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Nanobiotix met haar NBTXR3 richting €80,- in 2014 ? (Heden €17,-)

524 Posts
Pagina: «« 1 ... 20 21 22 23 24 ... 27 »» | Laatste | Omlaag ↓
  1. [verwijderd] 28 januari 2015 21:13
    Europe's Bioscience 'Oscars': The Contenders

    Sep 27, 2013
    By Peter O’ Donnell

    Pharmaceutical Executive
    Europe’s closest thing to an Oscar’s ceremony for bioscience will take place in early October. The EuropaBio award for the most innovative European Union biotechnology firm is limited to firms with fewer than 250 staff or turnover or balance sheet of less than about $50 million. The aim is to encourage smaller firms in the sector – the ones that could become the GSK or Sanofi of the future.

    This year the five contenders on the short-list are from France, the UK, and Italy.

    From the UK come two companies. E-Therapeutics is a pioneer in ‘network pharmacology,’ which exploits advances in network science and chemical biology in the search for novel treatments for cancer and disorders of the nervous system. UK-based PsiOxus Therapeutics makes use of directed evolution to develop a virus potent enough to kill cancer cells with minimal effects on healthy cells.

    Gensight biologics from France focuses on gene therapy-based treatments for degenerative retinal diseases. Nanobiotix, also from France, works on enhancing the efficacy of radiotherapy treatment in cancer with nanoparticles that can directly enter tumour cells through injection or topical application. And EryDel SpA of Italy specialises in innovative drug and diagnostics delivery through human red blood cells, with its own medical device designed to reduce toxicity and side effects.

    The winner receives a little over $10,000 – not much in financial terms, but worth more in terms of prestige, profile and contacts. To boost the impact, this year the award will be presented during the first-ever European Biotechnology Week, which will feature will events across Europe celebrating biotechnology in this 60th anniversary of the discovery of the DNA molecule. EuropaBio, the European association for bioindustries, which is organizing the event, says it hopes to spotlight the potential of Europe’s smaller biotech firms and to underline to European policymakers the challenges and financial constraints that they labor under.

    The UK bio-industry association has leapt to lend support to the event – unsurprisingly, in view of the strong UK presence on the shortlist. “Having two out of the five short-listed companies shows the strength of the UK biotech sector in Europe. It is great to see our member companies getting the recognition they deserve in this prestigious European competition,” said the association’s chief executive, Steve Bates.

    The extravagant praise from a fellow biotech association is warm, and doubtless welcome to the organizers. But it highlights at the same time the absence of wider public or media hysteria over the upcoming ceremony… Which in turn highlights the indifference – when not expressed as downright hostility – that the biotech sector suffers in Europe. The Oscar-like event is a valiant and imaginative attempt to break through that indifference, and for that alone Europabio deserves a ‘Bravo.’

  8. Ferdinand 62 20 februari 2015 09:36
    Belangrijk nieuws voor Nanobiotix. Ik ken deze professor niet maar schijnbaar heeft hij een zeer goede naam. Als ik het nieuws lees en kijk hoe hij in aanzien staat moet dit wel erg goed zijn. Beleggers zijn in ieder geval enthousiast. De koers stijgt flink en in een half uur tijd al meer dan 150 % aandelen verhandeld dan op een normale dag. Nu hopelijk snel richting koersdoel van € 33,-

    Professor Robert Langer joins Nanobiotix as Scientific Advisor
    02.19.2015
    Paris, France, 19 February, 2015 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announced that Professor Robert Langer, Institute Professor at the Massachusetts Institute of Technology (MIT), has become Scientific Advisor to Nanobiotix.

    Laurent Levy, CEO of Nanobiotix, commented: “We really appreciate that Professor Langer joined us as a Scientific Advisor. Professor Langer is a globally acknowledged nanomedicine expert and serial business innovator, and his involvement will be an asset for our technologies, our development and expansion beyond cancer“.

    Professor Langer presides over the largest academic biomedical engineering laboratory in the world. His laboratory is centered in the David H. Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology. His team has more than 100 researchers including chemists, biologists, materials science engineers and computer scientists.

    He is also a Principle Investigator at the MIT-Harvard Center for Cancer Nanotechnology Excellence, one of eight Centers of Cancer Nanotechnology Excellence awarded by The National Cancer Institute (NCI), part of the National Institutes of Health (NIH).

    Beyond his extensive involvement and leadership in MIT’s scientific community, Professor Langer’s research has spawned a vast array of innovative and disruptive technologies. He holds over 1 000 patents in diverse areas of biomedical technology and has been involved in the launch or acceleration of numerous biotech companies including BIND Therapeutics, Enzytech and Pervasis as examples.

    Professor Langer said: “Radical and disruptive technologies are always required. An interdisciplinary approach to research and development is critical to ensure that these technologies are developed to their fullest potential. I see NanoXray technology as one of the technologies that could make a significant difference to disease treatment. Nanobiotix has very exciting and innovative projects and I look forward to working with the Team”.

    In September 2014, Nanobiotix opened its US affiliate in the Boston Life Science hub, in Cambridge MA. The location provides access to a critical mass of academic and medical institutions as well as biopharmaceutical industries, and will ensure access to the research community and clinical expertise in the US.
  9. Laugh about it 27 februari 2015 20:24

    Paris, France, le 27 février 2015 – NANOBIOTIX (Euronext : NANO – ISIN: FR0011341205), société française pionnière en nanomédecine développant NanoXray, une approche thérapeutique révolutionnaire pour le traitement local du cancer, annonce aujourd’hui son chiffre d’affaires du quatrième trimestre et de l’exercice 2014, clos au 31 décembre 2014

    Le chiffre d’affaires de Nanobiotix au cours du quatrième trimestre 2014 correspond, d’une part, à la quote-part du paiement initial (upfront payment) perçue par la Société dans le cadre du contrat de licence signé avec la société taïwanaise PharmaEngine en août 2012, accord portant sur le développement et la commercialisation de NBTXR3 dans la région Asie-Pacifique. Ce paiement initial s’élève à 810 640 € et génère pour la période un produit de 46 351 €. Il est reconnu linéairement entre la date de signature du contrat et la date prévisionnelle de commercialisation sur la zone concernée.

    D’autre part, Nanobiotix a également reçu en octobre 2014 un paiement d’étape de 1 million de dollars (783 607 €) dans le cadre du contrat avec PharmaEngine, lié à l’intention de PharmaEngine de participer à l’étude pivot initiée par Nanobiotix pour le produit NBTXR3 dans le sarcome des tissus mous afin d’accélérer le développement du produit en région Asie-Pacifique. Selon les termes du contrat conclu avec PharmaEngine, Nanobiotix pourrait recevoir plusieurs paiements d'étape supplémentaires en fonction de la réalisation des différentes phases de développement et de commercialisation. L’ensemble de ces paiements pourrait atteindre un montant total de 56 millions de dollars, suivi de royalties à deux chiffres sur toutes ventes dans la région Asie-Pacifique.

    La facturation de prestations de services s’élève à 2 379 € pour la période du quatrième trimestre. Au total, le chiffre d’affaires du quatrième trimestre s’élève à 832 337 €, soit 972 908 € cumulés sur l’exercice 2014.

    En novembre 2014, la Société a fait entrer un nouvel investisseur américain, Capital Ventures International, par voie de placement privé d’actions nouvelles avec bons de souscription d’actions attachés, pour un montant total de 10 393 500 € (650 000 actions), représentant environ 4,85% du capital de la Société avant la réalisation du placement. A cela s’ajoute un montant supplémentaire potentiel de plus de 14,1 M€ si l’intégralité des bons étaient exercés ainsi qu’un engagement de cet investisseur de souscrire à une tranche additionnelle de 10 M€ qui serait réalisée à la discrétion de la Société, sous certaines conditions.

    Ces opérations sont plus amplement détaillées dans les communiqués publiés par la Société à l’occasion de la réalisation.

    Les objectifs de cette seconde augmentation de capital étaient de i) permettre à la Société d’élargir son programme clinique à de nouvelles indications et zones géographiques pour le développement de son produit leader NBTXR3, ii) d’avoir une visibilité financière pour mener sa stratégie de développement autonome aux Etats-Unis, avant de conclure un éventuel partenariat pour le marché américain et iii) de structurer son capital avec un nouvel investisseur américain.


    2014 – une année de succès en termes de résultats cliniques


    A la suite de la publication à l’ASCO en juin 2014 des résultats positifs de l’étude pilote de Phase I avec le produit NBTXR3, Nanobiotix a reçu l’autorisation de l’ANSM (l’Agence Nationale de Sécurité du Médicament et des produits de santé) de démarrer l’étude pivot de Phase II/III pour des patients atteints d’un sarcome des tissus mous (STM), dernière étape avant l’enregistrement du produit (marquage CE).

    La Société a également étendu son programme clinique, avec de nouvelles indications à fort potentiel aussi bien en Europe qu’aux Etats-Unis : les cancers du foie (primaire et métastatiques) et le cancer de la prostate, en parallèle des études européennes en cours pour des patients atteints de STM et de cancer de la tête et du cou.

    Suivez le lien ci-dessous pour télécharger le bilan 2014 :

    Nanobiotix Bilan 2014, perspectives 2015 et calendrier financier

    Prochaine communication financière : résultats annuels 2014 le 30 avril 2015
  10. Ferdinand 62 5 maart 2015 11:41
    Een mooi en duidelijk verhaal in UK today. Hieruit blijken wel de mogelijkheden voor Nanobiotix in een enorme markt.

    Pace quickening for Nanobiotix as promises radiotherapy revolution
    By Ian Lyall March 05 2015, 9:26am If the company is able to broaden out applications for NBTXR3 then there is a potential multi-billion euro opportunity for Paris-based NanobiotixIf the company is able to broaden out applications for NBTXR3 then there is a potential multi-billion euro opportunity for Paris-based Nanobiotix
    The pace of progress has ramped up several notches in the past year at Nanobiotix (EPO:NANO), developer of a nano-medical technology that promises a revolution in radiotherapy.
    Impressive early results treating soft tissue sarcoma – tumours that lodge and grow in fat and muscle – have allowed the company to progress into the registration phase for its lead product, NBTXR3.
    Not just that, Nanobiotix has successfully raised enough cash to fund studies here in Europe up to market and also initiation of clinical development in the US, the world’s largest medical market.
    And it is also rapidly expanding indications for NBTXR3 to treat other cancer types.
    It means that unlike a traditional fledgling biotech, Nanobiotix has multiple shots on goal.
    If the company is able to broaden out applications for NBTXR3 then there is a potential multi-billion euro opportunity for Paris-based Nanobiotix.
    To understand the market opportunity you have to be familiar with how the technology works.
    The process is fairly simple. Particles of hafnium oxide are injected directly to the tumour, although they can be administered intravenously or applied as a gel during surgery to give a targeted treatment.
    The non-toxic material is there to absorb x-rays as well as enhance the dose of radiotherapy. This targeted approach means the dose in the tumour can be increased without hurting healthy tissues surrounding it.
    It should be stressed that, while the NanoXray can be administered like a medicine and its particles are so tiny, thousands can fit around the circumference of a hair, the reaction is physical rather than chemical or biological.
    This is an important distinction. For while medicines react differently to the genetic make-up of each individual, the laws of physics are immutable.
    So, we know if we heat a cell to 80 degrees or similarly give a high dose of radiotherapy that cell – hopefully a dangerous cancer cell – will die no matter what the genetic make-up of the patient.
    What does this mean? Well, it creates a one-size-fits-all approach to treatment that you just don’t have with conventional medicine.
    Theoretically then, six million people annually who receive radio-therapy could be helped with this new enhanced form of the treatment.
    The other upside is the regulatory pathway for NBTXR3 should be much shorter than the winding, arduous route to approve traditional drugs, because variability of biology is less important when developing a physical treatment
    So, NBTXR3 could be registered commercially for use in soft tissue sarcoma by end of 2016 (so long as it proves its worth in ongoing pivotal trials). That’s less than four years after the first pilot studies took place on 25 patients.
    It is also worth noting that, as the product will be registered as a medical device, it will use the CE Mark scheme here in Europe to gain regulatory sign off.
    “Our belief is what we are developing is less risky than a biotech because it is physics,” said Laurent Levy, chief executive and founder of Nanobiotix, when he spoke to Proactive.
    “We have to spend a less money because the trials don’t involve thousands of people.
    “Yet at the end the return on investment could be equal if not bigger than some of the drugs that come to the market.
    “Remember, because this is physics we can target many, many patients.
    “If you put all this together you come up with something for the investor that could be very, very interesting.”
    The fine line between success and failure for businesses such as Nanobiotix is often not what happens in the lab, or in clinical trials – although failure here will be fatal. Access to capital, or lack of it, can also be terminal.
    The company has done better than most of its peers in this regard. It raised 28mln euros to fund pivotal trials of its technology on 156 patients that should, hopefully, see it claim that coveted CE Mark.
    It also completed a private placement that will fund its expansion into the US, the world’s largest medical market.
    While it received an initial 10mln euros this could balloon to 35mln euros if things pan out as expected Stateside.
    The company now has offices in Cambridge, Massachusetts, the hub for biotechnology and, crucially, nano-technology.
    In going it alone in America Nanobiotix delays the point at which it brings in a commercial partner (if indeed it does), which will then allow it to maximise the value realised from its breakthrough technology in this important market.
    The past year has seen the pace quicken for the Euronext-listed innovator, which has gone from being an early stage company to one now in the registration phase in Europe for soft tissue sarcoma.
    A more extensive trial on 156 patients will report interim data in the middle of next year at which point the group will decide whether or not to go on a bridge study that would prime NBTXR3 for US Food and Drug Administration (FDA) registration .
    This could be around a year after commercial sales begin in Europe and behind registration in Asia, where development is being carried out by Nanobiotix’s collaboration partner PharmaEngine.
    As mentioned earlier, the firm has broadened the scope. A pilot study on 40 patients with head and neck cancer in Europe should be complete late this year, while a pilot on liver cancer will begin recruiting the first of 24 patients in the middle of 2015.
    It has chosen the US to begin its pilot on prostate cancer patients.
    “We have shifted from an early clinical stage company last year into one this year that is starting the registration phase in Europe,” said CEO Levy.
    “We have been able to obtain the ’go’ from agencies to move forward for the registration phase quite fast and this first product in the market will be very important for us.
    “When you put it all together: the size of the market, timing risk and money spent and assuming that the results are positive, you could have a very good return on investment equation. Now let’s continue to work to deliver results that should feed this equation.”
  11. Laugh about it 17 maart 2015 21:59
    Parijs, Frankrijk , 18 maart 2015 - NANOBIOTIX ( Euronext : NANO - ISIN : FR0011341205 ) , een Franse pionier in het ontwikkelen van nanomedicine NanoXray een revolutionaire therapeutische aanpak voor de lokale behandeling van kanker , kondigde vandaag haar partnerschap met CordenPharma voor productie . De opening van een nieuwe productie en verhoogde productiecapaciteit is een belangrijke stap in de weg naar NBTXR3 marketing.

    Met een verwachte CE-merk in 2016 , is het bedrijf bereidt zich voor om de hoeveelheid product beschikbaar NBTXR3 intensivering van de productie te verhogen om de toekomstige behoeften van marketing te voldoen . DNA Therapeutics anticipeert verdere product eisen voor klinische proeven in
    Europa en de VS in de komende jaren . Deze nieuwe productie-eenheid is gevestigd in Frankrijk .

    CordenPharma is een CMO (contract manufacturing organisatie) International hebben gespecialiseerde technologische know-how in de ontwikkeling en productie van producten voor de gezondheidszorg. Het bedrijf is erkend door regulerende gezondheidsautoriteiten Europese en Amerikaanse (FDA en EMA) door middel van acht fabrieken GMP (Good Manufacturing Practice) in Europa en de Verenigde Staten, en werkt samen met farmaceutische en biotechnologische bedrijven. De planten worden regelmatig geïnspecteerd door de genoemde autoriteiten melden en goede balans.

    Laurent Levy, CEO van DNA Therapeutics opmerkingen: "Het vinden van de juiste partner voor de productie van fundamenteel belang is voor de mate waarin de kwaliteit te waarborgen en voldoende niveaus van het aanbod is van essentieel belang om aan de eisen van de markt en voor te bereiden groei van de Vennootschap.

    Yves Michon, voorzitter van Synkem - CordenPharma voegt hieraan toe: "Het product NBTXR3 Nanobiotix is ??een fascinerend product, niet alleen in termen van zijn eigenschappen, maar ook met betrekking tot de productie ervan. We werken nauw samen met Nanobiotix om een ??transparant proces en een verhoogde productiecapaciteit te waarborgen.

    NBTXR3 eerste product NanoXray portfolio omvat hafnium oxide nanodeeltjes direct geïnjecteerd in de tumor. Na activering door bestraling, de nanodeeltjes absorberen röntgenstralen en de potentiële effectiviteit van radiotherapie amplificeren binnen kankercellen zelfs wanneer de dosis röntgenstralen na door gezond weefsel blijft onveranderd. NBTXR3 zou kunnen hervormen de behandeling van kanker, wat een belangrijk klinisch voordeel voor patiënten.

    In november 2014 DNA Therapeutics kondigde haar globaal plan klinische ontwikkeling. In aanvulling op de aanwijzingen van Wekedelensarcoom en kanker van het hoofd en de nek, het plan bevat nu leverkanker uitgezaaide leverkanker en prostaatkanker. Tijdens de tweede helft van 2015, moet de lever ontwikkeling van kanker programma's en prostaatkanker de kliniek te gaan.

    Morgen weer eens een positieve boost naar boven op dit persbericht?!
  17. Ferdinand 62 25 maart 2015 20:26
    Weer een mooie publicatie. Eind van de dag schoot de koers opeens omhoog. Nu is duidelijk waarom!! Op het Franse forum is men zeer enthousiast over dit verhaal. Bij deze de publicatie met mogelijkheden en een aantal redenen om Nanobiotix te kopen.

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    The report also reviews key players involved in the therapeutic development for Rectal Cancer and special features on late-stage and discontinued projects. Companies discussed in this report include AbbVie Inc., Apogenix GmbH, Cerulean Pharma, Inc., GlaxoSmithKline plc, Hanwha Chemical Corporation, Incuron, LLC, Karyopharm Therapeutics, Inc., Nanobiotix, Peregrine Pharmaceuticals, Inc., Regeneron Pharmaceuticals, Inc., Synta Pharmaceuticals Corp.

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