EDO-S101 combines the DNA damaging effect of bendamustine with the pan-histone deacetylase inhibitor (HDACi) vorinostat, with the aim of increasing the efficacy of the alkylator through the HDACi-mediated chromatin relaxation.
The company noted that the first in human clinical trials will be initiated in the third quarter of this year.
The trial is designed to evaluate the safety and tolerability of EDO-S101 and its pharmacokinetic profile.
Data from this trial will be used to establish the dose of EDO-S101 to be used in subsequent Phase Ib and Phase II trials.
Alkylating agents have showed strong activity in a wide range of cancers and have been a mainstay of anti-tumor therapy for decades and in several malignancies these agents are still considered standard of care.
The company noted that bendamustine, which is the latest introduction, has showed good efficacy and tolerability in a number of haematological malignancies.
Mundipharma EDO managing director Thomas Mehrling said: "With this IND approval, Mundipharma EDO has transitioned from a pre-clinical company to a company in clinical stage in about two years.
"This successful IND represents the culmination of a focused and rigorous development program aimed at providing proof of efficacy and safety in animals to support human clinical trials of EDO-S101.
"Preparations are underway to start the first in human clinical trial in patients with relapsed-refractory haematologic malignances in quarter three 2015."