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// 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.

// 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.”

// 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. ”

// 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/.

// 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.

// 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)

// 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.”

// 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.”

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