DF6215 / Dragonfly Therap - LARVOL DELTA

DF6215-001: Study of DF6215 in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=255 | Recruiting | Sponsor: Dragonfly Therapeutics | N=102 ➔ 255 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Enrollment change • Monotherapy • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor

A novel alpha-active IL-2-Fc has expanded therapeutic index and robust monotherapy efficacy in mouse cancer models and strong synergy with PD-1 blockade (SITC 2024) - P1 | "Aldesleukin is an approved recombinant human IL-2; however, its short half-life, requirement for 5 days of hospitalization per cycle, and high toxicity [eg, cytokine related syndrome (CRS), capillary leak syndrome (CLS)] severely limit its clinical use. DF6215 is currently being evaluated in a Phase 1/1b clinical trial in patients with advanced solid tumors (NCT06108479). Ethics Approval All mouse studies were carried out according to protocols established by Explora BioLabs/CRADL IACUC committee."

Monotherapy • Preclinical • Melanoma • Oncology • Solid Tumor • CD8 • IL2 • STAT5

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

A phase 1/1b, first-in-human, multi-part study of DF6215, an engineered IL-2Rα-active agonist, to investigate the safety, tolerability, pharmacokinetics, and biological and clinical activity in patients with advanced solid tumors. (ASCO 2024) - P1 | "Aldesleukin is an approved rhIL-2; however, it has clinical limitations due to short half-life, requirement for 5 days of hospitalization per cycle, and high toxicity [eg, cytokine-related toxicity, capillary leak syndrome (CLS)] that limits its use [aldesleukin USPI]. 2015. Trends Immunol."

Clinical • IO biomarker • Metastases • P1 data • PK/PD data • Melanoma • Oncology • Solid Tumor • CD8

Dragonfly Therapeutics Initiates Phase 1/1b Study of its IL-2 Immunotherapy in Patients with Advanced Solid Tumors (BioSpace) - "'DF6215's therapeutic potential is particularly compelling,' said Dr. Benedito A. Carneiro, MD...'Dragonfly's IL-2 preclinical package shows strong anti-tumor activity in cold and hot tumor models and a favorable therapeutic window in cyno, with no signs of Vascular Leak Syndrome or Cytokine Release Syndrome - which we believe powerfully differentiates DF6215 from historic IL-2 drug candidates.'"

Media quote

Dragonfly Therapeutics Initiates Phase 1/1b Study of its IL-2 Immunotherapy in Patients with Advanced Solid Tumors (Canada Newswire) - "Dragonfly Therapeutics, Inc...today announced it recently dosed its first patient in a Phase 1/1b study of the Company's proprietary IL-2 investigational immunotherapy, DF6215, developed for patients with advanced solid tumors....DF6215-001 is currently recruiting at multiple sites in the U.S., with sites in additional regions scheduled to open in 2024."

Trial status • Oncology • Solid Tumor

Study of DF6215 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=102 | Recruiting | Sponsor: Dragonfly Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor