Start of MYASTERIX Phase 2/3 trial
We are pleased to announce the beginning of phase 2/3 of our active targeted immunotherapy for myasthenia gravis following the approval by the UZA Ethics Committee on 19 June 2017 and the Belgian and Dutch Regulatory Authorities (May 2017). Link to MYASTERIX on clinicaltrials.gov
Presentation of preliminary Phase 1B Clinical Trial Results now available
Prof. Rudy Mercelis's presentation at the 13th International Conference on Myasthenia Gravis and related disorders at the New York Academy of Sciences on 16 May 2017 is now available here for download. Rudy Mercelis is the Principal investigator of the Phase 1B clinical trial on patients of CV-MG01 vs. Placebo.
Myasterix at BIO 2017
Myasterix coordinator CuraVac will be present at BIO 2017 in San Diego, USA from 19 June to 22 June 2017.
Myasterix at New York Academy of Sciences: presentation of preliminary Phase 1B Clinical Trial Results
The preliminary results of the ongoing Phase 1B clinical trial on patients of CV-MG01 vs. Placebo were presented by Myasterix partner Prof. Rudy Mercelis, Antwerp University Hospital (UZA) at the 13th International Conference on Myasthenia Gravis and related disorders at the New York Academy of Sciences on 16 May 2017.
Update on Myasterix study: Safety report summary
The Myasterix Phase 1b study (EudraCT 2015-002880-41) is followed by a Data Review Committee which conducted a formal safety data review in August and then in December 2016.
The second review was carried out based on data collected on the participants enrolled in Cohorts 1 and 2 of the study, as planned by the protocol. Participants in Cohort 1 (8 patients) received a low dose of the active substance CV-MG01 or a placebo while participants in Cohort 2 (8 patients) were given a high dose or a placebo, administered as three subcutaneous injections over approximately 3 months.
The findings of the review are very positive, no Serious Adverse Event (SAE) occurred. The few Adverse Events (AE) observed, primarily injection site reactions (e.g. pain, small erythema and hardness at site of injection) were mostly considered of mild severity with very few moderate local reactions. These reactions resolved spontaneously after a few days.
The second data review also shows that the preliminary immunogenicity results and comparison of the 2 injection levels (Low Dose and High Dose) suggest that the High Dose has a greater immunogenic potential than the Low Dose. The High Dose level is therefore selected for dosing Cohort 3 subjects, as per protocol procedures.
Preliminary analyses of clinical scales and questionnaires specific to myasthenia gravis (e.g. QMG, MG-ADL, MGC, MG-QOL 15) are ongoing. All subjects who completed the first part of the Study (Part A) are now entering the observational Part B of the study.
Belgian investment & collaboration forum 22 November 2016
On behalf of Myasterix and CuraVac, Stéphane Huberty participated in the Belgian investment and collaboration forum on the 22nd of November 2016, organised by FlandersBio, Flanders Investment & Trade and BioWin at the Belgian Embassy in London. The aim of the event was to bring together early to mid-stage Belgian Biotech & MedTech companies with UK-based Investors and explore potential for technical & business collaboration with OBN member companies.
Stéphane Huberty won a prize for best presentation.
MYASTERIX at Bio-Europe 2016
Nicolas Havelange and Stéphane Huberty represented Myasterix at the business partnering event Bio-Europe in Cologne, Germany on 7-9 November.
2016 September - MYASTERIX progress
The 3rd MYASTERIX general meeting took place in Paris on 22-23 September 2016. It was the opportunity for the partners to present and discuss the progress made so far, at over halfway through the project. It was also the opportunity to obtain feedback from the representatives of the MYASTERIX Independent Advisory Board and the European Commission which is funding the project.
Since the start of the project in 2013, much progress has been made and the major milestones have been achieved.
A prerequisite for launching the phase 1b study was the timely supply of therapeutic vaccine batches for the preclinical toxicity studies and the phase1b clinical trial. piCHEM produced and released the drug substance and the drug product for the toxicity study. piCHEM then successfully produced and released the drug substance and drug product following Good Manufacturing Practice (GMP). Stability studies for all products used in toxicity and clinical trials have been launched and are ongoing.
The Clinical Trial Application (CTA) prepared by CuraVac, UZA, Aepodia, LUMC and piCHEM was accepted in October 2015 by the Belgian competent authorities and by the UZA Ethics Committee.
The MYASTERIX project Phase 1b study on patients for the therapeutic vaccine (active targeted immunotherapy) for Myasthenia Gravis (EudraCT 2015-002880-41) was then successfully launched at UZA in November 2015. The first patient was injected in March 2016. The recruitment was greatly facilitated by the involvement of several patient associations. As of 30 Sept 2016, a total of 16 patients have been enrolled, included, and dosed into the study of whic 14 received more than one injection of CV-MG01 or placebo, 6 patients received the three subcutaneous injections and 3 patients already completed the active part (Part A) and have entered the onservational part B of the study. After reviewing the safety and tolerability data at low dose on a first cohort of 8 patients, the data review committee approved the decision to test the high dose regimen in the next cohort of MG patients. Eight patients are currently receiving the high dose regimen of CV-MG01. The results are expected to be available during the second quarter 2017.
The next data review committee meeting is planned for the beginning of December 2016.
We are currently preparing for the Phase 2 trial which would take place in the beginning of third quarter 2017. Results of this study are expected for third quarter 2018.
2016 BIO International Convention
Nicolas Havelange and Stéphane Huberty (CuraVac) represented MYASTERIX at the 2016 BIO International Convention which took place in San Francisco June 6-9, 2016.
2016 June, 1st - Webinar MYASTERIX
The Belgian and Dutch patients associations on Myasthenia Gravis organised a webinar (in Dutch) on the clinical trial of the therapeutic vaccine developed in MYASTERIX project. The webinar took place on the 1st June 2016 from 18.00 to 19.00 CET. The presentation has been given by Professor Marc de Baets who is member of the MYASTERIX Independent Advisory Board.
More information here (in Dutch):
2016 April, 15th - Videoconference MYASTERIX, a vaccine for myasthenia (in French)
Dr. Stéphane Huberty, CEO of CuraVac, gave an overview of the MYASTERIX project during a videoconference organized by the French association Les AMIS on Friday, April the 15th. The presentation was followed by a Questions & Answers session.
MGTX congress 7th of January 2016
Preliminary results of thymectomy study, a study which lasted eight years, were presented at this conference. The results of this study of 126 patients will be published shortly. In this study, two groups of patients with myasthenia gravis are compared. One group used prednisone only while the other group got a thymectomy in combination with the use of prednisone.
MYASTERIX Phase 1b clinical study is launched - December 2015
See the Press Release
Aim of the tetanus trial is to assess whether myasthenia patients which may or may not have immunosuppressive drugs, still are able to respond to the tetanus vaccination. In addition, this study will evaluate whether revaccination causes a deterioration of the myasthenia.
Currently, for this study, all 50 ACHR myasthenia patients are vaccinated and blood samples are taken. At the moment, the results are being analyzed. New patients can not participate to this study anymore.
Manuscript Myasthenia Gravis
Prof NE Gilhus and Prof JJ Verschuuren have published a review in The Lancet Neurology named: “Myasthenia gravis: subgroup classification and therapeutic strategies”. Lancet Neurol. 2015 Oct: http://www.sciencedirect.com/science/article/pii/S1474442215001453)
This manuscript provides an perceptive overview and highlights the presence of myasthenia subgroups, its current treatment and prospective studies. This review emphasizes that for the various diagnostic subgroups of myasthenia gravis no antigen specific therapy is available. Currently, all patients are treated with the same type of immunosuppressive drugs. The pursuance is to specifically suppress the anti-AChR and anti-MuSK immune response without suppressing other immune responses.
Myasterix 2nd Annual Meeting – 17 & 18 September 2015
Myasterix next annual meeting took place in Leiden, the Netherlands, hosted by the LUMC partner. This meeting gathered the project partners to discuss the project progress in the presence of the members of the Independent Advisory Board and Ethics Operational Board.
Congress for muscle diseases (“Spierziekten congres”) at Veldhoven, the Netherlands - 12 Sept. 2015
The congress for muscle diseases is an annual event which is organized for members of ‘Spierziekten Nederland’. This congress aims to provide patients and families with information about their muscular disease. Leading experts and researchers from all over the Netherlands presented the latest developments in health care, clinical and basic research.
At this congress, which took place on the 12th of September in 2015 in the Netherlands, Prof. Verschuuren presented on the various diagnostic forms of Myasthenia, the underlying mechanism, current treatment and (prospective) studies. The Myasterix project was mentioned as well. The design of the study, the intended effect of the vaccine and the aim of this study is described in the Myasthenie newsletter of November 2015 in the Netherlands
Myasterix Annual Meeting - 26 & 27 September 2014
The Myasterix Annual Meeting was held in Graz, Austria on the 26-27 September 2014. All partners were represented and members of the Independant Advisory Board and Ethics Operational Board participated. The meeting was hosted by PiChem.
Award at Biovision 2014
MYASTERIX project was awarded the prize of the best project on immunotherapy and vaccines at the BIOVISION event in Lyon, France 6 June 2014.
Launch of the MYASTERIX project – 1st October 2013
The MYASTERIX kick-off meeting took place on November 29th 2013 in Brussels. The official launch event of the MYASTERIX FP7 European Research Project was hosted by CuraVac company, the organization which coordinates the scientific program of this European project. This meeting gathered all project partners coming from 4 countries (Belgium, Austria, France, the Netherlands) for fine-tuning the planned MYASTERIX workprogramme. Meeting took place in the presence of a representative from the European Commission and of the members of the Independent Scientific Advisory Board of the project who will carefully monitor and advise the consortium during the 5 years of activities.