DF6002 / Dragonfly Therap - LARVOL DELTA

CA101-001: A Study of DF6002 Alone and in Combination With Nivolumab (clinicaltrials.gov) - P1 | N=438 | Recruiting | Sponsor: Dragonfly Therapeutics | Phase classification: P1/2 ➔ P1 | Trial completion date: Dec 2025 ➔ Nov 2027 | Trial primary completion date: Jul 2024 ➔ Jan 2027

Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Dragonfly Therapeutics Announces the Publication of Preclinical Data Supporting DF6002, its Extended Half-life IL-12 Cytokine, as A Promising Treatment for Cancer (Canada Newswire) - "Dragonfly's preclinical data demonstrates that DF6002 is well tolerated when administered systemically and results in potent anti-tumor responses in multiple preclinical models as monotherapy and in combination with checkpoint inhibitors. Dragonfly's novel DF6002 IL-12 is designed for half-life extension which alters IL-12's pharmacodynamic response profile and expands its therapeutic index."

Preclinical • Oncology • Solid Tumor

An optimized IL-12-Fc expands its therapeutic window, achieving strong activity against mouse tumors at tolerable drug doses. (PubMed, Med) - "An optimized IL-12-Fc fusion protein increased the therapeutic window of IL-12, enhancing anti-tumor activity without concomitantly increasing toxicity."

Journal • Preclinical • Immune Modulation • Oncology • IFNG • IL12A

[VIRTUAL] Preclinical characterization of DF6002/BMS-986415, a novel differentiated IL-12 Fc-fusion protein with robust antitumor activity as monotherapy or in combination with anti-PD-1 (AACR 2021) - P1/2 | "DF6002/BMS-986415, a novel IL-12 Fc-fusion protein, retained the full potency of rhIL-12 and showed improved exposure and tolerability; mDF6006 exhibited greater antitumor activity than rmIL-12. These data support the ongoing first-in-human phase 1/2 study evaluating DF6002/BMS-986415 as a novel therapeutic for the treatment of solid tumors in combination with nivolumab (NCT04423029)."

Combination therapy • Monotherapy • Preclinical • Oncology • Solid Tumor • CD4 • CD8 • IFNG • IL12A

"#DragonflyTherapeutics Announces All Rights Revert to Dragonfly for #DF6002, its Proprietary #IL12 Investigational #Immunotherapy Program https://t.co/jGqLGXyIUU" (@1stOncology)

IL12A

Dragonfly Therapeutics Announces All Rights Revert to Dragonfly for DF6002, its Proprietary IL12 Investigational Immunotherapy Program (PRNewswire) - "Dragonfly Therapeutics, Inc...announced it now owns all rights to develop DF6002, its novel interleukin-12 (IL-12) cytokine investigational immunotherapy program, which is in Phase 1 clinical development, with dose escalation progressing successfully in monotherapy and in combination with nivolumab, in the U.S. and in Europe. Clinical development is currently being carried out by Bristol Myers Squibb, but will be transferred to Dragonfly over the coming weeks."

Commercial • Oncology • Solid Tumor

Dragonfly Therapeutics Announces Sixth Dragonfly TriNKET Opt-in by Bristol Myers Squibb (PRNewswire) - "Dragonfly Therapeutics, Inc...announced that Bristol Myers Squibb exercised its option to enter into an exclusive license for a sixth TriNKET Immunotherapy drug candidate, that will bring the total drug candidates licensed by Bristol Myers Squibb to seven including Dragonfly's novel IL12 cytokine DF6002/BMS-986415. Since their original 2017 collaboration focusing on hematology malignancies, the companies have agreed to two additional collaborations which include oncology and neuroinflammation targets. Today's announcement marks the first TriNKET opt-in outside of oncology."

Licensing / partnership • Oncology

A Study to Assess DF6002 (BMS-986415) Alone and in Combination With Nivolumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=473 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: May 2027 ➔ Dec 2025

Combination therapy • Monotherapy • Trial completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A Study to Assess DF6002 (BMS-986415) Alone and in Combination With Nivolumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=473 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Dec 2024 ➔ May 2027 | Trial primary completion date: Sep 2022 ➔ Aug 2024

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Dragonfly Therapeutics Announces Achievement of Phase 1 Clinical Development Milestone for IL-12 Investigational Immunotherapy Program with Bristol Myers Squibb (PRNewswire) - "Dragonfly Therapeutics...announced the achievement of a Phase 1 clinical development milestone for the DF6002/BMS-9896415 IL-12 program. DF6002/BMS-9896415 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses....Bristol Myers Squibb (NYSE:BMY) signed an exclusive worldwide license agreement with Dragonfly Therapeutics for its IL-12 investigational immunotherapy program, including its extended half-life cytokine DF6002, in August 2020."

Financing • Licensing / partnership • Oncology

Dragonfly Therapeutics Announces Sixth Dragonfly Drug to be Licensed by Bristol Myers Squibb and Receipt of Milestone Payments Following First Patient Dosing of Two TriNKET Immunotherapies (PRNewswire) - "Dragonfly Therapeutics, Inc...announced that Bristol Myers Squibb has licensed a fifth TriNKET™ Immunotherapy drug candidate, bringing the total drug candidates licensed by Bristol Myers Squibb to six including Dragonfly's novel IL-12 cytokine DF6002/BMS-986415. Since their original 2017 collaboration focusing on hematology malignancies, the companies have agreed to two additional collaborations which include oncology and neuroinflammation targets....Dragonfly also announced that the first patients have been dosed in Phase 1 clinical trials of both the CC-96191 and CC-92328 investigational immunotherapies, which are licensed to Bristol Myers Squibb."

Licensing / partnership • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology

Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications Escalada de dosis de DF6002 en pacientes con tumores sólidos avanzados, y expansión en indicaciones seleccionadas. (clinicaltrialsregister.eu) - P1/2; N=380; Ongoing; Sponsor: Dragonfly Therapeutics, Inc.

Clinical • Combination therapy • Monotherapy • New P1/2 trial • Breast Cancer • Head and Neck Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Tourette Syndrome • Triple Negative Breast Cancer • BRAF

Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications (clinicaltrials.gov) - P1/2; N=380; Recruiting; Sponsor: Dragonfly Therapeutics; N=260 ➔ 380

Clinical • Combination therapy • Enrollment change • Monotherapy • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • ALK • BRAF • EGFR • ER • HER-2 • PGR • ROS1

Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications (clinicaltrials.gov) - P1/2; N=260; Recruiting; Sponsor: Dragonfly Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Breast Cancer • Clear Cell Renal Cell Carcinoma • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

"Here's the Dragonfly (now $BMY) trial of DF6002. IL-12 for the win! https://t.co/eZ2jL8nVlg $LLY" (@JacobPlieth)

Dragonfly Therapeutics and Bristol Myers Squibb Announce Exclusive Global License for Dragonfly’s IL-12 Investigational Immunotherapy Program (Businesswire) - "Bristol Myers Squibb…and Dragonfly Therapeutics, Inc…announced that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted the global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002…Dragonfly will receive $475 million in near-term upfronts, and is eligible to receive performance-based development, regulatory and commercial milestone payments. In addition, Dragonfly will receive up to 24% royalties on worldwide net sales."

Licensing / partnership • Oncology

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

Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications (clinicaltrials.gov) - P1/2; N=260; Not yet recruiting; Sponsor: Dragonfly Therapeutics

Clinical • Combination therapy • Monotherapy • New P1/2 trial • Bladder Cancer • Breast Cancer • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Disorders • Hematological Malignancies • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • Urothelial Cancer