Argx 113

ARGX-113 is a potential breakthrough therapy for treatment of IgG-mediated autoimmune diseases. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on ARGX-113 is done in close collaboration with the Department of Immunology of Prof. E. Sally Ward at the University of Texas Southwestern Medical.

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Breda, the Netherlands / Ghent, Belgium - argenx (Euronext Brussels: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced that it has recruited 50% of the myasthenia gravis (MG) patients in the Phase 2 proof-of-concept study of ARGX-113. "We are encouraged by the pace of enrollment in this trial," commented Nicolas Leupin, Chief Medical Officer of argenx. "We now expect to present the top-line data of the ARGX-113 clinical trial in MG in the first quarter of 2018." The double-blind, placebo controlled Phase 2 study is enrolling up to 24 MG patients with confirmed generalized muscle weakness. ARGX-113 is being dosed on top of current standard of care, including cholinesterase inhibitors, steroids and/or immunosuppressants. The primary objectives of the trial are safety and tolerability, and secondary objectives include efficacy and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers. The MG clinical trial was launched in January of this year. ARGX-113 is also being studied in a Phase 2 proof-of-concept study for the treatment of primary immune thrombocytopenia, which was initiated in March 2017. About ARGX-113 ARGX-113 is an investigational therapy for treatment of IgG-mediated autoimmune diseases. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. About argenx argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. We are 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. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE Antibody(TM) Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.   www.argenx.com For further information, please contact: 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' actual results may differ materially from those predicted by the forward-looking statements. argenx undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.


Breda, the Netherlands / Ghent, Belgium - argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced the initiation of a Phase II proof-of-concept clinical trial of ARGX-113 in pemphigus vulgaris (PV) patients. "PV is a chronic, severe and potentially life-threatening orphan auto-immune disease of the skin for which limited treatment options exist. Disease severity is directly correlated to pathogenic antibodies of the immunoglobulin G (IgG) type targeting desmoglein-1 and -3 in the skin, leading to painful blister formation and skin damage," commented Nicolas Leupin, Chief Medical Officer of argenx. "Current treatment options are limited to high-dose steroids and chronic immunosuppression. We are thrilled about the therapeutic potential of ARGX-113 in PV, based on its mode of action of clearing IgGs. PV represents a clean and rapid proof-of-concept indication and, we believe, is therefore our ideal beachhead into the field of severe auto-immune blistering diseases of the skin." The open-label, non-controlled Phase II clinical trial will enroll up to 12 patients with mild to moderate PV who are either newly diagnosed or relapsing. The primary endpoints of the trial are safety and tolerability, and secondary endpoints include efficacy and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers. The study design will be presented in more detail during a PV Key Opinion Leader event which will take place in New York on November 10, 2017. ARGX-113 is currently being tested in two additional Phase II clinical trials in myasthenia gravis (MG) and immune thrombocytopenia (ITP). Topline date for MG and ITP are expected in the first quarter and second half of 2018, respectively. In a Phase I clinical trial, ARGX-113 was well-tolerated across multiple doses and dosing regimens with promising pharmacodynamic effects relating to speed, depth and duration of IgG reduction. About ARGX-113 ARGX-113 is an investigational therapy for treatment of IgG-mediated autoimmune diseases. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on ARGX-113 is done in close collaboration with Prof. E. Sally Ward (University of Texas Southwestern Medical and Texas A&M University Health Science Center, a part of Texas A&M University (TAMHSC)). About argenx argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. We are 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. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE Antibody(TM) Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.  www.argenx.com     For further information, please contact: Joke Comijn, Corporate Communications Manager +32 (0)477 77 29 44 +32 (0)9 310 34 19 info@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 and argenx's advancement of, and anticipated clinical development and regulatory milestones and plans related to ARGX-113. 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 U.S. Securities and Exchange Commission (SEC) filings and reports, including in the final prospectus related to argenx's initial U.S. public offering filed with the SEC pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.


Breda, the Netherlands / Ghent, Belgium - argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted orphan status for the use of ARGX-113 for the treatment of myasthenia gravis. MG is an autoimmune disorder associated with muscle weakness that is triggered by IgG auto-antibodies. These antibodies attack critical signalling proteins at the junction between nerve and muscle cells, thereby impairing their communications signals. There are limited effective and sustainable treatments for MG. ARGX-113 has the potential to eliminate patient symptoms while minimizing common side effects seen with current treatments by reducing the pathogenic IgG levels. About orphan drug designation Orphan drug status is granted by FDA to a drug or biological product to treat a rare disease or condition upon request of a sponsor. Orphan drug designation qualifies for various development incentives, including tax credits for qualified clinical testing, a waiver from FDA's application User Free for marketing application, and a 7-year period of marketing exclusivity in the US.   The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies. About ARGX-113 ARGX-113 is an investigational therapy for treatment of IgG-mediated autoimmune diseases. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on ARGX-113 is done in close collaboration with Prof. E. Sally Ward (University of Texas Southwestern Medical and Texas A&M University Health Science Center, a part of Texas A&M University (TAMHSC)). About argenx argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. We are 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. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE Antibody(TM) Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.  www.argenx.com     For further information, please contact: Joke Comijn, Corporate Communications Manager +32 (0)477 77 29 44 +32 (0)9 310 34 19 info@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 and argenx's advancement of, and anticipated clinical development and regulatory milestones and plans related to ARGX-113. 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 U.S. Securities and Exchange Commission (SEC) filings and reports, including in the final prospectus related to argenx's initial U.S. public offering filed with the SEC pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.


Breda, the Netherlands / Ghent, Belgium - argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced that it has recruited 50% of the immune thrombocytopenia (ITP) patients in the Phase 2 proof-of-concept study of ARGX-113. "We are pleased to have reached the 50% recruitment milestone in this study, which is enrolling on schedule," commented Nicolas Leupin, Chief Medical Officer of argenx. "We remain on track, and look forward to presenting top-line data from the ARGX-113 clinical trial in ITP in the second half of 2018, which will be our second indication with Phase 2 top-line data from ARGX-113." The double-blind, placebo controlled Phase II study will enroll up to 36 ITP patients with platelet levels lower than 30 million per milliliter. ARGX-113 will be dosed on top of current standard of care, including corticosteroids and/or immunomodulatory agents and/or TPO-R agonists. The primary endpoints of the trial are safety and tolerability, and secondary endpoints are effect on platelet count and use of rescue treatment, and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers. The ITP clinical trial was initiated in March 2017. ARGX-113 is also being studied in a Phase 2 proof-of-concept study for the treatment of myasthenia gravis (MG), which was initiated in January 2017. About ARGX-113 ARGX-113 is an investigational therapy for treatment of IgG-mediated autoimmune diseases. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on ARGX-113 is done in close collaboration with Prof. E. Sally Ward (University of Texas Southwestern Medical and Texas A&M University Health Science Center, a part of Texas A&M University (TAMHSC)). About argenx argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. We are 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. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE Antibody(TM) Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.   www.argenx.com For further information, please contact: 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 and argenx's advancement of, and anticipated clinical development and regulatory milestones and plans related to ARGX-113. 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 U.S. Securities and Exchange Commission (SEC) filings and reports, including in the final prospectus related to argenx's initial U.S. public offering filed with the SEC pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.


Workshop to occur on Sunday December 4th at 11:00 am PT Breda, the Netherlands / Ghent, Belgium - argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced that it will provide updates on its two lead programs, ARGX-113 and ARGX-110, during a workshop being held today in conjunction with the American Society of Hematology (ASH) Annual Meeting. The workshop is being held today at 11:00 am PT. The presentation of the event will be available on the Company's website at www.argenx.com. ARGX-113: New clinical data will be presented from the multiple ascending dose Phase I study in healthy volunteers showing comparable pharmacodynamics and pharmacokinetic patterns between the lower dose (10 mg/kg) and higher dose (25 mg/kg), justifying the selection of the lower dosing regimen for upcoming Phase II clinical trials. In addition, preclinical proof of concept data supporting myasthenia gravis (MG) and immune thrombocytopenia (ITP) as lead indications for Phase II clinical trials will be presented. argenx anticipates to start the first Phase II study in MG before the end of the year and in ITP in the first quarter of 2017. ARGX-110: Further efficacy and safety data will be presented from the currently ongoing Phase Ib study in relapsed/refractory T-cell lymphoma (TCL) patients who failed multiple lines of therapy: 5 out of 10 patients show encouraging signs of clinical activity including partial response (3/10) and stable disease (2/10). ARGX-110 continues to show a favorable safety and tolerability profile. Additionally, preclinical data supporting the start of the first combination study in newly diagnosed, elderly acute myelogenous leukemia (AML) patients will be reported. The preclinical work on ARGX-110 in AML was done in collaboration with the Tumor Immunology Lab of Prof. A. F. Ochsenbein at the University of Bern, who won the prestigious 2016 Otto Naegeli Prize for his breakthrough research on CD70/CD27 signaling with therapeutic potential for cancer patients. About ARGX-113 ARGX-113 is a potential breakthrough therapy for treatment of IgG-mediated autoimmune diseases. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on ARGX-113 is done in close collaboration with the Department of Immunology of Prof. E. Sally Ward at the University of Texas Southwestern Medical. About ARGX-110 ARGX-110 is a SIMPLE Antibody(TM) targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. ARGX-110 works in three ways: i) blocks growth of tumor cells, ii) kills cancer cells and iii) restores immune surveillance against tumors (Silence K. et al. mAbs 2014; 6 (2):523-532). ARGX-110 is currently being evaluated in hematological and solid tumors.  About argenx argenx combines the diversity of the llama immune system with antibody engineering to advance a clinical pipeline to treat patients with cancer and autoimmune diseases. Our platforms allow us to unlock novel and complex targets and develop antibody-based drugs designed for longer duration of effect and greater efficacy. The strength of our team, our deep understanding of the biology, and our committed collaborations with industry leaders contribute to the success of our journey. For further information, please contact: 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. argenx undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

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