EDO-S101 NDA Accepted for Relapsed or Refractory Malignancies
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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