-Dragonfly Therapeutics Announces Presentation of Phase 1 DF1001 TriNKET® Dose Escalation Results at ASCO Annual Meeting 2023

At ASCO's Developmental Therapeutics Session – Immunotherapy, Dr. Howard Safran presents encouraging data from Dragonfly's Phase 1/2 study of DF1001, a HER2-targeted immune-engaging TriNKET® in patients with advanced solid tumors.

WALTHAM, Mass., June 5, 2023 /PRNewswire/ -- Dragonfly Therapeutics, Inc., a clinical-stage biotechnology company developing novel immunotherapies, announces the first presentation of clinical data for its DF1001 TriNKET immune activator at the annual meeting from ASCO 2023 in Chicago. The presentation, by Principal Investigator Howard P. Safran, MD, Chief of Hematology/Oncology at Lifespan Cancer Institute and Medical Director of the Oncology Group at Brown University, describes the Phase 1/2 clinical trial of Dragonfly of its HER2-targeted TriNKET® DF1001, a first-in-human study exploring the safety, tolerability, and preliminary clinical and biological activity of DF1001.

"I am pleased to now share that Dragonfly's DF1001 has completed safety evaluation and reached its Phase 2 dose with 67% of paired patient biopsies showing a pharmacodynamic response and clear signs of clinical benefit in both monotherapy and combination therapy," he said. Dr Safran. "We have not observed toxicity or reached a maximum tolerated dose, and are seeing encouraging clinical efficacy signs in a heterogeneous population of patients with advanced cancer who have received intensive prior therapy. Single-agent activity was observed in patients with high HER2 and HER2-low who progressed on prior HER2-targeted therapies."

As of the April 14 cutoff for the ASCO submission, Dragonfly has treated 106 patients with DF1001 monotherapy. DF1001 was safe and well tolerated as monotherapy at biweekly doses up to 15 mg/kg and has successfully progressed through Phase 1 combinations with nivolumab and nab-paclitaxel. There has been no DLT with DF1001 during the monotherapy dose escalation phase.

The pharmacodynamic activity of DF1001 was demonstrated in 67% (28/42) of paired biopsies in monotherapy.

Preclinical data show that TriNKETs directly and indirectly stimulate NK cells, γδ T cells, and CD8 T cells. Biopsies, collected before and 4-6 weeks after patients started DF1001 treatment, showed a trend for increased CD8 T cell and/or NK cell infiltration into the tumor, demonstrating proof of concept.

DF1001 produced promising anticancer activity associated with immune cell infiltration and activation in tumors from heavily pretreated patients, who had received up to 16 lines of prior therapy, and with HER2-high and low-expressing cancers.

DF1001 has generated RECIST responders as monotherapy in patients with metastatic breast cancer (MBC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and gastroesophageal cancer who have received intensive treatment.

Across active dose ranges, twenty-five percent of MBC patients (most of whom were HER2-low) showed a clinical response, even when treated with an average of six lines of prior therapy.

"We are very encouraged by these Phase 1 data from DF1001 TriNKET, which confirm Dragonfly's preclinical studies showing TriNKET's remarkably attractive safety profile and remarkable efficacy, even in heterogeneous and low HER2 expression settings," said Joseph Eid, Dragonfly R&D President. "We look forward to our expansion Phase 2 signal-seeking trials, which have already begun in monotherapy and in combination with other therapies in defined patient populations, and in prior lines of therapy."

DF1001 has also demonstrated clinical benefit, including RECIST responses in combination with nivolumab or nab paclitaxel.

Clinical trial sites are open in the US, France, Belgium, Denmark and the Netherlands.

Additional information about the trial, including eligibility criteria, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04143711).

There are six drugs developed by Dragonfly in the clinic, including DF1001.

About DF1001

DF1001 is an investigational first-line drug candidate that targets HER2 that drives immune activation in solid tumors. DF1001 stimulates the coactivation of NK receptors, where costimulation of NKG2D and CD16 results in distinctive and potent activation of NK cells, γδ T cells, and CD8 T cells. DF1001 is being evaluated in adult patients for the treatment of HER2-positive 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 across a wide range of diseases.

About Dragonfly's TriNKET ® Platform

Dragonfly's TriNKET platform is the foundation of a portfolio of novel therapies that are designed as natural combinations that harness NK cells, γδ T cells, CD8 T cells, and other cells of the innate and adaptive immune system, which when activated cause cytolysis of cancer cells and provide a unique therapeutic window beyond current therapies for the treatment of cancer and chronic inflammatory diseases.

About Dragonfly

Dragonfly Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapies that use its novel biospecific antibody technology to harness the body's immune system and deliver innovative treatments to patients. In addition to its wholly owned clinical assets and multiple clinical assets with partners, Dragonfly has a large pipeline of wholly owned preclinical candidates developed using its proprietary platforms, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a wide range of disease areas

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

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

Photo - https://mma.prnewswire.com/media/2093025...Logo - https://mma.prnewswire.com/media/390962/...

View original content: https://www.prnewswire.com/news-releases/dragonfly-therapeutics-anuncia-los-resultados-del-aumento-de-dosis-de-df1001-trinket-en-asco-2023-301842702.html