Mundipharma (Early Development in Oncology) EDO has started the first human clinical trial of its investigational drug, EDO-S101, to treat relapsed-refractory (RR) haematological malignances.
The multi-centre Phase I trial is intended to assess the safety and tolerability of ascending doses of EDO-S101, as well as determine the pharmacokinetic profile in human afflicted with haematological malignancies for a period of 28 days and will be performed at several sites across the US and Europe.
EDO-S101 is based on A-DAC principle that uses fusion technology to combine an alkylating agent with a pan-histone deacetylase inhibitor (HDAC), in order to damage DNA and block damage repair at the same time.
The process has the ability to overcome resistance towards other conventional chemotherapies.
EDO-S101 combines the active structures of bendamustine and vorinostat, two molecules that have been identified to treat haematological malignancies, to create a single agent with characteristics superior to those of the parent compounds given in combination.
Mundipharma EDO CEO Dr Thomas Mehrling 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 potential 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 tolerability of EDO-S101 and its pharmacokinetic profile. This data will be used to establish the recommended dose, which will then be further evaluated for safety and efficacy."
EDO-S101 has exhibited efficacy in preclinical experiments against haematological malignancies including multiple myeloma, acute myeloid leukemia, mantle cell lymphoma, ABC type diffuse large B-Cell lymphoma, as well as hodgkin lymphoma.
The molecule is additionally active in primary resistant cells and cells that have acquired resistance.