DF9001 / Dragonfly Therap - LARVOL DELTA

KEYNOTE F92: Study of DF9001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: Dragonfly Therapeutics | Recruiting ➔ Completed | N=242 ➔ 24 | Trial completion date: Nov 2027 ➔ Aug 2025

Enrollment change • First-in-human • Monotherapy • Trial completion • Trial completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • ROS1

DF9001, an EGFR targeted immune engager, stimulates innate and adaptive anti-tumor immunity with a distinctive safety profile (SITC 2024) - P1/2 | "DF9001 stimulated potent NK cell-mediated lysis of EGFR+ tumor cells including those less susceptible to approved EGFR-targeting antibody cetuximab (e.g., harboring EGFR or KRAS mutations). These characteristics make DF9001 a promising therapeutic candidate against EGFR+ cancers, particularly those for which EGFR signal inhibition alone is ineffective. DF9001 is currently being evaluated in a PhI/Ib clinical trial in patients with EGFR-expressing advanced solid tumors (NCT05597839)."

Clinical • Oncology • Solid Tumor • CD8 • KRAS • NKG2D

Dragonfly Therapeutics to Present Preclinical Data on Clinical-Stage DF6215, its Engineered IL-2R alpha-active Agonist, and DF9001, its EGFR-targeting TriNKET, at the Society for Immunotherapy of Cancer (SITC) Annual Conference (PRNewswire) - "Data show that Dragonfly's DF6215 IL-2 cytokine drives greater therapeutic benefit in vivo than non-alpha IL-2, with no evidence of capillary leak syndrome or cytokine release syndrome. In addition, DF6215 synergizes with PD-1 blockade cancer treatment in the 'cold' B16F10 melanoma tumor model, without adding toxicity. 'DF6215 is a differentiated IL-2, specifically tuned to potently stimulate anti-tumor CD8 T cells and NK cells without incurring counterproductive Treg expansion or VLS,' said Ann Cheung, Chief Scientific Officer of Dragonfly Therapeutics....Data show superior anti-tumor activity via EGFR signal inhibition compared to cetuximab in a xenograft mice model, and that DF9001 induces potent in vivo efficacy via immune effector cells, even in cancer models not dependent on EGFR signaling."

Preclinical • Oncology • Solid Tumor

Dragonfly Therapeutics, Inc. Announces Clinical Collaboration to Evaluate DF9001, an EGFR targeting TriNKET, in Combination with KEYTRUDA (pembrolizumab) in Patients with Solid Tumors (PRNewswire) - "Dragonfly Therapeutics, Inc...announced that it has entered into a clinical collaboration with Merck (known as MSD outside the US and Canada), to evaluate DF9001, Dragonfly's EGFR immune engager, in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced solid tumors expressing EGFR....Dragonfly is the study sponsor and first patients are expected to receive DF9001 in combination with pembrolizumab in Q4 2024. Clinical trial sites are currently open for monotherapy dosing in the U.S., with additional sites in North America and Europe expected to open in 2024."

Licensing / partnership • Trial status • Oncology • Solid Tumor

Study of DF9001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=242 | Recruiting | Sponsor: Dragonfly Therapeutics | N=362 ➔ 242 | Trial completion date: Dec 2026 ➔ Nov 2027 | Trial primary completion date: Oct 2024 ➔ Aug 2025

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • ROS1

Study of DF9001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=362 | Recruiting | Sponsor: Dragonfly Therapeutics | Trial primary completion date: Oct 2023 ➔ Oct 2024

Combination therapy • Metastases • Monotherapy • Trial primary completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • ROS1

Study of DF9001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=362 | Recruiting | Sponsor: Dragonfly Therapeutics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • ROS1

Dragonfly Therapeutics Announces First Patient Dosed in Phase 1 Study of its EGFR-targeting TriNKET (Canada Newswire) - "Dragonfly Therapeutics, Inc...today announced the first patient dosed in a Phase 1/2 study of the Company's proprietary EGFR-targeting TriNKET....DF9001is the sixth Dragonfly-developed drug to enter into clinical trials."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Study of DF9001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=362 | Not yet recruiting | Sponsor: Dragonfly Therapeutics

Combination therapy • Monotherapy • New P1/2 trial • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • ROS1