Innovation & Business Idea
Proprietary technology for immune cell profiling from a drop of blood. Epimune’s approach uses DNA that can be isolated from fresh, frozen or dried blood. Uniquely suitable for clinical applications with limited availability of fresh blood samples– e.g. newborn screening, monitoring of home-bound patients and rapid diagnosis at the point of care.
Customers / Target Market
Epimune’s tests run on PCR platforms widely available in standard molecular diagnostic laboratories. Commercialization of in-vitro diagnostic (IVD) test kits to newborn screening labs and diagnostic laboratories providing blood analyses to specialists and general physicians. Epimune is also developing point-of-care applications. The combination of minimally invasive blood sampling (through a finger-prick) with telemedicine makes (near) home-based immune monitoring a realistic prospect.
Providers of flow cytometry reagents and instruments for diagnostics - e.g. Becton Dickinson, Beckman Coulter, Immudex. Providers of immune cell based IVD products using other technologies - e.g. HalioDx, Lophius Biosciences, Qiagen. Companies addressing similar clinical applications - e.g. PerkinElmer (newborn screening); CareDx (Transplantation). Novel technologies – mostly Next Generation Sequencing (NGS) - e.g. Adaptive Biotech (immune monitoring); Baby Genes (newborn screening). Epimune’s approach is low cost, robust and the ease of sample collection and transportation are especially beneficial in areas with limited medical infrastructure. The adaption of the current workflow to point-of-care platforms as well as novel technologies (NGS) offers applications in markets with the highest growth potentials in the IVD industry.
Intellectual Property Status
27 patent families (11 granted in various countries, rest under review) filed by Epiontis (now part of Precision for Medicine). Epimune has exclusive license to all epigenetic marker IP for IVD product development and commercialization.
Development Status & Future Steps
Currently developing a real-time PCR-based kit for quantification of most important immune cells from blood. Research Use Only (RUO) version of the kit to be distributed to selected key opinion leaders for clinical validation studies; currently establishing a Quality Management System according to ISO 13485; certification planned in 2019
Planning for long-term growth based on multiple attractive market opportunities. Partnering with strategic development partners and/or investors actively pursued. Future exit by M&A is envisioned.
Uwe Staub (Chief Executive) – 25 years experience in the IVD industry, past 5 years Vorstand at Epigenomics AG.
Christoph Sachsenmaier (Business Development) – more than 17 years business development expertise in positions of increasing responsibility at ProQinase, Epigenomics, Beckman Coulter Genomics and ApoCell.
Jeannette Werner (R&D) – joined Epiontis as Head of R&D 2 years before joining Epimune; holds a PhD from the Technical University, Berlin.
Janika Schulze (Quality Management) – 8 years with Epiontis; fundamentally involved in building the epigenetic immune cell quantification platform; currently finishing her PhD at Humboldt University, Berlin.
Helge Riemer (Finance) – responsible for Finance and HR at Epiontis since 2006; co-founder of Epimune.
Seed Financing Round of €1.5 M (2018) to cover CE-IVD mark of first product; preparing for Series A to support development and regulatory approval of product in USA and China; expansion into additional clinical applications and markets
Searching forCommercial Partner, Funding, Collaboration