Mundipharma EDO (Early Development in Oncology) has announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for EDO-S101 for the treatment of relapsed or refractory hematologic malignancies and solid tumors.
The primary goal of the 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. Gene expression profiles correlated with response or resistance to EDO-S101 will also be evaluated. A Phase 1 trial in solid tumors will be developed once the dose escalation part of the first-in-human study has been completed.
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.
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