DF1001 / Dragonfly Therap - LARVOL DELTA

Preclinical characterization of DF1001, a first-in-class dual NK and T cell engager targeting HER2-high or HER2-low tumors (SABCS 2024) - P1/2 | "DF1001 is uniquely differentiated from HER2-targeted therapeutics due to its distinct immune-engaging mechanism of action (MOA) which is active against HER2-low expressing cancers, where HER2 mAbs such as trastuzumab are clinically ineffective. The DF1001 TriNKET® targets robust immune-mediated activities, which enhances cytolytic responses directed at both HER2-high and HER2-low tumors and elevates local release of inflammatory cytokines/chemokines without causing CRS. DF1001 TriNKET's favorable drug safety profile and distinct immune-engaging MOA positions it to complement and synergize with SOC agents such as sacituzumab govitecan-hziy in the HER2-low solid tumor setting. DF1001 is currently under evaluation in patients with locally advanced or metastatic solid tumors in PhI/II trials (NCT04143711)."

Preclinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • CD8 • CXCL10 • FCGR3A • HER-2 • IFNG • NKG2D • TACSTD2 • TNFA

Dragonfly Announces Clinical Collaboration Exploring Combinations of Dragonfly's DF1001 HER-2 TriNKET with Gilead's Trodelvy in two Cancer Indications (PRNewswire) - "Dragonfly Therapeutics, Inc...today announced a new clinical collaboration designed to evaluate and combine DF1001, a HER-2 immune engager developed using Dragonfly's TriNKET technology platform and Dragonfly's lead clinical asset, with Trodelvy, Gilead's Trop-2-directed antibody drug conjugate (ADC), in metastatic breast cancer (mBC) and non-small cell lung cancer (NSCLC)....Dragonfly will have operational control of the study and first patients are expected to receive this combination in Q2 2024. Clinical trial sites are currently open in the U.S., France, Belgium, Denmark and the Netherlands. Additional sites in North America, Europe and Asia Pacific will open in 2024."

Licensing / partnership • Trial status • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of DF1001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=378 | Recruiting | Sponsor: Dragonfly Therapeutics | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jul 2025 ➔ Oct 2026

Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ALK • EGFR • ROS1

Phase 1/2 Study of DF1001, a novel tri-specific, NK cell engager therapy targeting HER2, in patients with advanced solid tumors: Phase 1 DF1001 monotherapy dose-escalation results. (ASCO 2023) - P1/2 | "In this dose escalation study, DF1001 is shown to be a safe and well-tolerated novel NK cell engager therapy targeting HER2. DF1001 monotherapy demonstrates promising anti-tumor activity in treatment refractory patients with a spectrum of HER2 expression as well as MOA consistent pharmacodynamic changes in the tumor. This promising data set supports further exploration of DF1001 alone, and in combination with other compounds, as a potential novel therapeutic option for patients with solid tumors."

Clinical • Metastases • Monotherapy • P1/2 data • Trispecific • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Fatigue • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD8 • HER-2

Dragonfly Therapeutics Announces the Presentation of Phase 1 DF1001 TriNKET Dose Escalation Results at ASCO 2023 Annual Meeting (PRNewswire) - P1/2 | N=490 | NCT04143711 | Sponsor: Dragonfly Therapeutics | "Dragonfly Therapeutics, Inc...announces the first presentation of its DF1001 TriNKET immune engager clinical data at the ASCO 2023 Annual Meeting in Chicago. The presentation, given by lead investigator Dr. Howard P. Safran, Chief of Hematology/Oncology at the Lifespan Cancer Institute and Medical Director for the Brown University Oncology Group, describes Dragonfly's Phase 1/2 clinical trial of its DF1001 HER2-targeting TriNKET®, a first-in-human study exploring the safety, tolerability, and preliminary biological and clinical activity of DF1001...DF1001 was safe and well tolerated as monotherapy at biweekly doses up to 15 mg/kg and has successfully progressed through Phase 1 combinations with both nivolumab and nab-paclitaxel. There have been no DLTs with DF1001 during the monotherapy dose-escalation phase. DF1001 pharmacodynamic activity was demonstrated in 67% (28/42) of paired biopsies in monotherapy."

P1/2 data • Oncology • Solid Tumor

Dragonfly Therapeutics to Present Phase 1 DF1001 Monotherapy Dose Escalation Results at ASCO 2023 Annual Meeting (PRNewswire) - "Dragonfly Therapeutics, Inc...announced an oral presentation of Phase 1 DF1001 Monotherapy Dose Escalation Results scheduled on Sunday June 4, from 11:45 - 11:57 a.m."

P1 data • Oncology • Solid Tumor

Study of DF1001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=490 | Recruiting | Sponsor: Dragonfly Therapeutics | N=220 ➔ 490 | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Apr 2022 ➔ Jul 2025

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ALK • EGFR • ROS1

Dragonfly Therapeutics Initiates Phase 2 Study of HER2 Targeting TriNKET DF1001 in Patients with Advanced Solid Tumors (Canada Newswire) - "Dragonfly Therapeutics...announced that the first patients have been dosed in the Phase 2 study of its HER2 targeting TriNKET® DF1001. The trial is recruiting patients across a range of advanced solid tumor indications at 34 sites in the United States and Europe. DF1001 is the first TriNKET to enter Phase 2 trials....DF1001's Phase 2 trial will expand development of DF1001 both as monotherapy and in combination with multiple agents, including Opdivo® and Abraxane®."

Trial status • Oncology • Solid Tumor

"#DragonflyTherapeutics Announces #DF1001 Granted #OrphanDrug Designation in the US for #EsophagealCancer https://t.co/N8TXmmLXCp" (@1stOncology)

Orphan drug • Esophageal Cancer • Gastrointestinal Cancer • Oncology

Dragonfly Therapeutics Announces DF1001 Granted Orphan Drug Designation in the US for Esophageal Cancer (Canada Newswire) - "Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, today announced that its wholly-owned HER2-targeted NK cell engager therapy, DF1001, has been granted Orphan Drug Designation (ODD) in the US for treatment of esophageal cancer."

Orphan drug • Esophageal Cancer • Gastric Cancer • Oncology

Enhanced Cadaverine Production by Engineered Escherichia coli Using Soybean Residue Hydrolysate (SRH) as a Sole Nitrogen Source. (PubMed, Appl Biochem Biotechnol) - "These proteins with small molecular weights and concentrated molecular weight distribution were favorable to be transformed by engineered E. coli DFC1001, and then SRH replaced completely yeast powder as an only nitrogen source for cadaverine production. The maximum cadaverine productivity was 0.52 g/L/h, achieved with a constant speed feeding strategy in the optimized SRH fermentation medium containing an initial total sugar concentration of 30 g/L and exogenous added minerals, which indicated that soybean residue could be a potential feedstock for economic cadaverine production."

Journal

Dragonfly Therapeutics Initiates Phase 1/2 Study of its IL12 Immunotherapy in Patients with Advanced Solid Tumors (PRNewswire) - "Dragonfly Therapeutics, Inc...announced it has dosed its first patient in a Phase 1/2 study of the Company's proprietary IL12 investigational immunotherapy, DF6002. Dragonfly's DF6002 clinical trial is currently recruiting patients with advanced solid tumors at Lifespan Cancer Institute at Rhode Island Hospital, the principal teaching hospital of Brown University, with additional sites scheduled to open shortly....'DF6002's therapeutic potential is particularly exciting,' said Dr. Mario Sznol....'In addition to DF6002, our productive collaborations building drugs for BMS, Merck, and Abbvie, and our DF1001 TriNKET presently advancing in the clinic, we're already racing to bring our second TriNKET to IND in 2021.'"

Clinical • Enrollment open • IND • Media quote • Oncology • Solid Tumor

Study of DF1001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=220; Recruiting; Sponsor: Dragonfly Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Newly added product (clinicaltrials.gov) - P2, oncology

Pipeline update