// 3 November 2020

eTheRNA extends mRNA contract manufacturing services

High throughput research grade material to GMP production batches.

Niel (Belgium)

In response to growing international demand, eTheRNA today announced the extension of its mRNA production services to include high throughout research grade mRNA in addition to its GMP capabilities. From its facilities on the Antwerp University Science Park in Niel, the company can develop processes and manufacture mRNA in amounts ranging from research and pre-clinical batches to full GMP production lots for clinical trial supplies. In providing these services, eTheRNA leverages extensive experience gained in developing its own pipeline of mRNA immunotherapies for the treatment of cancer and infectious disease.

Dr Bernard Sagaert, VP Manufacturing, eTheRNA commented: “We have extended our contract manufacturing services in response to a growing number of requests from third parties from around the world. With our two purpose-built mRNA-units, we have the optimal infrastructure to support mRNA-based projects from initial plasmid DNA development and optimization, through linearization, in-vitro translation, mRNA purification and quality control to industrialized GMP production. We can support customers ranging from small academic groups with whom we can partner through to established companies looking for GMP manufacturing capacity.”

The full range of services offered by eTheRNA includes:

Plasmid DNA – design and production of plasmid DNA tailored to customer requirements

Research Grade RNA – mRNA, Guide RNA, Long RNA and dsRNA can be supplied from 100 µg to gram scale and can include multiple constructs for screening purposes.

GMP Grade RNA – mRNA, Long RNA and Guide RNA drug substances can be manufactured by in-vitro transcription in quantities from 100 mg to gram scale. Various upstream and downstream purification processes are available including different capping and adenylation techniques and purpose-based purification techniques which include precipitation, column chromatography, double stranded RNA reduction, tangential flow filtration, bioburden reduction and sterile filtration. Multiple APIs can be formulated into a drug product and sterile fill & finish is available. GMP batch release is in full accordance with cGMP.

Also, by drawing on its own experience with clinical trials, eTheRNA can provide support to customers in CMC file writing.

 

About eTheRNA Immunotherapies

eTheRNA immunotherapies is a clinical-stage company delivering innovative cancer immunotherapies from its proprietary mRNA-based TriMix platform. eTheRNA’s goal is to commercialise these immunotherapies to deliver long lasting clinical remission to cancer patients. eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is backed by international life sciences investors.

Contact information:

Telephone : +32 3 369 17 40

Mobile: +32 477 38 03 95

// 8 October 2020

eTheRNA extends senior management team with appointment of Michael Mulqueen as VP Business Development

New hire will accelerate commercial development of Company’s proprietary TriMix mRNA platform for oncology and infectious disease immunotherapies

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 Michael Mulqueen has been appointed VP of Business Development. Following 15 years at F. Hoffman-La Roche in both scientific and management roles, Michael continued his successful career in business development with innovative companies such as Synosia and Silence Therapeutics.

“I am delighted to join eTheRNA at this exciting stage of its development when the Company is making major progress with the core oncology mRNA immunotherapy pipeline and accelerating the development of its infectious disease vaccine platform,“ said Mulqueen. “I have maintained a strong interest in vaccines and RNA, having originally been a virology team leader at Roche and more recently head of BD at Silence Therapeutics.”

CEO Steven Powell commented: “Michael will be a valuable addition to the team as we seek to leverage the potential of our TriMix platform both through our own pipeline development and through collaborations and partnerships.”

 

About eTheRNA Immunotherapies

eTheRNA immunotherapies is a clinical-stage company developing innovative immunotherapies from its proprietary mRNA TriMix platform. eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is developing products for the treatment of cancer and infectious disease.

 

Contact information:

// 16 June 2020

eTheRNA raises EUR 34 million in Series B financing to accelerate multiple mRNA therapeutic development programs through to clinical proof of concept

  • Advancing oncology and infectious diseases pipeline, including new SARS-CoV-2 program
  • Proprietary mRNA TriMix technology provides unprecedented immune responses
  • Ongoing clinical trials in metastatic melanoma and breast cancer
  • Proprietary LNP platform for intravenous delivery to enter clinical development in HPV-positive cancer
  • Enlarged international investor syndicate includes a new corporate investor

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 it has successfully raised Euro 34 million in a Series B equity financing round. All existing investors – LSP (the Netherlands), PMV (Belgium), Boehringer Ingelheim Venture Fund (Germany), Fund+ (Belgium) and Omega Funds (USA) – are participating in the round. They are joined by Grand Decade, a BVI subsidiary owned by China Grand Pharmaceutical and Healthcare Holdings Ltd (‘GP(HK)’; HKSE Stock code 00512), BNP Paribas Fortis Private Equity (Belgium), Yijing Capital (China) and Novalis LifeSciences LLC (USA). GP(HK) and eTheRNA have also agreed outline terms for a possible exclusive strategic partnership for mRNA manufacturing, independent research and development, production and commercialization in Greater China.

Proceeds of the financing will fund continued development and commercialization of proprietary mRNA technologies and a range of therapeutic products. eTheRNA’s TriMix platform is a core differentiating component in the Company’s product programs and comprises three mRNAs encoding proteins that act together to significantly increase immune responses. TriMix has demonstrated broad application across major cancer types, both preclinically and clinically, offering the prospect of therapeutic vaccines and localised tumor treatments acting synergistically with standard of care treatments. To facilitate its product development activities eTheRNA has developed a proprietary lipid nanoparticle (LNP) platform to enable intravenous delivery of various (neo)antigens, which in combination with TriMix results in unprecedented immune responses. Not only will eTheRNA start clinical development of its internal programs for intravenous mRNA delivery, the Company will also explore partnering opportunities. In infectious diseases, eTheRNA’s technologies are being deployed in an eTheRNA-led international consortium which is developing a cross-strain protective SARS-CoV-2 mRNA vaccine for high risk populations.

Dr Russell Greig, Chairman eTheRNA, commented: “The growing evidence of TriMix’s robustness and versatility as a differentiating immune stimulatory platform in a number of clinical indications was a key factor in the successful conclusion of this new funding round. We are excited that the current Series B financing provides eTheRNA with the opportunity to advance its oncology and infectious diseases pipeline further into the clinic, with the primary objective being to demonstrate clinical proof-of-concept in the near term, including for its proprietary LNP platform enabling intravenous delivery of (neo)antigens. We are delighted with the response from both existing and new investors. In addition, the strategic partnership with China Grand Pharma opens a wealth of opportunities in this potentially vast market and we are looking forward to concluding this partnership.”

About eTheRNA Immunotherapies

eTheRNA immunotherapies is a clinical-stage company developing innovative immunotherapies from its proprietary mRNA TriMix platform. TriMix comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that deliver optimal activation of dendritic cells. These cells behave as immune response mediators and mobilize the immune system to attack cancer cells or infectious agents by inducing a strong T-cell response. eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is developing products for the treatment of cancer and infectious disease.

Contact information:

// 22 April 2020

Frame Therapeutics and eTheRNA immunotherapies NV open a new research collaboration to develop mRNA cancer vaccines against immunogenic neoantigens

Amsterdam (Netherlands) – Niel (Belgium) 

Frame Therapeutics, a new biotechnology company focused on the development of neoantigen-based cancer vaccines, today announced that they have forged a research collaboration with eTheRNA immunotherapies NV, a clinical-stage company developing vaccines and immunotherapies from its proprietary mRNA TriMix platform.

The collaboration aims to develop a new generation of off-the-shelf neoantigen cancer vaccines by combining each company’s immunotherapy expertise and unique technologies. Frame Therapeutics will contribute the discovery and development of the highly immunogenic frameshift neoantigens that are only expressed in specific tumor types and thus offer a new level of patient and tumor specificity. eTheRNA will apply its vaccination technology platform to elicit anti-tumor T-cell responses based by employing its clinically validated TriMix mRNA platform.

Ronald Plasterk, CEO of Frame Therapeutics commented: “Our business is focused on discovery of new antigens for cancer vaccination. Our neoantigens form a good match with eTheRNA’s TriMix technology. By combining the best content with the best vaccine platform we are confident to make a major step forward in cancer therapeutic vaccines”.

Steven Powell, CEO of eTheRNA immunotherapies, commented: “Frame Therapeutics’ work with neoantigens is impressive and we see a natural fit with our TriMix platform. We look forward to studying the clinical potential of delivering neoantigens to tumors and opening a new chapter in cancer immunotherapy”.

About Frame Therapeutics

Frame Therapeutics is a privately funded startup company in the Amsterdam Science Park founded in December 2018. Frame Therapeutics’ goal is to develop its proprietary approach for immunotherapy against cancer, which is based on precise analysis of the DNA and RNA of the tumor of a patient, and using that information to supply the best vaccine against properties specific for the tumor. The strong anti-tumor immune response elicited by Frame vaccines may contribute to major clinical benefits for patients with cancer. www.frametherapeutics.com

About eTheRNA Immunotherapies

eTheRNA immunotherapies NV is a clinical-stage company delivering innovative cancer immunotherapies from its proprietary mRNA-based TriMix platform. eTheRNA’s goal is to commercialize these immunotherapies to deliver long lasting clinical remission to cancer patients. eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium. www.etherna.be

About TriMix

The TriMix platform, on which eTheRNA’s immunotherapies are based, comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that work to deliver optimal activation of dendritic cells. These cells behave as immune response mediators and mobilize the immune system to attack cancer cells through inducing a T-cell response. Clinical proof of concept for TriMix-based immunotherapies has been established through an extensive dataset demonstrating clear clinical benefits in advanced melanoma patients.

About Frame Technology

Frame Therapeutics’ neoantigen technology is based on the identification of a large number of shared neoantigens, which result from frameshift mutations in tumors. Although the majority of frameshift mutations occur at different positions in a gene, the resulting novel protein products are common to large numbers of tumors from different patients. Combined with the long stretches of novel amino acid sequences encoded by frameshifts, these neoantigens represent attractive and highly immunogenic targets for cancer immunotherapy.

// 24 MARCH 2020

eTheRNA Launches an International Consortium and Starts Development of Cross-strain Protective CoV-2 mRNA Vaccine for High Risk Populations

Niel (Belgium) 

eTheRNA immunotherapies NV (Niel, Belgium) announces that that a consortium has been formed with North American and European partners to develop a novel mRNA vaccine against CoV-2 and preclinical development has started. Chinese partners may be added in the consortium in due course.

Administered intranasally, the proposed vaccine is intended primarily for high risk populations such as healthcare workers and families of confirmed cases. It is also designed to be protective against future variations of the virus by targeting conserved epitopes from the whole CoV-2 genome. eTheRNA and its partners EpiVax, Nexelis, REPROCELL and CEV* have extensive experience in the mRNA vaccine field and this will help accelerate progress towards clinical trials with patient enrolment expected in early 2021.

Steven Powell, eTheRNA’s CEO, explained the aims of the consortium: “Viral variation means traditional medicinal and preventive vaccine approaches may fall short when confronted with seasonal or outbreak situations. A vaccine to defend against current and future outbreaks of coronavirus and other respiratory viral pathogens should be robust against viral genome changes, provide a platform that enables rapid introduction of a new viral target, be easy and safe to administer and be scaleable and suitable for stockpiling. The innovative vaccine program we have started with our partners incorporates all of these essential features.”

Traditional vaccines are based on generating an antibody response to outer surface viral protein targets. However, viral variation may greatly reduce the effectiveness of this approach. For example, the SARS-CoV-2 outer surface spike protein (S) is less than 40% homologous to SARS-CoV-1. Furthermore, it has also been reported in several cases that vaccines with suboptimal antibody response (too low or not neutralizing) have facilitated viral entry and been linked to disease enhancement.

The eTheRNA consortium’s approach selects conserved epitopes from the whole viral genome. Creating a vaccine that mounts a strong cellular (T cell) based response against these epitopes offers a better chance to overcome viral variability. Intranasal delivery has been chosen since the mucosa of the upper respiratory tract are the immune system’s primary line of defense. A strong nasal T cell effector and memory response is claimed to fight viral replication, colonization of the lung and thus disease. mRNA has also been demonstrated to induce strong T cell responses by intranasal delivery.

The development programme has been initiated and is focused on a vaccine candidate that integrates 3 different technologies:

  • eTheRNA’s proprietary Trimix technology: an mRNA-based vaccine adjuvant that stimulates dendritic cells into activating a strong CD4 and CD8 T cell response.
  • A combination of T cell epitopes from the virus brought together on a single mRNA construct. For SARS-CoV-2 this will employ an in-silico epitope prediction and design approach from EpiVax Inc. to identify the target.
  • An intranasal vaccine delivery platform using a nasal atomizer and a proprietary formulation that delivers the mRNA to the nasal mucosa and optimizes expression. One of the most promising formulation candidates is being repurposed for clinical use in collaboration with REPROCELL.

“While valuable initiatives and strong support are being deployed into the development of medicinal and vaccine solutions for immediate use against SARS-CoV-2, it is also important that development of solutions for the longer term should also start as soon as possible,” concluded Powell. “Our target is to bring this into clinical testing in early 2021.”

About eTheRNA Immunotherapies

eTheRNA immunotherapies is a clinical-stage company developing innovative immunotherapies from its proprietary mRNA TriMix platform. eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is developing products for the treatment of cancer and infectious disease.

About TriMix

The TriMix platform, on which eTheRNA’s immunotherapies are based, comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that work to deliver optimal activation of dendritic cells. These cells behave as immune response mediators and mobilize the immune system to attack cancer cells through inducing a T-cell response. Clinical proof of concept for TriMix-based immunotherapies has been established through an extensive dataset demonstrating clinical benefits in advanced melanoma patients.

About EpiVax

EpiVax is a 21-year old privately held biotechnology company located in Providence, Rhode Island. Scientists at EpiVax, led by co-founders Annie De Groot, MD and Bill Martin, lead in the fields of immunogenicity risk assessment and computational vaccinology with expertise in T cell epitope prediction, immune modulation, and rapid vaccine design. EpiVax’s broad portfolio of projects includes vaccines and immunotherapies for infectious diseases, autoimmunity and cancer. EpiVax’s proprietary in silico immunogenicity screening toolkits for therapeutics and vaccines, ISPRI and iVAX, are employed in advancing the research of a global roster of companies. Visit www.epivax.com for more information.

About Nexelis

With unrivaled expertise in immunology on both sides of the client/CRO relationship, and operating sites in North America (East and West Coast) and Europe, Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious diseases, metabolic diseases, and oncology fields. Our versatile team of scientists, working with our advanced technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines, anti-viral drugs, and immunotherapy, gene and cell therapy products. Visit www.nexelis.com for more information.

About REPROCELL

REPROCELL was established in 2003 to accelerate medical research via cutting-edge stem cell and human tissue-based technologies, including the use of novel transfection reagents and RNA-based methods for the generation of induced pluripotent stem cells. REPROCELL has further diversified its portfolio of products and services to include predictive drug discovery services in human fresh tissues, technologies for the manufacture of bioengineered human tissues, industry-leading gene editing technology and one of the largest commercial repositories of ethically sourced human tissue. Visit www.reprocell.com for more information.

About CEV

The Centre for the Evaluation of Vaccination (CEV) of the University of Antwerp, headed by Prof. Pierre Van Damme, is a clinical trial centre specialized in the conduct of vaccine trials. It has performed Phase I until Phase IV clinical trials in all age groups. The CEV is internationally known for its professional and qualitative vaccine clinical trial facility and organisation and is therefore a regular partner in vaccine clinical trials, i.e. for EU funded clinical trials, for investigator-driven vaccine trials as well as for industry funded clinical trials. For more information visit https://www.uantwerpen.be/en/research-groups/centre-for-evaluation-vaccination/

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