Drug intelligence / Profile preview

df9001

Development stage
Phase 2
Lead developer
Dragonfly Therapeutics
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

DF9001 is an investigational, first-in-class, multi-specific immune engager drug candidate developed using Dragonfly's TriNKET platform. It targets the epidermal growth factor receptor (EGFR) on tumor cells and simultaneously engages activating receptors NKG2D and CD16 on natural killer (NK) cells, gamma-delta T cells, and CD8 T cells. This dual mechanism allows DF9001 to both inhibit EGFR signaling—directly suppressing tumor cell growth—and stimulate anti-tumor immunity by redirecting innate and adaptive immune effector cells to kill EGFR-positive cancer cells. DF9001 has demonstrated potent activity in preclinical models against tumors with wild-type or mutant EGFR/KRAS that are less responsive to existing therapies like cetuximab. The drug is being evaluated in Phase 1/1b clinical trials for advanced solid tumors expressing EGFR, including non-small cell lung cancer, renal cell carcinoma, and head and neck squamous cell carcinoma.

Other names
EGFR tri-specific natural killer cell engager DF9001
02

Targets

NKG2D (Natural killer group 2 member D receptor)EGFR (Epidermal growth factor receptor)FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)

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