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// 22 March 2021

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

                                                                                                                                                                                                       

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

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

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

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

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

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

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

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

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

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

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

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

// 11 March 2021

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

Niel (Belgium)

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

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

// 4 March 2021

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

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

Niel (Belgium)

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

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

// 15 December 2020

eTheRNA immunotherapies & Frame Therapeutics are awarded EUR 1.9 million Eurostars research grant for their novel cancer vaccine collaboration

Niel (Belgium) & Amsterdam (Netherlands)

A collaborative project between eTheRNA immunotherapies NV and Frame Therapeutics has been awarded a Eurostars grant totalling EUR 1.9 million for the development of a therapeutic vaccine for the treatment of kidney cancer. The Eurostars program aims to stimulate partnerships between European SMEs and start-ups to foster international collaboration and development of innovative technologies. eTheRNA immunotherapies and Frame Therapeutics began collaborating early in 2020, deploying mRNA technologies to develop novel cancer vaccines based on unique genetic mutations in patient tumours to stimulate a patient’s immune system against the tumour .

// 1 December 2020

eTheRNA and China Grand Pharma enter a strategic collaboration in the Greater China Region focussed on eTheRNA’s proprietary mRNA development products and manufacturing capabilities

Niel (Belgium) 

eTheRNA immunotherapies NV (“eTheRNA”) today announced it has entered into a strategic cooperation and product license agreement with China Grand Pharmaceutical & Healthcare Holdings Ltd (“China Grand Pharma”) to establish a new joint venture company, Nanjing AuroRNA Biotech Co., Ltd. (“AuroRNA Biotech”) in Mainland China to deploy eTheRNA’s proprietary mRNA technology for pharmaceutical research and development and production in the Greater China Region. This follows an undisclosed equity investment by China Grand Pharma in eTheRNA’s Series B financing round earlier in 2020. Initially, China Grand Pharma will invest EUR 8.1 million in AuroRNA Biotech for a 75% equity interest, with eTheRNA holding the remaining equity. eTheRNA will also receive milestone and royalty payments for product developments.

// 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.

// 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.

// 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.

// 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.

// 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.

// 1 June 2019

Safety and immune stimulation data from an intranodal delivery of TriMix mRNA, in the adjuvant melanoma study E011-MEL

Niel (Belgium) 

eTheRNA immunotherapies NV (Niel, Belgium) announces that Dr. Ana Arance, Medical Oncologist at Hospital Clinic de Barcelona, will present safety and immune response data from the E011-MEL study at the ASCO (American Society of Clinical Oncology) Annual Meeting during the poster session “Developmental Immunotherapy and Tumor Immunobiology” on 01 June 2019. The study E011-MEL investigated the safety and immunogenicity of a mRNA-based immunotherapy ECI-006. ECI-006 is a combination of mRNAs encoding for the dendritic cell maturation triple mRNA TriMix together with mRNA coding for5 tumor-associated antigens, which aims to elicit an immune response against the tumor. Since the patients had been radically operated on, there was no expected, immediate clinical activity read-out.

The primary goal of the study was to study whether the injection of ECI-006 into inguinal or axillary lymph nodes was tolerable and clinically feasible. The intranodal injections were performed in the clinic under ultrasound guidance without anesthesia. There were two treatment arms, each of 10 patients. One group received a dose of 600 µg and the other a dose of 1800 µg per injection. The study was performed in centres in Belgium and Spain.

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