Synimmune initiates FiH study of Fc-optimized antibody Flysyn for the treatment of AML

Flysyn is the first antibody from the company's pipeline to be tested in humans.

The Phase I study of Flysyn is being conducted at the University Hospital Tuebingen and at the University Hospital Ulm in Germany and will enroll up to 28 AML patients with minimal residual disease. Four patient cohorts will receive increasing doses of Flysyn, each as a single intravenous infusion. The dose escalation phase will be followed by an expansion cohort phase to assess initial efficacy.

The primary endpoints of the study are safety and tolerability. Secondary endpoints include immunogenicity, pharmacokinetics and pharmacodynamics, as well as preliminary efficacy in terms of overall response rate and duration of response. Patients will be followed for up to 18 months. Preliminary results from the trial are expected in 2018, the trial is projected to complete in early 2019.

"The initiation of this Phase I study with Flysyn is a major milestone for Synimmune, as this is the first antibody from our pipeline to be tested in humans," said Dr Martin Steiner, CEO of Synimmune. "The key goals of this study are to determine the maximum tolerated dose and to assess the preliminary therapeutic effect of Flysyn in AML patients with minimal residual disease. Today, the majority of these patients relapse within several months. Our antibody is intended to delay or even prevent such relapse. We therefore believe that, if proven safe and effective, Flysyn could become an attractive treatment option for many AML patients."