// 22 September 2021

eTheRNA immunotherapies conference attendance from September to October 2021

Niel (Belgium)

eTheRNA immunotherapies NV (‘eTheRNA’), a private clinical-stage biotechnology company developing mRNA-based immunotherapies for the treatment of cancer and infectious diseases, will be attending the following conferences from September through to October 2021:

FlandersBio – Knowledge for Growth
27–29 September 2021
Michael Mulqueen, VP of Business Development, will be speaking as part of the ‘The Power of Cell & Gene- Personalised Medicine’ panel on Tuesday, 28 September from 11:00am-12:00pm CET.

Marina Cools, VP of Clinical Development and Board Member of FlandersBio, Tim Van Assche, Director of Business Development and Alliance Management, and Johanna Madero, Communications Coordinator, will be in attendance.

Optimum Healthcare Investor Conference
4 October 2021
Mathieu Lane, Chief Financial Officer, and President of eTheRNA Inc., will be in attendance.

AACR Virtual Conference on Tumour Immunology and Immunotherapy
5-6 October, 2021
Anna Kuchmiy, Discovery Scientist, will be in attendance.

Access Biotech China
14-15 October 2021
Steven Powell, Chief Executive Officer, will be speaking as part of the ‘Partnering with Chinese Companies and/or Investors’ panel, on Thursday, 14 October from 9:00am-10:30am CET.

Bio-Europe
25-28 October 2021
Michael Mulqueen, VP of Business Development, and Tim Van Assche, Director of Business Development and Alliance Management, will be in attendance.

Biologics Contract Manufacturing Europe
27-28 October 2021
Bernard Sagaert, COO and SVP of Manufacturing, will be speaking as part of the ‘GMP Manufacturing Requirements and Processes’ panel on Thursday, 28 October 2021 from 9:00am-9:30am CET.

David Ricketts, Director of Business Development, will be in attendance.

About eTheRNA immunotherapies
eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious disease from its mRNA chemistry, antigen identification, lipid chemistry and delivery and process engineering platforms. The company is headquartered in Belgium and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialised investors; BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company’s ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding. Further details relating to eTheRNA’s R&D pipeline can be found at https://www.etherna.be/immunotherapies-rd-pipeline/.

Contact Information

// 03 August 2021

eTheRNA immunotherapies opens office in Hong Kong to support and build on its growing activities in China and broader Asia-Pacific

Niel (Belgium)

eTheRNA immunotherapies NV (‘eTheRNA’ or the ‘Company’), a clinical-stage company developing mRNA-based immunotherapies for the treatment of cancer and infectious diseases, today announces the opening of its new subsidiary, eTheRNA Asia Limited (‘eTheRNA Asia’), with offices located in the Sheung Wan area of Hong Kong.

The Asia-Pacific region is growing in importance in the global healthcare sector and this new subsidiary will serve as a focus for eTheRNA’s increasing commercial activities in this area. In particular, eTheRNA Asia will focus on supporting business and investor relations in China and especially the relationship between eTheRNA and its strategic partner, China Grand Pharmaceutical and Healthcare Holdings Ltd (‘CGP’). CGP and eTheRNA’s relationship is centred on their joint venture company, Nanjing AuroRNA Biotechnology Company Limited.

Steven Powell, Chief Executive Officer of eTheRNA, said: “The strategic aim under the Healthy China 2030 plan is to improve cancer care and develop truly innovative oncology drugs in China itself. Through our Chinese investors and partners we have developed strong links with the region and look forward to increasing our activities and contributing to help fulfil this ambition.”

For more information, please contact:

eTheRNA immunotherapies
Johanna Madero

About eTheRNA immunotherapieseTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious diseases from its multiple RNA, formulation and manufacturing technology platforms. The Company is headquartered in Belgium, with subsidiaries in the USA and Hong Kong, and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialised investors: BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. Limited, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company’s ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding. Further details relating to eTheRNA can be found at www.etherna.be

// 27 July 2021

eTheRNA immunotherapies appoints Mathieu Lane as Chief Financial Officer and President of eTheRNA Inc. located in the U.S.A.

Niel (Belgium)

eTheRNA immunotherapies NV (‘eTheRNA’ or the ‘Company’), a clinical-stage company developing mRNA-based immunotherapies for the treatment of cancer and infectious diseases, today announced that it has appointed Mathieu Lane as Chief Financial Officer and President of eTheRNA Inc., its newly established U.S. subsidiary company.

Mathieu Lane brings a wealth of experience in the pharmaceutical and biotech industry. He served over 15 years in healthcare investment banking in New York, working on a broad range of financings and strategic transactions for both large pharmaceutical and emerging biopharma companies. He was most recently at Guggenheim Securities and, prior to this, at Bear Stearns. An organic chemist by training, Mathieu has also worked in lipid-based gene therapy research at Genzyme and in venture capital at SR One. He will be based in eTheRNA’s new office in New York.

Steven Powell, Chief Executive Officer of eTheRNA, said: “We are pleased to welcome Mathieu to eTheRNA as we look to maximise the potential of our mRNA and related technology platforms. Mathieu is a key addition to our senior leadership team and will play an important role in managing our future financing strategies and establishing our presence in North America. Today’s announcement is a significant step in the development and growth of our company as we look to strengthen our position in key geographies and accelerate development of our technologies and product pipeline.”

Mathieu Lane, Chief Financial Officer of eTheRNA, commented: “Over the last year we have seen the ability of mRNA technology to generate novel and effective therapeutics. eTheRNA has a powerful next-generation mRNA platform which offers enormous potential for the development of off-the-shelf therapies for cancer, infectious diseases and, potentially, auto-immune disorders.  I am delighted to be joining at this exciting time as we look to establish a footprint in the U.S.A and maximise the potential of eTheRNA’s technologies and product pipeline.”

eTheRNA’s corporate headquarters is in Niel, Belgium and its discovery facility is in Ghent, Belgium.

For more information, please contact:

eTheRNA immunotherapies
Johanna Madero

About eTheRNA immunotherapies
eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer, infectious diseases and auto-immune disorders from its multiple RNA, formulation and manufacturing technology platforms. The Company is headquartered in Belgium, with an office in the US, and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialised investors: BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company’s ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding. Further details relating to eTheRNA can be found at www.etherna.be

// 13 July 2021

eTheRNA immunotherapies and Ghent University Announce mRNA Delivery Collaboration and License Agreement

                                                                                                                                                                                              

  • Novel lipid nanoparticles for mRNA delivery will enhance thermostability, biodegradability and safety and pave the way for new off-the-shelf therapies

Niel and Ghent (Belgium)

eTheRNA immunotherapies NV (‘eTheRNA’), a clinical-stage company developing mRNA immunotherapies for the treatment of cancer and infectious diseases, announces a collaboration and license agreement with Ghent University.

Under the terms of the agreement, eTheRNA will receive exclusive worldwide rights to commercialise a new library of novel ionizable lipids, co-developed with the research group of Prof. Bruno De Geest from Ghent University, for a new generation of lipid nanoparticle (LNP) formulations. Ionizable lipids are a main driver of LNP activity, enhancing the entrapment and stabilisation of mRNA into the LNP and facilitating the release of the mRNA payload into the cell cytoplasm where the mRNA is subsequently translated into the protein of therapeutic interest. The ionizable lipids in the new library have been designed for improved biodegradability and therefore offer a better safety profile. In addition, LNPs formulated with these ionizable lipids are expected to have favourable thermostability properties, reducing the need for cold chain storage of the final product.

Steven Powell, CEO at eTheRNA immunotherapies commented: “We are delighted to collaborate with the laboratory of Prof. De Geest from Ghent University with their valuable, combined expertise in chemistry, nanotechnology and immunology. One of the bottlenecks with current mRNA pharmaceuticals is the need for elaborate cold-chain logistics. This collaboration and license agreement gives us access to lipid nanoparticles with enhanced thermostability and improved safety profiles. The new ionizable lipids with improved properties will provide the basis for our second generation of LNPs that will be used to develop future prophylactic vaccines and tumor-microenvironment modulating therapies.”

Prof. Bruno De Geest, Ghent University commented: “I am delighted that my long-lasting collaboration with Dr. Stefaan De Koker from eTheRNA immunotherapies has culminated in this successful technology platform. I also wish to acknowledge support from the European Research Council (ERC) which enabled my lab to endeavor into this field of research.” Dr. Dominic De Groote, Business Development Manager at Ghent University added: “This partnership is the result of continuing efforts by Ghent University and Ghent University Hospital to become a leading academic and clinical center for the development of advanced therapy medicinal products (ATMPs). This LNP technology is part of our growing portfolio of ATMP related assets that we are actively developing from the bench to the bedside through our translational platform GATE.”

About eTheRNA immunotherapies
eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious disease from its multiple RNA, formulation and manufacturing technology platforms. The company is headquartered in Belgium and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialised investors; BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company’s ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding. Further details relating to eTheRNA can be found at www.etherna.be.

About Ghent University
Ghent University (UGent) is a top 100 university in the Shanghai Ranking and one of the largest Belgian universities in the heart of Europe. We are an active partner in national and international educational, scientific and industrial cooperation. Our organization is committed to research and innovation with more than 5,500 researchers active in a wide range of the life, physical and social sciences. GATE – the Ghent Advanced Therapies and Tissue Engineering platform (www.gatehealth.be) – connects researchers and clinicians in the field of gene and cell therapy, and regenerative medicine, covering the complete process from early research to first-in-human clinical trials. GATE works together with UGent TechTransfer and UGent Business Development Centers to support researchers in developing groundbreaking science to bring innovations to the market. More information at www.ugent.be

For more information, please contact:
eTheRNA immunotherapies
Johanna Madero

Ghent University
Dr. Dominic De Groote

// 29 June 2021

eTheRNA immunotherapies and Quantoom Biosciences Announce a Strategic Collaboration for the Development of a Novel RNA Production System

                                                                                                                                                                                                                                                                                                                                                                                

  • The objective is to make RNA therapeutics accessible to global patient populations.  
  • Makes large scale decentralized RNA production economically viable.

Niel and Brussels (Belgium)

eTheRNA immunotherapies NV (‘eTheRNA’), a clinical-stage company developing mRNA-based immunotherapies with in-house GMP certified production and process development capabilities, and Quantoom Biosciences S.A. (“Quantoom”), a biotech company aiming to improve access to essential medicines through innovative bioproduction methods, today announce that they are to collaborate on the development of a revolutionary RNA production system (RPS) for both research and GMP-grade material.                                    

Quantoom and eTheRNA will work together to build an advanced, small footprint technology platform for the production of affordable RNA-based therapies, that can be used either within existing facilities or rapidly deployed to areas of urgent need. Unlike large and costly existing RNA production plants, the RPS will manufacture RNA small modular units, which can be shipped easily across multiple geographic regions. The RPS is intended to be scaled seamlessly from small scale preclinical batches to mass production of GMP-grade RNA. The only requirement will be for the RPS to be located inside a suitable clean room with an uninterrupted utility supply.

Under the terms of the agreement, eTheRNA will transfer manufacturing technology to Quantoom with all materials and data necessary for the development of the novel RPS. Following completion of the RPS, Quantoom will be responsible for commercialization of the system on a worldwide basis, with sales-related royalties payable to eTheRNA. International sales and distribution are expected to commence in 2023 following RPS production in Belgium.

Bernard Sagaert, SVP Manufacturing and COO of eTheRNA, commented: “This cooperation aligns with our goals for RNA production; namely cost reduction, process scalability from small to large scale, portability and process automation. Currently, the global supply of RNA is hampered by the lack of dedicated production facilities and by the cost of constructing new plants. The RPS will revolutionize the way RNA is produced and distributed globally and we are excited to be able to work with a leading developer and manufacturer like Quantoom to bring this vision to the market.”

José Castillo, CEO of Quantoom Biosciences, commented: “We are delighted to enter into this collaboration agreement with eTheRNA, which has extensive experience in the field of RNA and like Quantoom, has a mission to change the RNA world. Through our combined knowhow, I am confident that Quantoom will be able to develop an open, integrated RNA platform that will enable manufacture of RNA-based vaccines and therapeutics at scale, resulting in affordable development and production of RNA-based drugs. ”

 

About eTheRNA immunotherapies
eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious disease from its multiple RNA, formulation, and manufacturing technology platforms. The company is headquartered in Belgium and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialist investors; BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company’s ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding. Further details relating to eTheRNA’s R&D pipeline can be found at https://www.etherna.be/immunotherapies-rd-pipeline/.

About Quantoom Biosciences
Quantoom Biosciences is a biotech with the mission to deliver greater access and autonomy through innovation in bioproduction that will address some of the biggest production challenges in vaccines and therapeutics. As a Univercells company, Quantoom Biosciences provides open, integrated, affordable and (pre)clinically proven platforms to make biologics available for all. Our facilities are strategically located in Belgium, in the heart of Europe, benefiting from an exceptional biotech ecosystem.
www.quantoom.com  

Disclosure Statement
The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements”. These forward-looking statements can be identified using forward-looking terminology, including the words “believes”, “estimates,” “anticipates”, “expects”, “intends”, “may”, “will”, “plans”, “continue”, “ongoing”, “potential”, “predict”, “project”, “target”, “seek” or “should”, and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company’s actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. 

// 23 JUNE 2021

eTheRNA and VUB expand strategic collaboration to engineer next generation mRNA therapeutics with TetraMix®

                                                                                                                                                                                                                                                                                                                                                       

  • Extension to proven TriMix® adjuvant technology intended to boost dendritic cell activation

Niel (Belgium) eTheRNA immunotherapies NV (‘eTheRNA’), a clinical-stage company developing mRNA-based immunotherapies as off-the shelf products for the treatment of cancer and infectious diseases,

announces the expansion of its strategic collaboration with Vrije Universiteit Brussel (VUB) with the signing of an exclusive license for TetraMix® , a new generation of the TriMix® adjuvant technology.

Clinical and preclinical data have demonstrated clinical safety of TriMix, together with its ability to amplify immune responses in multiple disease indications. This new license stems from the collaboration between the VUB and eTheRNA focussed on directed activation of dendritic cells and leverages research performed at the Laboratory for Molecular and Cellular Therapy (LMCT) of the VUB. In the presence of specific antigens, dendritic cells behave as immune response modulators, directing the immune system to attack target cells through the activation of directed CD4+ T-helper and CD8+ cytotoxic T-cell responses.

“We have already demonstrated that TriMix has a benign safety profile and promotes high mRNA expression levels,” comments Steven Powell, CEO, eTheRNA. “TetraMix will now be integrated into our programs to engineer new generation mRNA immunotherapies offering even greater efficacy and immunogenicity.”

“VUB has been an internationally recognised centre of excellence for RNA research for the last decade with numerous breakthroughs originating from LMCT,” comments Professor Dr. Karine Breckpot, Director of LMCT. “TriMix’s robustness and versatility as an immune stimulatory platform has been proven in a number of clinical indications and we are delighted to now introduce TetraMix. We are confident that TetraMix’s new way of immune activation will certainly set a precedent for future immunotherapies.”

Please visit our Strategic Collaborations webpage to find out more about eTheRNA’s multiple partnerships: https://www.etherna.be/strategic-collaborations/.

About eTheRNA immunotherapies
eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious disease from its multiple RNA, formulation, and manufacturing technology platforms. The company is headquartered in Belgium and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialist investors; BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company’s ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding. Further details relating to eTheRNA’s R&D pipeline can be found at https://www.etherna.be/immunotherapies-rd-pipeline/.

About VUB Vice-Rectorate Innovation & Industry Relations
The mission of the Vice-Rectorate Innovation & Industry Relations is to create a positive impact on society through the valorisation of scientific research. Its operational and multidisciplinary team, VUB TechTransfer, aims to connect the university’s research expertise with society and industry, together with its partners VUB Foundation and Crosstalks.

https://www.vub.be/en/innovate

About VUB
Vrije Universiteit Brussel is an internationally oriented university in Brussels, the heart of Europe. By providing excellent research and education on a human scale, VUB wants to make an active and committed contribution to a better society.

www.vub.be

About the Laboratory for Molecular and Cellular Therapy
The goal of the research activities at the Laboratory for Molecular and Cellular Therapy (LMCT) is to develop innovative immunotherapy strategies, among which immunotherapy strategies that exploit the immune orchestrating activity of dendritic cells, exemplified by the development of the TriMix and more recently TetraMix technology. Other strategies under development include adoptive T-cell therapy and therapies that support the activity of T-cells, be it stimulated by dendritic cells or adoptively transferred, in the tumor microenvironment. Technologies such as mRNA, lentiviral vectors, and single domain antibodies (better known as nanobodies) are employed for these purposes.

https://lmct.research.vub.be/en/home

Contact information

// 11 MAY 2021

eTheRNA immunotherapies conference attendance for May- June 2021

Niel (Belgium) eTheRNA immunotherapies NV (‘eTheRNA’), a clinical-stage company developing LNP-formulated mRNA immunotherapies as off-the shelf products for the treatment of cancer and infectious diseases, will be attending the following conferences during May and June:

BioEquity Europe
17–19 May 2021
Steven Powell, CEO will be speaking as part of the ‘West-East Roundtable: Next Act Europe-China Collaborations’ panel, on Tuesday 18th May 2021.

  • Volker Germaschewski, Senior VP of R&D, Michael Mulqueen, VP of Business Development, Ulrich Platte, CFO and Tim Van Assche, Director of Business Development & Alliance Management, will also be attending the conference.

Sachs 7th Immuno-oncology Innovation Forum
18–20 May 2021
Michael Mulqueen, VP of Business Development will be speaking as part of the ‘Cancer Vaccines, Neo Antigens & Related Modalities’ panel, on Wednesday 19th May 2021 at 8.50am CET.

AngloNordic Conferenece
25–26 May 2021
Steven Powell, CEO will be speaking on the ‘If I knew then what I know now’ panel, on Wednesday 26th May 2021 at 5.15pm CET.

Flanders Vaccine General Assembly
27 May 2021
Marina Cools, VP of Clinical Development will be speaking as part of the Flanders Vaccine General Assembly, on Thursday 27th May 2021.

Informa Industry Experts Panel
9 June 2021
Steven Powell, CEO will be speaking as part of the ‘Designing the Deal’ panel, on Wednesday 9th June 2021 at 1pm CET.

Belfius and Kepler Cheuvreux Digital Life Science Days
21-22 June 2021
Steven Powell, CEO will be giving a presentation on the Company, on Tuesday 22nd June 2021.

About eTheRNA immunotherapies NV
eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious disease from its multiple RNA, formulation and manufacturing technology platforms. The company is headquartered in Belgium and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialised investors; BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company’s ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding. Further details relating to eTheRNA’s R&D pipeline can be found at https://www.etherna.be/immunotherapies-rd-pipeline/.

Contact information

// 11 MARCH 2021

eTheRNA extends leadership team with the appointment of Dr. Volker Germaschewski as Senior Vice President for R&D

Niel (Belgium) 

eTheRNA immunotherapies NV (‘eTheRNA’ or ‘The Company’), a clinical-stage company developing immunotherapies from its proprietary mRNA TriMix platform for the treatment of cancer and infectious diseases, announced today that Dr. Volker Germaschewski has been appointed Senior Vice President for R&D. Volker joins eTheRNA from Kymab Ltd. (Cambridge, UK) where, over 10 years, he was initially Senior Director Discovery and subsequently Vice President of Haematology. Prior to that he held several positions in Biopharm R&D at GlaxoSmithKline.

“I am excited to join eTheRNA at this incredible time of unprecedented advances in mRNA technologies within vaccine and therapeutics development”, said Dr. Germaschewski. “I am looking forward to working with the team at eTheRNA and our partners and our collaborators as we accelerate development of our promising and innovative oncology and infectious disease technologies and products.”

About eTheRNA immunotherapies NV
eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious disease from its multiple RNA, formulation and manufacturing technology platforms. The company is headquartered in Belgium and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialised investors; BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company’s ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding. Further details relating to eTheRNA’s R&D pipeline can be found at https://www.etherna.be/immunotherapies-rd-pipeline/.

Contact information

// 22 MARCH 2021

Consortium led by eTheRNA immunotherapies Awarded EU Commission TIGER Grant of EUR 6.9 million

                                                                                                                                                                                                   

  • Accelerate development of novel mRNA vaccine for hard-to-treat cancers
  • Clinical trial to commence end of 2021

Niel (Belgium) eTheRNA immunotherapies NV (‘eTheRNA’), a clinical-stage company developing mRNA-based immunotherapies as off-the shelf products for the treatment of cancer and infectious diseases, announces the award of a TIGER grant of EUR 6.9 million from the EU commission. The grant was awarded to a consortium led by eTheRNA and will be used to accelerate the development of a novel, potentially best-in-class therapeutic mRNA cancer vaccine for treating recurrent/metastatic Human Papillomavirus strain 16 positive (HPV16+) cancers such as head and neck cancer, cervical cancer, anogenital cancer.

eTheRNA’s mission is to develop mRNA-based immunotherapies as off-the-shelf products for the treatment of cancer and infectious diseases through its next generation mRNA vaccines development platform and its in-house manufacturing.  Head and neck squamous cell carcinomas (HNSCCs) are the sixth leading cause of cancer worldwide.  Early data suggests mRNA may play a key role in treating cancers and autoimmune diseases with potential mRNA market of approx. $37bn in 2030.

The Phase I/IIa trial for the mRNA vaccine will be administered either as a stand-alone therapy or supplementary to PD-1 inhibitor standard of care. Safety, immunogenicity and clinical activity are the key endpoints of the clinical program. Biomarker and Patient Reported Outcome Measure (PROM) research conducted in parallel with the study will facilitate future, informed therapeutic and care decisions by both patients and care teams. The mRNA cancer vaccine will be optimized for intravenous (IV) administration.

Safety and efficacy of the IV mRNA lipid nanoparticle (LNP) product has already been demonstrated in preclinical development studies. Furthermore, eTheRNA has proven the safety and efficacy of its mRNA cancer vaccines in previous clinical trials, albeit with the mRNA vaccine delivered via different routes of administration.

Marina Cools, VP of Clinical Development at eTheRNA, commented: “eTheRNA and its collaborators welcome the award of this grant. In addition to HPV, this collaboration will investigate the possibility of applying mRNA technologies to the treatment of other cancer indications with poorly met medical needs.” 

Jean-Pascal Machiels, Head of the Medical Oncology Department at the King Albert II Institute of Saint-Luc University Clinics in Brussels, commented: “The King Albert II Institute of Saint-Luc University Clinics is proud to contribute to this project with their expertise in conducting clinical trials of innovative treatments. This Horizon 2020 grant acknowledges and reaffirms the Institute’s excellence in cancer research for the benefit of patients.”

Antonella Cardone, Director of European Cancer Patient Coalition, commented: “We are very happy to be part of the eTheRNA project. Representing the largest cancer patient community in Europe, ECPC will ensure that the patients’ perspective is heard throughout the implementation of the project. We strongly advocate the involvement of cancer patients in research projects as they provide invaluable understanding of the challenges that they face throughout their cancer journey.”

The antigens comprise mRNAs encoding the HPV16 proteins E6 and E7 as well as eTheRNA’s proprietary TriMix mRNAs. TriMix acts as an adjuvant to activate dendritic cells to induce strong T-cell responses to the antigens. The mRNAs are formulated in novel patented LNPs, which prolong the half-life of the mRNA and deliver it to immunoactive antigen-presenting cells, which enhances T-cell responses. These LNPs also offer superb thermostability at 4°C.

The consortium project encompasses essential elements for preparing therapy validation in later stage clinical studies while addressing patient needs, values and choices. Scale up of GMP-production using eTheRNA’s in-house manufacturing platform for IV mRNA vaccines will enable further clinical studies.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 945011.

Collaborators include:
1. Amsterdam UMC (Netherlands)
2. BiotechSubsidy (Belgium)
3. Ceratium B.V. (Netherlands)
4. eTheRNA immunotherapies NV (Belgium)
5. European Cancer Patient Coalition (Belgium)
6. Radiomics (Belgium)
7. SAGA Diagnostics AB (Sweden)
8. Saint-Luc University Clinics (Belgium)

About eTheRNA immunotherapies NV
eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious disease from its multiple RNA, formulation and manufacturing technology platforms. The company is headquartered in Belgium and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialised investors; BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company’s ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding. Further details relating to eTheRNA’s R&D pipeline can be found at https://www.etherna.be/immunotherapies-rd-pipeline/.

About TriMix
The TriMix platform comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that work synergistically to deliver optimal activation of dendritic cells. These cells behave as immune response mediators and mobilize the immune system to attack cancer cells through inducing a T-cell response. Clinical proof of concept for TriMix-based immunotherapies has been established through a series of clinical trials demonstrating safety and clear clinical benefits in advanced melanoma patients. Additional clinical trials are planned.

Contact information

// 4 March 2021

eTheRNA appoints David Ricketts as a Consultant Director of Business Development for Manufacturing Services

New hire joins as demand for company’s GMP RNA contract manufacturing services grows

Niel (Belgium)

eTheRNA immunotherapies NV (‘eTheRNA’ or ‘The Company’), a clinical-stage company developing immunotherapies from its proprietary mRNA TriMix platform for the treatment of cancer and infectious diseases, today announced that David Ricketts has been appointed as Consultant Director of Business Development for Manufacturing Services. Following 11 years as Director of Business Development for numerous life science companies, David continued his successful career as CEO of PharmaDiagnostics NV and then as CEO at Link Technologies Ltd.

David Ricketts commented: “I am impressed with eTheRNA’s manufacturing capabilities – a professional multidisciplinary team with world class expertise and resources and a can-do mindset, and who are very well positioned to meet the growing international demand for RNA manufacture. I’m delighted to be part of the team.”

About eTheRNA immunotherapies NV
eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious disease from its multiple RNA, formulation and manufacturing technology platforms. The company is headquartered in Belgium and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialised investors; BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company’s ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding. Further details relating to eTheRNA’s R&D pipeline can be found at https://www.etherna.be/immunotherapies-rd-pipeline/.

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