This combination is part of the company's multi-pronged strategy to develop a treatment for multiple myeloma and will be deployed in the ongoing UNIVERSAL trial. Enrollment in this cohort is expected to begin in the first quarter of 2021.
'We are delighted that the FDA has cleared our IND application for ALLO-715 in combination with nirogacestat,' said
Gamma secretase is an enzyme that cleaves BCMA from the surface of myeloma cells. In preclinical models, nirogacestat has been shown to prevent the cleavage and shedding of BCMA, leading to an increase in the cell surface density of BCMA and reduced levels of soluble BCMA.1 Increasing BCMA surface expression with gamma secretase inhibitor may enable deeper and more durable responses to ALLO-715 in patients with multiple myeloma.
Multiple myeloma is the second most common hematological malignancy in
The Phase 1 combination trial is being advanced pursuant to a clinical trial collaboration agreement that Allogene and SpringWorks entered into in
About ALLO-715
ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies. Multiple myeloma originates in the bone marrow and it is characterized by abnormalities in plasma cells that reproduce uncontrollably in the bone marrow and other disease sites.3 Multiple myeloma is incurable for most patients, as relapses occur despite most treatments available.4 Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented at an oral session of the
ALLO-715 utilizes the TALEN gene-editing technology pioneered and owned by
About Nirogacestat
Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often recurrent, debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.
In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy binding molecules for BCMA-directed therapies. Nirogacestat's ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma.
Nirogacestat has received Orphan Drug Designation from the
About
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as 'predicts,' 'believes,' 'potential,' 'proposed,' 'continue,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'may,' 'could,' 'might,' 'will,' 'should' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and timing to initiate a clinical trial of ALLO-715 in combination with nirogacestat; ability to manufacture ALLO-715; the ability of ALLO-715 in combination with nirogacestat to enable deeper or more durable responses and the potential benefits of AlloCAR T therapy. Various factors may cause differences between Allogene's expectations and actual results as discussed in greater detail in Allogene's filings with the
Contact:
Tel: (714) 552-0326
Email: Christine.Cassiano@allogene.com
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