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®.

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.

Lisa Huberts, MA

Clinical Trial Associate

Lisa Huberts joined Xenikos in 2018. After four years as Project Manager and Office Manager, Lisa has now officially joined the Clinical team...

…as Clinical Trial Associate. With degrees in both history and journalism, as well as her four years of previous experience at Xenikos, she has developed a broad set of skills that are well suited to the many aspects of both her current and previous job at Xenikos, making her a real Jill of all trades.

As Clinical Trial Associate, Lisa provides all kinds of support to Xenikos’ Clinical Operations – from developing story boards, maintaining and helping develop the eTMF, vendor management, tracking study-level progress, reviewing regulatory documents from sites, taking care of annual clinical administrative updates (e.g. with EMA and FDA) and providing overall clinical administrative support, to acting as the clinical operations central point of contact for delegated study communications, correspondence, and associated documentation.

Prior to joining Xenikos, Lisa studied history at Radboud University in Nijmegen, after which she moved to Antwerp, Belgium in 2015 to pursue a second Master’s 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.

Bram Nillessen

Bioprocess Technologist DSP

Bram Nillessen joined the Xenikos team in 2022. After his graduation in biochemistry, he started working in the downstream field of the biopharmaceutical industry.

During his time at Synthon, Bram obtained a lot of experience in development of monoclonal antibodies and antibody-drug-conjugates as therapeutic agents, mainly in the field of oncology. When the company was rebranded to Byondis, Bram was involved in development, scale-up and technology transfer of several phase I products. In addition, he was involved in lead optimization work; finding new clinical candidates, discover new technologies and/or biological/chemical entities for drug development.

At Xenikos, Bram works as a Bioprocess Technologist DSP, where his focus is to manage the development, implementation, characterization and validation of biopharmaceutical manufacturing processes.

Fokke Venema

Director Bioanalytical Development/Principal Scientist

Fokke has more than 25 years of experience in the development and validation of bio-analytical assays in the diagnostic and pharmaceutical industry.

In the last 10 years he applied analytical tools to understand the behavior of influenza vaccine proteins under stress conditions and used this knowledge to optimize the influenza vaccine production process. His broad knowledge of both chemical and biological processes helped to develop, optimize, improve and implement new methods to further assure the quality of the influenza product.

Fokke is a motivating group leader with excellent overview in complex technical challenging projects. This in combination with his organizational skills resulted in a successful track record to solve complex production, characterisation or analytical challenges. As subject matter expert he likes to bring knowledge of multidisciplinary team members together and subsequently translates this knowledge in a logic and achievable strategy towards acceptable short and long term solutions.

Before joining Xenikos in 2022, Fokke was principal scientist and group leader for 12 years at Abbott Biologicals in Weesp, the Netherlands where he managed a team of (senior) scientists focusing on: lab automatization in a GMP environment, assay development and validation under ICH guidelines, understanding, optimizing and validating up- and downstream processes under GMP regime. Furthermore he and his team collaborated closely with QC, QA and RA departments to assure that the CMC parts of all Influenza related dossier variations, including bi-annual (seasonal) updates of the influvac© core dossiers were up to the highest standards.

At Xenikos, Fokke will be responsible for the development, optimization and validation of new and existing bio-analytical assays to release the T-Guard® products, and to support the optimization of the manufacturing process.

Joep Houkes

Scientist Bioprocessing

Joep Houkes obtained his BSc from the Hogeschool van Arnhem en Nijmegen (HAN) where he studied biology and medical laboratory research.

After that, Joep obtained his Biotechnology MSc at Wageningen university, where he continued to do a PhD at the microbiology department. There he worked in a multi-disciplinary consortium with the aim to build a synthetic cell. His work mostly focused on genome organization of synthetic cells.

Joep joined the CMC team at Xenikos as Scientist Bioprocessing in January 2022, he is involved in upstream process development and commercialization including process characterization, process validation, and regulatory support of the T-Guard project.

Olivia van Huyssteen, B Cur, MPH

Clinical Trial Manager

Olivia joined Xenikos in 2022 as a clinical trial manager, where she supervises the execution of clinical trials involving Xenikos’ lead compound, T-Guard, and other potential future compounds.

Olivia received her Bachelor of Nursing Science (B Cur) degree at the University of Pretoria, South Africa, in 2014. In 2019, Olivia received her Master of Public Health degree at the University of South Africa, focusing on HIV/AIDS in a rural farming community in Limpopo, South Africa.

Prior to joining Xenikos, Olivia worked for five years in the pharmaceutical research industry as a research nurse, study manager, and site manager at a clinical research site in South Africa. Olivia has experience in a wide range of therapeutic areas and trial phases.

Rebecca Rogier, PhD

Quality Assurance Manager

Rebecca joined Xenikos as a QA manager in May 2022. Rebecca studied Medical Biology at the Radboud University, then received her PhD in the Department of Experimental Rheumatology...

at Radboud University Medical Center, where she studied the role of intestinal microbiota in the development of autoimmune arthritis. Prior to joining Xenikos, Rebecca worked for four years as a quality assurance officer and product development leader at Eurotrol B.V.

Ylja Oldenkamp

Office Manager

Ylja Oldenkamp joined Xenikos as Office Manager in March 2022. With working experience for several companies as Office Manager she developed a broad set of skills...

that are well suited to the many aspects of her job. Overseeing the daily agenda, administration, HR, organizing meetings and function as a contact person.

After finishing Schoevers ESA and office management she started as officemanager at Transavia.com. After moving to France for a period of 3 years with her family she returned to the Netherlands and worked for a few years at Fermacell BV and in the meantime converted a typical Dutch farmhouse into a family home. After moving in a new job started in Arnhem at beslist.nl as Executive Assistant and PA.

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.