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arGEN-X Nieuws 2017

568 Posts, Pagina: « 1 2 3 4 5 6 7 ... 25 26 27 28 29 » | Laatste
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Pokerface schreef op 15 maart 2017 11:52:

PB ziet er hoopvol uit. Er staat veel te gebeuren de komende tijd.
Klopt.
Dit is werkelijk een topbedrijf . Ontwikkelingen volgen elkaar vliegensvlug op .

En het mooiste is, dat nog niet veel beleggers dit in de gaten hebben .

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Pokerface
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Inderdaad, maar niemand lijkt het te willen zien. Of men weet al wat er in staat. Het kan natuurlijk alle kanten op bij biotech. Je kan natuurlijk altijd na de PB's instappen.
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Die PB's gaan alleen over het starten van nieuwe studies... Gaat de koers niet omhoog lijkt me. Pas bij bericht van resultaten over die studies en dat duurt nog even.
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Benny Lava schreef op 18 maart 2017 10:25:

Die PB's gaan alleen over het starten van nieuwe studies... Gaat de koers niet omhoog lijkt me. Pas bij bericht van resultaten over die studies en dat duurt nog even.
Ik denk van wel . Pipeline wordt steeds groter en komt steeds verder . Steeds meer partners .
Als GLPG een nieuwe studie in fase 2 start , vliegt de koers wel omhoog . Waarom zou dat hier niet zo zijn . Dit aandeel wordt(nog) zwaar onderschat .
Kwaliteit zal vanzelf boven komen boven drijven en dan ontstaat er een run . Ik ben mijn positie nog steeds verder aan het uitbreiden .
Pokerface
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Ik denk ook dat de koers wel op die PB's gaat reageren. Gepartnerde medicijnen willen nog wel eens mijlpaal betalingen opleveren bij start of finish van een onderzoek en de start van een onderzoek geeft meestal ook beter zicht op de einddatum van een onderzoek. De koers kan in de aanloop naar zo'n einddatum oplopen omdat aandeelhouders bepaalde verwachtingen hebben bij een onderzoek.
Een kleine kanttekening: Tegenvallende resultaten geven natuurlijk ook een reactie op de koers...
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Hoppa

En de volgende partnership in the pocket

Published: 07:00 CET 21-03-2017 /GlobeNewswire /Source: argenx N.V. / : ARGX /ISIN: NL0010832176

argenx announces collaboration with Broteio Pharma to develop therapeutic antibody for severe autoimmune diseases





- Differentiated antibody to address complement target -

- Represents latest collaboration to stem from the argenx Innovative Access Program -

- argenx granted option to license program after preclinical proof-of-concept -



21 March 2017



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 entered into a new collaboration with Broteio Pharma B.V. to develop an antibody against a novel target in the complement cascade with therapeutic potential in autoantibody- and complement-mediated indications including autoimmune haemolytic anaemia (AIHA) and antibody mediated rejection (AMR) following organ transplantation.



"This collaboration represents the latest success for our Innovative Access Program and aligns with our corporate mission to develop differentiated antibodies for cancer and severe autoimmune diseases. The novel antibody targets a component of the complement cascade with therapeutic potential in both orphan and large market indications like Ischemia/Reperfusion Injuries (IRI)," comments Tim Van Hauwermeiren, CEO of argenx. "This new therapeutic antibody has the potential to act alongside our lead product candidate ARGX-113 in a synergistic fashion. ARGX-113 targets FcRn in order to clear pathogenic IgG antibodies while our new complement-targeted antibody can also address IgM mediated autoimmune diseases. This transaction positions us to further build out the depth and breadth of our autoimmune disease pipeline."



Under the terms of the agreement, argenx and Broteio will jointly develop the complement-targeted antibody to establish preclinical proof-of-concept using argenx's proprietary suite of technologies. Upon successful completion of these studies, argenx may exercise an exclusive option to license the program and assume responsibility for further development and commercialization.



About the Innovative Access Program

Through our Innovative Access Program (IAP) argenx is able to serially collaborate closely with academic experts and small biotech companies, bringing antibody discovery technologies to the heart of novel target research. The IAP allows our partners use of our technologies for the development of antibodies to help validate novel targets. In return argenx is granted early access to these targets. The diversity of argenx's SIMPLE AntibodyTM immune repertoires help streamline target validation, with the potential to transform novel proteins into next generation therapeutic antibody programs.



Role of complement in auto-immune diseases

The classical pathway of the complement system is composed of a series of proteins that are activated when IgG or IgM (auto)antibodies bind to their targets. This mechanism contributes to tissue damage and organ dysfunction in a number of (auto)immune inflammatory diseases. The novel complement target is key in the lysis of antibody-decorated cells and is active when an immune reaction is taking place. The novel antibody has therapeutic potential in orphan and large population autoimmune indications including autoimmune haemolytic anaemia (AIHA) and antibody mediated rejection (AMR).





About Broteio

Based in Utrecht, the Netherlands, Broteio Pharma B.V. ("Broteio") is a joint venture between Prothix B.V. and Bioceros Holding B.V. established to develop anti-complement monoclonal antibodies.



About argenx

argenx a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe auto-immune 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 AntibodyTM 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

Pokerface
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En de koers doet weer helemaal niks. Kan de waarde van dit PB ook niet echt inschatten.
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Dit alles is uiteraard waarde op LT . Voor nu geldt dat de risico's steeds verder gespreid worden over meer partnerships en pipeline . Argen-X schiet altijd onverwacht naar boven . Ik verwacht wel in de komende periode een aantal hogere koersdoelen . Geduld . Zie hoe het GLPG is vergaan . ALs er 1 schaap over de dam is ......
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Achter deze clubs zit Prof erik Hack, topper in dit gebied en destijds bij Crucell. Anti complement antibodies zijn nog nooit echt ontwikkeld omdat de complement eiwitten nooit als goede tragtes werden beschouwd. Deal is inderdaad nog moeilijk op waarde te schatten dus doet de koers niet veel. Ben ondanks het cashen van Tim weer klein beetje ingestapt want blijf de technologie en slimme mensen als de CSO Hans de Haard aantrekkelijk vinden.
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Welcome terug Fly

Jij was de trendsetter om dit aandeel onder de aandacht te brengen ( en terecht zo blijkt). Je weet dat ik in het begin een beetje afhoudend/afwachtend was . Heb echter na veel lezen mijn positie opgebouwd vanaf ca 10 euro . Deze gaat er bij mij niet meer uit de komende jaren . Het bedrijf ontwikkeld zich gedegen en razend snel . Paar mooie potentiële blockbusters in de pipeline en steeds meer partnerships . LT

Het is jammer dat mijn aandelen aantallen niet omgedraaid zijn tov Ablynx . Daar heb ik er nl 2 x zoveel van . Daar gaat het echter met enige vertraging ook binnenkort los.

vandaag
KBC biotech & Healthcare Conference, Brussels March 29, 2017 Tim Van Hauwermeiren, CEO & Joke Comijn, IR Manager
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Dank Bio en was eerder uitgestapt met mooie winst door verkopen van Tim. begreep echter dat Hans de CSO en de andere MT leden nog niet verzilverd hebben dus zal Tim zoasl wel meer CEO's wat aan het spelen en bij aan cashen zijn. Ben weer beetje ingestapt omdat platform nog steeds geweldig is en er van veel kanten interesse bestaat.
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De persberichten zouden nu toch wel zo'n beetje moeten gaan binnen druppelen de komende dagen .

The past year was one of significant growth for argenx, and we have seen the momentum maintained into the first months of 2017. We continued to build our proprietary pipeline and advanced both our lead programs, ARGX-113 and ARGX-110, through key safety and early efficacy inflection points. Our early studies guided us on the attributes of each drug and enabled us to choose the indications we believe were best-suited for Phase 2 study. By the end of the first quarter, we plan to launch four proof-of-concept Phase 2 studies: MG and ITP for ARGX-113, and AML and TCL for ARGX-110,” commented Tim Van Hauwermeiren, CEO of argenx. “We were also busy outside the clinic with the start of our collaboration with AbbVie for our novel immuno-oncology product, ARGX-115,
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argenx announces first patient dosed in Phase II proof-of-concept study of ARGX-113 for the treatment of primary immune thrombocytopenia

March 31, 2017
•Topline data from the study expected in second half of 2018

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 the dosing of the first patient in a Phase II proof-of-concept study of ARGX-113 in patients with primary immune thrombocytopenia (ITP).

“The initiation of the second Phase II trial for our lead candidate, ARGX-113, is an important milestone for the company as it exemplifies the breadth of potential this compound has to address a wide variety of diseases that are driven by pathogenic IgGs,” commented Nicolas Leupin, CMO of argenx. “We believe ARGX-113 could be a breakthrough therapy in an indication like ITP where current therapies do not adequately address symptoms or achieve remissions.”

The double-blind, placebo controlled Phase II study will enrol 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, corticosteroids and/or immunomodulatory agents and/or TPO-R agonists. The primary endpoints of the trial are safety and tolerability and secondary endpoints include effect on platelet count and use of rescue treatment, and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers.

In Phase I clinical trial, ARGX-113 demonstrated favorable safety and tolerability across multiple doses and dosing regimens with promising pharmacodynamics effects relating to speed, depth and duration of IgG reduction.



About ARGX-113

We are developing our lead product candidate, ARGX-113, for the treatment of patients with myasthenia gravis and primary immune thrombocytopenia, both of which are rare and severe autoimmune diseases associated with high levels of pathogenic IgGs. Few innovative biologic treatments have been approved addressing these circulating auto-antibodies and severe unmet medical need exists. ARGX-113 is the Fc-portion of an antibody and utilizes our ABDEG engineering technology. It is designed to block the recycling of IgG antibodies, which results in their removal from circulation. 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 a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe auto-immune 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 AntibodyTM 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
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Bedankt Breugell voor het plaatsten . Had ik het goed verwacht . Mooie ontwikkelingen
Pokerface
1
PB:

argenx launches Phase II study of ARGX-110 as a monotherapy in relapsed/refractory CTCL patients

Interim data expected by end of 2017
12 April 2017

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 the initiation of a Phase II trial of ARGX-110 as a monotherapy in patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL). ARGX-110 is the Company's SIMPLE Antibody(TM) targeting CD70.

"We have previously observed evidence of biological activity and a promising safety profile in several CD70-positive CTCL patients treated in an ongoing Phase I safety-expansion cohort, resulting in several patients with partial response or stable disease. Based on these preliminary results, we opted to further evaluate ARGX-110 as a monotherapy in an exploratory Phase II study to demonstrate the intrinsic activity of the drug in relapsed/refractory CTCL patients and to broaden our efficacy database," commented Nicolas Leupin, CMO of argenx. "This marks the second Phase 1/2 study of ARGX-110 with the first having launched in December 2016 as a combination therapy with standard of care in AML."

The Phase II clinical trial will enroll up to 10 additional relapsed/refractory CTCL patients, and will be conducted at multiple centers in Europe. The primary endpoints of the trial are safety and efficacy and secondary endpoints include pharmacokinetics and immunogenicity. Interim data are expected by the end of 2017, and we expect to report topline data in the second half of 2018.

ARGX-110 is also being studied as a combination therapy with standard of care azacitidine in newly diagnosed, elderly acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) patients.

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 a Phase II combination trial in patients with newly diagnosed acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome and a Phase II trial in patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL). 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 together with Prof Manz from the University Hospital of Zürich, the prestigious 2016 Otto Naegeli Prize for his breakthrough research on CD70/CD27 signaling with therapeutic potential for cancer patients.

About CTCL
Lymphoma is the most common type of blood cancer. TCL accounts for 6% of all cases of lymphoma and can be divided into subtypes such as peripheral TCL (PTCL), angioimmunoblastic TCL (AITL), anaplastic large cell lymphoma (ALCL), and CTCL. According to the Cutaneous Lymphoma Foundation, the incidence of CTCL in the United States is approximately 3,000 new cases per year. The two most common types of CTCL are mycosis fungoides, representing approximately 50% of CTCL patients, and a more advanced form known as Sezary syndrome, representing approximately 15% of CTCL patients. In both mycosis fungoides and Sezary syndrome, visible skin lesions offer an ongoing means with which to monitor both the progression of disease and the impact of treatment. Sezary syndrome is distinguished by the presence of malignant lymphocytes in the blood, an extensive rash covering over 80% of the body and tumors visible on the skin.

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. 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 AntibodyTMPlatform, 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
Pokerface
1
PB:

argenx receives first preclinical milestone payment in AbbVie collaboration


13 April 2017

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 the achievement of the first of two preclinical milestones on its way to the investigational new drug (IND) filing of ARGX-115, triggering a $ 10 million payment from AbbVie.

In April 2016, argenx entered into a collaboration agreement with AbbVie to develop and commercialize ARGX-115. Under the terms of the collaboration agreement, argenx is responsible for conducting and funding all ARGX-115 research and development activities up to completion of IND-enabling studies.

argenx has granted AbbVie an exclusive option, for a period following completion of IND-enabling studies, to obtain a worldwide, exclusive license to the ARGX-115 program to develop and commercialize products. argenx is eligible to receive two near-term preclinical milestones of $ 10 million each. The first milestone was achieved today.

About ARGX-115
ARGX-115 employs argenx's SIMPLE Antibody(TM) technology and works by stimulating a patient's immune system after a tumor has suppressed the immune system by co-opting immunosuppressive cells such as activated regulatory T-cells (Tregs). While the normal function of Tregs is to suppress portions of the immune system to prevent a self-directed immune response through the release of active transforming growth factor beta (TGF-beta), Tregs can also prevent the immune system from recognizing and suppressing pathogenic cells including cancer cells. By binding to glycoprotein A repetitions predominant (GARP), which plays a key role in the regulation of production and release of active TGF-beta, ARGX-115 works to limit the immunosuppressive activity of Tregs and thereby stimulate the immune system to attack cancer cells. We believe this specific inhibition of TGF-beta release by Tregs is potentially superior as a therapy to systemic inhibition of TGF-beta activity or the depletion of Tregs with a potentially improved safety profile.
ARGX-115 was discovered under argenx's Innovative Access Program with the de Duve Institute / Université Catholique de Louvain / WELBIO.

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
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