(Information sent by the signatory company)

-Dragonfly Therapeutics Begins Phase 2 Study of TriNKET® DF1001, Targeted Against HER2, in Patients With Advanced Solid Tumors

In Phase 1, DF1001 was well tolerated and showed encouraging pharmacodynamic effects and clinical response, with reductions in tumor burden in various tumor types, including in HER2-low and heavily pretreated patients.

In Dragonfly's Phase 2 trial to further evaluate DF1001 as monotherapy and in combination with Opdivo® or Abraxane®, the first patients have been dosed.

WALTHAM, Mass., Dec. 6, 2022 /PRNewswire/ -- Dragonfly Therapeutics, Inc. ("Dragonfly"), a biotechnology company developing new therapies that harness the immune system to treat a wide range of diseases, today announced that has dosed the first patients in the Phase 2 study of its HER2-targeted drug, TriNKET® DF1001. The trial is enrolling patients at 34 centers in the United States and Europe for various indications of advanced solid tumors.

DF1001 is the first TriNKET to enter phase 2 trials. Six drugs developed by Dragonfly are already in the clinical phase.

DF1001 was well tolerated, with no dose-limiting toxicities during dose escalation in the phase 1 study. The study showed encouraging pharmacodynamic effects, including NK cell and T cell infiltration into tumors. DF1001 also demonstrated clinical response as monotherapy and in combination with nivolumab or nab-paclitaxel, with reductions in tumor burden in several solid cancer types representing both HER2-low and HER2-high, and in heavily pretreated patients.

"Having seen the effect of DF1001 in my breast cancer patients, including heavily pre-treated and multi-drug resistant, I am very encouraged by the prospects for DF1001," said Dr. Emanuela Romano, Director of the Center for Immunotherapy against Cancer from the Curie Institute in Paris. "These early indications were seen at doses significantly lower than recommended for Phase 2."

"The Phase 1 study of DF1001 provided encouraging early evidence of safety and clinical activity in adults with advanced solid tumors, as anticipated by our preclinical work," said Jean-Marie Cuillerot, Dragonfly's chief marketing officer. "For example, we have seen RECIST responses in multiple tumor types in patients receiving DF1001 monotherapy and in combination with Opdivo and Abraxane, starting at very low doses, including in patients with low HER2 expression or in patients with high HER2 expression. who had progressed after receiving a full series of other treatments, including ADCs such as Enhertu®."

The Phase 2 trial of DF1001 will further the development of DF1001 as monotherapy and in combination with multiple agents, including Opdivo® and Abraxane®.

About DF1001

DF1001 is a first-line investigational drug being evaluated in adult patients for the treatment of advanced solid tumors. DF1001 was discovered and developed using Dragonfly's TriNKET platform. DF1001 has the potential to stimulate effective antitumor immunity in patients who do not qualify for or do not respond adequately to current therapies. DF1001 is the most advanced in a series of TriNKETs that Dragonfly is developing to address the large unmet needs of patients with different types of cancer.

About Dragonfly

Dragonfly Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapies that use its novel bispecific antibody technology to harness the body's immune system and deliver innovative treatments to patients. Dragonfly has built a broad pipeline of proprietary preclinical and clinical candidates discovered through its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead, and Bristol Myers Squibb across a wide range of diseases.

For more information, visit: www.dragonflytx.com https://www.linkedin.com/company/dragonfly-therapeutics-inc./ https://twitter.com/dragonflytx

DRAGONFLY MEDIA CONTACT: Anne E. Deconinck | anne@dragonflytx.com

Logo - //photos.prnewswire.com/prnh/201607...

View original content: https://www.prnewswire.com/news-releases/dragonfly-therapeutics-comienza-el-estudio-de-fase-2-de-trinket-df1001-dirigido-contra-her2-301696340.html