Author: ethmin

mRNA technology gained worldwide recognition through the COVID-19 vaccines. Researchers from the Biomedical Research Institute (BIOMED) at Hasselt University and the Belgian biotech company etherna have now demonstrated that the same technology also holds promise for a very different application: the targeted treatment of autoimmune diseases. Their findings have been published in the leading scientific journal Advanced Science.

In autoimmune diseases, the immune system mistakenly attacks healthy body tissue. Many existing treatments suppress this immune response, but they do not always do so in a targeted manner. This new mRNA approach aims to modulate the immune system more precisely. The researchers successfully reduced disease severity in preclinical models of multiple sclerosis (MS) and type 1 diabetes.

Simple injection proves equally effective

With this study, the researchers demonstrate that mRNA can be used not only to activate the immune system, as is the case with vaccines against infectious diseases, but also to selectively suppress harmful immune responses. One of the study’s most remarkable findings is that a simple intramuscular injection proved to be just as effective as intravenous administration. This is important because intramuscular injections are much easier to administer and could significantly improve the practical applicability of future mRNA therapies.

Although further research is required to demonstrate safety and efficacy in humans, these findings represent an important step towards the development of new targeted therapies for autoimmune diseases.

Strong collaboration

The research is the result of a close collaboration between etherna and the Biomedical Research Institute (BIOMED) at Hasselt University, bringing together the complementary expertise of both partners. etherna contributed its expertise in mRNA and lipid nanoparticle (LNP) technology, while the BIOMED research team led by Professor Bieke Broux and Dr Paulien Baeten provided immunological expertise and in-depth knowledge of the mechanisms underlying autoimmune diseases.

“For more than a decade, we have built etherna’s mRNA-LNP platform on one simple conviction: this technology is far more versatile than vaccines alone. These results prove it. They show that our platform can be used not only to activate the immune system, but also to calm it and re-establish immune tolerance in models of multiple sclerosis and type 1 diabetes. This achievement was only possible through collaboration. Combining our platform technology with BIOMED’s leading immunology expertise, is exactly the kind of partnership that turns scientific ambition into therapeutic progress.” – Bernard Sagaert, CEO, etherna

A major driving force

“For my team and me, developing effective treatments for people with autoimmune diseases is the greatest driving force behind everything we do. What we have achieved together with etherna is, quite honestly, remarkable. Although further validation in patients remains essential, these findings demonstrate great potential, not only for multiple sclerosis and type 1 diabetes, but possibly for a broader range of autoimmune diseases.” – Professor Bieke Broux, BIOMED, Hasselt University

“Results like these remind us why our research matters. This project also demonstrates what becomes possible when scientific expertise and biotechnology reinforce one another.” – Dr Paulien Baeten, BIOMED, Hasselt University

This project was supported by VLAIO and carried out in collaboration with researchers from Ghent University–VIB and UMass Chan Medical School (USA).

The study was published in Advanced Science and is available here.

About etherna

etherna is a leading technology platform company pioneering the development of mRNA and lipid nanoparticle (LNP) technologies, including manufacturing up to GMP grade. With more than a decade of expertise, the company provides pharmaceutical and biotech partners with an integrated suite of proprietary platform technologies, including customizable lipid nanoparticles (cLNPs) and advanced mRNA chemistry, enabling the delivery of high-quality and effective nucleic acid-based therapeutics.

About BIOMED at Hasselt University

The Biomedical Research Institute (BIOMED) at Hasselt University is a multidisciplinary research institute where advanced technologies are used to generate new insights into three disease domains: immunology, neurosciences and cardiovascular diseases. The institute combines high-quality fundamental research with translational research programmes to develop applications for patients and the healthcare sector. Its work focuses on identifying risk factors throughout the different stages of life, improving our understanding of disease mechanisms, monitoring diseases, and developing strategies to manage, treat and prevent disease.

More information

etherna: media@etherna.be

Prof. Dr. Bieke Broux (BIOMED UHasselt): +32 468 14 30 54

• Valerio Therapeutics announces binding offer for the proposed acquisition of etherna immunotherapies, creating a global leader in targeted RNA medicines
• The proposed acquisition represents a major step in Valerio’s strategy to become a leading developer of next-generation targeted RNA medicines targeting cells beyond the liver, addressing diseases with high unmet medical needs
• The Acquisition aims to create the only player combining active sdAb targeting and passive LNP delivery within a fully integrated RNA medicines platform, accelerating the development of therapeutics and supporting a growing proprietary pipeline
• The news follows the recent appointment of seasoned biotech leader Gilles Besin as Chief Executive Officer to lead Valerio’s next phase of innovation in precision targeted therapeutics, bringing deep expertise in RNA medicines, targeted delivery and in vivo cell therapy
• Supported by leading life sciences investors, with key etherna shareholders becoming Valerio shareholders as part of the transaction, reflecting confidence in the strategic vision and value creation potential of the combined entities
• 6-week exclusivity period to finalize transaction documentation under the binding offer
• Binding offer at €30 million enterprise value (cash and shares), subject to Belgian FDI clearance, financing (secured by subscription undertakings covering the cash consideration) and shareholders’ approval on the share consideration (secured by voting undertakings above 70% of the voting rights)
• The binding offer has received the unanimous approval of Etherna’s board of directors

1 July, 2026 — Valerio Therapeutics (FR0010095596 – ALVIO), a biotechnology company pioneering next-generation precision-guided RNA therapeutics (“Valerio” or the “Company”), today announces that it has signed a binding offer for the acquisition of 100% of the share capital of etherna immunotherapies NV (“etherna“) (the “Acquisition”).

etherna is a leading technology platform company pioneering the development of mRNA and lipid nanoparticle (LNP) technologies, including manufacturing up to GMP. With over a decade of expertise, etherna has built an integrated suite of proprietary technologies, including customizable lipid nanoparticles (cLNPs) and advanced mRNA chemistry, enabling the development and delivery of differentiated RNA therapeutics.

The Creation of a Global Leader in Targeted RNA Medicines
The Acquisition marks a major milestone in Valerio’s strategy to become a global leader in targeted nucleic acid medicines. By uniting three complementary technology platforms – nucleic acid chemistry, LNP delivery and targeted moiety engineering – within a fully integrated biotech supported by in-house manufacturing capabilities, the Acquisition positions Valerio to accelerate the development of next-generation RNA medicines targeting cells beyond the liver.

The Acquisition combines Valerio’s proprietary sdAb-targeting and conjugation technologies with Etherna’s mRNA and LNP capabilities. Together, these technologies enable targeted delivery of nucleic acid payloads to specific cell types and tissues, while in-house GMP manufacturing and CMC capabilities address a key bottleneck many nucleic acid companies face when scaling programs into the clinic.

The Acquisition would create a fully integrated RNA medicines company with a proprietary pipeline and the capabilities to discover, develop and manufacture its own product candidates, with the ambition to advance at least two programs in immunological indications through IND-enabling studies and into the clinic within 18 to 24 months. The lead program demonstrates the potential of the combined platform, focused on the development of an in vivo CAR-T approach to target and modulate pathological B- and T cells in immunological diseases. Furthermore, the company aims to unlock substantial partnership, co-development, and licensing opportunities with major pharmaceutical companies seeking to extend nucleic acid medicines beyond the liver and into a broader spectrum of tissues and indications, while continuing to support existing collaborations and partnerships through its manufacturing capabilities.

Today’s announcement follows the appointment of Gilles Besin as Chief Executive Officer. Dr. Besin brings more than 20 years of experience in drug discovery, immunology, and RNA-based medicine, and has played a key role in building and scaling several biotechnology companies. Most recently, he served as Chief Scientific Officer at Orbital Therapeutics, an in vivo CAR‑T company that leveraged targeted LNP technology and was acquired by BMS in 2025. Following the acquisition, he led BMS’s RNA and in vivo CAR‑T programs. Earlier in his career, he held senior leadership roles at Affinivax, playing a key role in the acquisition by GSK, and Moderna.

“The acquisition of Etherna is a transformative moment for Valerio, propelling us toward our vision of building a fully integrated RNA therapeutics company. By bringing together Etherna’s cutting-edge science with our proprietary targeted delivery technologies, we are creating a powerful engine for innovation. Together, these capabilities position us to efficiently and confidently advance the next generation of RNA medicines beyond the liver, opening new therapeutic frontiers and expanding what is possible for patients worldwide.” said Gilles Besin, Ph.D., CEO of Valerio.

“This transaction represents a natural next step in Etherna’s mission to unlock the full potential of nucleic acid-based medicines. Together with Valerio, we will have the scientific capabilities, leadership and ambition to translate these technologies into a growing pipeline of targeted medicines, building long-term value while advancing novel therapies for patients – while continuing to support our partners in discovery, development and manufacturing.” said Bernard Sagaert, CEO of etherna.

Terms and Conditions of the Acquisition
The acquisition of 100% of the share capital and voting rights of etherna is contemplated for a total enterprise value of €30 million, subject to customary adjustments.
The Acquisition would be settled through a mix of:
(i) a cash consideration, fully backed by committed financing from Valerio’s existing shareholders; and
(ii) a share consideration consisting of contribution in kind of etherna shares (the “Contributions”) to the Company.

The Acquisition is supported by leading life sciences investors, with key etherna shareholders becoming Valerio shareholders as part of the transaction, reflecting confidence in the strategic vision and value creation.
Completion of the Acquisition remains subject to (i) applicable regulatory approvals in the relevant jurisdictions, including foreign direct investment control, (ii) finalizing of the transaction documentation (iii) completion of a financing pursuant to outstanding shareholders’ resolutions, fully secured by subscription undertakings from Valerio’s existing shareholders up to the cash consideration, and (iv) the approval by Valerio’s shareholders of the Contributions at an extraordinary general meeting to be convened for that purpose, secured by voting undertakings from shareholders representing more than 70% of the voting rights, whose decision shall be based in particular on a report by a contributions auditor assessing the fairness of the contribution transaction.
The parties have entered a 6-week exclusivity period to finalize the definitive transaction documentation required in the context of the contemplated Acquisition, in accordance with the provisions of the binding offer.

The binding offer has received the unanimous approval of etherna’s board of directors.

Advisors
Van Lanschot Kempen NV is serving as exclusive financial advisor to Valerio Therapeutics with Goodwin Procter LLP serving as legal counsel.
Moelis & Company is serving as financial advisor to etherna with Deloitte serving as legal counsel.

About etherna

etherna is a leading technology platform company pioneering the development of mRNA and lipid nanoparticle (LNP) technologies, including manufacturing up to GMP grade. With over a decade of expertise, the company provides pharma and biotech partners with an integrated suite of proprietary platforms, including customizable lipid nanoparticles (cLNPs) and advanced mRNA chemistry to enable the delivery of high-quality and efficacious Nucleic Acid based therapeutics.

About Valerio Therapeutics
Valerio Therapeutics (FR0010095596 – ALVIO) is a pioneering biotechnology company specialized in the discovery and development of innovative targeted RNA therapeutics. The Company is listed on Euronext Growth Paris.
For more information: https://valeriotx.com/.

CONTACTS

etherna Media Relations: media@etherna.be
Valerio Therapeutics
Investor Relations: ir@valeriotx.com | +33 (0) 1 45 58 95 10

Niel, Belgium – May 19, 2026 – etherna (www.etherna.be), a leading provider of cutting-edge mRNA and lipid nanoparticle (LNP) technologies across the biotech and pharma industry, today announces a major milestone in its ongoing partnership with Dropshot Therapeutics. Dropshot has officially decided to advance one of its selected targets in renal disease to the clinical stage, successfully validating etherna’s platform technologies. Notably, this milestone marks the advancement of an mRNA LNP renal disease clinical trial.

Moving forward, the collaboration will leverage etherna’s extensive manufacturing capabilities. In fact, GMP-grade material manufacturing is a critical step in the mRNA LNP clinical trial process for renal disease. The partnership will now focus on manufacturing GMP-grade material for IND enabling studies and intended Phase I clinical trials.

Executive Quotes

“We are pleased to see that Dropshot has achieved their preclinical milestones based on our nucleic acid and LNP platforms and has decided to move to the next steps. We will now support them fully in all manufacturing and regulatory steps needed to launch the clinical campaign in 2027.”
— Bernard Sagaert, CEO of etherna

“Dropshot Therapeutics is committed to advancing innovation to address unmet medical needs in renal and cardiac diseases. We are very pleased with the results we have obtained. We are delighted to see the rapid progress of our collaboration, based on etherna’s nucleic acid and LNP capabilities, which has paved the way for a renal disease mRNA LNP clinical trial.”
— Marijn Dekkers, CEO of Dropshot

About etherna

etherna is a leading technology platform company pioneering the development of mRNA and lipid nanoparticle (LNP) technologies, including manufacturing up to GMP. Through collaborations like the mRNA LNP renal disease clinical trial, etherna continues to support innovative projects. Having evolved into a key strategic partner for the global life sciences industry, etherna supports projects from early research over development to GMP manufacturing.

Key commercial highlights:

• Decade of Expertise: Offers over 10 years of experience providing pharma and biotech partners with an integrated suite of proprietary platforms.
• Advanced Technologies: Utilizes advanced mRNA chemistry and customizable lipid nanoparticles (cLNPs) to enable the delivery of differentiated and efficacious RNA therapeutics. Importantly, these technologies support innovative clinical trials such as those targeting renal disease with mRNA LNPs.
• Strong Foundation: Founded in 2013 as a spin-off from the Vrije Universiteit Brussel (VUB).
• Global Reach: Headquartered in Niel, Belgium, with specialized R&D facilities in Ghent and commercial operations in the U.S.

About Dropshot Therapeutics

• Dropshot Therapeutics is an early stage biotechnology company dedicated to developing innovative RNA-based therapeutics for heart and kidney diseases. Through their partnership, a pioneering mRNA LNP clinical trial in renal disease is now underway.
• The company is based near Boston, USA and was co-founded in 2023.
• Its co-founders are Kenneth R. Chien, co-founder of Moderna and former Professor at Karolinska Institutet, and Marijn E. Dekkers, Chairman of Novalis LifeSciences and former CEO of Bayer and of Thermo Fisher Scientific.

Contact Information

• etherna Media Relations: media@etherna.be
• Dropshot Therapeutics: info@dropshottherapeutics.com

Niel, Belgium – February 19th, 2026 – etherna, a leading provider of cutting-edge mRNA and
lipid nanoparticle (LNP) technology across the biotech and pharma industry, announces that one
of its key collaborators, Almirall (www.almirall.com), a leading medical dermatology company,
nominated LAD116 as a novel therapy targeting non-melanoma skin cancer for further
development in IND enabling studies. LAD116 is based on etherna’s intratumoral mRNA/LNP
platform for therapies intended to generate a potent immune response directly within the tumor
microenvironment. The collaboration with Almirall on this potential new therapy will now focus
on manufacturing and producing GMP-grade material for IND enabling studies and intended
Phase I clinical trials.

Bernard Sagaert, CEO, etherna, added:
“This collaboration is a perfect example of what can be achieved when teams are fully aligned
and driven to succeed. The combined efforts of both companies to discover and advance an
mRNA-LNP based therapy to preclinical candidate nomination, on time and on budget, has been
outstanding. We are extremely happy to continue to support Almirall as they advance this
promising approach for non-melanoma skin cancer patients.”

Karl Ziegelbauer, Chief Scientific Officer, Almirall, commented:
“Almirall is committed to advancing innovation in medical dermatology to address significant
unmet medical needs. We are very excited to advance this innovative intratumoral approach to
potentially treat patients with non-melanoma skin cancer and we are delighted to see rapid
progress of our collaboration with etherna based on their mRNA and LNP capabilities.”

About etherna
etherna is a leading technology platform company pioneering the development of mRNA and
lipid nanoparticle (LNP) technologies, including manufacturing up to GMP. With over a decade of
expertise, the company provides pharma and biotech partners with an integrated suite of
proprietary platforms, including customizable lipid nanoparticles (cLNPs) and advanced mRNA
chemistry to enable the delivery of differentiated and efficacious RNA therapeutics. Founded in
2013 as a spin-off from the Vrije Universiteit Brussel (VUB), etherna has evolved from a developer
of immunotherapies into a key strategic partner for the global life sciences industry, supporting
projects from early research over development to GMP manufacturing. The company is
headquartered in Niel, Belgium, with R&D facilities in Ghent and commercial operations in the
U.S. and Asia. www.etherna.bio

Media Contact: 

media@etherna.be

Niel, Belgium, July 22, 2025 –  etherna immunotherapies NV (“etherna”), a biotech company and a platform technology leader in pioneering mRNA and Lipid Nanoparticle (LNP) technologies, today announces breakthrough innovation in the efficient in vivo extrahepatic delivery of mRNA to several key tissues, including to hematopoietic and progenitor stem cells (HSPCs) in bone marrow and to T cells. Key highlights of the data presented include:

• New rodent and non-human primate data on proprietary etherna vaccine LNPs that outperform by at least 5-fold the clinical benchmark LNP compounds for vaccine applications
• New rodent and non-human primate data using etherna liver LNP that outperform by at least 4-fold the clinical benchmark LNP compounds for liver repeat dose protein expression and gene editing applications
• New LNPs that have been optimized for efficient delivery of RNA payloads to hematopoietic stem and progenitor cells (HSPC) in the bone marrow, achieving mRNA payload expression in over 90% of all mouse bone marrow HSPCs using an untargeted LNP
• Other newly described and optimized LNPs that have shown efficient delivery to T cells in vivo in both mice and humanized mouse models, including demonstration of robust CAR-T mediated killing using both untargeted and CD8 antibody-targeted LNP
• Data to be presented by Antonin de Fougerolles at the 5^th annual mRNA-based Therapeutics Summit held in Boston

Nucleic acid-based therapeutics, including mRNA-based medicines, are rapidly reshaping the treatment landscape for genetic diseases, vaccines, and protein replacement therapies. While lipid nanoparticles (LNPs) have proven highly effective in liver-targeted applications, achieving robust delivery to extrahepatic cells remain a major challenge.

etherna’s proprietary library of bio-reducible ionizable lipids has been key in addressing this delivery challenge. In etherna’s recent Non-Human Primate (NHP) studies, the company’s proprietary LNP formulations demonstrated at least 5-fold improved mRNA expression compared to clinical benchmarks for both vaccine and liver repeat-dose protein expression applications. These LNPs were also very well tolerated in NHP and this improvement in liver-directed expression was also demonstrated in a rodent transthyretin gene editing study where it significantly outperformed the LP01 clinical benchmark and where equivalent efficacy was seen at ¼ the LP01 dose. These results are further proof of the potency and translational potential of etherna’s proprietary lipid library.

etherna has now developed a Bio-Reducible LNP for delivery of mRNA to bone marrow stem cells, a novel LNP platform optimized for extra-hepatic delivery. This platform is systematically optimized for increased mRNA expression through proprietary linker, tail, and headgroup chemistry modifications.

We have optimized an LNP formulation specifically for hematopoietic stem and progenitor cells (HSPCs). This formulation enabled a controlled shift in biodistribution away from the liver and toward bone marrow tissue. The resulting formulations achieved mRNA expression in over 90% of all bone marrow HSPCs, marking a transformative leap in the ability to deliver RNA therapeutics systemically to extrahepatic cell types.

This breakthrough was made possible through a structure activity relationship (SAR) optimization process which significantly enhanced the targeting of hematopoietic stem cells (HSCs). By adjusting lipid composition and systematically analyzing biodistribution outcomes, the research team unlocked a delivery profile that favors bone marrow uptake while maintaining stability, safety, and high transfection efficiency.

In addition, using a similar but slightly different approach, etherna scientists have optimized other LNP formulations for improved delivery to T cells. Efficient delivery to T cells using a passive targeting approach (consisting of just an ionizable lipid, helper lipid, cholesterol, and PEG lipid) was demonstrated in rodents. The addition of an anti-CD8 antibody on the LNP surface served to further increase in vivo uptake and mRNA expression in CD8+ T cells.

Importantly, we also demonstrated the ability of both our non-targeted and targeted T cell LNP formulations to deliver mRNA in a humanized mouse (mice reconstituted with human immune cells). When we used these formulations to deliver a CD19-CAR mRNA, a dramatic CAR-T-mediated killing of B cells was seen with both our untargeted and targeted LNP formulations. The level of CAR-T expression and activity seen using an unoptimized CD19-CAR mRNA was comparable to the current pre-clinical state of the art in the field, and we expect this to improve a further 3-5 fold upon incorporation of etherna’s proprietary mRNA designs.

These innovations represent a major advancement in the field of in vivo liver gene editing and therapeutic protein expression in hematopoietic stem cells and T cells. etherna’s breakthrough research offers a new treatment possibilities for hematologic disorders and beyond.

These data will be presented on July 22^nd 2025 at the 5^th annual mRNA-based Therapeutics Summit in Boston. This innovation positions etherna as a leader in Bio-Reducible LNP for delivery of mRNA to bone marrow stem cells, addressing a key challenge in extrahepatic targeting.

We welcome partners who are committed to pushing the boundaries of what’s possible in nucleic acid-based medicine therapeutics and delivery of payload to extrahepatic cell types.

Contact information:

etherna: media@etherna.be

www.etherna.be/contact

Niel, Belgium and Boston, USA, January 9, 2025 – etherna immunotherapies NV (“etherna”), a technology platform leader pioneering mRNA and lipid-based nanoparticle (LNP) technologies, announces a strategic collaboration with Dropshot Therapeutics (“Dropshot”). The collaboration combines the cutting-edge platforms of both companies to accelerate the development of RNA-based therapeutics for the development of multiple new drug candidates across several indications. etherna will receive an upfront payment and research funding, and potentially milestone payments during development and tiered royalties following product launch, together estimated to be up to USD 950 million.

As a recognized leader in mRNA and LNP technology, etherna has developed a suite of proprietary lipid nanoparticle formulations. These technologies enable precise delivery and expression of RNA therapeutics in targeted organs and cells, forming the foundation for groundbreaking treatments across multiple therapeutic areas.

Dropshot, focused on addressing unmet medical needs in cardiac and renal diseases, has been at the forefront of developing novel therapies utilizing LNPs to deliver RNA payloads. The collaboration builds on Dropshot’s prior evaluation of etherna’s mRNA and LNP platforms and is intended to create novel proprietary therapeutics based on etherna’s mRNA and its LNP formulations to move rapidly from pre-clinical animal studies into clinical human studies.

“This agreement underscores etherna’s commitment to driving innovation through collaboration,” said Bernard Sagaert, CEO of etherna. “Dropshot’s expertise in heart and kidney disease aligns with etherna’s mission to be a technology leader in the development of nucleic acid-based medicines. etherna aims to empower our partners to create transformative therapeutics and improve patients’ lives.

Marijn Dekkers, CEO of Dropshot, said “At Dropshot we have been working with etherna for some time evaluating their technology solutions to meet our needs to develop new potential RNA therapeutics. We are excited about this strategic collaboration wtih Dropshot to bringing our expertise in cardiac and renal disease biology together with etherna’s mRNA and LNP technology. We look forward to bringing multiple new drug candidates into active development.”

About Dropshot Therapeutics
Dropshot Therapeutics is an early stage biotechnology company dedicated to developing innovative RNA-based therapeutics for heart and kidney diseases. The company is based near Boston, USA and was co-founded in 2023 by Kenneth R. Chien, co-founder of Moderna and former Professor at Karolinska Institutet, and Marijn E. Dekkers, Chairman of Novalis LifeSciences and former CEO of Bayer and of Thermo Fisher Scientific.

Contact information:
etherna: media@etherna.be
Dropshot: info@dropshottherapeutics.com

Niel, Belgium, December 10, 2024. etherna, a biotech company pioneering mRNA and Lipid-based-nanoparticle (LNP) technologies, today announced the publication of pre-clinical data showing the therapeutic potential of a new mixture of mRNA-encoded immune modulators designed to activate the immune system to eradicate tumors.

The study, published in Nature Communications and conducted in collaboration with the researchers from the Vlaams Instituut voor Biotechnology (VIB) Vrije Universiteit Brussel (VUB) and Universiteit Gent (UGent), highlights the unique potential of etherna’s mRNA and LNP platforms to yield improved anti-cancer immunotherapies.

This study revealed that a combination of three mRNAs (named “Triplet”) encoding for the cytokines IL-21 and IL-7 and the membrane-bound co-stimulator 4-1BBL (named Triplet) acts synergistic in stimulating anti-tumor T cells and evoking regression of injected and distal tumors upon LNP-mediated intratumoral injection.

Notably, the triplet combination showed remarkable efficacy in triple-negative breast cancer, an aggressive disease with limited treatment options. In these models, the therapy achieved an 85% tumor regression rate.

Additionally, the triplet therapy proved effective in immune checkpoint blockade-resistant cancer models, showcasing its potential to overcome resistance to existing immunotherapy treatments. Early translational steps confirmed that the LNP-encapsulated Triplet mRNA can be successfully expressed by myeloid and tumor cells derived from non-small cell lung carcinomas, indicating potential applicability in human clinical settings.

mRNA-based immunotherapy has garnered significant attention for its ability to stimulate the immune system to recognize and destroy cancer cells. However, challenges such as mRNA instability, rapid degradation, and poor cellular uptake have hindered its clinical potential. etherna’s mRNA-LNP technology addresses these obstacles, providing a robust delivery platform to maximize therapeutic efficacy.

Dr. Florence Lambolez, Pharmacology Director at etherna, highlighted the potential: “The ability to achieve robust preclinical results while taking early steps toward human applicability demonstrates the promise of our platform. We’re committed to advancing these therapies toward clinical trials and, ultimately, improving outcomes for patients battling hard-to-treat cancers.”

Dr. Stefaan De Koker, VP Technology and Innovation at etherna, added: “These results validate the versatility and effectiveness of our immunotherapeutic platform. In addition to screening many combinations of cytokines and co-stimulators to arrive at the Triplet mix, advanced mRNA sequence engineering and LNP optimization were needed to achieve robust anti-tumor efficacy. The platform’s adaptability allows us to tailor therapeutic mRNAs to meet the unique challenges of various cancers.”

Bernard Sagaert, CEO of etherna, commented on the findings: “This research underscores our commitment to advancing mRNA-based therapies. By demonstrating the combined power of mRNA and lipid nanoparticle technology, we are paving the way for a new era in cancer treatment.”

Dr. Damya Laoui of VIB-VUB emphasized the importance of the approach: “Our use of LNPs for delivering therapeutic mRNA directly to tumors has shown strong immune activation and tumor elimination with minimal side effects. Importantly, it also induces immunological memory, offering protection against future tumor recurrences.”

We are pleased to announce that Antonin (Tony) de Fougerolles has been appointed as our new Chair. Tony, has been a key member of our Board since January 2023, and we are confident that his extensive experience and vision will drive our mission forward. Our outgoing Chair, Marijn Dekkers, will remain on the Board, continuing his contributions.

Tony brings a wealth of expertise in mRNA and Lipid Nanoparticle (LNP) therapeutics, having held pivotal leadership roles at Moderna and Alnylam. His accomplishments include pioneering modified mRNA as a therapeutic and vaccine modality and advancing several new drug modalities to the market. His leadership will be instrumental as we continue to expand our partnerships.

Bernard Sagaert, our CEO, expressed his enthusiasm: “I am thrilled to work more closely with Tony. His vast experience, business relationships, and strategic vision in the field will further accelerate the development and success of etherna.”

Tony de Fougerolles, etherna Chair added: “Over the last 18 months I have seen first-hand how the cLNPs and mRNA manufacturing expertise that etherna has developed is world-leading and impressive in its quality, breadth, and novelty. The recently announced partnership with Almirall is a clear recognition of this. I look forward to guiding Bernard and his talented team to seize exciting opportunities to bring novel mRNA-based therapeutics to patients.”

Marijn Dekkers, etherna Board Member noted: “Tony has already proven to be an extremely valued addition to the Board and therefore I am delighted to welcome him as my successor. His combination of scientific and entrepreneurial excellence as well as clear strategic vision will enable him to steer etherna successfully through the next stage of its development.”

Meet our board members 

• Combines etherna’s mRNA and LNP technologies expertise with Hasselt University’s leading autoimmune research
• Focuses on developing a tolerizing mRNA-LNP platform that restores immune homeostasis and that can be deployed across a variety of auto-immune diseases
• Funded by Euros 1.7 million Flanders Innovation & Entrepreneurship (VLAIO) grant

Niel, Belgium, May 21, 2024 – etherna, a leading mRNA technologies company, announced today that it has entered a research collaboration with Hasselt University (UHasselt) to develop an mRNA-LNP based treatment for auto-immune disorders.  Funded by Flanders Innovation & Entrepreneurship (VLAIO), the project aims to combine etherna’s vast expertise in developing customized mRNA and lipid-based nanoparticle technologies for immuno-modulation with UHasselt’s renowned research into autoimmune diseases with a particular focus on multiple sclerosis.

Prof. Dr. Bieke Broux, Faculty of Medicine and Life Sciences, UHasselt said: “This innovative project was created by bringing together the expertise of etherna in mRNA and LNP technologies and the extensive immunological knowledge available in the Biomedical Research Institute (BIOMED) of Hasselt University. My team focuses specifically on finding solutions for the autoimmune disease multiple sclerosis. To this end, we use human in vitro models, as well as laboratory animal models to translationally test our findings.”

Dr. Paulien Baeten, Postdoctoral researcher commented: “The collaboration with etherna in this VLAIO-funded project is a great opportunity to contribute to the application of mRNA technologies in the fight against autoimmune disorders. This gives us as academic researchers the opportunity to convert our acquired knowledge into a solution for patients.”

Dr. Stefaan De Koker, VP Technology & Innovation at etherna, added: “We are delighted to receive this grant from VLAIO and enter into collaboration with UHasselt. We see autoimmune diseases as one of the key opportunities for mRNA-LNP autoimmune therapy alongside oncology and infectious diseases. The aim is to develop tolerizing mRNA therapeutics that selectively amplify immune-suppressive regulatory T cells (Tregs) and deplete disease-causing auto-reactive effector T cells (Teffs) whilst avoiding generalized immune activation. etherna’s ability to provide ultrapure, non-inflammatory mRNA, and immune-silent LNPs targeting antigen presenting cells alongside UHasselt’s immunological expertise will be key to success.”

Since etherna was founded in 2013, the company has established an integrated set of proprietary capabilities for end-to-end design, development, and manufacture of next-generation mRNA products. These include molecular designs, lipid chemistry expertise, customized lipid nanoparticle formulations (cLNPs), mRNA-based T cell adjuvants, and advanced manufacturing processes. etherna’s business model is to partner with both emerging and established biopharma companies, allowing them to resolve the current challenges mRNA therapeutics face.

About Hasselt University
In five decades, Hasselt University has grown into a civic university dedicated to the region, connected in and with the world. UHasselt has two campuses (Diepenbeek and Hasselt), ten faculties and schools (Architecture and Art, Business Economics, Medicine and Life Sciences, Industrial Engineering, Law, Sciences, Educational Studies, Social Sciences, Rehabilitation Sciences & Mobility Sciences), and seven research institutes and centers (biomedical, statistical and environmental, and materials research & research into mobility, digital media and the clinical research center LCRC). Hasselt University has more than 7,000 students and 1,600 staff members.

About BIOMED
The Biomedical Research Institute (BIOMED) of Hasselt University is a multidisciplinary institute where high-end technologies are used to gain new insights into three disease domains: immunology, neuroscience, and cardiovascular disease. The institute combines high-quality fundamental research with translational programs to develop applications for patients and the healthcare sector. This focuses on identifying risk factors throughout the different phases of life, developing better insights into disease mechanisms, monitoring conditions, and devising strategies to deal with, treat, and prevent conditions.

This work paves the way for the design of mRNA vaccines to combat infectious diseases and cancers with enhanced efficacy and improved tolerability. The inclusion of lipid nanoparticles is crucial in this advancement, making mRNA vaccines with lipid nanoparticles a significant focus for future innovations.

Niel, Belgium – Feb 13, 2024 – etherna, a leading RNA technology company has announced the publication of a peer-reviewed paper in Advanced Functional Materials showcasing the strengths of etherna’s proprietary Lipid-based nanoparticle (LNP) platform.

The work, which was conducted in collaboration with the lab of Prof. De Geest at Ghent University, describes how delivery of mRNA-encoded antigens in LNPs comprising a novel class of ionizable lipids enhances the induction of antigen-specific immune responses while reducing undesired off-target expression in the liver, thereby minimizing the risk of adverse events, thus emphasizing the vital role lipid nanoparticles play in mRNA vaccine efficiency.

The researchers compared the transfection ability and toxicity arising from the use of two different mRNA encapsulation materials, MC3 (which served as a benchmark) and etherna’s S-Ac7-DOG. Their findings included significant improvements in mRNA vaccines lipid nanoparticles interaction, considerably lowering toxicity.

In mouse models, the team found that S-Ac7-DOG encapsulated mRNA demonstrated markedly higher transfection, lower reactogenicity, and higher accumulation in the vaccine-draining lymph nodes, tissues where immune responses against microbial antigens and tumor antigens are typically induced. The role of LNPs in enhanced mRNA vaccine delivery was evident.

Hypothetically, any mRNA-based drug using S-Ac7-DOG as the lipid base would therefore have improved efficacy and a better safety profile. Eventually, these findings could lead to the development and subsequent delivery of highly efficacious, safe cancer vaccines and treatments, transforming oncology as we know it. It emphasizes how mRNA vaccines lipid nanoparticles work together for better treatment options.

Stefaan De Koker, etherna’s Vice President, Technology & Innovation, describes the paper as a “landmark” for the company and its technology.
“The publication in Advanced Functional Materials demonstrates several key advantages of etherna’s mRNA and lipid nanoparticle offerings and, for the first time, demonstrates the two together. Whilst the currently published work focuses on the design of mRNA LNPs for more effective vaccines, we also have designed LNP platforms based on similar chemistries for the immune-silent delivery of mRNA to hematopoietic stem cells, macrophages, and hepatocytes, thereby extending the utility of our LNP platforms to hematological disorders, rare genetic diseases, and auto-immunity.
It is our view that mRNA therapies, when successfully deployed, could be used to save the lives of millions of patients worldwide,” he says. “As a company, we are now even better positioned to sign development agreements with large pharmaceutical companies who require additional assistance in bringing their own mRNA therapies to market.”

Kenneth Chien, Karolinska Institute Distinguished Professor Emeritus of the Swedish Research Council added: “This study establishes the value of combining the design of custom LNPs ( cLNPs) with state-of-the-art mRNA chemistry based on the optimization of the 5’ and 3’ untranslated regions along with enhanced algorithms for codon optimization. The etherna paradigm for cLNP design is ushering in the rapid generation of novel families of delivery systems for not only vaccination but also for in vivo tolerization for a host of autoimmune diseases.” In this context, the synergy between mRNA vaccines lipid nanoparticles is crucial for advancing therapeutic solutions.

About Advanced Functional Materials
Advanced Functional Materials is part of the Wiley family of scientific publications. Published weekly since 2013, the journal has an impact rating of 19 and focuses on articles that demonstrate advances in the chemical and physical properties of known materials.
Although Advanced Functional Materials’ most-cited articles focus on battery and semiconductor technology, its readers and submissions come from a broad range of backgrounds, including those from elsewhere in the materials science sector, physicists, engineers, biologists, and medical researchers.

• The multi-target research and development partnership will focus on severe skin diseases. Research into mRNA therapies for skin diseases will be a key component of this focus.
• The collaboration leverages etherna’s proprietary mRNA and lipid nanoparticle (LNP) technology with Almirall’s expertise in the dermatology space
• In addition to upfront and technology access payments, etherna is eligible to receive €300 million in development and commercial milestones as well as tiered royalties

BARCELONA, Spain and NIEL, Belgium. December 12th 2023 – Almirall, S.A. (ALM), a global pharmaceutical company focused on medical dermatology, and etherna, an mRNA/LNP technology platform company, announced today a multi-target alliance to discover and develop new mRNA-based therapies for severe skin diseases, including non-melanoma skin cancer.

The alliance combines and leverages etherna’s innovative proprietary mRNA capabilities and LNP formulations with Almirall’s leading expertise in medical dermatology to accelerate discovery of novel treatment options. Delivery of LNP-formulated mRNA for transient and local translation of therapeutic proteins offers a unique opportunity to encode for multiple therapeutically active components in a single treatment, underpinning the potential for mRNA therapies specifically designed for skin diseases.

Etherna and Almirall will work collaboratively on the research activities, while Almirall will lead clinical development and commercialization. Under the terms of the agreement, etherna will receive upfront and technology access payments. In addition, etherna is eligible to receive success-based development and commercial milestone payments that could exceed €300 million contingent upon launch and commercial success of multiple products, as well as tiered royalties based upon future global sales. Further financial details were not disclosed.

Dr. Karl Ziegelbauer, Chief Scientific Officer of Almirall, stated: “At Almirall, we always look for new solutions for patients suffering from skin diseases and we are thrilled about the strategic alliance with etherna to strengthen our pipeline with mRNA-based assets that can potentially lead to novel therapies for skin conditions.”

Bernard Sagaert, CEO of etherna, stated: “We are excited to partner with Almirall to advance mRNA therapeutics into medical dermatology. Almirall and etherna share the vision that intradermal application of LNP-formulated mRNA is a highly promising strategy to bring novel, efficacious new treatment options that will deliver huge benefits to patients through innovative mRNA therapies for skin diseases.”

• Sagaert’s CEO appointment follows his successful interim period implementing etherna’s new partnership-driven business strategy. The etherna CEO appointment marks a pivotal point in the company’s strategic direction.
• Sagaert joined etherna in 2017 and brings extensive operational and strategic experience in the life sciences industry.
• Dekkers, who is the founder of investment and advisory firm Novalis Capital Partners LLC and former CEO of Bayer AG and Thermo Fisher Scientific, is widely recognized as a visionary industry leader.
• etherna’s integrated technology offering is internationally recognized as key differentiator – proprietary RNA chemistry and customized LNP platforms matched with deep GMP process know-how.
• The company has also rebranded its name from eTheRNA immunotherapies to etherna, and has launched new websites.

Niel, Belgium, October 16, 2023 – etherna (“the Company”), a leading mRNA/LNP technologies company, announced today that Bernard Sagaert has been confirmed as Chief Executive Officer. This follows an interim 12-month period during which he has successfully led the Company’s pivot to a new partnership-driven business strategy. At the same time Marijn Dekkers, an existing Board Member representing investor Novalis LifeSciences LLC, has been appointed Chairman of the Board. Both appointments come as etherna’s new strategy is gaining significant traction globally. The etherna CEO appointment further establishes firm leadership in the company. etherna is enabling a growing number of life science and pharma companies to accelerate their pursuits into the fast-growing nucleic acid sector by leveraging the Company’s industry-leading proprietary RNA-based chemistry, its custom LNP delivery platforms, and its GMP process knowhow.

Prior to the interim CEO role, Bernard Sagaert was COO at etherna. The significance of Sagaert’s etherna CEO appointment is evident in his extensive career, having joined the Company in 2017 after a successful career in both industry and consulting including roles as QA & Supply Chain Director at Mylan in Belgium, and VP QA EMEAA at Sterigenics, a Sotera company.

Marijn Dekkers is the Founder and Chairman of Novalis Capital Partners LLC, an investment and advisory firm for the Life Science industry. Previously, he served as CEO of Bayer AG in Leverkusen, Germany and as CEO of Thermo Fisher Scientific near Boston, MA, USA.

Tony de Fougerolles, Board Member and Head of Remuneration Committee added: “Bernard has shown exceptional leadership and clarity of purpose over the last year. I am therefore pleased to confirm his appointment as CEO. Equally I congratulate Marijn on his appointment to Chairman and look forward to working with both of them as etherna further exploits its mRNA/LNP expertise that is world-leading and impressive in both its breadth and novelty.”

Bernard Sagaert commented: “I am delighted to be confirmed as CEO and thank the board for their confidence. I also welcome Marijn as Chairman, and would like to thank Russell Greig, our previous Chairman, for his long term engagement with the company and the support he has given me during the Interim CEO period. etherna’s new partnership strategy has been very well-received in both Europe and the US. With the help of our highly dedicated and professional team, I now intend to continue and accelerate our drive towards becoming the premier discovery and development partner for pharma and biotech aiming to deliver novel RNA-based therapeutics to patients.”

Marijn Dekkers, new etherna Chairman said: “I am honored to be asked to take the role of Chairman at this exciting Company and working closely with Bernard, the etherna leadership team, and the board. Already as COO, Bernard was instrumental in building etherna’s unique technology platform. During the past 12 months, he has demonstrated strong and focused leadership as the Company has introduced the new business partnership strategy. The board has now confirmed his permanent appointment, confident in his ability to lead the company to its next stage of development, contributing its breakthrough technologies to the development of mRNA-based therapeutics, an area that is full of unimaginable opportunities.”

Since etherna was founded in 2013, the Company has established an integrated set of proprietary capabilities for end-to-end design, development and manufacture of next-generation mRNA products, with a focus on modulated expression delivery platforms, optimized RNA chemistry supported by proprietary process technologies. These include molecular designs, lipid biochemistry expertise, customized lipid nanoparticle formulations (cLNPs), mRNA-based T cell adjuvants, and advanced manufacturing processes, and they overcome the current challenges facing the development of mRNA therapeutics. etherna’s business model utilizes this suite of capabilities as enablers to deliver superior products for partners in both early-stage research as well as later-stage development for mRNA therapeutics.

To reflect both the new business strategy, board restructuring and permanent appointment of Sagaert, the Company has also rebranded its name from “eTheRNA Immunotherapies” to “etherna”. The updated website for the Partnerships can be found at www.etherna.be