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.

"The primary goal of this first clinical trial is to evaluate the safety and tolerability of EDO-S101 and its pharmacokinetic profile."

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.