Dragonfly receives a milestone payment from Bristol Myers Squibb for progression of its Phase 1 DF6002-001 study with a PK profile and peripheral PD consistent with preclinical models

WALTHAM, MA, USA I March 1, 2022 I Dragonfly Therapeutics, Inc. (“Dragonfly”) today 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.

Dragonfly received investigational new drug approval for DF6002 from the U.S. Food and Drug Administration in May 2020, and its Phase 1/2 clinical trial for patients with advanced solid tumors began in July 2020.  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. Bristol Myers Squibb intends to advance the research and development of DF6002 in oncology and hematology.

Bristol Myers Squibb is responsible for the development and any subsequent commercialization of DF6002/BMS-9896415 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing. Dragonfly is eligible to receive additional performance-based development, regulatory and commercial milestone payments. Dragonfly will receive up to 24% royalties on worldwide net sales.

“We are very encouraged by the progress being made on the DF6002/BMS-9896415 program and with Bristol Myers Squibb, whose broad range of oncology agents will help to accelerate the development of DF6002, the most advanced cytokine in Dragonfly’s pipeline,” said Bill Haney, Co-founder and CEO of Dragonfly Therapeutics. “We remain confident that the talent, experience and commitment to science-driven innovation of the Bristol Myers Squibb team will enable DF6002/BMS-9896415 to discover novel, life-saving solutions for patients.”

“We are pleased to see results in the clinic bearing out the original hypothesis that DF6002/BMS-9896415 offers a remarkably differentiated profile from other cytokine programs,” said Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., Executive Vice President, Research & Early Development, Bristol Myers Squibb. “We look forward to our continued work with Dragonfly to further guide the program’s clinical data at this pivotal point in its development, as we continue to deliver on our commitment to serve more patients with cancer.”

About DF6002
DF6002, an extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002 is the most advanced in a pipeline of cytokines developed by Dragonfly to address the high unmet need in patients with advanced cancer.

The Phase 1/2 clinical trial for DF6002/BMS-986415 is a first-in-human open-label, dose-escalation study with a consecutive parallel-group efficacy expansion study, designed to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of DF6002 as monotherapy and in combination with nivolumab. Additional information about the trial, including eligibility criteria, can be found at: https://clinicaltrials.gov/ (ClinicalTrials.gov Identifier: NCT04423029).

About Dragonfly
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel technology to harness the body’s innate immune system to bring breakthrough treatments to patients. Dragonfly has a deep pipeline of wholly-owned clinical and preclinical candidates discovered using its proprietary platform that are progressing toward the clinic, as well as productive collaborations with Bristol Myers Squibb, Merck and Abbvie across a broad range of disease areas. For more information visit us at www.Dragonflytx.com, or follow us on Linkedln and Twitter.

SOURCE: Dragonfly Therapeutics