// 16 October 2018

Mymetics Starts Research Collaboration Project in Cancer Immunotherapy with eTheRNA

Epalinges (Switzerland) 

Mymetics Corporation (OTCQB:MYMX), a pioneer and leader in the research and development of virosome-based vaccines, announced today that Mymetics BV, the Dutch subsidiary of Mymetics Corporation, has entered into a research collaboration project with eTheRNA immunotherapy NV, a clinical stage biotech company developing novel mRNA cancer immunotherapies.

The objective of the project is to evaluate the suitability of Mymetics’ proprietary virosome vaccine delivery technology in combination with eTheRNA’s proprietary TriMix mRNA. eTheRNA will evaluate the duration and intensity of mRNA expression when formulated with virosome technology in vivo and the induction of antigen specific T cells and antitumor efficacy upon therapeutic vaccination in selected tumor models.

Mymetics’ virosome particles have shown to be able to trigger good specific T cell responses as virosomes are able to be absorbed and processed by dendritic cells, thereby presenting specific antigens to T cells to promote immunity against these foreign antigens.

The project is the first step in determining if there is a basis for a further collaboration between Mymetics and eTheRNA.

“We have been interested in further evaluating Mymetics’ virosomes in cancer immunotherapies for a while, so we look forward to work with eTheRNA in this explorative project to evaluate their innovative mRNA constructs in combination with our virosomes and to test the efficacy in tumor models,” stated Ronald Kempers, CEO of Mymetics Corporation.

“mRNA-based therapies have a unique potential to enhance cancer immunotherapy. For mRNA to reach its target, the cellular cytosol and have an optimal effect, the selection of an appropriate delivery vehicle is key. As viruses have evolved highly effective mechanisms to deliver their nucleic acids across cellular membranes, we believe Mymetics’ virosomes might synergize with our mRNA platform and thus further boost the potency of eTheRNA’s mRNA immunotherapies,” stated Peter Tomme, head of preclinical development of eTheRNA.

About Mymetics

Mymetics Corporation (OTCQB:MYMX) is a Swiss based biotechnology company, with a research lab in the Netherlands, focused on the development of next-generation preventative vaccines for infectious and life disabling diseases. It currently has several vaccines in its pipeline: HIV-1/AIDS, intranasal Influenza, malaria, Chikungunya and the RSV vaccine and a collaborative project in the field of allergy immunotherapy with Anergis SA.

Mymetics’ core technology and expertise are in the use of virosomes, lipid-based carriers containing functional fusion viral proteins and natural membrane proteins, in combination with rationally designed antigens. For further information, please visit www.mymetics.com.

About eTheRNA immunotherapies

eTheRNA immunotherapies is a clinical-stage company working to deliver 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 a broad range of cancer patients. eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is backed by leading international life sciences institutional investors.

// 8 October 2018

eTheRNA opens state-of-the-art manufacturing facility in Belgium to support the development of its TriMix-based mRNA cancer immunotherapies

Niel (Belgium) 

eTheRNA immunotherapies, a clinical-stage company developing novel cancer immunotherapies based on its proprietary mRNA-based TriMix platform, announces the opening of a state-of-the-art mRNA manufacturing facility enabling the production of mRNA immunotherapies.

Designed to Current Good Manufacturing Practices (cGMP) specifications and certified by the Belgian Federal Agency for Medicines and Healthcare Products, the new EUR 5 million facility, adjacent to its headquarters in Niel, gives eTheRNA the capacity to manufacture mRNA-based TriMix immunotherapies for Phase 1 and 2 clinical development programs as well as for preclinical studies. Initially, eTheRNA intends to use the facility exclusively to supply material for its own existing and planned clinical studies. Depending on future demand, the Company has the option to expand capacity allowing it to manufacture mRNA products for strategic partnerships with third parties.

eTheRNA’s mRNA immunotherapy pipeline is based on its TriMix platform, which comprises three mRNAs encoding proteins that work synergistically to deliver optimal activation of dendritic immune cells. These cells behave as immune response mediators and so mobilize the immune system to attack cancer cells through inducing a directed cytotoxic T-cell response.

A Phase 1b study (E011-MEL) evaluating ECI-006, a TriMix-based immunotherapy boosted with mRNAs encoding five melanoma tumor-specific antigens, is on-going in melanoma patients. Completion of enrolment for a low dose cohort of the study and initial safety data were announced in March, with ten patients recruited. No adverse safety signals were observed in this cohort, which has completed the dosing phase. The treatment via intranodal administration was well tolerated. The study is progressing in a high-dose cohort with results, including immunological responses and the full safety dataset, from both cohorts anticipated in the first half of 2019. Further clinical studies for TriMix immunotherapies are expected to commence in 2018 and 2019 using material produced at the new manufacturing facility.

Dr. Russell G. Greig, Chairman of eTheRNA, said: “This manufacturing facility is core to our long-term strategy and brings us closer to the industrialisation of our TriMix immunotherapies. It will enable us to leverage the potential of the TriMix platform, control our supply chain and provide the necessary scale and flexibility to support development of our mRNA-based immunotherapy portfolio. We also believe this facility to be an opportunity to develop new global R&D collaborations based on our manufacturing capabilities.”

The facility was officially inaugurated in a ceremony today by Philippe Muyters, Flemish minister for Work, Economy, Innovation and Sports, and Tom De Vries, Mayor of Niel.

Philippe Muyters, Flemish minister for Work, Economy, Innovation and Sports, said: “I am very happy that I had the honour to officially open this unique mRNA production facility. This event provides further confirmation of the important role that Flanders plays in the field of research and development of innovative therapies. Innovation is in our DNA, as already evidenced by the successes of several other companies in the biotechnology and related sectors, headquartered in Flanders.

Innovation is also in our mRNA, thus enabling Flanders to provide a significant contribution to the development of novel immunotherapies against various diseases including cancer.”

About eTheRNA immunotherapies

eTheRNA immunotherapies is a clinical-stage company working to deliver 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 leading international life sciences investors.

About TriMix

The TriMix platform, on which eTheRNA’s immunotherapies are based, comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that work synergistically to deliver optimal activation of dendritic cells. These cells behave as immune response mediators and so 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.

The Phase 1b study, E011-MEL, recruited its first patient in June 2017 and is assessing two different doses of ECI-006.

Further clinical studies for TriMix immunotherapies are planned to initiate in 2018/19, focused on melanoma and breast cancer indications. These and further studies are designed to determine the optimal route of administration and confirm the potential of TriMix-based treatments as a cornerstone for cancer immunotherapy, both alone and in combination with checkpoint inhibitors.

// 31 May 2018

eTheRNA to present at Sachs’ 4th Annual Immuno-Oncology BD&L and Investment Forum

Niel (Belgium) 

eTheRNA immunotherapies, a clinical-stage company developing novel cancer immunotherapies based on its unique mRNA-based TriMix platform, announces that Acting CEO Marc Dechamps will present an overview of the Company, its technology and ongoing and planned clinical trials at Sachs’ 4th Annual Immuno-Oncology BD&L and Investment Forum on 1 June in Chicago, US.

Details of the presentation are as follows:

Date: Friday 1 June 2018
Time: 15:40-16:00

Location: Sinclair North, Waldorf Astoria Chicago HotelTaking place on the first day of ASCO, the 4th Annual Immuno-Oncology BD&L and Investment Forum is designed to bring together thought leaders from cancer research institutes, patient advocacy groups, pharma and biotech to facilitate partnering, funding and investment, with over 200 delegates expected to attend.

About eTheRNA immunotherapies

eTheRNA immunotherapies is a clinical-stage company working to deliver 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 a broad range of cancer patients.

eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is backed by leading international life sciences investors.

About TriMix

The TriMix platform, on which eTheRNA’s immunotherapies are based, comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that work synergistically to deliver optimal activation of dendritic cells. These cells behave as immune response mediators and so 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.

The Phase 1b study, E011-MEL, recruited its first patient in June 2017 and is assessing two different doses of ECI-006.

Further clinical studies for TriMix immunotherapies are planned to initiate in 2018/19, focused on melanoma and breast cancer indications. These and further studies are designed to determine the optimal route of administration and confirm the potential of TriMix-based treatments as a cornerstone for cancer immunotherapy, both alone and in combination with checkpoint inhibitors.

// 24 May 2018

eTheRNA enrols first patient in high dose cohort of Phase 1b study of TriMix mRNA-based cancer specific immunotherapy (ECI-006) in melanoma

Niel (Belgium) 

eTheRNA immunotherapies, a clinical-stage company developing novel cancer immunotherapies based on its unique mRNA-based TriMix platform, announces that it has enrolled the first patient in the high dose cohort of its Phase 1b study (E011-MEL) of ECI-006 as an adjuvant therapy in metastatic melanoma patients.

The high dose cohort (1800 µg) of the E011-MEL study aims to recruit ten patients, at centers in Belgium and Spain, who will receive five injections of ECI-006 administered intranodally over a period of 14 weeks.

ECI-006 is an investigational therapy designed to boost the immune system through eTheRNA’s unique TriMix platform. This novel platform combines three mRNAs coding for constitutively activated TLR4, CD40 ligand and CD70 that act synergistically on distinct pathways to activate dendritic cells, which play a critical role in anti-tumor immune responses. ECI-006 also contains mRNAs encoding five melanoma tumor-specific antigens, with the aim of generating a targeted and robust anti-tumor T-cell response.

E011-MEL is an ongoing multicenter open-label Phase 1b study evaluating the safety and tolerability of two different doses (600 µg or 1800 µg) of ECI-006 administered intranodally in stage IIc/III/IV melanoma patients after surgical removal of their tumor lesions. The study will also assess immune response following treatment with ECI-006.

Completion of enrolment for the low dose cohort of the study and initial safety data were announced in March, with ten patients recruited. No adverse safety signals were observed in this cohort, which has now completed the dosing phase. The treatment via intranodal administration was tolerated extremely well.

Results, including immunological responses and the full safety dataset, from both cohorts in the E011-MEL study are anticipated in the first half of 2019.

Marina Cools, Clinical Lead at eTheRNA, said: “We continue to make good progress with the E011-MEL study, our first clinical trial assessing a directly injectable TriMix formulation in cancer patients. We would like to thank investigators for their efforts throughout the study so far and we look forward to progressing the high dose cohort over the coming months.”

Marc Dechamps, Acting CEO of eTheRNA, commented: “We are pleased to announce this development in our Phase 1b study in melanoma, which is progressing well and will read-out in early 2019. New clinical studies will be initiated over the coming year to provide further support for our mRNA-based TriMix immunotherapies and the vast potential they have in cancer, not only in activating the immune system but also in targeting it to tumour cells.”

About eTheRNA immunotherapies

eTheRNA immunotherapies is a clinical-stage company working to deliver 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 a broad range of cancer patients.

eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is backed by leading international life sciences investors.

About TriMix

The TriMix platform, on which eTheRNA’s immunotherapies are based, comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that work synergistically to deliver optimal activation of dendritic cells. These cells behave as immune response mediators and so 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.

The Phase 1b study, E011-MEL, recruited its first patient in June 2017 and is assessing two different doses of ECI-006.

Further clinical studies for TriMix immunotherapies are planned to initiate in 2018/19, focused on melanoma and breast cancer indications. These and further studies are designed to determine the optimal route of administration and confirm the potential of TriMix-based treatments as a cornerstone for cancer immunotherapy, both alone and in combination with checkpoint inhibitors.

// 14 May 2018

eTheRNA to present at Bio€quity Europe

Niel (Belgium) 

eTheRNA immunotherapies, a clinical-stage company developing novel cancer immunotherapies based on its unique mRNA-based TriMix platform, announces that Acting CEO Marc Dechamps will present at Bio€quity Europe, which takes place from 14-16 May in Ghent, Belgium.

The presentation will provide an overview of the Company as well as ongoing and planned clinical trials for the development of its directly injectable formulations of cancer immunotherapies based on its innovative mRNA TriMix platform. Details for the presentation are as follows:

Date: Tuesday 15 May 2018
Time: 16:40-17:00
Location: Level 1+, Priorzaal, Het Pand, Ghent University

Bio€quity Europe is a life science focused investor and partnering event organised by BioCentury, now celebrating its 19th annual meeting. It has showcased more than 700 leading European companies to thousands of investment and pharma business development professionals.

About eTheRNA immunotherapies

eTheRNA immunotherapies is a clinical-stage company working to deliver 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 a broad range of cancer patients.

eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is backed by leading international life sciences investors.

About TriMix

The TriMix platform, on which eTheRNA’s immunotherapies are based, comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that work synergistically to deliver optimal activation of dendritic cells. These cells behave as immune response mediators and so 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.

The Phase 1b study, E011-MEL, recruited its first patient in June 2017 and is assessing two different doses of ECI-006.

Further clinical studies for TriMix immunotherapies are planned to initiate in 2018/19, focused on melanoma and breast cancer indications. These and further studies are designed to determine the optimal route of administration and confirm the potential of TriMix-based treatments as a cornerstone for cancer immunotherapy, both alone and in combination with checkpoint inhibitors.

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