Category: News
- Brings strong US business development track record
- Focus on expanding partnerships with biopharma and pharma
- Integrated offering key differentiator – Proprietary customized RNA chemistry and lipid nanoparticles (cLNPs) expertise combined with GMP process knowhow
Niel, Belgium, April 16, 2024 – etherna (“the Company”), a leading mRNA technologies company, announced today that Shelly West has been appointed Business Development Director US. She joins as the Company gains increasing traction for its proprietary RNA-based medicines and LNP delivery platforms in North America and brings extensive experience in building strategic contacts, networks, and business relationships.
Shelly arrives from Cellpoint Biosciences, the Houston-based cell therapy CDMO where she was Senior Director, Business Development, having previously held senior roles at Recipharm, MaxCyte, and Synthego. Shelly holds a B.S. in Microbiology from North Carolina State University.
Shelly commented: “RNA therapeutics are among the most exciting areas currently in life sciences. etherna is a highly innovative leader in the mRNA and lipid nanoparticle field and I look forward to helping build partnerships with US pharma and biotech companies to create novel medicines for patients.”
Bernard Sagaert, CEO etherna, added: “Shelly’s network and experience will enable us to accelerate our growth in this key market. As the range of opportunities for mRNA therapeutics continues to expand beyond oncology and respiratory diseases into areas such as autoimmune, we are getting increasing interest in our partnership model.”
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, and 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 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.
This work paves the way for the design of mRNA vaccines to combat infectious diseases and cancers with enhanced efficacy and improved tolerability
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.
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.
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.
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.
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.”
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
• 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.
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.”
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.”
• Sagaert’s CEO appointment follows his successful interim period implementing etherna’s new partnership-driven business strategy.
• 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. 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. He 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
- Combines strong US business development track record with in-depth mRNA expertise
- Global remit with focus on growth of etherna’s portfolio of partners
- Integrated offering key differentiator – Proprietary customized RNA chemistry and lipid nanoparticles (cLNPs) expertise combined with GMP process knowhow
Niel, Belgium, June 8, 2023 – etherna (“the Company”), a leading mRNA technologies company, announced today that Steffen Helmling, PhD has been appointed Chief Business Officer. He joins as the Company continues to invest in its proprietary RNA-based medicines and LNP delivery platforms to exploit its expertise in the field. Leveraging over 18 years of experience in business development, alliances and pharma partnering, Steffen will focus on growing etherna’s portfolio of partners globally.
Steffen Helmling arrives from X-Chem, Inc., the Boston-based pioneer of DNA-Encoded Library (DEL) technology where he was Chief Business Officer in charge of business development, licensing, marketing and alliance management. Steffen holds a PhD in RNA processing from Tufts University’s School of Biomedical Sciences.
Steffen commented: “I am excited to be back in the transformational field of RNA-based medicines. etherna is a highly innovative leader in the mRNA and lipid nanoparticle field. I look forward to driving our business strategy of being the premier discovery and development partner to pharma and biotech to create novel medicines for patients.”
Bernard Sagaert, interim CEO of etherna, added: “Having Steffen on board will be invaluable in helping us reach out to partners with a route into mRNA therapeutics based on our industry-leading leading platforms. His extensive US network will help us accelerate this process in this key market.”
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 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.
Belgian Royal delegation visits the Afrigen facilities where Univercells and etherna will be supporting the development of the first African-owned mRNA COVID-19 vaccine.
CAPE TOWN (SOUTH AFRICA) & BRUSSELS (BELGIUM), MARCH 25, 2023 – HM King Philippe and HM Queen Mathilde, currently on a state visit to South Africa until March 27, visited the Afrigen Biologics facility in Cape Town to learn more about how two Belgian companies, Univercells and etherna, are supporting the development of the first African- developed mRNA COVID-19 vaccine. The King and The Queen are accompanied by five ministers of federal and regional governments, as well as a business delegation including several Belgian companies. The intention is to further discuss cooperation and partnership between the two countries and focus, among other things, on business and development.
Given the strong commitment from Belgium and the European Union towards supporting regional production autonomy in the region, and the fact that the mRNA Technology Transfer Program co-led by the World Health Organization (WHO) and Medicines Patent Pool (MPP), is at the epicenter of this global effort, the Royal delegation made it a point to include a visit to Afrigen as part of their stay.
Quantoom Biosciences, a Univercells’ company, is leading the development of the mRNA production technology that encompasses all the steps of RNA production, from sequence construct to large scale production, allowing for rapid growth and scale-up. Dramatically more efficient than existing methods, it was built with distributed and de-centralized manufacturing in mind – ensuring that processes can be easily transferred across low- and middle-income countries (LMICs). Today, the project has delivered exceptional results based on the analytical characterization proven to be compliant to Critical Quality Attributes (CQA) specifications, allowing the company to transfer its process to Afrigen.
Afrigen and Univercells are supported in the collaboration by mRNA expert development partner etherna. The company has enabled the development of the RNA production equipment and developed a thermostable COVID-19 vaccine and platform which enables distribution across the continent to even the remotest rural communities, an essential part of the collaboration, and is sharing the way this LNP formulation needs to be produced.
It is in this context that the King and the Queen decided to visit Afrigen and meet both Belgian companies and South African partners who are working together for the development of this milestone vaccine.
The Afrigen guided tour started in the production area, followed by the R&D department and laboratories. As part of the tour, each partner provided the delegation with an update on their involvement and the status of work.
As they were passing by the R&D facilities, Bernard Sagaert, interim Chief Executive Officer of etherna, explained how the project is benefiting from etherna’s technologies, at multiple levels and stages: “We are delighted to partner with Univercells and Afrigen Biologics on this important project by providing expert support and knowhow in all the key areas of mRNA vaccine development. The resulting vaccines validates our integrated approach using our unique skillset – from optimizing RNA payload, through formulation of the lipid nanoparticle delivery system to enhancing thermostability for mass manufacturing. This will allow for storage in normal fridges which are more accessible than -20 or -80°C freezers, especially in LMICs and significantly improve the prospects of making vaccines more accessible globally.”
José Castillo, co-founder of Univercells Group and CEO of Quantoom Biosciences continued: “Almost one year after signing the agreement we are thrilled to be back at Afrigen and meet all partners to discussion the progress and project deliverables. Over the last months, three batched of RNA were produced and Quantoom’s NtensifyTM midi system will be delivered at Afrigen within the next weeks.”
Petro Terblanche, Afrigen Chief Executive Officer, declared: “The COVID-19 pandemic has shown that there is a pressing need to build sustainable capabilities in vaccine development and manufacturing in African and other LMICs. I am thrilled to see how the project is moving forward bringing cutting edge technology to Afrigen to integrate into the technology and manufacturing platforms we are building and transferring to partners in Africa and other LMICs. This is driven by our quest for enabling access to life-saving vaccines and medicines for the people living in the global South.”
Charles Gore, Medicines Patent Pool, added: “Since the start of the mRNA Technology Transfer Program in June 2021, it is impressive to see the amazing developments here at Afrigen and all that has been achieved in mRNA vaccine development. None of it would have been possible without the Program funders, and I particularly want to thank the Kingdom of Belgium for their support from the outset of the project. ”
Dr Owen Kaluwa, World Health Organization, concluded: “ The mRNA Technology Transfer Program is built on partnerships and working closely will leading technologies and experts is essential. Through this cutting-edge technology that has been developed with LMICs in mind, and that provides an inclusive solution, Afrigen with the support of Quantoom and etherna can ow move rapidly to the next phase of mRNA vaccine development. It is still WHO firm belief that a more widely distributed access to technologies and vaccine manufacturing capacity will reduce the gap in making vaccines available promptly for everyone, everywhere and accelerates the impact of the necessary collective effort to control outbreaks.”
CONCLUSION
Next steps include receiving the Quantoom’s NtensifyTM midi system in Afrigen, and etherna’s proprietary lipid to enable Afrigen to replicate the production of mRNA drug substance and drug product according to Quantoom and etherna’s processes, respectively.
- Follows recent financing round led by Novalis LifeSciences LLC, with investors Dr. Marijn
Dekkers and Moderna’s co-founder Dr. Kenneth Chien joining the board of directors - Strategic focus includes customized lipid nanoparticles (cLNPs)
- mRNA chemistries and process capabilities as enabling technologies driving company excellence
Niel, Belgium, January 9, 2023 – etherna (“the Company”), a leading mRNA technologies company, announced today that Antonin (Tony) de Fougerolles has joined its board of directors as an independent member. This follows the Company’s recent Series B2 financing round to expand investment in its integrated mRNA technology platform and further pursue its new partnership-driven business strategy.
Tony is currently the CEO of Evox Therapeutics, an Oxford-based company developing exosome therapeutics, and has an extensive background in mRNA and more specifically LNPs through his roles at Moderna and Alnylam. He has nearly 25 years of biotech R&D experience in building out drug pipelines, and he has played a key role in developing and successfully advancing 3 new drug modalities to the market (mRNA, RNAi, single domain antibodies) and in helping build several multi-billion-dollar companies from start-up stage. As founding Chief Scientific Officer (CSO) at Moderna Therapeutics, he pioneered modified mRNA as a new therapeutic and vaccine drug modality and the mRNA chemistry and delivery systems that form the basis of the approved COVID-19 mRNA vaccines. Prior to that, as VP of Research at Alnylam, he helped develop RNA interference (RNAi) as a new drug modality, including overseeing development of the first approved LNP-based RNAi delivery system and the development of several approved RNAi drugs including inclisiran. Author of over 60 scientific publications and an inventor on over 100 issued US patents, Tony has also a ‘Belgian’ connection, from his time as CSO at Ablynx (now Sanofi) where he played a key role in the approval of the first single domain antibody drug, caplacizumab. Tony obtained his PhD in Immunology from Harvard University.
“Tony is exceptionally qualified to help ensure etherna’s future corporate growth,” added Russell Greig, PhD, Chair of etherna’s board of directors. “His addition to the board will add momentum to the company’s mission to deliver cutting edge advances in mRNA and LNP technologies for the treatment of unmet medical needs.”
“I am thrilled to be joining etherna’s board and contributing to its future growth,” commented Tony de Fougerolles. “The cLNPs and mRNA manufacturing expertise that the company has developed is world leading and impressive in both its breadth and novelty. As is increasingly being understood, the ability to robustly deliver mRNA and other genetic medicines to new cell types and tissues is the central element needed to enable their wider application.”
Marijn Dekkers, Chairman of Novalis LifeSciences, said: “We are excited to have Tony join at this important stage of the Company’s development. He is a fantastic addition to the competences we have already gathered on the board. In addition to scientific excellence, he is a proven entrepreneur with an incredible track record of commercializing new modalities and technology platforms.”
Bernard Sagaert, interim CEO of etherna said: “We are delighted to have Tony join the board, as he brings, together with Ken, vast experience in cLNPs and mRNA to etherna, and is well connected in the industry. Having him on board will be invaluable in helping us implement our new business strategy. Strengthening and expanding our significant expertise in designing, synthesizing, and manufacturing cLNPs for a range of prophylactic and therapeutic indications, will enable the Company to accelerate near-term revenue growth through technology licensing and mRNA cGMP manufacturing services for multiple future partners.”
etherna is an mRNA technology platform company with integrated capabilities including mRNA construct design and optimization, coupled with specialized expertise in designing and manufacturing customized lipid nanoparticles (cLNP) formulations tailored for the prevention and treatment of various pathological states, providing end-to-end solutions for next generation mRNA therapeutics. The company believes that customized LNPs are critical enablers in advancing mRNA technologies to new levels of prophylactic and therapeutic utility.