FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

Jul 31 2015

First in human clinical trials to commence Q3 2015

Mundipharma EDO GmbH (Early Development in Oncology) is pleased to announce that the United States Food and Drug Administration ("FDA") has accepted the company's Investigational New Drug Application ("IND") for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours.

EDO-S101 is a first in class fusion molecule that 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.

It is anticipated that EDO-S101 may have significant activity in various haematological malignancies and solid tumours and may have the potential to break through resistance towards other conventional chemotherapy.

Alkylating agents have demonstrated strong activity in a wide range of cancers and have been a mainstay of anti-tumour therapy for decades. In several malignancies alkylating agents are still considered standard of care. Bendamustine, the latest introduction, has demonstrated good efficacy and tolerability in a number of haematological malignancies.

Thomas Mehrling, MD, Ph.D, Managing Director of Mundipharma EDO, stated that this is a significant milestone for the company. "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 3 2015."

The primary goal of this first clinical trial is to evaluate the safety and tolerability of EDO-S101 and its pharmacokinetic profile. This information will be used to establish the dose of EDO-S101 to be used in subsequent Phase 1b and Phase 2 trials. A further objective will be to evaluate gene expression profiles correlated with response or resistance to EDO-S101, in order to better characterize its future applications.

A phase 1 trial in solid tumors will be developed once the dose escalation part of the first in human study has been completed.

SOURCE Mundipharma EDO GmbH