Cullinan Oncology Receives Investigational New Drug (IND) Clearance from the FDA for CLN-049, a FLT3 x CD3 Bispecific Antibody for the Treatment of Relapsed/Refractory AML
CAMBRIDGE, Mass., June 07, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM) (“Cullinan”), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that the U.S. Food and Drug Administration (FDA) has cleared Cullinan Florentine’s IND application for CLN-049, a FLT3 x CD3 bispecific antibody for the treatment of relapsed/refractory acute myeloid leukemia (AML).
“IND clearance by the FDA paves the way to test a differentiated treatment approach by targeting extracellular FLT3, an oncogenic driver in AML,” stated Patrick Baeuerle, Cullinan’s Chief Scientific Officer, Biologics. “We are excited to initiate human dosing of CLN-049, a T cell-engaging, IgG-like antibody in patients with relapsed/refractory AML.”
In preclinical studies, CLN-049 led to potent FLT3-dependent killing of leukemic cells in vitro at a wide range of FLT3 expression levels on AML cells. Treatment with CLN-049, even at low doses, led to survival benefit in an AML xenograft model and complete elimination of leukemic blasts in various mouse models implanted with primary patient leukemic cells or AML cell lines.
About Cullinan Oncology
About Cullinan Florentine
Cullinan Florentine is a partially owned subsidiary of Cullinan Oncology that has exclusive worldwide rights to CLN-049 pursuant to a License with the Deutsches Krebsforschungszentrum, or DKFZ, Eberhard Karls University of Tübingen, Faculty of Medicine, or University of Tübingen, and Universitätsmedizin Gesellschaft für Forschung und Entwicklung mbH, Tübingen, or UFE.