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Dragonfly Therapeutics to Study DF9001 With Keytruda in EGFR-Expressing Solid Tumors

NEW YORK – Dragonfly Therapeutics on Tuesday announced a clinical trial collaboration with Merck to study its EGFR immune engager, DF9001, with checkpoint inhibitor Keytruda (pembrolizumab) in patients with advanced solid tumors expressing EGFR.

Dragonfly, based in Waltham, Massachusetts, will study the combination in its ongoing Phase I trial of DF9001, which has been evaluating the drug as a monotherapy. The firm said it expects to begin treating patients in the trial with DF9001 and Keytruda in Q4 2024.

The dose expansion portion of the study will include three tumor types: non-small cell lung cancer, renal cell cancer, and head and neck cancer. The collaboration will focus on evaluating DF9001 plus Keytruda as a second-line treatment for renal cell and head and neck cancer expressing EGFR.

DF9001 was developed using Dragonfly's TriNKET platform and is designed to stimulate both natural killer cells in the innate immune system and CD8+ T cells in the adaptive immune system to enhance the benefit of immunotherapy.

"In preclinical models, DF9001 engages multiple immune effector cells to drive anti-tumor activity and induces PD-L1 expression in tumor cells, sensitizing cold tumors to checkpoint inhibitors," Dragonfly CEO Bill Haney said in a statement. "We are hopeful that DF9001 in combination with Keytruda will drive potent anti-tumor activity in a broad range of indications and are excited to further accelerate progress in the clinic to benefit patients in need."

Dragonfly's pipeline also includes an IL-12-targeted program, an IL-2-targeted agent, and a HER2-targeted immune engager, which it is studying as a monotherapy and with Bristol Myers Squibb's Opdivo (nivolumab) in HER2-expressing solid tumors.