XBiotech

    IPO erfolgt, an der Nasdaq gelistet. D. Vasella im VR


    http://www.nasdaq.com/press-re…c-offering-20150417-00510


    http://www.handelszeitung.ch/n…-jungunternehmen-xbiotech

    Daniel Vasella wird Verwaltungsrat bei US-Jungunternehmen XBiotech

    Zürich (awp) - Der ehemalige Novartis-Chef Daniel Vasella engagiert sich beim US-Start-up XBiotech. Vasella werde neuer Verwaltungsrat des US-Unternehmens mit Sitz in Austin/Texas, schreibt der "Tages-Anzeiger" (Ausgabe 05.11.). Für das Jungunternehmen seien unter anderen bereits Nobelpreisträger und Ex-Novartis-Verwaltungsrat Rolf Zinkernagel sowie Thomas Kündig, ein Forschungsleiter am Unispital Zürich, seit Jahren im Hintergrund tätig.

    Vasella erhalte für sein Mandat wie alle VR-Mitglieder jedes Jahr Optionen von XBiotech. Das Unternehmen wolle noch vor Jahresende an die Börse gehen, heisst es weiter. Das Unternehmen soll mit dem Börsengang 100 Mio USD am Markt aufnehmen wollen.

    XBiotech ist in den Bereichen Onkologie, Therapie von Antibiotika-resistenten Erregern, Herz-Kreislauferkrankungen, Dermatologie und Diabetes Typ 2 aktiv, wie der Webseite des Unternehmens zu entnehmen ist. Derzeit werden Patienten für zwei Phase-III-Studie mit dem Prüfmedikament Xilonix zur Behandlung von Kolorektalkrebs sowie für Phase-II-Tests mit RA-18C3 zur Therapie der schweren Hauterkrankung Pyoderma Gangrenosum (Dermatitis ulcerosa) rekrutiert. Der Ansatz des Unternehmens basiert dabei auf menschlichen Antikörpern, die aus der Reaktion des menschlichen Immunsystems stammen.

    1mia mkap !?


    btw;

    Thomas Gut

    UFC Ltd. Family Office

    Selnaustrasse 5

    8001 Zurich, Switzerland

    Ownership.

    As of April 17, 2015:

    *angel*Amount Beneficially Owned:

    2,318,583 shares.

    (b)Percent of Class:

    7.31%. Based upon 31,716,631 shares of common stock outstanding at April 17, 2015.

    05.18.15 - XBiotech Secures Approval from Data Safety Monitoring Board to Continue Phase 3 Registration Study in Europe for its Novel Cancer Immunotherapy

    XBiotech (NASDAQ: XBIT), developer of Xilonix anti-cancer therapy for the treatment of colorectal cancer, announced today that the Data Safety Monitoring Board (DSMB) has recommended continuation of the Company’s Phase 3 registration study underway in Europe. The study, launched in March of 2014, is on schedule for completion this year. The DSMB decision follows a pre-scheduled interim review as part of the study plan. The DSMB board consists of an independent panel of medical experts that oversee execution of the study. While a DSMB’s primary responsibilities are related to safety, they also generally evaluate study conduct with respect to good clinical practices and make recommendations concerning continuation, modification or termination of the trial.

    As part of the only planned DSMB review, the group was tasked with assessing what fraction of patients enrolled had completed all endpoints. Normally, not all patients enrolled make it through all the data endpoints. Based on these findings, the DSMB was to make a recommendation for increasing the patient sample size to maintain statistical power of the study. The DSMB made a recommendation for sample size increase that was within expectations and the Company states enrollment remains on pace to meet the completion timelines.

    The primary objective of the double-blinded, placebo-controlled, multi-center study is to assess the effectiveness of Xilonix for treating patients with symptomatic colorectal cancer. Xilonix blocks interleukin-1 alpha (IL-1a), an inflammatory mediator that acts at the site of the tumor to stimulate growth of tumor blood supply and support tumor growth. In addition, IL-1a may aid circulating tumor cells to form new sites of metastasis and also be involved as a messenger in the brain, where it can trigger fatigue, anxiety and metabolic dysregulation seen in advanced cancer. In a previous study at MD Anderson, Xilonix therapy appeared to not only have anti-tumor effects and prolong survival, but also seemed to improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with advanced cancer.

    In the current study, anti-tumor effect will be measured by assessing the change in these symptoms for patients treated with Xilonix versus those treated with placebo. Reversal of muscle loss will be assessed with a novel type of radiology called dual energy X-ray absorptiometry, or DEXA. Improvement in pain, appetite loss, and fatigue will be measured with a well-established and validated questionnaire that reliably assesses patient well being as reported by patients themselves.

    John Simard, President and CEO of XBiotech, commented, “The DSMB recommendation is indeed an important milestone for our lead oncology therapy. While the DSMB outcome confirms Xilonix’s extraordinary safety profile, this result also demonstrates that our study is being well-executed and proceeding according to plan. We are all looking forward to unblinding this remarkable study later this year.”

    XBiotech Successfully Clones First Anti-Ebola Therapeutic Antibody Product Candidate

    AUSTIN, Texas, May 26, 2015 (GLOBE NEWSWIRE) -- XBiotech (XBIT), the developer of True Human(TM) therapeutic antibodies, announced today that it has successfully isolated and cloned an anti-Ebola product candidate using its True Human antibody discovery platform.

    True Human antibodies are derived directly from human donors that have natural immunity to disease. The anti-Ebola product candidate was developed from a blood donation received earlier this year from a patient who recovered from Ebola infection.

    John Simard, President and CEO of XBiotech, stated, "Our response to the Ebola outbreak has been a very special project in several ways. Our technology offered us the ability to develop a curative therapy to a deadly disease that was ravaging nations and even threatened us here at home; and it offered the potential to develop a therapy with unparalleled speed. What started with selfless donations from Ebola survivors only a few months ago has resulted in a True Human antibody therapeutic candidate that could be used to treat the disease. We are very proud of the capabilities we have developed and are humbled by the potential to address serious unmet medical need at home and abroad."

    Simard continued, "Additionally, the results of our Ebola program further represent how XBiotech's core strength in efficient drug discovery makes the company uniquely capable to quickly respond to disease outbreaks."

    Sole69 hat am 27.05.2015 - 16:17 folgendes geschrieben:

    Quote

    Fulminanter Start und würde mich nicht wundern, falls der noch ins minus dreht………sind doch gute Nachrichten?

    Definitiv gute Nachrichten - Da jedoch momentan keine Ebola Panik herrscht verpufft diese wieder oder das GAP wird noch schnell geschlossen. Mal schauen :)

    Sole69 hat am 27.05.2015 - 16:39 folgendes geschrieben:

    Quote

    Siehst du da schon noch ein grosses Potenzial bei dieser Aktie?

    Ja definitiv - XBIT ist meine grösste Position.


    Schau mal die Pipeline (spannende Indikationen) an und die True Human Antibodies Plattform / Technologie.


    Denke viele haben XBIT noch nicht auf dem Radar... Seit Montag ist zumindest die "quiet-period" zu Ende!


    Bin gespannt auf KZ der Analysten.

    XBiotech Launching Phase 1/2 Clinical Study of Novel True Human(TM) Therapeutic Antibody for Treating Serious Infections Due to Staphylococcus Aureus


    AUSTIN, Texas, May 28, 2015 (GLOBE NEWSWIRE) -- XBiotech Inc. (XBIT), a leading developer of next-generation True Human(TM) therapeutic antibodies, announced today that the Food and Drug Administration (FDA) has lifted its clinical hold from the Company's IND, enabling launch of its therapy for S. aureus infections. XBiotech was placed on clinical hold while it worked with the agency to prepare its novel therapy and manufacturing process for human studies. XBiotech will now begin enrollment of approximately 52 patients in a Phase 1/2 randomized, placebo-controlled, dose escalation study, which will evaluate safety and efficacy of the therapy to treat serious S. aureus infections.

    This drug candidate was developed using XBiotech's True Human antibody discovery platform, which involves screening healthy individuals to identify those with natural immunity to specific diseases. The therapy was derived from an individual that harbored natural antibodies capable of neutralizing S. aureus, including drug-resistant strains of the disease. The treatment is being developed to treat all forms of staph infections and will first be tested in patients with life-threatening infections that are present in the blood, known as bacteremia. The antibody is capable of blocking the key mechanism that S. aureus uses to evade the body's immune system. The therapy can thus at once undermine the bacteria's escape mechanism and facilitate its natural clearance by the body's immune system.

    John Simard, the Company's Chief Executive Officer said, "We are grateful to the FDA for working very closely with us to launch the first of our new infectious disease therapies. It would be difficult to overstate the potential impact this new therapy could have on how therapies are developed and used to treat infections. Derived from natural immunity, this true human antibody offers the means to provide safer, more effective treatments that are not susceptible to present forms of drug resistance. Our antibody therapy represents what we foresee as the launch of '21st century antibiotics,' and the coming of age of biotechnology in the area of infectious disease."

    Sole69 hat am 28.05.2015 - 15:43 folgendes geschrieben:

    Ja solche Schwankungen sind an sich nichts speziellen bei Biotechs aber es erstaunt mich schon, dass nach zwei positiven PE wir tiefer stehen. Naja ich sehe XBIT als sehr LONG an.