On May 2, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) and Dragonfly Therapeutics reported a collaboration designed to advance a number of Dragonfly’s novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation indications (Press release, Gilead Sciences, MAY 2, 2022, View Source [SID1234613274]). NK cell engagers represent a novel mechanism with the potential to address a broad range of cancers, including potential for activity in checkpoint resistant and refractory tumors, as well as other disease areas such as inflammation. Under the agreement, Gilead will receive an exclusive, worldwide license from Dragonfly for the 5T4-targeting investigational immunotherapy program, DF7001. The agreement also grants Gilead options, after the 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, recruiting NK and cytotoxic T cells into the tumor microenvironment.
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DF7001 is a TriNKET designed to activate and direct NK and cytotoxic T cell killing against cancer cells. The target of DF7001 is 5T4, a protein expressed on cancer cells and stromal cells that support tumor growth associated with poor prognosis in several cancers, including non-small cell lung cancer (NSCLC), pancreatic cancer, breast cancer, and head and neck squamous cell carcinomas (HNSCC). DF7001 has the potential to trigger the killing of 5T4+ expressing cells, including tumor cells, cancer-associated fibroblasts and cancer stem cells. The program is on track for filing an Investigational New Drug (IND) application in the first half of 2023.
"We are excited to partner with Dragonfly as we expand our pipeline with innovative NK cell engager programs. Using our scientific framework to focus our efforts, we are growing our portfolio with assets that have complementary MOAs and strong scientific rationale for combination opportunities," said Flavius Martin, MD, Executive Vice President, Research at Gilead. "We look forward to working with the Dragonfly team to explore novel NK engager treatments across diverse therapeutic areas to address some of the greatest gaps in care for cancer and inflammatory diseases."
"Gilead’s investment in Dragonfly, and specifically in DF7001, reinforces the value of our TriNKET platform and the differentiated and sustainable approach focused on people with cancer and inflammatory diseases," said Bill Haney, Co-Founder and Chief Executive Officer of Dragonfly. "Gilead has a well-established track record in development and commercialization and is a well-matched partner for our scientific expertise and platform. We look forward to working with the Gilead team to advance new treatment options where there is a high unmet need."
Terms of the Agreement
Under the terms of the agreement, Gilead will make a $300 million upfront payment to Dragonfly. In addition, Dragonfly is eligible to receive potential opt-in payments and performance-based development, regulatory and commercial milestone payments. Dragonfly will also be eligible to receive royalties of up to 20% on worldwide net sales.
The transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
DF7001 is an investigational product candidate; it is not approved by any regulatory agency for any use and has not been proven safe or efficacious.