- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
First-in-human trial of MundiPharma’s EDO-S101 starts
14 July 2016 • Author: Victoria White, Digital Content Producer
A first-in-human clinical trial of MundiPharma’s investigational drug candidate EDO-S101 has started.
EDO-S101 is currently being developed for the treatment of relapsed-refractory haematological malignances. This phase I study is designed to evaluate the safety and tolerability of ascending doses of EDO-S101 and will be conducted at several sites across the United States and Europe.
EDO-S101 is the first representative of the A-DAC principle, a new approach in chemotherapy that uses fusion technology to combine an alkylating agent with a pan-histone deacetylase inhibitor (HDAC) to simultaneously damage DNA and block damage repair. The combination of the two different modes of action has the potential to overcome resistance towards other conventional chemotherapies.
EDO-S101 combines the active structures of bendamustine and vorinostat, two molecules that have been well established in the treatment of haematological malignancies, to produce a novel single agent with efficacy characteristics superior to those of the parent compounds given in combination.
Significant activity against haematological malignancies
Preclinical experiments demonstrated that EDO-S101 exerts significant activity against haematological malignancies including multiple myeloma (MM), acute myeloid leukemia (AML), mantle cell lymphoma (MCL), ABC type diffuse large B-Cell lymphoma (DLBCL) as well as hodgkin lymphoma (HL). In addition, the molecule is active in primary resistant cells as well as in cells that have acquired resistance.
Commenting on the announcement, Dr Thomas Mehrling, CEO, Mundipharma said: “Today EDO forges ahead with even greater momentum following this important milestone of a first-in-human trial. EDO-S101 is making significant progress in its clinical development journey and we are passionate about its po- tential to treat patients with relapsed-refractory haematological malignances, who are in dire need of new treatment options. The primary goal of this first clinical trial is to evaluate the safety and tol- erability of EDO-S101 and its pharmacokinetic profile. These data will be used to establish the rec- ommended dose which will then be further evaluated for safety and efficacy.”
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics