OUR TEAM - Xenikos - Resetting the immune system

Ypke van Oosterhout, Ph.D.

Founder and Chief Executive Officer

Ypke van Oosterhout is the Founder and CEO of Xenikos BV and the pioneering scientist behind T-Guard®’s development.

Ypke discovered T-Guard while working in the Hematology Department of the Radboud University Medical Center (Nijmegen, the Netherlands), after earning his MSc in biology from the University of Nijmegen. Recognizing T-Guard’s clinical potential, Ypke focused his PhD study on its mode of action, safety and efficacy.

Based on early positive clinical results, Ypke was awarded a STIGON Grant from the Dutch government initiative supporting entrepreneurship and research into innovative medicines, to continue exploring the clinical and commercial potential of T-Guard. T-Guard was developed further at Immunotoko B.V., a company founded by Ypke with the Radboudumc and Henogen (now Novasep Belgium). Ypke then founded Xenikos B.V. in 2009, to continue the development of T-Guard, through registration for marketing approval as an orphan drug for the treatment acute Graft-versus-Host Disease, as well as other indications (aGVHD).

Maarten Frijlink, MSc

Chief Operating Officer

Maarten Frijlink has over 25 years of business experience and has served in a broad range of managerial roles.

Prior to joining Xenikos in 2015, he held leading positions in quality affairs, business development, manufacturing, process development and project management in small biotechnology and large pharmaceutical firms. He shaped many biopharmaceutical product development initiatives from both a scientific and strategic business planning perspective. He made critical contributions to regulatory submissions for several innovative biopharmaceuticals and managed the corresponding pre-approval regulatory site inspections.

At Xenikos, Maarten is responsible for CMC development, manufacturing, logistics and related regulatory and quality assurance.

Eric van Hooren, MSc

Chief Development Officer

Eric van Hooren has over 25 years of experience in the pharmaceutical industry. He has a broad background in strategic drug development...

…for both new biological and new chemical entities, as well as in global clinical trial management and medical marketing.

Prior to joining Xenikos in 2016, Eric was Director Clinical Operations at Acerta-Pharma, where he was responsible for the set up and line management of the European clinical operations group, including the execution of Phase 1, 2 and 3 clinical trial programs with the compound acalabrutinib, a potential best-in-class irreversible oral Bruton’s tyrosine kinase (BTK) inhibitor, that contributed to a major transaction with AstraZeneca in December 2015. Eric previously worked as a Program Manager at Merck, where he managed Women’s Health Programs. He also worked at Organon for many years, in positions of increasing responsibility in both clinical development and medical marketing.

At Xenikos, Eric is responsible for the worldwide clinical development of T-Guard®.

Lisa Huberts, MA

Project Manager

Lisa Huberts joined Xenikos as Project Manager in 2018. With degrees in both history and journalism, she has developed a broad set...

…of skills that are well suited to the many aspects of her job at Xenikos – from data management, processing patient files, editing, writing and translating both scientific and non-scientific documents, to overseeing the administration, finances and daily agenda, HR, organizing meetings, and functioning as a contact person. She is currently also in training to become a Clinical Research Assistant (CRA).

Lisa studied history at Radboud University in Nijmegen, after which she moved to Antwerp, Belgium in 2015 to pursue a second degree in journalism at KU Leuven, specializing in both human-interest journalism and science journalism. She did an internship at National Geographic Magazine NL, where she researched and wrote about complex scientific issues.

Maria Marza Perez, Msc

CMC Project Manager

Maria Marza Perez has over 11 years of experience in the Pharmaceutical industry. Prior to joining Xenikos in 2019, she worked at...

…Synthon Biopharmaceuticals for almost 12 years, starting at the bioanalytical department in 2008. In 2009 she moved to the Downstream Process department, first as junior DSP researcher, and as senior DSP scientist from 2014 onwards.

During her time at Synthon, Maria has focused on the development of purification processes of monoclonal antibodies and ADC’s (from small to large scale), the planning of relevant CMC-related studies, writing specific project documentation, reviewing GMP-related documentation, and leading process scale up and technology transfer to the manufacturing plant, amongst others.

At Xenikos, Maria works as CMC Project Manager, and is responsible for managing the development, implementation and validation of biopharmaceutical manufacturing processes.

Jürgen van de Lagemaat, PhD

Director, Process Development & Commercialization

Jürgen has more than 15 years of experience in the biopharmaceutical industry as a bioprocessing professional with extensive...

…knowledge in mammalian cell culture and fungal fermentation. He is a leader with a successful track record as a line manager, project manager, and subject matter expert in the mid-to-late-stage development and commercialization of biopharmaceuticals.

Prior to joining Xenikos in 2019, Jürgen was the Upstream Process Technology Lead at MSD Netherlands, where he managed a team of senior scientists in various programs focused on developing cell culture procedures for biotherapeutic proteins such as monoclonal antibodies (mAbs) and gonadotropins. Jürgen previously worked as a Product Steward at MSD and was responsible for providing global technical and scientific support of the upstream manufacturing of mAbs for Keytruda® (pembrolizumab), MSD’s immuno-oncology blockbuster. Prior to MSD, he worked at Organon in upstream process development.

At Xenikos, Jürgen is responsible for the development and commercialization of the manufacturing process for T-Guard® and other products.

Willem Klaassen, MSc.

Director, Clinical Projects

Willem Klaassen has spent nearly 20 years in the pharmaceutical and biotech industry as an accomplished clinical project manager...

…and team leader, with experience ranging from first-in-human studies through Phase 4 drug development for a broad range of therapeutic applications.

Prior to joining Xenikos in 2020, Willem was the Head of Clinical Operations at Acerta Pharma BV, where he was responsible for the European Clinical Operations group and its expansion to include 18 full-time employees. Willem was also the Clinical Project Lead for several studies, including the acalabrutinib (Calquence®) ACE-LY-004 trial in mantle cell lymphoma, which led to the company’s first New Drug Application (NDA) approval and contributed to a major transaction with AstraZeneca in 2015.

At Xenikos, Willem is responsible for overseeing clinical projects with T-Guard® in support of obtaining NDA approval for T-Guard.

Nicole Niesler, Dr. rer. nat.

Bioanalytical Scientist

Nicole Niesler studied biology at the Freie Universität Berlin (Free University of Berlin), then obtained her doctorate and postdoctoral...

…training at the Charité – Universitätsmedizin in Berlin, where she produced and purified recombinant proteins and active toxins using bacterial expression systems. Her thesis focused on developing a new recombinant drug by linking the toxin to a targeting ligand using either gene fusion technology or chemical coupling. Nicole joined Xenikos in early 2020 as a Bioanalytical Scientist, bringing her academic research expertise and experience, particularly in the field of drug development.

In her role as a Bioanalytical Scientist, Nicole is part of the CMC team and is primarily responsible for the development, implementation, and validation of analytical methods, as well as product characterization, managing the T-Guard stability program, and drafting and reviewing SOPs, protocols, reports, and studies.

Sonja Christis, MSc.

Manager, CMC Regulatory Affairs

Sonja Christis joined Xenikos in 2020 with more than 12 years of experience in biopharmaceutical development and has worked for the Dutch...

…regulatory authority CBG (College ter Beoordeling van Geneesmiddelen, the Dutch Medicines Evaluation Board).

In the pharmaceutical industry, Sonja held several positions in analytical development (e.g., scientist, project manager, and scientific writer) and was involved in the development, commercialization, and post-marketing of biologics, with a focus on monoclonal antibodies. At CBG, she assessed all CMC-related sections of dossiers for biologics submitted to the board. Recently, Sonja worked as a CMC regulatory affairs consultant, where she defined regulatory strategies for clinical trial applications.

At Xenikos, Sonja is responsible for the CMC team’s regulatory affairs activities and supports analytical activities.

Hassan Aly, MD, PhD

Chief Medical Officer

Hassan Aly has extensive experience treatment patients with malignant hematological diseases, including allogeneic autologous HSCTs, at...

…several university hospitals in the UK and Germany. He received his training in hematology at the University of Cambridge and has an MD and PhD in clinical medicine. Hassan has more than 10 years of experience in clinical development, medical affairs, and pharmacovigilance at several leading pharma and biotech companies, including Anocca, AstraZeneca, and Boehringer Ingelheim. He has authored and co-authored more than 100 peer-reviewed publications and 70 abstracts for clinical and laboratory research regarding the biology and treatment of hematological malignancies. He is currently a member of the editorial and review boards of several hematology journals.

As Xenikos’ CMO, Hassan is responsible for overseeing the clinical development and Phase 3 testing of T-Guard for the treatment of SR-aGVHD.

André de Lege, CA

Controller / Accountant

André de Lege is a chartered accountant and hands-on finance professional with thirty years of broad expertise, including taxes, grants and legal.

André began his career at accounting firm Deloitte. Prior to joining Xenikos he served as CFO of Fame Holding (EMCM and Bactimm/Farmalyse), an international medical device company.

André has been CFO at Xenikos since 2012. In this role, he is responsible for financial reporting, cash flow forecasts, treasury and tax matters.

Suzanne Vink-Hermeling, PhD

Manager Quality Assurance and Qualified Person

Suzanne Vink-Hermeling studied pharmacy at Utrecht University, where she also started her PhD at the Department of Pharmaceutics and...

… the Department of Animal Laboratory Facilities. Her PhD focused on the unwanted immunogenicity of therapeutic proteins.

Prior to joining Xenikos, she worked as a project manager and scientist with OctoPlus, where she started in 2005, and helped several clients to develop stable formulations and produce clinical trial material under GMP conditions. In 2008 she became Qualified Person at OctoPlus. She was also responsible for the validation of Octoplus’ new production building and performed several roles in various quality functions. In 2014 she started her own consultancy company, Svinx Consultancy BV.

Suzanne joined Xenikos in 2015, as Manager QA and Qualified Person.

Stijn Muller, BSc, BaSc

Project Planner

Stijn is an IPMA-PMO certified project planner with over twenty years of expertise in value-adding project management within the...

…pharmaceutical industries. He is used to translating complex processes into easy-to-understand overviews and visualizes the fastest development path possible.

Stijn began his career at Organon and started his own consultancy firm in 2015. In his role as Project Planner for Xenikos, he transforms data from the different CROs to a critical-path planning and monitors it on progress. Data is analyzed in MS Project and MS Access to visualize the current challenges and to calculate different scenarios. The ultimate goal is to have T-Guard registered and available for patients as soon as possible.