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Catalyst Info & Data Links
TITLE: Flotetuzumab in Acute myeloid leukemia - Phase 2 Data
ClinicalTrial.gov (NCT03739606): Flotetuzumab in Treating Patients With Recurrent or Refractory CD123 Positive Blood Cancer
WHAT IS THE CATALYST EVENT?
Phase 2 Data
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
Q4 2020 (see slide 15)
ASH 2019 - Immune Landscapes Predict Chemotherapy Resistance and Anti-Leukemic Activity of Flotetuzumab, an Investigational CD123 ×CD3 Bispecific DART® Molecule, in Patients with Relapsed/Refractory Acute Myeloid Leukemia
ASH 2019 - Flotetuzumab: an Investigational CD123xCD3 Bispecific DART® Protein-Induced Clustering of CD3+ T Cells and CD123+ AML Cells in Bone Marrow Biopsies is Associated with Response to Treatment in Primary Refractory AML Patients
ASH 2017 - Preliminary Translational Results from an Ongoing Phase 1 Study of Flotetuzumab, a CD123 x CD3 DART® Protein, in AML/MDS: Rationale for Combining Flotetuzumab and Anti-PD-1/PD-L1 Immunotherapies
2020: TP53 abnormalities correlate with immune infiltration and associate with response to flotetuzumab immunotherapy in AML. Blood Advances (2020) 4 (20): 5011–5024.
2020: Flotetuzumab as Salvage Immunotherapy for Refractory Acute Myeloid Leukemia
doi.org/10.1182/blood.2020007732; BLOOD, September 2020.
2016: Targeting CD123 in acute myeloid leukemia using a T-cell–directed dual-affinity retargeting platform Blood 2016 127:122-131
MECHANISM OF ACTION / RATIONALE
Flotetuzumab is a humanized DART® molecule that recognizes both CD123 and CD3. CD123, the Interleukin-3 receptor alpha chain, has been reported to be over-expressed on cancer cells in a wide range of hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). AML and MDS are thought to arise in and be perpetuated by a small population of leukemic stem cells (LSCs) that generally resist conventional chemotherapeutic agents. LSCs are characterized by high levels of CD123 expression that is low or absent in the corresponding hematopoietic progenitors and stem cell populations in normal human bone marrow.
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