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ARGEN-X 2018 nieuws THE BIG SURPRISER FOR NEXT YEARS 2018 nieuws

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Yearling
0
Dag Ooievaar, niet meteen een reden, denk ik. Eerder een combinatie van factoren als het afgelopen mindere sentiment + de zomerperiode + weinig nieuws te verwachten voorlopig...
Maar het najaar komt er met stille schreden aan :)
Cf ook het Beursig forum en check de post van Lama Dalai om 7u45
jodu
3
daar gaan we :
argenx announces that AbbVie has exercised its exclusive option to license ARGX-115, a novel immuno-oncology antibody



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 exercise by AbbVie of its exclusive license option to develop and commercialize ARGX-115, an antibody targeting the novel immuno-oncology target glycoprotein A repetitions predominant (GARP).


"We are very excited by AbbVie's decision to exercise its option to license and develop ARGX-115, given its compelling track record in oncology. We are proud of the work that this milestone represents for argenx - both in efficiently advancing a premier Innovative Access Program candidate to clinical development and in facilitating wider recognition of the important research out of the de Duve Institute / Université Catholique de Louvain around this first-in-class target," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "Our Innovative Access Program remains a strategic priority for us, capitalizing on the combined strengths of the argenx antibody platform and the deep disease biology expertise at research institutions. We continue to seek out cutting-edge research and targets while advancing our current collaborations, all with the potential to broaden our pipeline and demonstrate our discipline as a strategic partner."

"Immuno-oncology is one of AbbVie's key focus areas in our mission to discover and develop medicines that drive transformational improvements in cancer treatment," said Tom Hudson, M.D., Vice President, Oncology Early Discovery and Development, AbbVie. "Our collaboration with argenx over the past two years has been productive, and we look forward to continue working together to fuel scientific progress for patients."

argenx and AbbVie entered into an option and license agreement for ARGX-115 in April 2016. With the option exercise announced today, AbbVie obtains a worldwide, exclusive license to develop and commercialize ARGX-115-based products. argenx is now eligible to potentially receive development, regulatory and commercial milestone payments of up to $625 million, as well as tiered royalties on ARGX-115-based product sales, if approved. argenx also has the right to co-promote ARGX-115-based products in the EU and Swiss Economic Area.

About ARGX-115

ARGX-115 employs argenx's SIMPLE Antibody(TM) technology and binds specifically to the protein glycoprotein A repetitions predominant (GARP), which plays a key role in the regulation of production and release of active transforming growth factor beta (TGF-beta). ARGX-115 is believed to selectively limit the immunosuppressive activity of activated regulatory T-cells (Tregs), thereby stimulating the immune system to attack cancer cells. While the normal function of Tregs is to suppress certain compartments of the immune system to prevent self-directed immune responses through the release of active TGF-beta, Tregs can also prevent the immune system from recognizing and suppressing pathogenic cells including cancer cells. argenx believes the selective inhibition of TGF-beta release by Tregs is potentially superior to systemic inhibition of TGF-beta activity or depletion of Tregs and may give rise to therapeutic products with an improved safety profile.



ARGX-115 was discovered under argenx's Innovative Access Program with the de Duve Institute / Université Catholique de Louvain / WELBIO and exclusively licensed under a research and option agreement in 2013.



About the Innovative Access Program (IAP)

Through the IAP, argenx collaborates closely with academic centers of excellence and emerging biotechnology companies, bringing cutting-edge antibody discovery technologies to the heart of novel target research. The extraordinary diversity of the immune repertoires comprising its SIMPLE Antibody(TM) Platform streamlines target validation, transforming novel protein discoveries into next generation therapeutic antibody programs.

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. 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 antibody technologies. The SIMPLE Antibody(TM) 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.

Tuut
0
22 augustus 2018

Breda, Nederland / Gent, België - argenx (Euronext & Nasdaq: ARGX), een biotechnologiebedrijf in de klinische fase dat een diepgaande pijplijn van gedifferentieerde op antilichamen gebaseerde therapieën voor de behandeling van ernstige auto-immuunziekten en kanker ontwikkelt, heeft vandaag de oefening van AbbVie aangekondigd van zijn exclusieve licentie-optie voor de ontwikkeling en commercialisering van ARGX-115, een antilichaam gericht tegen de nieuwe immuno-oncologie doel glycoproteïne A herhalingen overheersend (GARP).

"We zijn zeer verheugd over de beslissing van AbbVie om gebruik te maken van de optie om ARGX-115 te licentiëren en ontwikkelen, vanwege zijn indrukwekkende staat van dienst in de oncologie." We zijn trots op het werk dat deze mijlpaal vertegenwoordigt voor argenx, zowel bij het efficiënt bevorderen van een vooraanstaand Innovatief Toegangsprogramma. Kandidaat tot klinische ontwikkeling en in het faciliteren van bredere erkenning van het belangrijke onderzoek van het de Duve Instituut / Université Catholique de Louvain rond dit first-in-class doel, "zei Tim Van Hauwermeiren, CEO van argenx. "Ons Innovative Access-programma blijft een strategische prioriteit voor ons, waarbij we profiteren van de gecombineerde krachten van het argenx-antilichaamplatform en de diepgaande biologie-expertise van onderzoeksinstellingen." We blijven zoeken naar baanbrekend onderzoek en doelen terwijl we onze huidige samenwerkingen bevorderen, allemaal met de potentie om onze pijplijn te verbreden en onze discipline als strategische partner te demonstreren. "

"Immuno-oncologie is een van AbbVie's belangrijkste aandachtsgebieden in onze missie om geneesmiddelen te ontdekken en te ontwikkelen die transformerende verbeteringen in de behandeling van kanker stimuleren", aldus Tom Hudson, MD, Vice President, Oncology Early Discovery and Development, AbbVie. "Onze samenwerking met argenx in de afgelopen twee jaar is productief en we kijken ernaar uit om samen verder te werken aan het bevorderen van de wetenschappelijke vooruitgang voor patiënten."

argenx en AbbVie sloten in april 2016 een optie- en licentieovereenkomst voor ARGX-115 af. Met de vandaag aangekondigde optie-oefening verkrijgt AbbVie een wereldwijde, exclusieve licentie voor de ontwikkeling en commercialisering van op ARGX-115 gebaseerde producten. argenx komt nu in aanmerking voor het ontvangen van ontwikkelings-, regelgevende en commerciële mijlpaalbetalingen van maximaal $ 625 miljoen, evenals gelimiteerde royalty's op ARGX-115-gebaseerde productverkoop, indien goedgekeurd. argenx heeft ook het recht om op ARGX-115 gebaseerde producten mede te promoten in de EU en de Zwitserse Economische Ruimte.
Tom3
0
Blij dat ik afgelopen weken niets verkocht heb. Denk dat de Nasdaq (die gisteravond al vooruitliep op het nieuws) de actie van Abbvie ook wel weet te waarderen. Hierbij vergeleken is Galapagos maar een kneus. Hoeveel incasseert Argenx eigenlijk upfront?
aossa
0
Polylepis
0
Toch jammer dat er niks bekend wordt gemaakt van een e.v.t. upfront bij uitoefenen licentie. Mag hopen dat daar ook nog enkele miljoenen aan verbonden in. Destijds 40 milj bij opstellen contract..
Pokerface
0
quote:

Tom3 schreef op 22 aug 2018 om 11:22:


... Hoeveel incasseert Argenx eigenlijk upfront?


Ik denk niks, anders had dat wel in het PB gestaan.
de tuinman
0
corporate presentation augustus 2018 www.argenx.com/handlers/downloa ... t-2018.pdf
Nog te verwachten nieuws met grote impact op de koers !
3de kwartaal ( zitten we in ) Immune Thrombocytopenia
3Q18: Phase 2 topline resultsT-Cell Lymphoma ASH18:
Phase 2 topline results CTCLAcute Myeloid Leukemia ASH18:
Phase 1 full data in AML/MDS
Myasthenia Gravis 2H18: Start Phase 3
Lees meer op: beursig.com/forum/viewtopic.php?f=4&a...

Tx Bioscience
oki cd
0
vanuit de nieuwskamer van Bolero:

BRIEF-Argenx Receives Feedback From Japan's PMDA On Phase 3 Clinical Trial
07:06 (29/08) - Bron: Reuters
Aug 29 (Reuters) - ARGENX SE ARGX.BR :
* REG-ARGENX RECEIVES FEEDBACK FROM JAPAN'S PMDA ON PHASE 3
CLINICAL TRIAL AND REGULATORY PATHWAY FOR EFGARTIGIMOD IN
GENERALIZED MYASTHENIA GRAVIS
* DATA FROM PLANNED GLOBAL PHASE 3 REGISTRATION TRIAL, IF
POSITIVE, TO SERVE AS BASIS TO SUBMIT FOR MARKETING
AUTHORIZATION IN JAPAN
* PLANS TO INITIATE GLOBAL PHASE 3 REGISTRATION TRIAL OF
EFGARTIGIMOD IN GMG BEFORE END OF 2018
* EXPECTS DATA FROM PLANNED GLOBAL PHASE 3 REGISTRATION
TRIAL, IF
POSITIVE, WILL SERVE AS BASIS TO SUBMIT FOR MARKETING
AUTHORIZATION IN JAPAN.
* GLOBAL PHASE 3 TRIAL EXPECTS TO ENROLL APPROXIMATELY 150
PATIENTS WITH GMG, INCLUDING PATIENTS FROM JAPAN AS WELL AS
NORTH AMERICA AND EUROPE
* DATA, IF POSITIVE, MAY SERVE AS BASIS FOR BIOLOGICS
LICENSE
APPLICATION IN U.S. BASED ON FEEDBACK FROM FDA
* PATIENTS CAN ROLL OVER INTO AN OPEN-LABEL EXTENSION STUDY
FOR A
PERIOD OF ONE YEAR

Source text for Eikon:
Further company coverage:

(Gdynia Newsroom:)
Brammeke
0
argenx doses first patient in global Phase 3 registration trial of efgartigimod for the treatment of generalized myasthenia gravis September 6, 2018Breda, 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 dosing of the first patient in a global Phase 3 registration trial of efgartigimod (ARGX-113) in patients with generalized myasthenia gravis (gMG)."The dosing of the first patient represents an important milestone in advancing efgartigimod towards registration with the hopes of providing more therapeutic options for gMG patients globally. With planned enrollment of 150 patients, this will be the broadest trial of its kind in gMG, and the first to address both acetylcholine receptor (AChR) autoantibody positive as well as AChR autoantibody negative patients like those with MuSK MG," commented Nicolas Leupin, CMO of argenx. "Our Phase 2 results in gMG demonstrated rapid and sustained benefits in disease scores, correlating with a fast and deep reduction of auto-antibodies and a favorable tolerability profile, which we will continue to study in the Phase 3 trial."The randomized, double-blind, placebo-controlled, multicenter trial will enroll approximately 150 patients with gMG in North America, Europe and Japan. The global Phase 3 trial will evaluate the efficacy of a 10 mg/kg intravenous (IV) dose of efgartigimod over a 26-week period. The company expects to enroll AChR autoantibody positive patients and also AChR autoantibody negative patients whose disease is driven primarily by MuSK and LRP4 autoantibodies. The decision to include both patient subgroups results from the significant IgG reductions seen across all four IgG isotypes in the Phase 2 MG trial and the Phase 1 healthy volunteer trial. Patients in the Phase 3 clinical trial will be able to roll over into an open-label extension trial for a period of one year. The primary endpoint of the trial is efficacy as assessed by the Myasthenia Gravis Activities of Daily Living (MG-ADL) score and secondary and other endpoints include additional efficacy, safety, tolerability, quality of life and impact on normal daily activities measures.In the Phase 2 clinical trial of efgartigimod in gMG, data showed clinical improvement of efgartigimod over placebo results through the entire 11-week duration of the trial. Efgartigimod was well-tolerated in all patients, with most adverse events (AEs) characterized as mild and deemed unrelated to the study drug. No serious or severe AEs were reported.
Brammeke
0
Argenx (advies KBC Securities: "Opbouwen" - koersdoel 87 euro)
Argenx laat weten dat de eerste patiënt gedoseerd is in de Efgartigomod fase III-studie bij diagnose Myasthenia Gravis, die naar verwachting vóór eind 2018 zou starten. In totaal zullen 150 patiënten intraveneus worden behandeld met Efgartigimod gedurende een periode van 26 weken. De mening van KBC Securities: Analiste Sandra Cauwenberghs stelt vast dat Argenx zijn leidende positie in het domein behoudt. De fase III-studie verloopt volgens aanvankelijk gecommuniceerde tijdlijnen en zit dus goed op schema. De tweede helft van 2018 wordt voor Argenx belangrijk wat betreft publicatie van resultaten voor verschillende studies.
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