Dragonfly Therapeutics, Inc. Announces Clinical Collaboration to Evaluate DF9001, an EGFR targeting TriNKET®, in Combination with KEYTRUDA® (pembrolizumab) in Patients with Solid Tumors

DF9001 is currently being evaluated as a monotherapy for the treatment of Non-Small Cell Lung Cancer, Renal Cell Carcinoma and Head and Neck Squamous Cell Carcinoma. The clinical trial collaboration will focus on evaluating the investigational combination in second line Renal Cell Carcinoma and second line Head and Neck Squamous Cell Carcinoma.

WALTHAM, Mass., May 21, 2024 /PRNewswire/ -- Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, today announced that it has entered into a clinical collaboration with Merck (known as MSD outside the US and Canada), to evaluate DF9001, Dragonfly's EGFR immune engager, in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors expressing EGFR.

"Merck, a trusted leader in drug development, has been a wonderful collaborator with Dragonfly since we signed our first collaboration agreement in 2018," said Bill Haney, co-founder and CEO of Dragonfly Therapeutics. "We are pleased to enter into this agreement with Merck for our ongoing, investigational Phase 1 trial of DF9001. 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. 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 is the study sponsor and first patients are expected to receive DF9001 in combination with pembrolizumab in Q4 2024. Clinical trial sites are currently open for monotherapy dosing in the U.S., with additional sites in North America and Europe expected to open in 2024. Additional information about the trial, including eligibility criteria, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT 05597839).

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About DF9001
DF9001 is an investigational first-in-class multi-specific drug candidate that targets EGFR and potently redirects natural killer (NK) cells, gamma-delta T cells, and CD8 T cells by engaging activating receptors NKG2D and CD16. DF9001 was discovered and developed using Dragonfly's TriNKET® platform. DF9001 is being evaluated in adult patients for the treatment of advanced solid EGFR-positive tumors. DF9001 has the potential to stimulate anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF9001 is the second wholly owned drug candidate in a pipeline of TriNKETs that Dragonfly is developing to address high unmet needs for patients across a broad range of disease areas.

About Dragonfly
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing novel therapies that harness the body's immune system to bring breakthrough treatments to patients. In addition to a set of advanced programs in the clinic, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platforms that are progressing toward the clinic, as well as productive collaborations with AbbVie, Bristol Myers Squibb, Gilead and Merck in a broad range of disease areas.

For more information visit:

Anne E. Deconinck | anne@dragonflytx.com

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SOURCE Dragonfly Therapeutics, Inc.

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