The first targeted
clot busting therapy

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TargED Biopharmaceuticals B.V. is a biotechnology company that develops first-in-class biological drugs to improve treatment of thrombosis. TargED stands for Targeted Enzyme Delivery. Their biological drugs are unique by using small antibodies (“VhH”) to deliver enzymes to sites of thrombosis, enabling ‘targeted’ thrombolysis. The lead compound is Microlyse, which is currently under development for thrombotic thrombocytopenic purpura (TTP) and Acute Ischemic Stroke (AIS). The objective is to accelerate thrombolysis in all forms of thrombosis, irrespective of the thrombus composition. TargED, a spin-off of the University Medical Center Utrecht, was founded in July 2020 by Associate Professor at the Department of Clinical Chemistry and Haematology, Coen Maas, PhD, an expert in thrombosis and hemostasis, Steven de Maat, PhD, an expert in recombinant protein development and optimization, Marc van Moorsel, researcher with focus on Acute Ischemic Stroke and Kristof Vercruysse, with more than 20 years of experience in bringing biopharmaceutical compounds from pre-clinical proof of concept to market, most notably, Caplacizumab for Thrombotic Thrombocytopenic Purpura at Ablynx between 2007 and 2013.

Team

Kristof Vercruysse has over 15 years of experience in bringing biopharmaceutical compounds from preclinical proof of concept towards market authorization. Kristof gained hands-on experience with the development of Caplacizumab for treatment of TTP at Ablynx between 2007 and 2013. Subsequently, he joined Sourcia, a full-service boutique CRO that delivers tailor-made clinical drug development for biotech companies. Kristof holds a Masters in Biomedical Science from Vrije Universiteit Brussel.

Marc van Moorsel holds a Masters in Innovation Sciences from Vrije Universiteit Amsterdam and is currently finishing his PhD at University Medical Centre Utrecht, investigating blood vessel markers towards innovative diagnostics and therapeutics in cardiovascular disease. Marc aims to combine his scientific understanding of drug development gained during his PhD with his passion: establishing a biopharmaceutical start-up.

Steven de Maat is an expert in developing and improving recombinant proteins – including nanobodies – in various expression systems. Steven holds a Masters in Biomolecular Sciences from Utrecht University and received his PhD in 2016 from University Medical Centre Utrecht. Together with Coen Maas, Steven is inventor of two patents. In addition, he received his VENI laureate in 2019 on hematology-related blood proteins.

Gerben van ‘t Klooster is a seasoned pharmaceutical executive with over 30 years of experience in drug development and commercialization. Most recently, he served as the Senior Vice President, Alliance Management at Galapagos after heading their early development portfolio for many years. Gerben held multiple senior positions in international pharmaceutical and biotech companies Kiadis, Tibotec and Janssen Pharmaceutica.

Josi Holz has over 25 years of experience in pharmaceutical drug development in Europe and North America. In executive managerial positions at international pharmaceutical and biotechnology companies and as clinical advisor, she has succesfully advanced novel therapeutics into clinical development and lead clinical programs towards commercialization.

Emile van Corven holds a Masters Degree in Biology/Biochemistry and obtained his PhD in 1987. He decided to enter the biopharmaceutical industry in 1992 and has fulfilled several positions with increasing responsibility, up to Chief Development Officer/Managing Director. With more than 30 years of Biotech experience, he finally decided to start as an independent consultant in April 2022 and he has joined TargED as Vice President Chemistry Manufacturing & Control.

Marèl de Wit holds a Masters Degree in Medical Biology and obtained her PhD focussing on Infectious Diseases and Immunology from Utrecht University, the Netherlands. Marèl is a quality oriented Regulatory professional with >15 years of experience in the Biological field. She has previously fulfilled several Regulatory Affairs positions, both in pre- and post-marketing, with increasing responsibility and now fulfills the position of Director Regulatory Affairs at TargED.

Sarah Mc Fie holds degrees in Molecular Biology, Neuroscience and Neuropsychology and obtained her PhD from the University of Cape Town, South Africa. Her PhD investigated the genetic risk factors for head injury outcome. In addition, she completed a one-year Clinical Neuropsychology internship in the Neurology Ward of the Groote Schuur Hospital and a Postdoctoral Fellowship in the Neurosurgery department of the University of Cape Town. Her passion lies in medical science and scientific communication.

Antoine Thomas is a Senior CMC expert with >20 years of experience in the pharmaceutical industry spanning from early to late phase development of small molecules, biologicals and gene therapy products. Prior to joining TargED, Antoine served as the Head of Manufacturing at ExeVir Bio, a spin-out of the VIB in Belgium. Prior to this, he has fulfilled several CMC related positions with increasing responsibility. Antoine holds a PhD in Organic Chemistry from the Université Henri Poincaré Nancy 1 (France).

Xander Speet holds a Bachelor Degree in Organic Chemistry from Noordelijke Hogeschool Leeuwarden, the Netherlands with a minor in Drug Design & Synthesis. He has been working in the biopharmaceutical industry since 2010 with previous roles as Project Manager Chemistry, Manufacturing & Controls (CMC) and Associate Director of Drug Product Manufacturing, Clinical Supplies & Logistics. Xander has proven to be a talented Project Manager with a great eye for detail.

Volker Laux is an expert in thrombosis and hemostatis, who has been working as a Pharmacologist for >25 years. Until 2019, he was Vice President for Hemostatic & Acute Care Diseases at Bayer Pharma in Wuppertal and San Francisco, and from 2020-2021 Division Head of Preclinical Research at the Fraunhofer Institute for Translational Medicine & Pharmacology in Frankfurt. He has been responsible for the translation of several discovery projects into development in thrombosis, hemophilia, ischemic stroke and Intensive care research.

Katja Wosikowski is a nonclinical research and development expert and licensed pharmacist. During her >20 years of experience in drug discovery and development, she has worked for several biopharmaceutical companies, bringing nonclinical development projects of innovative compounds into the clinic. Katja holds a Masters Degree in Pharmacy from the Rijksuniversiteit Groningen and obtained her PhD focussing on the role of the growth factor signaling pathway in breast cancer from the Universität Basel, Switzerland.

Sjoert van der Berg has over a decade of experience in finance, accounting, audit & controlling. He brings his expertise to drive financial strategies and management in his role as Head of Finance at TargED. Simultaneously, Sjoert works as Finance Director at AM-Pharma. Prior roles include Associate Director of Finance at Genmab and Auditor at KPMG, where he conducted audits for prominent domestic and international clients. Sjoert is a Certified Public Accountant (CPA) with a Masters degree in Accountancy from the University of Tilburg.

Danielle Versluis holds a Bachelors Degree in Biomedical Sciences and currently finishes her Masters in Biology of Diseases, both at Utrecht University (the Netherlands). Earlier, she performed two internships (1 year each). The former focussed on pyruvate kinase deficiency, the latter on regenerative orthopaedics. Her scientific interests lays with Cardiovascular disorders.

Filio Petsini holds a Masters degree in Biochemistry and is currently finishing her PhD studies in Biochemistry, both at Harokopio University in Greece. She has more than 5 years of experience in platelet-activating factor (PAF) analysis and metabolism and has also worked as a researcher in scientific programs at the university. Her scientific interests revolve around cardiovascular diseases.

Oyin Pelejeyu is a Neuroscience Graduate from London, who has a keen interest in the areas of Stroke, neurological diseases, and translational neuroscience. She has had more than 2 years of experience of working within clinical trials, and before graduating, she contributed to a clinical trial that focused on patients suffering with Idiopathic and Connective Tissue disease associated Pulmonary Arterial Hypertension. This was then later published in the European Respiratory Journal.

Eva Zethof holds a dual Associate degree from Schoevers (the Netherlands) in Office Management and Medical Secretary. Eva has >5 years of experience as Management Assistant in the pharmaceutical industry. Previously she worked for Guerbet (Gorinchem, the Netherlands), where she assisted various members of the Management Team and the Sales Team. In addition, she implemented a new CRM system and was responsible for company compliance and sponsorships (CGR).

Johan Renes is a Partner at Simmons & Simmons in Amsterdam since May 2021, and is TargED’s go-to partner when it comes to Intellectual Property practices. He has >30 years of experience in the Life Sciences industry and has been involved in international patent litigation. As a former life science entrepeneur, Johan is also experienced in the commercial and strategic aspects of drug development. He has guided companies from inception to IPO and beyond, negotiating licensing and collaboration deals, securing investments and implementing aligned R&D, business and IP strategies.

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Scientific Advisory Board Acute Ischemic Stroke

Technology

Our lead product, Microlyse, is a first-in-class proprietary clot-busting compound which binds to a protein present in all forms of thrombosis. Microlyse is the first compound to achieve targeted enzyme delivery, using a single domain antibody (VhH), directly to blood clots. Due to the targeted nature of the therapy, it is expected to lead to a superior side effect profile alongside the potential for exceptional potency compared to current agents. Microlyse’s unique mechanism of action allows for potential applications in a variety of indications involving thrombosis, including the life-threatening disease aTTP. The ground-breaking work demonstrating that Microlyse specifically targets blood clots leading to their desolution faster and safer compared to standard of care recently featured on the cover of the journal Blood (Microlyse: a thrombolytic agent that targets VWF for clearance of microvascular thrombosis).

Therapeutic areas

The human body controls rupturing of vessels by beneficial wound healing. Wound healing is initiated by the binding of platelets to unrolled Von Willebrand Factor (VWF), a multimeric blood protein. The developing molecular ‘band-aid’ can later be strengthened by the formation of fibrin. When this process is uncontrolled, obstructive blood clots can develop, known as ‘thrombosis’. These clots prevent sufficient blood supply to organs. Dependent on the affected organ, this can result in for example stroke, myocardial infarction or kidney failure. Interestingly, thrombi always contain platelets and VWF, but they do not always contain fibrin. We are currently developing Microlyse for the thrombotic indications TTP and acute ischemic stroke.

Thrombotic Thrombocytopenic Purpura (TTP)
TTP has an orphan EMA/FDA designation and it affects 2-10 patients per million per year. In physiology, the enzyme ADAMTS13 cleaves VWF and prevents progressing into pathological thrombosis. In TTP patients, ADAMTS13 activity is impaired. Consequently, TTP patients experience acute attacks during which they develop countless thrombi composed of ultra large VWF molecules (UL-VWF) and platelets. These thrombi generally affect the microvasculature of organs such as the kidneys, heart and brain, leading to tissue ischemia and multi-organ failure. TTP patients risk shortened life expectancy and long-term complications. When untreated, mortality is 90%.

Microlyse is revolutionary in inducing the active degradation of VWF strands. As a result, the duration of tissue ischemia can be reduced, resulting in less organ failure and lower mortality.

Acute ischemic stroke (AIS)
AIS is the largest thrombotic indication worldwide, affecting 17 million people per year. Since the late 90s, AIS patients are treated with recombinant tPA (tissue plasminogen activator) to recanalize the occluded blood vessel. tPA becomes less effective when administered later after symptom onset. Consequently, administration >4.5 hours after onset is avoided as efficacy is outweighed by the unavoidable bleeding risk that comes with tPA therapy.

The reasons for the limited efficacy of tPA are still largely unclear. However, tPA requires the availability of fibrin in order to degrade thrombi. In AIS, thrombi often originate from vessel damage elsewhere, after which thrombi-parts dislodge, embolize and occlude arteries in the brain. These thrombi always contain VWF, but the presence of fibrin is uncertain and varies between cases. We and others therefore suggest that degrading VWF in addition to fibrin forms an attractive strategy to treat thrombosis in stroke.