FOSTER CITY, Calif. & WALTHAM, Mass.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Dragonfly Therapeutics today announced a collaboration aimed at advancing a suite of Dragonfly’s novel natural killer (NK) cell-based immunotherapies for indications in oncology and inflammation. NK cell engagers represent a novel mechanism that has the potential to treat a wide range of cancers, including potential for activity in checkpoint-resistant and refractory tumors, as well as other disease areas such as inflammation. Under the terms of the agreement, Dragonfly will grant Gilead an exclusive, worldwide license to the DF7001 anti-5T4 immunotherapy investigational program. The agreement also grants Gilead the option, upon completion of certain preclinical activities, to license exclusive, worldwide rights to develop and commercialize additional NK cell engager programs using the Dragonfly Tri-specific NK Engager (TriNKET™) platform. TriNKETs are activators of the innate and adaptive immune systems that recruit NK and cytotoxic T cells into the tumor microenvironment.
DF7001 is a TriNKET designed to activate and direct NK and cytotoxic T cell killing against cancer cells. DF7001 targets 5T4, a protein expressed on cancer cells and stromal cells that supports tumor growth associated with poor prognosis in several cancer types including non-small cell lung cancer (NSCLC), pancreatic cancer, breast cancer and head and neck Squamous Cell Carcinoma (HNSCC). DF7001 has the potential to induce killing of 5T4+-expressing cells, including tumor cells, cancer-associated fibroblasts and cancer stem cells. The program is on track to submit an Investigational New Drug (IND) application in the first half of 2023.
“We are excited to partner with Dragonfly as we expand our pipeline of innovative NK cell engager programs. We use our scientific framework to focus our efforts and are expanding our portfolio with assets that have complementary MOAs and a strong scientific rationale for possible combinations,” said Flavius Martin, MD, executive vice president, research at Gilead. “We look forward to collaborating with the Dragonfly team to explore novel NK-Attacher treatments across multiple therapeutic areas to address some of the greatest unmet medical needs in cancer and inflammatory diseases.”
“Gilead’s investment in Dragonfly, and DF7001 in particular, reinforces the value of our TriNKET platform and differentiated and sustainable approach focused on people living with cancer and inflammatory diseases,” said Bill Haney, Dragonfly co-founder and chief executive officer. “Gilead has a solid track record of development and commercialization and is a well-suited partner for our scientific expertise and platform. We look forward to working with the Gilead team to advance new treatment options where there is high unmet need.”
Terms of Agreement
Under the terms of the agreement, Gilead will make an upfront payment to Dragonfly of US$300 million. In addition, Dragonfly is eligible for potential opt-in payments and performance-based development, regulatory and commercial milestone payments. Dragonfly is also entitled to royalties of up to 20% on worldwide net sales.
The transaction is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act 1976.
DF7001 is an investigational product candidate; It is not approved by any regulatory body for any use and has not been proven safe or effective.
Dragonfly Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapies that utilize its novel TriNKET™ technology to harness the body’s innate immune system to bring breakthrough treatments to patients.
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About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has been pursuing and making breakthroughs in medicine for more than three decades with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, cancer and inflammation. Gilead operates in more than 35 countries worldwide and is headquartered in Foster City, California.
Gilead Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the parties’ ability to complete the transaction in a timely manner or at all; the possibility that various closing conditions for the transaction will not be satisfied or waived, including the possibility that a governmental authority prohibits, delays or refuses approval for the closing of the transaction; the risk that Gilead may not recognize the potential benefits of this collaboration with Dragonfly or other investments in oncology; difficulties or unanticipated expenses related to the collaboration and the potential impact on Gilead’s sales and earnings; the parties’ ability to initiate, continue or complete clinical trials within the timelines currently anticipated, or at all, and the possibility of adverse results from ongoing or additional trials, including those involving DF7001 or any other NK cell engagement program; the parties’ ability to submit regulatory approval applications or receive timely or at all regulatory approvals, including those affecting DF7001 or any other NK cell engager program, and the risk that such approvals may be subject to significant use restrictions; the possibility that the parties may, at any time, make a strategic decision to terminate the collaboration, including the development of DF7001 or any other NK cell engagement program; and any assumptions underlying the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the US Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those projected in the forward-looking statements. All statements, other than statements of historical fact, are statements that may be deemed to be forward-looking statements. Readers are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intention to update any such forward-looking statements.
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