Dragonfly Therapeutics Announces Achievement of Phase 1 Clinical Development Milestone for IL-12 Investigational Immunotherapy Program with Bristol Myers Squibb
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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, Mass., March 1, 2022 /PRNewswire/ -- 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 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 Contacts Dragonfly
SOURCE Dragonfly Therapeutics, Inc. |
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Company Codes: NYSE:BMY |
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