DF-1001

Trodelvy and HER-2 TriNKET combinations will be in metastatic breast cancer (mBC) and non-small cell lung cancer (NSCLC). WALTHAM, Mass., Feb. 15, 2024 /PRNewswire/ -- Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies today announced a new clinical collaboration designed to evaluate and combine DF1001, a HER-2 immune engager developed using Dragonfly's TriNKET technology platform and Dragonfly's lead clinical asset, with Trodelvy, Gilead's Trop-2-directed antibody drug conjugate (ADC), in metastatic breast cancer (mBC) and non-small cell lung cancer (NSCLC). "DF1001 is the first of eight Dragonfly-developed drugs in the clinic and has shown clinical benefit in mBC, NSCLC and colorectal cancer (CRC) in a heterogeneous Phase 1 population with 22% RECIST responders and 39% clinical benefit in mBC patients at active dose levels, with no DLTs, even in a heavily-pre-treated population," said Joseph Eid, Dragonfly President of R&D. "It has been demonstrated to be well tolerated across all dose levels in the Phase 1 study as monotherapy, and pharmacodynamic activity was demonstrated in 28/42 (67%) paired biopsies from 0.5-15mg/kg, where increase in CD8 and NK cell infiltration was observed consistent with preclinical models and supporting the TriNKET immune modulating MoA. Our preclinical work has shown the powerful combinatorial effect of TriNKETs with ADCs, and highlighted the potential benefits to patients of using Gilead's Trodelvy in combination with DF1001." "We are delighted to further strengthen our partnership with Gilead by launching this new clinical stage collaboration," said Bill Haney, CEO and Dragonfly co-founder. "Dragonfly has promising pre-clinical data that highlights the potential for synergistic efficacy when DF1001 is combined with Trodelvy in mBC and NSCLC. We are excited to work with our colleagues at Gilead to bring this combination to patients in need." Dragonfly will have operational control of the study and first patients are expected to receive this combination in Q2 2024. Clinical trial sites are currently open in the U.S., France, Belgium, Denmark and the Netherlands. Additional sites in North America, Europe and Asia Pacific will open in 2024. Additional information about the trial, including eligibility criteria, can be found at: (ClinicalTrials.gov Identifier: NCT04143711). About DF1001 DF1001 is an investigational first-in-class drug candidate that targets natural killer (NK) cells and T-cell activation signals to co-activating NK receptors, where NKG2D and CD16 co-stimulation yields distinctive and potent NK cell activation. DF1001 is being evaluated in adult patients for the treatment of advanced solid HER-2 positive tumors. DF1001 was discovered and developed using Dragonfly's TriNKET platform. DF1001 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF1001 is the most advanced 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: DRAGONFLY MEDIA CONTACT: Anne E. Deconinck | [email protected] Logo -

In the ASCO Developmental Therapeutics – Immunotherapy Session, Dr. Howard Safran presents encouraging data on Dragonfly's phase 1/2 study of DF1001, an immune engaging TriNKET ® targeting HER2 in patients with advanced solid tumors. WALTHAM, MA, USA I June 5, 2023 I Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, announces the first presentation of its DF1001 TriNKET immune engager clinical data at the ASCO 2023 Annual Meeting in Chicago. The presentation, given by lead investigator Dr. Howard P. Safran, Chief of Hematology/Oncology at the Lifespan Cancer Institute and Medical Director for the Brown University Oncology Group, describes Dragonfly's Phase 1/2 clinical trial of its DF1001 HER2-targeting TriNKET ® , a first-in-human study exploring the safety, tolerability, and preliminary biological and clinical activity of DF1001. "I am glad to now share that Dragonfly's DF1001 has completed safety evaluation and reached its Phase 2 dose with 67% of patient paired biopsies showing pharmacodynamic response, and clear signs of clinical benefit in both monotherapy and in combination," said Dr. Safran. "We have not seen toxicity nor hit a Maximum Tolerated Dose, and we are seeing encouraging clinical efficacy signals in a heavily pretreated heterogeneous population of patients with advanced cancer. Single agent activity was seen in both HER2 high and HER2 low patients who previously progressed on prior HER2 directed therapies." As of the April 14 th data cutoff for ASCO presentation, 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 both nivolumab and nab-paclitaxel. There have been no DLTs with DF1001 during the monotherapy dose-escalation phase. DF1001 pharmacodynamic activity was demonstrated in 67% (28/42) of paired biopsies in monotherapy. Preclinical data shows TriNKETs directly and indirectly stimulate NK cells, γδ T cells, and CD8+ T cells. The biopsies, collected before and 4-6 weeks after patients started DF1001 treatment, showed a trend of increased infiltration with CD8+ T-cells and/or NK cells in the tumor, demonstrating proof of concept. DF1001 yielded promising anticancer activity associated with immune cell infiltration and activation in tumors of heavily pretreated patients - who had received up to 16 lines of prior therapy and with both HER2 low and HER2 high expressing cancers. DF1001 has generated RECIST responders as a monotherapy in heavily pretreated patients with Metastatic Breast Cancer (MBC), Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC) and Gastro Esophageal Cancer. At active dose ranges, twenty-five percent of MBC patients (the majority 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 this Phase 1 DF1001 TriNKET data, which confirm Dragonfly's preclinical studies showing TriNKETs' remarkably appealing safety profile, and notable efficacy including in low- and heterogeneous HER2 expression environments," said Joseph Eid, Dragonfly's President of R&D, "we look forward to our Phase 2 signal-seeking expansion trials, which have begun already in monotherapy and in combination with other therapies in defined patient populations, and in earlier lines of therapy." DF1001 has also shown clinical benefit including RECIST responses in combination with nivolumab or nab paclitaxel. Clinical trial sites are open in the U.S., 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 Dragonfly developed drugs in the clinic – including DF1001. About DF1001 DF1001 is an investigational first-in-class immune engaging drug candidate targeting HER2 that drives immune activation in solid tumors. DF1001 stimulates co-activating NK receptors, where NKG2D and CD16 co-stimulation yields distinctive and potent NK cell, γδ T cell, and CD8+ T cell activation. DF1001 is being evaluated in adult patients for the treatment of advanced solid HER2-positive tumors. DF1001 was discovered and developed using Dragonfly's TriNKET Platform. DF1001 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF1001 is the most advanced 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's TriNKET ® Platform Dragonfly's TriNKET Platform is the basis for a portfolio of novel therapeutics that are designed as natural combinations harnessing NK cells, γδ T cells, CD8+ T cells and other cells of the innate and adaptive immune system, which when activated cause cancer cell cytolysis and provide a unique therapeutic window beyond current therapies for treatment of cancer and chronic inflammatory diseases. About Dragonfly Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing therapies that use its novel bispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly-owned clinical assets and multiple assets in the clinic with partners, Dragonfly has a deep 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 broad range of disease areas. SOURCE: Dragonfly Therapeutics