The purpose of this trial is to determine the safety, tolerability and feasibility of the immunotherapy with MVX-ONCO-1, in patients with advanced metastatic solid tumors in progression who are not or not any longer amenable to any standard therapy of their tumour diseases.
Status: Enrolment completed
Macarena DiazMacarena Díaz joined MaxiVAX in June 2022 as CMC & Quality Manager.
Macarena has accumulated over 8 years of experience, primarily in the field of Quality Assurance and also in Regulatory Affairs and Pharmacovigilance.
Macarena worked for different multinational companies. She started her career with Saval laboratories in the regulatory affairs department before moving to Sanofi to work in Quality Assurance. More recently, she worked for Ferring as Quality Assurance country responsible and carried out other consultancy activities for pharmaceutical distributors. She was in charge of implementing and maintaining quality systems, performing quality audits and managing relationship and documentation with third parties.
Macarena received a pharmacist degree from University of Chile.
Fabien CourtoutFabien Courtout joined Nicolas Mach’s research group in 2022 and is in charge of GMP manufacturing of MVX-ONCO-1. He holds a Master’s degree in Biotechnologies. He has worked as laboratory technician in Yeast biology and genetic research. He also performed genetic test and FACS data analysis for pharmaceutical groups.
Adrien EngelAdrien Engel joined MaxiVAX in November 2020. He supports the executive team to develop MaxiVAX’ next encapsulated cell technologies from the proof of mechanism to clinical phase.
Adrien worked on treatments based on dendritic cell vaccination and subcutaneous cellular implants against autoimmune diseases. He holds a Master’s degree in synthetic biology from Paris Descartes University. He recently was awarded a PhD in immunology from the University of Lausanne.
Bruno Osterwalder, M.D., FFPMChief Medical Advisor
Dr Bruno Osterwalder joined MaxiVAXs executive team as a consultant in 2020. He is a board-certified hematologist and oncologist with 15 years of academic clinical practice in internal medicine, hematology and oncology (Swiss board certifications). This was followed by 19 years of experience in functions with increasing scientific and managerial responsibilities in global drug development and strategic portfolio management at F. Hoffmann-Roche Basel in the areas of hematology, (immuno-) oncology and renal and cancer anemia (global approvals for Xeloda in breast and colon cancer, Rituximab in DLBCL and Mircera in renal anemia), and over 6 years at Merck Serono Darmstadt (Tepotinib, approval in Japan in NSCLC), including experience in Japan and China and a focus on early POC stages, translational medicine and biomarker questions, and with broad experience in interactions with regulatory authorities worldwide. Since 5 years, his experience in in-licensing evaluations resulted in a worldwide consulting function primarily for biotech’s. Dr. Osterwalder is a member of ASCO, AACR, ASH, ESMO and SITC.
Nicolas Mach, MD
Marie-Claude Belkouch
M.Sc., PMKsenija Pavletic Aranicki, M.Sc., MBA
Julien Grogg, M.Sc., PMPJulien Grogg joined MaxiVAX in January 2014 to launch and lead the First In Human clinical trial of MVX-ONCO-1. He is now serving as Vice President of Technology and leads the development of MaxiVAX’s novel product platform from early proof of mechanism to clinical translation. Julien has over 15 years of global pharma/biotech experience in both preclinical and clinical development of drugs, medical devices, cell therapy products and ATMPs under the auspices of the FDA, the EMA and Swissmedic. Amongst others, Julien filed and maintained market access and CE mark registration dossier of an implantable cell encapsulation product in Europe and in Mexico. He is the co-inventor of 2 patented medical products harnessing cell encapsulation technology.
Born in Switzerland, Julien is a Biomedical engineer by training and holds a M.Sc. in Clinical Research from the University of Edinburgh. He is also a certified PMP(r) from the Project Management Institute.
Clarence PeterMr. Clarence Peter is one of the three founders of MaxiVAX and an active Board member since its incorporation in December 2005. He is a senior partner of the law firm Kellerhals Carrard Geneva; advisor of multiple national and international firms with a focus on new technologies and med-tech. He has a large experience in assisting commercial clients in all stages of their development including litigation, cross-border transactions and M&A. Mr Clarence Peter is proud to be an entrepreneur, dedicated to the value creation.
Muriel UrwylerMuriel Urwyler joined Nicolas Mach’s research group in 2016 to work on the development of MaxiVAX’s next generation cell line. More recently, she also joined the manufacturing team. She holds a Bachelor and a Master of Science in biochemistry from the University of Geneva. Prior to joining Nicolas Mach’s research group, Muriel worked as a Research Laboratory Technician in oncology, in the development of a vaccine against cerebral tumors. She also worked in the development of novel cell therapies to treat diabetes.
Jessica Renaux, M.Sc.Jessica Renaux joined MaxiVAX in August 2020 as a Senior Clinical Trial Manager.
Prior to this, Jessica gathered 14 years of experience in drug discovery and development, both in the big pharma and not-for-profit organisation environments. After an early career as a medicinal chemist at GSK UK, she held different positions within the GSK early clinical development organisation, as a Clinical Data Manager, Clinical Study Manager and as a Clinical Lead for multiple small molecule and biopharmaceutical assets in the immuno-inflammation area. More recently, she led the set-up and conduct of a large pivotal multi-country phase III trial for a novel antibiotic within the GARDP Foundation based in Geneva Switzerland.
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Emily Charrier, Ph.D.Emily Charrier, joined MaxiVAX in February 2018, as Research Associate. At MaxiVAX, she is in charge of research projects in cancer immunotherapy and immune reactions induced by immunotherapy. Prior to MaxiVAX, Emily worked 10 years in the development of immune-monitoring for anti-cancer immunotherapies. She was awarded a Master’s degree from Grenoble University in France and a PhD in immunology from the University of Montreal in Canada.
Olivier von RohrOlivier von Rohr joined Nicolas Mach’s research group in 2017 and is in charge of the GMP manufacturing of MVX-ONCO-1. During his studies as Biology Laboratory Technician (2012-2015), he gained experience in genetic research, microbiology and toxicology.
Valentin Saingier joined Nicolas Mach’s research group in 2020 and is in charge of the GMP manufacturing of MVX-ONCO-1. He holds a Bachelor degree in biotechnologies. He worked in different resaearch areas such as Alzheimer, stem cells cryopreservation, genetic analyses and vegetal pathology, both in wet lab and GMP manufacturing facilities.
