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

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  1. Laugh about it 3 juli 2015 21:34
    Nanobiotix receives thumbs up from City broker Stifel
    Share
    08:08 03 Jul 2015
    Broker Stifel's highly regarded healthcare team has repeated its bullish stance of the French nano-medical technology

    The broker Stifel repeated its ‘buy’ advice and its bullish price target on Nanobiotix (EPA:NANO), after the developer of nano-medical technology was given the go ahead to start two new cancer trials.

    Stifel, which reckons the stock is worth €30.10 (current price €17.95), said the authorisations reveal the company is on track with its development plans for the year.

    It was given clearance to start new clinical trials for its lead NanoXray product, NBTXR3, which will be used to treat patients with hepatocellular cancer (the most common liver cancer) and liver metastases.

    It brings to five the number of cancer studies Nanobiotix currently is currently running.

    The latest test will evaluate the use of NBTXR3 in conjunction with high precision radiation therapy, delivered as high dose fractions, known as Stereotatic Body Radiation Therapy (SBRT).

    SBRT is the safest and most modern radiotherapy currently available for the treatment of malignant liver tumours, but it has been shown to be efficient only in specific subsets of population with small tumours, and complete response is a rare event.

    Nanobiotix's lead NanoXray product, NBTXR3, is activated by radiotherapy and works by the deposit of increased energy doses (radio-enhancement) within the tumour.

    Nanobiotix's technology works by allowing radiotherapy to be administered in a very targeted and effective way, thus destroying more of the tumour.

    “Most cases of hepatocellular cancer or liver metastases are inoperable,” said Stifel analyst Michael King.

    “While radiation therapy has been shown to improve clinical outcomes, high doses are usually not possible, so the increase in energy doses provided by NBTXR3 could significantly improve efficacy.”

    Nanobiotix’s liver cancer trial has been supported by a broad NBTXR3 pre-clinical programme specific to these cancers, showing that the use of the product is feasible and well-tolerated in animals.
  2. Laugh about it 28 augustus 2015 22:20

    Paris, France, le 27 août 2015 – NANOBIOTIX (Euronext : NANO – ISIN: FR0011341205), société française pionnière en nanomédecine développant NanoXray, une approche thérapeutique révolutionnaire pour le traitement local du cancer, annonce ses résultats consolidés audités pour le premier semestre 2015, arrêtés au 30 juin 2015.

    Informations financières
    · Le chiffre d’affaires total est d’environ 1,7 M€ (S1 2014 : 1 M€), correspondant à la quote-part du premier versement effectué par PharmaEngine (91K€), au Crédit d’impôt Recherche (1,4 M€) et autres subventions (149 K€)
    · Augmentation des coûts de R&D (6,1 M€ contre 3,3 M€ au 30 juin 2014) en support de l’accélération du plan de développement clinique, avec notamment l’expansion de l’essai pivot (phase II/III) pour le sarcome des tissus mous, l’étude tête et cou de phase I/II et la préparation de nouveaux essais cliniques
    · Augmentation des frais généraux à 2,8 M€ (S1 2014 : 1,8 M€) résultant principalement du développement du groupe, en ce compris notamment les analyses préparatoires à la mise sur le marché (market access) du produit NBTXR3, les projets de business development et les activités de la filiale américaine
    · La perte opérationnelle s’établit à -7,8 M€ (S1 2014 : -4,1 M€) sur la période, conformément aux prévisions
    · La trésorerie est de 25 M€ au 30 juin 2015 (S1 2014 : 27 M€)

    Principaux évènements opérationnels
    · Expansion de l’étude pivot avec NBTXR3 dans le sarcome des tissus mous (STM) à trois nouveaux pays européens et demandes d’approbation en cours dans d’autres pays d’Europe, en Asie et au Canada, conformément aux plans de la Société
    · Résultats préliminaires positifs de l’essai clinique de phase I/II dans les cancers de la tête et du cou avec le produit NBTXR3
    · Recrutement de CordenPharma, nouveau partenaire pour la production afin d’augmenter la disponibilité du produit NBTXR3 en amont du marquage CE anticipé à fin 2016
    · Professeur Robert Langer, Institute Professor au Massachusetts Institute of Technology (MIT), expert mondialement reconnu en nanomédecine et entrepreneur dynamique, devient Conseiller Scientifique de Nanobiotix

    Principaux évènements survenus depuis la clôture du premier semestre
    · Démarrage d’un essai clinique de Phase I/II pour NBTXR3 dans deux nouvelles indications : le carcinome hépatocellulaire (HCC) et les métastases du foie

    Laurent Levy, président du Directoire et co-fondateur de Nanobiotix déclare :
    « Nous avons réalisé des avancées significatives au cours des six derniers mois, particulièrement concernant le développement clinique de notre produit NBTXR3. Nous menons maintenant des essais cliniques dans 5 indications : le sarcome des tissus mous, le cancer de la tête et du cou, le cancer du rectum (par PharmaEngine) et les cancers du foie, ce qui témoigne bien de la transférabilité potentielle de l’usage de NBTXR3 dans différents types de cancers. Nous allons poursuivre l’extension du développement clinique de NBTXR3 en lançant d'autres indications comme par exemple le cancer de la prostate, prévu aux Etats-Unis d'ici la fin de l'année. La situation financière de Nanobiotix demeure solide et conforme aux prévisions de la Société. Les mois à venir devraient être productifs au regard de notre développement clinique, et nous sommes sur la bonne voie pour obtenir à la fin de l’année 2016, le marquage CE pour notre produit leader, dans le sarcome des tissus mous. »
  3. Ferdinand 62 4 november 2015 08:28
    Mee eens Laugh about it, dit speelt zeker mee. En wat mogelijk ook nog meespeelt is de kans op overnames binnen de biotechnologie. Kijk eens naar Cellectis, in een week tijd. Ik schreef hier al een paar keer over. Vorige week woensdag nog een slot van € 22,43 en gisteren een slot van € € 32,30. Ik ben zelf gisteren uit Cellectis gestapt met een hele mooie winst maar als ik naar de opening kijk had ik nog wel kunnen blijven zitten. hopelijk gaat Nano eenzelfde sprong maken. Mijn positie in Nano hou ik voorlopig vast en ik hoop Cellectis over een tijdje weer lager te kunnen kopen.
  4. Omnius 4 januari 2016 12:05
    www.nanobiotix.com/news/release/fda-a...

    FDA approved Investigational New Drug for NBTXR3 in a new clinical study in prostate cancer
    01.04.2016
    Paris France, Cambridge MA, USA, January 4th, 2016 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces the US Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application on the 30th of December. This allows Nanobiotix to launch its first clinical study in the US for its lead product NBTXR3 in prostate cancer, a new and very significant indication.

    The FDA approval enables the Company to initiate a phase I/II prospective, open-label, two cohorts and non-randomized trial, in the large prostate cancer patient population. The first part of the trial should involve departments of radiation oncology of from three reference US oncology centers.

    Nanobiotix is seeking to develop NBTXR3 for patients with intermediate and high-risk prostate cancer, with the aim of providing effective tumor destruction and disease control. Prostate cancer is the second most common form of cancer in the US among the male population: one out of seven men will be diagnosed with prostate cancer, and it is the second leading cause of cancer death (American Cancer Society).

    Efficient local control is key for treatment of the primary prostate tumor to prevent relapse and subsequent spreading of the disease (metastasis). Radiotherapy is used for that purpose, but presents limitations in such patient population. The importance of the delivered energy dose in improving disease outcome has been extensively demonstrated. More precisely literature data have shown that increasing the radiotherapy energy dose significantly improve the local control and decrease the distant failure.

    NBTXR3 is a nano-sized radio-enhancer that operates at the tumor level, bound and captured by cancer cells. Using NBTXR3 in combination with radiotherapy may significantly open the therapeutic window and improve efficacy by increasing the energy dose deposit within the malignant tissues, without adding toxicity to surrounding healthy tissues.

    Laurent Levy, Nanobiotix CEO commented: “The FDA approval opens the regulatory pathway for our lead product NBTXR3 in the US, the largest market for cancer therapeutics. Expansion in new indications and global development of NBTXR3 are key to establish this technology as a new standard of care”.

    In addition to the prostate cancer trial, Nanobiotix is currently running trials in five indications across Europe and the Asia-Pacific Region: a registration trial in soft tissue sarcoma and Phase I/II trials in liver cancers (HCC and liver metastases), head and neck cancers and rectal cancer (in Asia by Nanobiotix’s partner PharmaEngine).

    -Ends-
  5. Ferdinand 62 5 januari 2016 08:24
    Gaat dit dan eindelijk het jaar van Nanobiotix worden? Ik heb er alle vertrouwen in en de nieuwsberichten zijn er alvast dit jaar.


    Nanobiotix starts a new research program in Immuno Oncology with its lead product NBTXR3

    01.05.2016



    Paris, Cambridge, January 5, 2016 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces today that, in addition to its current advanced clinical development program, the Company has started exploring the use of NBTXR3 for combination in Immuno Oncology.

    Elsa Borghi, Nanobiotix’s Medical Director, commented: “With six ongoing indications, our global clinical development of NBTXR3 as a radio-enhancer, is progressing well. This Immuno Oncology program could bring new applications and confirm that additional patient populations could benefit from treatment with NBTXR3”.

    NBTXR3 current clinical development

    NBTXR3 is a radio-enhancer, using a physical mode of action to destroy cancer cells in any solid tumors, in combination with radiotherapy.

    Nanobiotix is running a global clinical development program with its lead product NBTXR3, in six indications across Europe, the US and the Asia-Pacific Region: a registration trial in soft tissue sarcoma, and Phase I/II trials in liver cancers (HCC and liver metastases), prostate cancer, head and neck cancer and rectal cancer (in Asia by Nanobiotix’s partner PharmaEngine).

    In situ (intratumoral) vaccination with NBTXR3 opens new potential prospects in Immuno Oncology

    The aim of Immuno Oncology (IO) is to boost patients’ immune systems to fight cancer, through different approaches. It is very efficient for a limited number of patients whose tumors have natural and sufficient immunogenicity. However, to exploit the full potential of immune therapies it is necessary to increase this immunogenicity at tumor level.

    Indeed, it has been demonstrated that radiotherapy can be used to improve immunogenicity, by creating Immunogenic Cell Death (ICD) in many situations.

    NBTXR3 nanoparticles’ activation enhances the energy deposited where they are injected, improving the cancer cell death and efficacy of radiotherapy. This technology is based on physics and can potentially be applied across all radiotherapy indications. All preclinical model have shown a systematic superiority of cell killing, when using NBTXR3 with radiotherapy, compared to radiotherapy alone.

    Hence, NBTXR3 could have the potential to be used as an in situ (intratumoral) vaccination that would create ICDs which, in turn, could bring a new dimension and broaden the usage of immuno therapies in oncology.

    To explore this brand new field of development opportunities, the Company has launched a pre-clinical development program.
  6. Ferdinand 62 2 februari 2016 11:26
    Er begint weer beweging in het aandeel te komen. De verwachtingen voor dit jaar zijn hoog en zoals CEO Levy aan heeft gegeven was de belangrijkste zaak van vorig jaar meer bekend worden en werken aan productontwikkeling. Het ziet er naar uit dat dit een mooi jaar gaat worden. de koers werkt de laatste dagen in ieder geval weer mee. Op 20 januari een dieptepunt van € 12,39 maar inmiddels weer ruim boven de € 16,- Er zijn twee koersdoelen die beiden boven de € 30,- staan. Potentie genoeg nu nog afwachten of het dit jaar word waargemaakt.
  7. Ferdinand 62 4 maart 2016 09:30
    Vandaag weer mooie berichten over Nanobiotix. Gilbert Dupont geeft een koersdoel voor 12 maanden van € 31,- en voor de verdere toekomst zelfs mogelijkheden tot € 131,- Uiteraard afhankelijk van de opbrengsten van de behandelingen. Maar feit is wel dat de vooruitzichten erg goed zijn en met sprongen vooruit gaan. Ook in de huidige koers is te zien dat er meer vertrouwen komt. 21 januari stond de koers nog op € 13,02 en inmiddels ruim boven de € 17,-
  8. Ferdinand 62 2 mei 2016 16:58
    Op 29 april is Nanobiotix met haar cijfers gekomen over 2015. Naar aanleiding hiervan heeft Gilbert Dupont Het koersdoel vandaag gezet op € 42,90. De koers staat op dit moment ongeveer 5 % hoger, iets boven de € 18,- Een mooi moment om in te stappen of bij te kopen. Zelf zit ik er al behoorlijk in en zie ook de mogelijkheden voor Nanobiotix.
  9. Ferdinand 62 31 mei 2016 09:04
    Geweldig nieuws van Nanobiotix! Ik geef al een tijd aan dat dit volgens mij een bedrijf is met veel mogelijkheden en dit onderstaande bericht geeft hier weer een bevestiging van. Zoals eerder gemeld zit ik er zelf behoorlijk in, maar blijf altijd objectief. Verdiep je in het aandeel en doe er je voordeel mee.

    Nanobiotix establishes promising preclinical proof-of-concept in Immuno Oncology

    05.31.2016



    Paris, France, Cambridge, MA, USA May 31, 2016 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces today that the Company has established preliminary preclinical proof-of-concept (POC) with the lead product NBTXR3 for its new program in Immuno Oncology (IO).
    Delivering first promising data with its Immuno Oncology preclinical program, showing the potential to turn the tumor itself into a vaccine using NBTXR3
    Creating a potential new usage and new market for NBTXR3 in parallel to its mainstream clinical development
    Providing new opportunities by combining NBTXR3 with other Immuno Oncology drugs with a unique competitive advantage

    Immuno-oncology works by boosting patients’ immune systems to recognise and attack tumours and therefore, kill the cancer. The approach is very efficient for a limited number of patients whose tumors have the ability to provoke an immune response i.e. they have a natural and sufficient immunogenicity, and are referred to as ‘hot’ tumors. However, in many patients, the tumours are ‘cold’ and the therapeutic approach has little response.

    To be able to expand the number of patients that can respond to IO, thereby exploiting its full potential, immunogenicity needs to be increased at the tumor level. Nanobiotix’s approach to achieve this is to trigger Immunogenic Cell Death (ICD) at the tumor level, transforming “cold tumors” into “hot tumors”.

    Preliminary in vitro and in vivo preclinical data suggest that Nanobiotix’s radioenhancer NBTXR3 might be used, not only to destroy tumors (as it is currently being clinically developed), but also to enhance the power of radiotherapy to create intratumoral vaccines for IO, and convert ‘cold’ tumours to ‘hot’.

    NBTXR3 current clinical development to destroy tumors and provide better local control of cancer

    NBTXR3 is a radio-enhancer, using a physical mode of action to destroy cancer cells in any solid tumors, in combination with radiotherapy.

    Nanobiotix is running a global clinical development program with its lead product NBTXR3, in six indications across Europe, the US and the Asia-Pacific Region: a registration trial in soft tissue sarcoma, and Phase I/II trials in liver cancers (HCC and liver metastases), prostate cancer, head and neck cancer and rectal cancer (in Asia by Nanobiotix’s partner PharmaEngine).

    New usage of NBTXR3 for in situ (intratumoral) vaccination opening new potential prospects in Immuno Oncology: preliminary preclinical proof of concept

    NBTXR3 nanoparticles’ activation by radiation enhances the energy deposited where they are injected, improving cancer cell death and the efficacy of radiotherapy. This technology is based on physics and can potentially be applied across all radiotherapy indications. All preclinical model (in vitro and in vivo) have shown a systematic superiority of cell killing, when using NBTXR3 with radiotherapy, compared to radiotherapy alone.
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