ARGENX SE
argenx will receive the first development milestone payment of
'This milestone payment marks the progress made across our global collaboration with Janssen. Two trials are now underway in newly diagnosed populations with more trials expected to intiate next year in different AML settings and subpopulations. We continue to believe in the potential of the CD70/CD27 axis as a novel approach within the AML treatment landscape. The data update today further support the use of cusatuzumab in combination to treat this vulnerable patient population,' commented
Key Highlights from ASH
100% of patients achieved a response including eight with a complete response (CR), two with a complete response with incomplete hematologic recovery (CRi), and two with a partial response (PR); 83% of patients achieved either a CR or CRi
Of the nine CR/CRi patients evaluable for minimal residual disease (MRD) negativity, four achieved MRD negativity using a threshold of 10-3 which is consistent with the previous data cut-off in
Four patients have remained in the study for at least 12 months
Three patients from the study have been re-classified with risk category based on new mutation information or a reassessment of existing mutation information
Cusatuzumab continued to be well-tolerated in patients with AML across the different doses
In addition to the CULMINATE trial in the newly diagnosed unfit AML population, cusatuzumab is also being evaluated in a Phase 1b platform study to explore combinations with standard AML therapies with the first trial exploring combinations of venetoclax, cusatuzumab and azacytidine.
About argenx
argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe auto-immune diseases and cancer. The company is focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need. argenx's ability to execute on this focus is enabled by its suite of differentiated technologies. The SIMPLE Antibody Platform, based on the powerful llama immune system, allows argenx to exploit novel and complex targets, and its three complementary Fc engineering technologies are designed to expand the therapeutic index of its product candidates.
Contact:
Tel: +1 518 424 4980
Email: bdelgiacco@argenx.com
Forward-looking Statements
The contents of this announcement include statements that are, or may be deemed to be, 'forward-looking statements.' These forward-looking statements can be identified by the use of forward-looking terminology, including the terms 'believes,' 'estimates,' 'anticipates,' 'expects,' 'intends,' 'may,' 'will,' or 'should' and include statements argenx makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including argenx's expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx's reliance on collaborations with third parties; estimating the commercial potential of argenx's product candidates; argenx's ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx's limited operating history and argenx's ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx's
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