// 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.

Nineteen out of 20 patients completed the treatment. One patient discontinued the study after 4 doses due to disease relapse. Administration of ECI-006 was well tolerated in all patients with no serious side effects. ELISPOT and intracellular cytokine staining were performed on T cells pre-stimulated in vitro for 10-12 days. Vaccine-induced immune responses were detected in 4/10 and 3/10 patients treated with the low and high dose, respectively.

Dr Arance commented “it is very encouraging that we see immune responses against most of the antigens used in the vaccine. Clinically this therapy was eminently well tolerated and feasible. Future studies should include patients with metastatic disease and test whether dosing with a concomitant check-point inhibitor can be additive”

Dr Bertil Lindmark, CMO of eTheRNA Immunotherapies stated “The study showed that intranodal therapy is clinically feasible and well tolerated. Specific Immune responses in 35% of the patients in the adjuvant setting gives a good basis for coming studies in metastatic melanoma on top of a checkpoint inhibitor”

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 science investors.

About TriMix

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 science investors.

// 29 May 2019

Appointment of Chief Financial Officer

Niel (Belgium) 

eTheRNA immunotherapies NV, the mRNA immunotherapy company, is pleased to announce the appointment of Ulrich Platte as the Company’s Chief Financial Officer. Ulrich will join the company on 3rd June 2019.

Ulrich has a broad experience acquired over the last 20 years in different industries including the life sciences, medical device and pharmaceutical sectors. He has held progressively senior positions in financial management roles, including previous CFO roles, and his operational experience encompasses corporate finance, group financial control, strategic planning and M&A. Latterly Ulrich has been engaged in a number of early-stage companies in the life science sector supporting financing and business development activities. He is a graduate in business administration and holds an MBA from the University of Chicago.

Steven Powell, Chief Executive of eTheRNA, said: “I am delighted to welcome Ulrich to the Company. He has extensive financial leadership skills and experience in the sector, which will be of great benefit to eTheRNA. We are at an exciting stage of the Company’s development and Ulrich’s business experience in international commercial and large-scale research and development organisations will assist the Board and management team in delivering both our strategic and R&D objectives.”

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 science investors.

About TriMix

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 science investors.

// 4 MARCH 2019

eTheRNA immunotherapies completes patient enrolment for Phase Ib-study in adjuvant melanoma

Brussels – Niel (Belgium) 

eTheRNA immunotherapies, a clinical-stage company developing cancer immunotherapies based on its proprietary mRNA TriMix platform, announces the completion of the high-dose cohort of its Phase 1b study (E011-MEL) evaluating ECI-006 (TriMix with tumor specific antigens) in an adjuvant setting in melanoma patients after surgical removal of lesions. The E011-MEL study confirms the feasibility of developing mRNA immunotherapy for direct injection intranodally, in addition to a previously used dendritic cell infusion-based approach.

The E011-MEL Phase 1b study was designed to evaluate intranodal (injection into the inguinal lymph nodes) administration of ECI-006 in adjuvant melanoma patients. ECI-006 is a TriMix-based immunotherapy boosted with mRNA encoding melanoma tumor-specific antigens. The study comprises a low-dose and a high-dose cohort, each enrolling 10 patients. Investigative centres were in Belgium and Spain. The objective of the study is to assess safety and tolerability of mRNA administered intranodally and to seek evidence of immune-stimulation.

Completion of enrolment of the low-dose cohort was reported previously in March 2018, along with initial safety data. No adverse safety signals were observed in the low-dose cohort, which has already completed its dosing phase.

Today, the company reports completion of patient recruitment for the high-dose cohort. No adverse safety signals were observed in the high-dose cohort either. Results from the immunomonitoring of the immunological responses elicited by ECI 006 will be presented at a later date.

Dr. Bertil Lindmark, Chief Medical Officer, eTheRNA immunotherapies commented: “With this study we have shown that intranodal injection of an mRNA based immunostimulatory vaccine is clinically feasible and well tolerated. This is an important result as it advances our strategy to develop mRNA based immunotherapies to treat patients with cancer. The ECI-006 can effectively induce immune priming so that we may see amplified efficacy when combined with a checkpoint inhibitor”

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 science investors.

About TriMix and ECI-006

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. ECI-006 contains TriMix and mRNA coding for tumor associated antigens, which have been chosen to elicit immune response in melanoma. Preclinical data suggest that TriMix based immunostimulation may elicit additive or possibly synergistic effect when combined with an immune checkpoint inhibitor.

// 12 February 2019

First patient recruited in collaborative Phase 1 study to evaluate TriMix in breast cancer patients

Brussels – Niel (Belgium) 

VUB, the Vrije Universiteit Brussel, and eTheRNA immunotherapies, a clinical-stage company developing cancer immunotherapies based on its proprietary mRNA-based TriMix platform, announce the recruitment of the first patient for a collaborative TriMix-BRE study to investigate the effect of the TriMix product as neo-adjuvant treatment (treatment before planned surgery) for breast cancer patients. The study will deliver mRNA via intratumoral injection in patients with non-metastatic breast cancer before planned surgery and will recruit patients with resectable breast cancer irrespective of subtype of breast cancer.

Dr. Marian Vanhoeij, Head of the Breast Clinic of the University Hospital, UZ Brussel and principal investigator of this investigator-initiated study: “We are pleased to contribute to the further clinical development of the TriMix-platform, which has been developed at our university and is now the backbone of eTheRNA immunotherapies, a spin-off from the VUB university. While the proof of concept for the TriMix platform has been delivered in multiple studies involving melanoma patients, we are convinced of the potential for TriMix in other therapeutic areas including breast cancer. In the TriMix-BRE study, a total of 36 breast cancer patients will be enrolled at the Brussels university hospital (UZ Brussel). The TriMix product will be administered 3 times in the tumor of the patients before surgical removal or before start of neo-adjuvant chemotherapy.”

Bertil Lindmark, CMO of eTheRNA immunotherapies, commented: “This is the first study in which a TriMix therapy for intratumor administration is studied in breast cancer. The proof of concept for our TriMix mRNA platform was established via a dendritic cell infusion approach, where cells are extracted from the patient and then loaded with immunogenic mRNA, after which they are returned into the body. In this study, TriMix is administered in the tumor of breast cancer patients before surgery to determine whether we can elicit a local immune response against the tumor.”

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 science 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.

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