heather Humphreys, Professor Michael O’Dwyer, Chief Scientific Officer of ONK Therapeutics welcomed the announcement and said that he looked forward to developing novel NK cell based therapeutics for cancer in collaboration with consortium partners, NUI Galway and Janssen.

For further information please contact:

Prof. Michael O’Dwyer
Founder & Director of ONK Therapeutics
Email: michael.odwyer@onktherapeutics.com
Tel: +353 87 250 6638
www.onktherapeutics.com