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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International

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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