FLYSYNAlternative Names: 4G8-SDIEM
Latest Information Update: 02 Mar 2017
At a glance
- Originator Synimmune
- Class Antineoplastics; Monoclonal antibodies
- Mechanism of Action Fms-like tyrosine kinase 3 inhibitors; Immunostimulants; Natural killer cell stimulants
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
On Fast track
Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.
- New Molecular Entity Yes
Highest Development Phases
- Phase I/II Acute myeloid leukaemia
Most Recent Events
- 01 Feb 2017 Phase-I/II clinical trials in Acute myeloid leukaemia (Monotherapy) in Germany (IV) (NCT02789254)
- 13 May 2016 Synimmune plans a phase Ib/IIa trial for Acute myeloid leukaemia in Germany (NCT02789254)