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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

Excerpt from the Press Release:

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.”

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