On November 4, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported six clinical and preclinical abstracts related to acute myeloid leukemia (AML) and flotetuzumab, an investigational bispecific CD123 × CD3 DART molecule, and one abstract related to tebotelimab, an investigational bispecific PD-1 × LAG-3 DART molecule, to be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, December 5-8, 2020 (Press release, MacroGenics, NOV 4, 2020, View Source [SID1234569852]).
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"We look forward to presenting clinical and biomarker results for flotetuzumab in patients with relapsed or refractory acute myeloid leukemia at the 2020 ASH (Free ASH Whitepaper) annual meeting," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "The first of our two oral presentations will address results of the role of immune senescence and exhaustion-related RNA profiles in predicting outcomes in AML. The second oral presentation will provide the results on the use of flotetuzumab as salvage therapy in AML patients who failed induction therapy or experienced an early relapse. Together with our four posters, these presentations add to the growing medical and scientific interest in the potential of flotetuzumab in AML. Finally, we are very pleased to present data from the cohort of diffuse large B-cell lymphoma (DLBCL) patients who were treated in the dose expansion study of tebotelimab."
Oral Presentations
An Immune Senescence and Exhaustion-related RNA Profile Predicts Clinical Outcomes in Acute Myeloid Leukemia
Session Name: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Single Cell Profiling and Novel molecular Markers
Session Date: Saturday, December 5, 2020
Session Time: 7:30 AM – 9:00 AM
Presentation Time: 8:15 AM
Flotetuzumab as Salvage Therapy for Primary Induction Failure and Early Relapse Acute Myeloid Leukemia
Session Name: 613. Acute Myeloid Leukemia: Novel Therapies and Treatment Approaches
Session Date: Sunday, December 6, 2020
Session Time: 9:30 AM – 11:00 AM
Presentation Time: 9:45 AM
Poster Presentations
Prophylactic Ruxolitinib for Cytokine Release Syndrome (CRS) in Relapse/Refractory (R/R) AML Patients Treated with Flotetuzumab
Session Name: 613. Acute Myeloid Leukemia: Clinical Studies: Poster III
Date: Monday, December 7, 2020
Tp53 Abnormalities Correlate with Immune Infiltration and Associate with Response to Flotetuzumab Immunotherapy in Acute Myeloid Leukemia
Session Name: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Poster II
Date: Sunday, December 6, 2020
Immune Senescence and Exhaustion Correlate with Response to Flotetuzumab, An Investigational CD123 × CD3 Bispecific DART Molecule, In Acute Myeloid Leukemia
Session Name: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Poster III
Date: Monday, December 7, 2020
Flotetuzumab and other Cellular Immunotherapies Upregulate MHC Class II Expression on Acute Myeloid Leukemia Cells In Vitro and In Vivo
Session Name: 704. Immunotherapies: Poster III
Date: Monday, December 7, 2020
A Phase 1, Open-Label Study of MGD013, a Bispecific DART Molecule Binding PD-1 and LAG-3 in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Session Name: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III
Date: Monday, December 7, 2020
The above abstracts were published today on the ASH (Free ASH Whitepaper) website at View Source
About Flotetuzumab
Flotetuzumab (also known as MGD006) is a clinical-stage bispecific, investigational DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on malignant cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cells. MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with primary induction failure / early relapse (PIF/ER) AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the primary endpoint. The study will be conducted as a continuation of the ongoing Phase 1/2 study (NCT02152956). The FDA has granted orphan drug designation to flotetuzumab for the treatment of AML.
About Tebotelimab
Tebotelimab (also known as MGD013) is a clinical-stage bispecific, investigational DART molecule designed to independently or coordinately block PD-1 and LAG-3 checkpoint molecules to sustain or restore the function of exhausted T cells for the treatment of cancer. Data from the Phase 1 dose escalation study in cohorts of patients with advanced solid tumors at escalating flat doses of 1-1200 mg every two weeks were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program. A maximum tolerated dose was not identified. At the same meeting, it was reported that LAG-3 expression on immune effector cells was shown to be enhanced by margetuximab, MacroGenics’ investigational Fc-engineered monoclonal antibody targeting HER2. Given the early signal of activity and acceptable safety profile observed in an initial, small expansion cohort of patients, the Company is evaluating the combination of tebotelimab and margetuximab in patients with HER2-positive tumors. The Company believes that combining Fc-engineering and checkpoint blockade has the potential to engage both innate and adaptive immune responses against a broad range of tumors with varied tumor microenvironments. For more information about the study design, please visit ClinicalTrials.gov (NCT03219268).