Stage (next event)
Phase 3 (Regulatory Submission)
Catalyst Info & Data Links
Title: TG-1101 and TG-1202 (UNITY) in Chronic Lymphocytic Leukemia (CLL) (FL & R/R)
ClinicalTrial.gov (NCT02612311): Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Untreated and Previously Treated Chronic Lymphocytic Leukemia (UNITY-CLL)
WHAT IS THE NEXT CATALYST EVENT?
Phase 3 Data
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
12-08-2019Oral Presentation of Umbralisib, Ublituximab and Venetoclax Triple Combination Phase I/II Data in Relapsed/Refractory CLL at the 61st American Society of Hematology Annual Meeting and Exposition
2019: March 2019 DSMB Update
Mechanism of Action
MECHANISM OF ACTION / RATIONALE
Ublituximab - A chimeric recombinant IgG1 monoclonal antibody directed against human CD20 with potential antineoplastic activity. Ublituximab specifically binds to the B cell-specific cell surface antigen CD20, thereby potentially inducing a B cell-directed complement dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC) against CD20-expressing B cells, leading to B cell apoptosis. CD20 is a non-glycosylated cell surface phosphoprotein that is exclusively expressed on B cells during most stages of B cell development and is often overexpressed in B-cell malignancies. Ublituximab has a specific glycosylation profile, with a low fucose content, that may enhance its ADCC response against malignant B cells (source - National Cancer Institute).
Obinutuzumab - A glycoengineered, humanized IgG1 monoclonal antibody with potential antineoplastic activity. Obinutuzumab, a third generation type II anti-CD20 antibody, selectivity binds to the extracellular domain of the human CD20 antigen on malignant human B cells. The Fc region carbohydrates of the antibody, enriched in bisected non-fucosylated glycosylation variants, contribute to its higher binding affinity for human FcgammaRIII receptors compared to non-glycoengineered antibodies, resulting in enhanced antibody-dependent cellular cytotoxicity (ADCC) and caspase-independent apoptosis. In addition, modification of elbow hinge sequences within the antibody variable framework regions may account for the strong apoptosis-inducing activity of R7159 upon binding to CD20 on target cells (source - National Cancer Institute).
Updated by HC
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