On August 17, 2020 Bristol Myers Squibb (NYSE: BMY) and Dragonfly Therapeutics, Inc. ("Dragonfly"), reported 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 (Press release, Dragonfly Therapeutics, AUG 17, 2020, View Source [SID1234563717]). DF6002 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.
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Under the agreement, Bristol Myers Squibb will become responsible for the development and any subsequent commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing. 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. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Dragonfly received U.S. Food and Drug Administration clearance in May 2020 for its investigational new drug application to develop DF6002. In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. Bristol Myers Squibb intends to advance the research and development of DF6002 in oncology and hematology.
"As we continue to expand our focus in oncology, we are pleased to be adding an IL-12 Fc-fusion protein to our oncology pipeline in the form of DF6002," said Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., Executive Vice President & 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."
"We are excited to be collaborating once again with Bristol Myers Squibb, whose broad range of oncology agents makes it a fantastic partner 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 are confident that the talent, experience and commitment to science-driven innovation of the Bristol Myers Squibb team will enable DF6002 to discover novel, lifesaving solutions for patients."
About DF6002
DF6002, Dragonfly’s 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 that Dragonfly is developing to address the high unmet need in patients with advanced cancer.