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Onxeo 2019

77 Posts
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  1. Heinz 3 januari 2019 19:32
    Paris (France), January 3, 2019 – 6.00 pm CET - Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (“Onxeo” or “the Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology, in particular against rare or resistant cancers, today announces the identification of predictive biomarkers for AsiDNA™, its first-in-class non-targeted DNA Damage Response (DDR) inhibitor, which enables personalized medicine approaches.

    Judith Greciet, Chief Executive Officer of Onxeo, said: “The development of AsiDNA™ is undergoing a strong momentum both in terms of preclinical and clinical activities. Identifying predictive biomarkers is an important step forward that will assist in the design of the next phases of the clinical development of AsiDNA™. Indeed, these biomarkers will make possible an upstream selection of the patients with a better sensitivity to treatment with AsiDNA™, which will maximize the likelihood of success for upcoming clinical studies as well as enable a personalized medicine approach for these patients over time. We now have a robust and state-of-the-art set of preclinical and clinical data for this particularly promising drug candidate in the field of DDR. The identified biomarkers are important components in the design of future studies and will be included as soon as the next phase 1b/2 combination study that we expect to initiate in the coming weeks, thanks to the favorable intermediate results of activity and tolerance in the ongoing DRIIV-1 study. Each of these advances in our developments significantly enhances the value of AsiDNA™ and our R&D assets."

    Preclinical studies identified predictive biomarkers for patient selection in upcoming studies of AsiDNA™

    Extensive tests investigated AsiDNA™ sensitivity signature using bioinformatics analysis from transcriptomic experiments, validated this signature in vitro on multiple cell lines and then analyzed the genes presenting an expression profile highly correlated with sensitivity to AsiDNA™.

    These studies showed that sensitivity to AsiDNA™ is correlated with the level of DNA repair gene expression in the tumor and identified several tumor genes for which the level of expression is the most correlated to AsiDNA™ sensitivity. A low level of these genes expression in a patient’s tumor greatly increases the likelihood that the patient will respond to treatment with AsiDNA™. As a result, analysis of these genes will be used to select the patients with the highest sensitivity to treatment and thus the greater probability of response in upcoming trials.

    Use of such predictive biomarkers is part of the best practices in clinical trial design and in treatment (personalized medicine) today. During clinical development, their use greatly reduces risks and maximizes the chances of success. In clinical practice, prior assessment via predictive biomarkers allows for personalized care that optimizes the patient's chances by selecting the most appropriate treatment for a given patient.
  2. forum rang 9 rationeel 12 maart 2019 19:42
    Onxeo maakt de financiële resultaten voor het volledige jaar 2018 bekend en biedt een zakelijke update


    Klinische ontwikkeling van AsiDNA ™ gaat door in fase 1 studie DRIIV-1
    Activiteit van AsiDNA ™ aangetoond door de gemarkeerde activatie van zijn cellulaire doelen waardoor de actieve doses en het gunstige tolerantieprofiel kunnen worden bepaald
    Dreigende initiatie van een fase 1b-onderzoek in combinatie met op platina gebaseerde chemotherapie en paclitaxel; voorlopige resultaten verwacht voor het einde van 2019
    Nieuwe lead-compound afkomstig van platON ™, gereed voor het invoeren van preklinische proof-of-concept-onderzoeken
    Kaspositie van € 11,3 miljoen op 31 december 2018 en nieuwe aandelenfinanciering onderhandeld om te zorgen voor cash runway in Q2 2020
  3. forum rang 9 rationeel 12 maart 2019 19:44
    Judith Greciet, Chief Executive Officer van Onxeo, zei:"2018 werd gekenmerkt door belangrijke prestaties die het potentieel van onze unieke aanpak van DNA-schade (DDR) bevestigden met onze eerste leidende kandidaat-geneesmiddel AsiDNA ™. In termen van ontwikkeling hebben we opmerkelijke gegevens verkregen uit verschillende preklinische studies van AsiDNA ™ in combinatie met andere kankerbehandelingen zoals chemotherapie en PARP-remmers, met name op tumorcellijnen die resistent zijn tegen PARP-remmers. We hebben ook voorspellende biomarkers voor respons op AsiDNA ™ geïdentificeerd, waarmee we de weg vrijmaken voor gebruik in gepersonaliseerde geneeskunde.

    Vanuit klinisch standpunt gaat onze fase 1-dosisescalatiestudie, DRIIV-1, van AsiDNATM die intraveneus wordt toegediend in geavanceerde vaste tumoren, op volle snelheid verder en heeft de activiteit van AsiDNA ™ al aangetoond door de activering van zijn tumorceldoelen, met een goede tolerantieprofiel. We zijn nu klaar om een ??uitbreiding van Fase 1b-onderzoek naar AsiDNA ™ in combinatie met chemotherapie te starten met behulp van de actieve doses die zijn bepaald in DRIIV-1. Voorlopige resultaten van deze DRIIV-1b-studie worden verwacht voor het einde van het jaar en zullen een belangrijke mijlpaal zijn voor AsiDNA ™.

    Naast ons positieve momentum met AsiDNA ™, is onze eerste verbinding afkomstig van platON ™ klaar om de preklinische proof-of-concept-fase in te gaan. Deze nieuwe kandidaat, die profiteert van een gedifferentieerde reeks functies van AsiDNA ™, zal onze pijplijn vergroten en onze unieke positionering in het DDR-veld versterken. "


    Over Onxeo
    Onxeo (Euronext Paris, NASDAQ Kopenhagen: ONXEO) is een biotechnologiebedrijf in klinische fase en ontwikkelt innovatieve oncologische geneesmiddelen gericht op tumor DNA-bindende functies via unieke werkingsmechanismen in het gewilde DNA-schadebereik (DDR). Het bedrijf richt zich op het brengen van first-in-class of disruptieve compounds (proprietary, acquired of in-licensed) van translationeel onderzoek naar klinische proof-of-concept, een waarde creërend buigpunt dat een beroep doet op potentiële partners.

    Onxeo ontwikkelt AsiDNA ™ , een first-in-class, sterk gedifferentieerde DNA-beschadigingsrespons (DDR) -remmer op basis van een uniek lokmiddel en agonistmechanisme dat stroomopwaarts van meerdere DDR-routes werkt. Translationeel onderzoek heeft de unieke eigenschappen van AsiDNA ™ benadrukt, met name het vermogen om resistentie tegen PARP-remmers tegen te gaan en zelfs om te keren, ongeacht de genetische mutatiestatus en de sterke synergie met andere tumor DNA-beschadigende middelen zoals chemotherapie en PARP-remmers. De lopende fase I-studie DRIIV-1 (DNA-reparatie-inhibitor-intraveneus toegediend) evalueert AsiDNA ™ door systemische toediening (IV) in solide tumoren en heeft onlangs gunstige tolerantie- en activiteitsresultaten opgeleverd.

    AsiDNA ™ is de eerste verbinding die wordt gegenereerd op basis van platON ™ , het eigen chemieplatform van decoy-oligonucleotiden dat is bedoeld om nieuwe innovatieve verbindingen te genereren en de pijplijn van Onxeo te verbreden.

    Het portfolio van Onxeo omvat ook belinostat , een HDAC-remmer (epigenetica). Belinostat is in de VS al voorwaardelijk door de FDA goedgekeurd als behandeling op de tweede lijn voor patiënten met perifeer T-cellymfoom en wordt in de VS op de markt gebracht door Onixo's partner, Acrotech Biopharma LLC, onder de naam Beleodaq® (formulier Belinostat IV).



    Ga voor meer informatie naar www.onxeo.com.
  4. sp1946 25 maart 2019 20:12

    Onxeo to Present Data supporting Lead Asset AsiDNA™
    in 5 Poster Presentations at 2019 American Association for Cancer Research Annual Meeting

    The full press release in PDF

    Paris (France), March 25, 2019 – 6.00 pm CET - Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (“Onxeo” or “the Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR) in oncology, in particular against rare or resistant cancers, today provides details on the presentation of data from five studies supporting the company’s lead drug candidate, AsiDNA™, in poster sessions at the upcoming American Association for Cancer Research (AACR) Annual Meeting being held March 29 - April 3, 2019, in Atlanta, GA, USA.

    Françoise Bono, PhD, Chief Scientific Officer, commented: “We are very pleased to have five studies accepted and presented at the prominent AACR meeting as it reflects the interest, the quality and the diversity of our current translational research on AsiDNA™. Through these data, we further demonstrate the uniqueness of our lead compound in terms of mechanism of action and its related unique properties, especially on preventing the occurrence of resistance to treatment, one of the major issues in oncology today. All these data complement and reinforce our rationale for the continued clinical development of AsiDNA™ expected to start in the coming weeks, now that we have identified the active doses that trigger target engagement and confirmed the favorable safety profile in our phase I DRIIV study. We look forward to presenting and discussing our very exciting findings during the conference."

    Details of the sessions on April 1 and 2, 2019 include:

    Abstract 2095 / Poster 2 – AsiDNA™, a targeted therapy with no acquired resistance
    • Session: PO.ET03.03. Drug Resistance 3
    • Date: Monday, April 1
    • Time: 1:00 p.m. – 5:00 p.m. ET
    • Location: Section 11
    AsiDNA™ is the first antitumor drug with an agonist activity. This study demonstrates that long term exposure of cancer cells to the strong alarm signal, generated by AsiDNA™ does not promote resistance emergence. It induces a stable new state characterized by the down regulation of the targeted pathways that persists for months after treatment. This property is due to the original mechanism of action of AsiDNA™, which acts by over-activating a “false” signaling of DNA damage through DNA-PK and PARP enzymes. Such property is not observed with other DNA repair inhibitors such as the PARP inhibitors olaparib and talazoparib. Long term treatment with AsiDNA™ induces the occurrence of an “alarm down” state in the tumor cells that increases product’s efficacy. These results suggest that agonist drugs such as AsiDNA™ could promote a state-dependent tumor cell evolution by lowering their ability to respond to damage signal.

    Abstract 2130 / 7 – Development of a biomarker-driven patient selection strategy for AsiDNA™ treatment (collaboration with Institut Curie)
    • Session: PO.ET04.04 - Molecular Classification of Tumors
    • Date: Monday, April 1
    • Time: 1:00 p.m. – 5:00 p.m. ET
    • Location: Section 12
    Accurate evaluation and prediction of response to anti-cancer treatment remain a great challenge. Stratification biomarkers are of great value to identify responders or non-responders to a specific drug, or even to distinguish between early and delayed responses. In this study, we identified a gene signature to predict AsiDNA™ treatment efficacy in patients. As AsiDNA™ is being currently tested in a clinical trial, a potential exists for a rapid validation of our gene set in the aim to develop a biomarker-driven patient selection strategy for AsiDNA™ treatment.

    Abstract 2918 / 6 – Molecular analysis of the mechanism of action of AsiDNA™ brings new clues on DNA damage response regulation
    • Session: PO.TB09.01 - Tumor Radiosensitivity or Resistance
    • Date: Tuesday, April 2
    • Time: 8:00 a.m. – 12:00 p.m. ET
    • Location: Section 8
    In this study, we investigated the different steps involved in AsiDNA™ activity. Data show that AsiDNA™ inhibits NHEJ and HR double-strand break DNA repair by preventing the recruitment of key enzymes at break sites. The inhibition of NHEJ proteins recruitment is the earliest event and requires PARP activity. The inhibition of HR proteins appears lately and is dependent upon DNA-PK activation. PARP activation induces metabolism change that might participate to the antitumoral activity of AsiDNA™. These results highlight the unique mechanism of action of AsiDNA™ through the activation of two complementary key enzymes involved in DNA damage response.

    Abstract 2865 / 6 – AsiDNA™, a novel DNA repair inhibitor to sensitize aggressive medulloblastoma subtypes (Institut Curie)
    • Session: PO.TB09.01 - Targets and Therapies in Pediatric Cancer
    • Date: Tuesday, April 2
    • Time: 8:00 a.m. – 12:00 p.m. ET
    • Location: Section 6
    Medulloblastoma is pediatric tumor of the cerebellum. It represents the most frequent malignant brain tumor in childhood. Patients who survive often present severe treatment-related morbidity. It is therefore important to improve treatment efficacy in more aggressive subgroups as well as reduce treatment-related morbidity across all subgroups. In this study, no increase of irradiation toxicity was observed with AsiDNA™. In vivo, AsiDNA™ alone significantly enhances survival rates (p=0.005) and increases radiotherapy efficacy. When combined with radiotherapy, AsiDNA™ led to delay in tumor growth and survival improvement as compared to radiotherapy alone.

    Abstract 3797 / 2 – AsiDNA™ abrogates acquired resistance to PARP inhibitors
    • Session: PO.ET03.05 - Drug Resistance 5
    • Date: Tuesday, April 2
    • Time: 1:00 p.m. – 5:00 p.m. ET
    • Location: Section 10
    PARP inhibitors (PARPi) are approved for the treatment of homologous recombination (HR)-deficient cancers. Despite the success of this approach, drug resistance remains a clinical hurdle. In our study, long term exposure of cancer cells to PARPi induced the emergence of resistance in all the tested independent populations, raising the question of the clinical benefit of long-term maintenance monotherapy with PARPi. Interestingly, double-treated populations with AsiDNA™ (2.5µM - low non cytotoxic dose) and talazoparib or olaparib showed a significant lower probability of resistance occurrence. Furthermore, AsiDNA™ is able to partially revert talazoparib resistance in resistant populations. Our results indicate that AsiDNA™ may abrogate and reverse PARPi acquired resistance by the normalization of the expression and activity of involved proteins.

  5. forum rang 4 RW1963 24 april 2019 19:12
    quote:

    rationeel schreef op 24 april 2019 09:40:

    Nee. Nog geen bodem.

    Het lijkt er op, dat het aandeel nog een keer down gaat. Er zou een dubbele bodem gevormd kunnen worden.

    Er is een lange bullflag gevormd, dus er is alle hoop voor de toekomst:)
    Geen idee wat je allemaal schrijft :-), maar het laatste gedeelte van jouw zin bevalt mij wel. Hopelijk duurt die toekomst alleen geen jááááren :-)
  6. Heinz 6 mei 2019 21:24
    Onxeo Announces Treatment of First Patient in DRIIV-1b, a Phase 1b Clinical Trial of AsiDNA™ in Combination with Chemotherapy.

    • DRIIV-1b is designed to assess the clinical potential of AsiDNA™ in combination with carboplatin and with carboplatin plus paclitaxel in patients with solid tumors eligible to such treatments
    • Initial results are expected in the second half of 2019

      Upcoming events
    • Shareholder’s ordinary general meeting : May 22, 2019 (Paris, France)
    • Bio International Convention : June 3-6, 2019 (Philadelphia, USA)
77 Posts
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