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Aandeel VALERIO TX PSE:ALVIO.FR, FR0010095596

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Onxeo 2019

77 Posts
Pagina: «« 1 2 3 4 »» | Laatste | Omlaag ↓
  1. ReBa 6 mei 2019 22:35
    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

    Paris (France), Mai 6, 2019 – 6:00 pm CEST – 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 announces a new milestone in the clinical development of AsiDNA™ with the treatment of the first patient in DRIIV-1b, a phase 1b clinical study of AsiDNA™, a first-in-class tumor DNA repair inhibitor, in combination with carboplatin and with carboplatin plus paclitaxel, in patients with solid tumors eligible to such treatments.

    DRIIV-1b is an extension of the DRIIV-1 (DNA Repair Inhibitor administered IntraVenously) phase 1 study currently being completed, in which AsiDNA™, administered intravenously (IV) demonstrated its intratumoral activity by inducing a significant increase in its activity biomarkers in the tumor cells of patients, with a favorable safety profile at various active doses.

    At the active dose of 600 mg, among the three patients included in the cohort, two patients with relapsed, multi-treated metastatic colorectal cancer were controlled with medical imaging, which showed no further disease progression after the second treatment cycle, and continued their treatment with AsiDNA™ for three months. The 600 mg active dose was considered to be optimal for further development of AsiDNA™ in combination with chemotherapy.

    DRIIV-1b aims at showing the safety and efficacy of a 600 mg dose of AsiDNA™ in combination with carboplatin, and carboplatin plus paclitaxel, in up to 18 patients with solid tumors eligible for such treatments (lung, breast, ovarian or head and neck cancers, …). The efficacy of the combinations will be evaluated every six to eight weeks by medical imaging in accordance with RECIST criteria (Response evaluation criteria in solid tumors). The study will take place in Belgium, and initial results are expected in the second half of 2019.

    Dr Nuria Kotecki of the Institute Jules Bordet in Brussels commented: “The «DDR» (DNA Damage Response) approach represents a particularly interesting alternative in cancer treatment. Indeed, combining AsiDNA™, a tumor DNA repair inhibitor, with agents such as carboplatin, that causes breaks in that same DNA, is a very promising approach in terms of synergistic efficacy. On the basis of the safety profile of AsiDNA™ observed in monotherapy, this combination can be considered as we are looking for greater efficacy without aggravating the toxicity observed with chemotherapy. We are thrilled to start this DRIIV-1b study, which should enable us to confirm the preclinical and clinical results already obtained.”

    This first combination trial represents a major milestone in the clinical development of AsiDNA™. Thanks to its highly differentiated mechanism of action, confirmed by exhaustive preclinical studies, the combination of AsiDNA™ with various anti-cancer treatments appears especially relevant to increase their efficacy and avoid the occurrence of resistance from tumors.

    DRIIV-1b is the first combination study of AsiDNA™ by IV administration, aimed at confirming such synergistic efficacy on tumors for which the medical needs remain immense. Positive results from this study will represent a proof of the interest of AsiDNA™ combined with chemotherapy and will open the door to further clinical development of AsiDNA™ IV in a phase 2 program in one or several indications.

    Olivier de Beaumont, Onxeo’s Chief Medical Officer, concluded: “This study marks the start of the clinical development of AsiDNA™ in combination with chemotherapy. The results, expected by the end of the year, will enable us to confirm the potential of our flagship product in indications with strong medical needs. Other combination studies are also being prepared to further support the growing interest in AsiDNA™ and its broad clinical potential. We are very pleased to be continuing our collaboration with Dr Nuria Kotecki, a clinical investigator already involved in the DRIIV-1 study, and we thank her for her help and support in this promising research program.”
  2. forum rang 10 rationeel 7 mei 2019 19:15

    Onxeo (EPA: ONXEO.PA) announced that it has dosed the first patient in the DRIIV-1b expansion Phase Ib study evaluating AsiDNA, the Company’s lead clinical candidate, in combination with carboplatin, and carboplatin plus paclitaxel in patients with advanced solid tumors that are candidates for platinum-based chemotherapy. The study intends to enroll up to 18 patients, and Onxeo expects to deliver initial data in H2 2019. The Company also gave an update from its ongoing DRIIV Phase I study, showing signs of disease control in 2 patients. Full data from that study are expected in H1 2019 – the next inflexion point for the Company.

    First Patient Dosed in DRIIV-1b Combination Study – Topline Data in H2 2019. Onxeo previously showed positive preclinical data combining AsiDNA with other therapeutic agents targeting the DDR pathway including poly ADP ribose polymerase (PARP) inhibitors and carboplatin. Potential additive effects between AsiDNA and carboplatin are supported by data showing increased sensitivity of DDR deficient tumors to platinum-based therapies (DNA-damaging agents). The DRIIV-1b study is being conducted in Belgium, and Onxeo plans to release topline data in H2 2019.

    An Update From the DRIIV-1 Study – AsiDNA Shows Evidence of Controlling Disease. Recall that Onxeo previously announced interim data from 10 patients in its ongoing Phase I DRIIV-1 trial evaluating AsiDNA monotherapy, which included safety and pharmacodynamic measures. The data suggested that AsiDNA was well-tolerated and induced changes in pharmacodynamic biomarkers that indicate a response to double stranded breaks (DSB). In this update, Onxeo reported data from a cohort of patients (n=3) treated with 600 mg of AsiDNA. Medical imaging analysis showed disease control in 2 heavily treated patients with metastatic CRC. Both patients remain on therapy with no evidence of disease progression. We await further information regarding responses and duration of response, when the Company presents full data – H1 2019.

    The DRIIV-1b Study Design. This is a Phase Ib study evaluating AsiDNA plus carboplatin and the triple combination of AsiDNA plus carboplatin and paclitaxel in patients with advanced tumors that are eligible for platinum- based chemotherapies– likely patients with NSCLC, breast, ovarian, and head and neck cancer. Up to 18 patients are expected to receive 600 mg (the defined optimal combinatorial dose) of AsiDNA plus carboplatin, and carboplatin plus paclitaxel. Onxeo is expected to report safety and efficacy data – the aim of the study – in H2 2019.

    Analysts
    Sam Slutsky (AC)
    (212) 915-2573
    sslutsky@lifescicapital.com
    Jacques Villefranc, Ph.D.
    (646) 597-6997
    jvillefranc@lifescicapital.com
    Market Data
    Price $0.91
    Market Cap (M) $49
    EV (M) $49
    Shares Outstanding (M) 54.1
    Fully Diluted Shares (M) 59.6
    Avg Daily Vol 87,529
    52-week Range: $0.88 - $1.56
    Cash (M)* $8.4
    Net Cash/Share $0.01
    Annualized Cash Burn (M) $12.7
    Years of Cash Left* 0.7
    Debt (M) $8.0
    All relevant values converted at 1 Euro to 1.12 USD
    *pro forma
    *Does not include negotiated equity line of credit
    Financials
    FY Dec 2015A 2016A 2017A 2018A
    EPS H1 (0.66) (0.30) (0.27) (1.32)
    H2 NA NA NA NA
    FY (0.53) (0.53) (1.26) (0.22)
    Expected Upcoming Milestones
    H1 2019 – Launch Proof – of – Concept study with AsiDNA plus chemotherapy in solid tumors.
    H1 2019 – Full results from Phase I DRIIV-1 study of IV AsiDNA in solid tumors.
    H1 2019 – Begin preclinical evaluation of platON lead candidate.
    H2 2019 – Initiation of IND filing in the US.
    Risk to Investment
    We consider an investment in Onxeo to be a high-risk investment. There are clinical and commercialization risks associated with their programs, and as with any company, Onxeo may be unable to obtain sufficient capital to fund planned development programs. There are regulatory risks associated with the development of any drug, and Onxeo may not receive FDA or EMA approval for its drug candidates despite significant time and financial investments. Regulatory approval to market and sell a drug does not guarantee that the drug will penetrate the market, and sales may not meet expectations.

  3. forum rang 10 rationeel 7 mei 2019 19:21
    Analyst Certification
    The research analyst denoted by an “AC” on the cover of this report certifies (or, where multiple research analysts are primarily responsible for this report, the research analyst denoted by an “AC” on the cover or within the document individually certifies), with respect to each security or subject company that the research analyst covers in this research, that: (1) all of the views expressed in this report accurately reflect his or her personal views about any and all of the subject securities or subject companies, and (2) no part of any of the research analyst's compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst(s) in this report.

    DISCLOSURES
    Neither the research analyst(s), a member of the research analyst’s household, nor any individual directly involved in the preparation of this report has a financial interest in the securities of the subject company/companies.

    LSC (or an affiliate) has provided non-investment banking securities-related services, non-securities services, and other products or services other than investment banking services to Onxeo S.A. and received compensation for such services within the past 12 months.

    LSC (or an affiliate) has received compensation from Onxeo S.A. for producing this research report. LSC is paid a monthly payment of $1,000 from the Affiliate for preparing and distributing research pertaining to each subject company under contract with the Affiliate. The subject company of this report is covered by this arrangement between LSC and the Affiliate, and LSC has therefore indirectly received compensation from the subject company for publishing this report. No explicit or implicit promises of favorable research coverage have been made to the subject company by LSC or the Affiliate. Neither LSC nor the Affiliate has promised any specific research content as an inducement for the receipt of business or compensation.

    Neither LSC nor any of its affiliates beneficially own 1% or more of any class of common equity securities of the subject company/companies.

    This research contains the views, opinions and recommendations of LifeSci Capital, LLC (“LSC”) research analysts.

    Additionally, LSC expects to receive or intends to seek compensation for investment banking services from the subject company/companies in the next three months.

    LSC does not make a market in the securities of the subject company/companies.

    LSC is a member of FINRA and SIPC. Information used in the preparation of this report has been obtained from sources believed to be reliable, but LSC does not warrant its completeness or accuracy except with respect to any disclosures relative to LSC and/or its affiliates and the analyst's involvement with the company that is the subject of the research. Any pricing is as of the close of market for the securities discussed, unless otherwise stated. Opinions and estimates constitute LSC’s judgment as of the date of this report and are subject to change without notice. Past performance is not indicative of future results. This material is not intended as an offer or solicitation for the purchase or sale of any financial instrument. The opinions and recommendations herein do not take into account individual client circumstances, objectives, or needs and are not intended as recommendations of particular securities, companies, financial instruments or strategies to particular clients. The recipient of this report must make his/her/its own independent decisions regarding any securities or financial instruments mentioned herein. Periodic updates may be provided on companies/industries based on company specific developments or announcements, market conditions or any other publicly available information. Additional information is available upon request.

    Please visit www.lifescicapital.com/equity-research/ for disclosures related to each company that is a subject of this report. Alternatively, please contact us by telephone at (646) 597-6991 or by mail at LifeSci Capital LLC, Attn: Compliance, 250 West 55th Street, Suite 3401, New York, NY 10019 to obtain disclosures relating to any of the companies that are the subject of this report.

    No part of this report may be reproduced in any form without the express written permission of LSC. Copyright 2019.
  4. forum rang 10 rationeel 22 mei 2019 19:49
    Press release

    ONXEO

    Ordinary General Meeting of May 22, 2019

    Renewal of the terms of office of Danièle Guyot-Caparros, Jean-Pierre Bizzari and Jean-Pierre Kinet
    Appointment of Danièle Guyot-Caparros as Chairman of the Board of Directors
    ?
    The press release in PDF

    Paris (France), May 22, 2019 – 6:00 pm CEST – 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, announces that the Ordinary Shareholders’ General Meeting held today approved all resolutions submitted to the vote.

    The Ordinary General Meeting renewed the terms of office of Danièle Guyot-Caparros, Jean-Pierre Bizzari and Jean-Pierre Kinet.

    Mr Joseph Zakrzewski, Chairman of the Board, whose term of office ended at the date of the General Meeting, had indicated that he did not wish to have the renewal of his term of office on the agenda of the meeting.

    Ms Danièle Guyot-Caparros was appointed as the new Chair of the Board of Directors at the end of this meeting, which renewed her office, taking over Mr Joseph Zakrzewski as Chair of the Board, whose term of office ended at the date of the General Meeting.

    Ms Danièle Guyot-Caparros has been an independent director of Onxeo and chairman of its audit committee since June 2013 and, since October 2015, was Senior Director, in charge of governance practices.

    Joseph Zakrzewski, outgoing Chairman of the Board of Directors of Onxeo, said: “I hand over my office as Chairman of the Board to Danièle today knowing that the employee team and my fellow members of the Board of Directors are well positioned to ensure the company’s success in the future. I would like to thank them warmly for their work and determination in making Onxeo a success.”

    Danièle Guyot-Caparros, Chairman of the Board of Directors of Onxeo, added: “I am much honored to hold this office at a time when the Company is executing major developments which are paving the way for future successes. I’m convinced that Onxeo has the means to become a leading player in oncology in the booming field of DNA damage response and I am delighted to continue contributing to this enterprise. "

    Judith Greciet, Chief Executive Officer of Onxeo, concluded: “We are very pleased that Danièle is taking over the position of Chairman of the Onxeo Board of Directors. Her knowledge of the Company and her expertise in the life sciences and biotechnology sectors will be extremely valuable to Onxeo's strategic direction. I would also like to warmly thank Joseph for his support and contributions over the last years.”

    The result of the votes is available on the Company’s website: www.onxeo.com.

    Upcoming events

    - Bio International Convention : June 3-6, 2019 (Philadelphia, USA)

    About Onxeo

    Onxeo (Euronext Paris, NASDAQ Copenhagen: ONXEO) is a clinical-stage biotechnology company developing innovative oncology drugs targeting tumor DNA-binding functions through unique mechanisms of action in the sought-after field of DNA Damage Response (DDR). The Company is focused on bringing early-stage first-in-class or disruptive compounds (proprietary, acquired or in-licensed) from translational research to clinical proof-of-concept, a value-creating inflection point appealing to potential partners.

    Onxeo is developing AsiDNA™, a first-in-class, highly differentiated DNA Damage Response (DDR) inhibitor based on a distinctive decoy & agonist mechanism acting upstream of multiple DDR pathways. Translational research has highlighted the unique properties of AsiDNA™, notably its ability to oppose and even reverse tumor resistance to PARP inhibitors regardless of the genetic mutation status, and its strong synergy with other tumor DNA-damaging agents such as chemotherapy and PARP inhibitors. The DRIIV-1 (DNA Repair Inhibitor-administered IntraVenously) phase I study to evaluate AsiDNA™ by systemic administration (IV) in advanced solid tumors has confirmed the active doses and a favorable human safety profile. The ongoing DRIIV-1b extension study is designed to assess the safety and effectiveness of a 600 mg dose of AsiDNA™ in combination with carboplatin, and carboplatin and paclitaxel, in patients with solid tumors who are eligible for such treatments.

    AsiDNA™ is the first compound generated from platON™, the Company’s proprietary chemistry platform of decoy oligonucleotides dedicated to generate new innovative compounds and broaden Onxeo’s product pipeline. A new compound will begin preclinical trials in the first half of 2019.

    Onxeo’s portfolio also includes belinostat, an HDAC inhibitor (epigenetics). Belinostat is already conditionally FDA-approved in the US as a 2nd line treatment for patients with peripheral T cell lymphoma and marketed in the US under the name Beleodaq® (belinostat IV form).

    For further information, please visit www.onxeo.com.
  5. ReBa 28 mei 2019 18:41
    Onxeo announces final positive data from DRIIV-1 Phase 1
    Study of AsiDNA™ in Advanced Solid Tumors

    Primary safety and activity endpoints met
    Favorable safety profile, maximum tolerated dose not reached, optimal active dose determined
    AsiDNA™ induced the intratumoral activation of its DNA-PK target, confirming its mechanism of action
    The full results of the study will be presented at upcoming international scientific meetings

    The press release in PDF

    Paris (France), May 28, 2019 – 6:00 pm CEST – 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 announced positive final results from the DRIIV-1 phase 1 study assessing the safety and the activity of AsiDNA™, the Company’s first-in-class DNA repair inhibitor, when administered intravenously in patients with advanced solid tumors.

    Olivier de Beaumont, Medical Director of Onxeo, commented: "DRIIV-1 successfully achieved each of its core objectives, including further demonstrating the favorable safety profile of AsiDNA™, confirming its ability to be combined with other agents and validating its mechanism of action in patients’ tumor cells through the marked activation of its targets. Importantly, the optimal active dose of AsiDNA™ has been determined and is being utilized in our ongoing DRIIV-1b study combining AsiDNA™ with chemotherapy. We intend to present the full results of the DRIIV-1 study at future scientific meetings."

    AsiDNA™ is the first compound of a novel class of anti-tumor products. By simulating a DNA break (decoy effect), it binds to the DNA-repairing proteins, thereby preventing the recruitment of these proteins to the damaged genomic site, leading to tumor cells death.

    DRIIV-1, a phase 1 dose-escalation study of AsiDNA™ administered intravenously, was designed to evaluate its toxicity profile as well as its pharmacokinetics and pharmacodynamics parameters via intratumoral activity biomarkers. The study was conducted in four centers in France and Belgium and enrolled twenty-two adult patients. All patients had metastatic cancers and were failing or progressing after one or more standard treatments with no further therapeutic options.

    Five dose levels have been tested (from 200 to 1,300mg) out of the six planned. It was deemed unnecessary to test the sixth dose (1,800mg) since the therapeutic window between the optimal dose of 600mg and the highest tested dose of 1,300mg is considered sufficient.

    Overall, the tolerance profile of AsiDNA™ was considered favorable by the DSMB experts, with 90% of all product-related adverse events being non-specific grade 1 and 2 events. The maximum tolerated dose (MTD) was not reached.

    Most importantly, AsiDNA™ demonstrated systemic activity in DRIIV-1 through the strong activation of its targets, as evidenced by the significant increase, of two intratumoral biomarkers of DNA-PK and the decrease of a tumor proliferation biomarker. At the dose of 600mg, among the 3 patients included in the cohort, 2 patients with relapsed multi-treated metastatic colorectal cancer were controlled without progression at medical imaging at the end of the second cycle of treatment with AsiDNA™, with maintenance of treatment for 3 months.

    This dose was considered optimal for the further development of AsiDNA™ in combination with chemotherapy (carboplatin and carboplatin plus paclitaxel) which started early May 2019 with the first patient treated in the phase 1b trial, DRIIV-1b.

    Judith Greciet, Chief Executive Officer of Onxeo, concluded: “The successful completion of DRIIV-1 is a major milestone for Onxeo as this study validates both the systemic activity of AsiDNA™ and its tolerance profile well-suited for combination treatments. We expect to maintain a strong development momentum and have already started the evaluation of AsiDNA™ in combination with chemotherapy in the DRIIV-1b study. Our teams are already actively working on other clinical development pathways in combination, notably with PARP inhibitors. We would like to warmly thank our investigators and their teams for their support and valuable contributions to this trial and the upcoming ones.”

    About Onxeo
    Onxeo (Euronext Paris, NASDAQ Copenhagen: ONXEO) is a clinical-stage biotechnology company developing innovative oncology drugs targeting tumor DNA-binding functions through unique mechanisms of action in the sought-after field of DNA Damage Response (DDR). The Company is focused on bringing early-stage first-in-class or disruptive compounds (proprietary, acquired or in-licensed) from translational research to clinical proof-of-concept, a value-creating inflection point appealing to potential partners.
    Onxeo is developing AsiDNA™, a first-in-class, highly differentiated DNA Damage Response (DDR) inhibitor based on a distinctive decoy & agonist mechanism acting upstream of multiple DDR pathways. Translational research has highlighted the unique properties of AsiDNA™, notably its ability to oppose and even reverse tumor resistance to PARP inhibitors regardless of the genetic mutation status, and its strong synergy with other tumor DNA-damaging agents such as chemotherapy and PARP inhibitors. The DRIIV-1 (DNA Repair Inhibitor-administered IntraVenously) phase I study to evaluate AsiDNA™ by systemic administration (IV) in advanced solid tumors has confirmed the active doses and a favorable human safety profile. The ongoing DRIIV-1b extension study is designed to assess the safety and effectiveness of a 600 mg dose of AsiDNA™ in combination with carboplatin, and carboplatin and paclitaxel, in patients with solid tumors who are eligible for such treatments.
    AsiDNA™ is the first compound generated from platON™, the Company’s proprietary chemistry platform of decoy oligonucleotides dedicated to generate new innovative compounds and broaden Onxeo’s product pipeline.
    Onxeo’s portfolio also includes belinostat, an HDAC inhibitor (epigenetics). Belinostat is already conditionally FDA-approved in the US as a 2nd line treatment for patients with peripheral T cell lymphoma and marketed in the US under the name Beleodaq® (belinostat IV form).

    For further information, please visit www.onxeo.com.
  11. forum rang 10 rationeel 30 mei 2019 12:38
    Risk to Investment:

    We consider an investment in Onxeo to be a high-risk investment. There are clinical and commercialization risks associated with their programs, and as with any company, Onxeo may be unable to obtain sufficient capital to fund planned development programs. There are regulatory risks associated with the development of any drug, and Onxeo may not receive FDA or EMA approval for its drug candidates despite significant time and financial investments. Regulatory approval to market and sell a drug does not guarantee that the drug will penetrate the market, and sales may not meet expectations.
  14. sp1946 20 juni 2019 19:45

    Onxeo Expands its Pipeline with New Optimized Lead OX401 Entering Proof-of-Concept Preclinical Phase

    • OX401 is the second candidate utilizing Onxeo's proprietary platform of decoy agonists, platON™
    • OX401 is optimized to be a next-generation PARP inhibitor, designed to act on both the DNA Damage Response and the activation of immune response
    • In vivo proof-of-concept results alone and in combination with cancer immunotherapies are expected by early Q4 2019

    The press release in PDF

    Paris (France), June 20, 2019 – 6:30 pm CEST – 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 announced that its new optimized drug candidate, OX401, has started its proof-of-concept preclinical phase. Results of these studies are expected by early Q4 2019.

    OX401 was designed by capitalizing on Onxeo’s expertise of oligonucleotides acting as decoy agonists and exhibits very original properties. During optimization, OX401 has demonstrated that it inhibited the DNA Damage Response by acting on PARP proteins. In parallel, OX401 activated the STING pathway, a recent and promising field of research in immuno-oncology, which makes it amenable to combinations with immuno- oncology agents such as checkpoint inhibitors.

    A comprehensive patent has been filed for OX401 to protect Onxeo's intellectual property rights on this product, alone and in combination with cancer immunotherapies, until 2039.

    Françoise BONO, scientific director, commented: "This new development program represents a significant milestone for Onxeo, as it expands our R&D pipeline and prominently positions the Company at the crossroads of two of the most active fields in oncology, DNA damage response and cancer immunotherapy. Based on the experience and insights gained during the development of AsiDNA™, our first-in-class DNA repair inhibitor, we have developed and optimized OX401 to maintain its unique mechanism of action, while targeting other DNA-binding proteins and other mechanisms of tumor growth, such as the immune response. OX401 could represent a new generation of PARP inhibitors that do not have the limitations of current products, such as the induction of resistance, while providing improved biological properties, especially the activation of innate immunity within tumors."

    While the clinical relevance of PARP inhibitors is now well-established, this class still has a number of limiting factors, particularly the relatively rapid onset of resistance. Its decoy agonist mechanism of action positions OX401 as a next-generation PARP inhibitor that should not present these limitations and instead offer a lack of acquired resistance and more specificity to cancer cells.

    OX401 was also developed to induce a strong immune response through the activation of the STING pathway, an area of significant interest in immuno-oncology. However, current molecules have experienced challenges, notably in terms of toxicity. OX401 is based on the same decoy agonist mechanism as AsiDNA ™, Onxeo’s first-in-class DNA repair inhibitor, which showed good tolerance in the DRIIV-1 Phase 1 study, and should trigger a rapid and significant inducing effect of innate immunity against tumor cells.

    Preclinical proof-of-concept results showing OX401 efficacy, alone and in combination with immunotherapy treatments, are expected early Q4 2019.


    Upcoming events
    • Healthtech Investor Days – Paris June 24-25, 2019 - www.htid-paris.com/

    About Onxeo
    Onxeo (Euronext Paris, NASDAQ Copenhagen: ONXEO) is a clinical-stage biotechnology company developing innovative oncology drugs targeting tumor DNA-binding functions through unique mechanisms of action in the sought-after field of DNA Damage Response (DDR). The Company is focused on bringing early-stage first-in-class or disruptive compounds from translational research to clinical proof-of-concept, a value-creating inflection point appealing to potential partners.
    platON™ is Onxeo’s proprietary chemistry platform of oligonucleotides acting as decoy agonists, which generates new innovative compounds and broaden the Company’s product pipeline.
    AsiDNA™, the first compound from platON™, is a first-in-class, highly differentiated DNA Damage Response (DDR) inhibitor based on a decoy and agonist mechanism acting upstream of multiple DDR pathways. Translational research has highlighted the distinctive properties of AsiDNA™, notably its ability to abrogate tumor resistance to PARP inhibitors regardless of the genetic mutation status, and its strong synergy with other tumor DNA-damaging agents such as chemotherapy and PARP inhibitors. The DRIIV-1 (DNA Repair Inhibitor-administered IntraVenously) phase I study has evaluated AsiDNA™ by systemic administration (IV) in advanced solid tumors and confirmed the active doses as well as a favorable human safety profile. The ongoing DRIIV-1b extension study is assessing the safety and efficacy of a 600 mg dose of AsiDNA™ in combination with carboplatin, and carboplatin and paclitaxel, in patients with solid tumors who are eligible for such treatments.
    OX401 is a new drug candidate from platON™, optimized to be a next-generation PARP inhibitor acting on both the DNA Damage Response and the activation of immune response, without inducing resistance. In vivo preclinical proof-of-concept data are expected early Q4 2019.
    Onxeo’s portfolio also includes belinostat, an HDAC inhibitor (epigenetics). Belinostat is already conditionally FDA-approved in the US as a 2nd line treatment for patients with peripheral T cell lymphoma and marketed in the US under the name Beleodaq® (belinostat IV form).
    www.onxeo.com

    Onxeo
    Valérie Leroy
    Investor relations
    Phone nb.: +33 1 45 58 76 00
    Email: investors@onxeo.com
    NewCap
    Dušan Orešanský / Emmanuel Huynh
    Investor Relations / Strategic Communications
    Phone nb.: +33 1 44 71 94 92
    Email: onxeo@newcap.eu

    NewCap
    Nicolas Merigeau
    Media Relations
    Phone nb.: +33 1 44 71 94 98
    Email: onxeo@newcap.eu
    LifeSci Advisors
    Brian Ritchie
    Investor Relations US
    Phone nb.: +1 212 915 2578
    Email: britchie@lifesciadvisors.com

  16. sp1946 1 juli 2019 10:59
    The equity research company KEPLER CHEUVREUX initiates the coverage of ONXEO with a "Buy" recommendation


    Paris (France), July 1st, 2019 – 7:00 a.m. CEST - Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (hereinafter “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 announced the publication of an initiation report by KEPLER CHEUVREUX, a leading independent European financial services company specialized in research, execution and advisory services.

    KEPLER CHEUVREUX will now cover the ONXEO share on the stock exchange*.

    The financial analysis published on June 28, 2019 by Kepler Cheuvreux is available on the website www.keplercheuvreux.com, section "Research Public Access".

    *This information does not constitute an offer to sell or subscribe, or the solicitation of an order to buy or subscribe for securities in France, Europe, the US or any other country. ONXEO and KEPLER CHEUVREUX have agreed on a service for the production and distribution of financial analyses.

    ***
    About Kepler Cheuvreux
    Kepler Cheuvreux is a leading independent European financial services company specialized in research, execution, advisory services and asset management.
    Headquartered in Paris, the group employs approximately 600 people and operates in 14 major financial centres in Europe and the United States: Amsterdam, Boston, Brussels, Frankfurt, Geneva, London, Madrid, Milan, New York, Oslo, Paris, Stockholm, Vienna and Zurich.
    With an average of €1 billion in shares traded daily and the leading equity research coverage in continental Europe, Kepler Cheuvreux is the leading independent equity broker in Europe.


    About Onxeo
    Onxeo (Euronext Paris, NASDAQ Copenhagen: ONXEO) is a clinical-stage biotechnology company developing innovative oncology drugs targeting tumor DNA-binding functions through unique mechanisms of action in the sought-after field of DNA Damage Response (DDR). The Company is focused on bringing early-stage first-in-class or disruptive compounds from translational research to clinical proof-of-concept, a value-creating inflection point appealing to potential partners.
    platON™ is Onxeo’s proprietary chemistry platform of oligonucleotides acting as decoy agonists, which generates new innovative compounds and broaden the Company’s product pipeline.
    AsiDNA™, the first compound from platON™, is a first-in-class, highly differentiated DNA Damage Response (DDR) inhibitor based on a decoy and agonist mechanism acting upstream of multiple DDR pathways. Translational research has highlighted the distinctive properties of AsiDNA™, notably its ability to abrogate tumor resistance to PARP inhibitors regardless of the genetic mutation status, and its strong synergy with other tumor DNA-damaging agents such as chemotherapy and PARP inhibitors. The DRIIV-1 (DNA Repair Inhibitor-administered IntraVenously) phase I study has evaluated AsiDNA™ by systemic administration (IV) in advanced solid tumors and confirmed the active doses as well as a favorable human safety profile. The ongoing DRIIV-1b extension study is assessing the safety and efficacy of a 600 mg dose of AsiDNA™ in combination with carboplatin, and carboplatin and paclitaxel, in patients with solid tumors who are eligible for such treatments.
    OX401 is a new drug candidate from platON™, optimized to be a next-generation PARP inhibitor acting on both the DNA Damage Response and the activation of immune response, without inducing resistance. In vivo preclinical proof-of-concept data are expected early Q4 2019.
    Onxeo’s portfolio also includes belinostat, an HDAC inhibitor (epigenetics). Belinostat is already conditionally FDA-approved in the US as a 2nd line treatment for patients with peripheral T cell lymphoma and marketed in the US under the name Beleodaq® (belinostat IV form).
    www.onxeo.com

    Onxeo
    Valérie Leroy
    Investor relations
    Phone nb.: +33 1 45 58 76 00
    Email: investors@onxeo.com
    NewCap
    Dušan Orešanský / Emmanuel Huynh
    Investor Relations / Strategic Communications
    Phone nb.: +33 1 44 71 94 92
    Email: onxeo@newcap.eu

    NewCap
    Nicolas Merigeau
    Media Relations
    Phone nb.: +33 1 44 71 94 98
    Email: onxeo@newcap.eu
    LifeSci Advisors
    Brian Ritchie
    Investor Relations US
    Phone nb.: +1 212 915 2578
    Email: britchie@lifesciadvisors.com

  17. sp1946 4 juli 2019 19:24
    AsiDNA™ Letter - No. 1

    The field of DDR and the strategic advantages of AsiDNA™





    Ladies, Gentlemen and Shareholders,

    The clinical development of AsiDNA™ is well on its way and we would like to inform you regularly about the progress being made through a Letter dedicated to this first-in-class candidate. In this first issue, we go back to the fundamentals of the DNA Damage Response (DDR) therapeutic approach in oncology, which consists of fighting cancer by preventing it from repairing its DNA, and for which PARP inhibitors are the most advanced representatives.

    The mechanism of action of AsiDNA™ is particularly innovative and offers unprecedented biological properties which we recall here, and that are highly sought after in a booming field in terms of scientific, financial and strategic agreements.

    In our upcoming issues, we will cover, in detail, the indications and combinations, which we plan to assess very soon in new clinical studies with AsiDNA™.

    We hope you enjoy this summertime read and look forward to sharing with you the next AsiDNA™ Letter in a few weeks’ time.

    > Read the Letter
    Judith Greciet
    CEO



  20. forum rang 10 rationeel 18 juli 2019 18:44
    A WORD FROM THE MEDICAL DIRECTOR

    Ladies, Gentlemen and Shareholders,

    The complexity and diversity of cancers require multiple
    therapeutic approaches. The combination of several anti-cancer
    agents has become the norm in oncology, especially to treat the
    very>>> aggressive or resistant cancers.>>>
    Thanks to its original anti-tumor activity and its good tolerance
    already clinically demonstrated>>>, AsiDNA™>>> is ideally positioned
    to play a key role in new combination strategies aiming to treat
    these cancers, for which the medical needs remain significant.
    AsiDNA™ could therefore become a new essential anti-cancer
    agent in>>> numerous combinations>>>, and this is the objective that
    we are setting through a reasoned and ambitious clinical
    development program.
    We have already started the>>> DRIIV-1b>>> clinical study that
    combines AsiDNA™ with>>> two reference chemotherapy
    treatments>>> and expect to initiate new combination studies
    within the coming months, notably with a>>> PARP inhibitor.>>>
    In this Letter, we are approaching these combinations from the
    standpoint of two potential indications for AsiDNA™,>>> triplenegative breast cancer>>> and >>>advanced ovarian cancer>>>, two
    aggressive pathologies with an unfavorable prognosis.
    I wish all of you pleasant reading and look forward to >>>the end of
    summer>>> for new information regarding the >>>progresses in our
    developments.>>>

    WHY COMBINE ANTI-CANCER TREATMENTS?

    Surgery, radiation, and chemotherapy have been the traditional,
    treatments for cancer for a long time, used alone, successively or in
    combination. For example, many solid tumors are treated first by radiation
    to reduce the tumor, then by surgery to remove as much tumor as possible,
    and finally, by chemotherapy treatment(s) to eliminate every remaining
    tumor cell. Similarly, the reference treatment for some cancers such as
    >>>breast or ovarian cancer>>> is the combination of two chemotherapy
    treatments,>>> carboplatin and paclitaxel.>>>

    Most often, combined therapy increases the chances for recovery or for
    long-term remission. Indeed, a first treatment can make a tumor more
    vulnerable to a second one. Or else, the medications act together, each one
    >>>increasing the strength>>> of the other ones, so that their combined
    effectiveness is>>> greater than the addition of their individual impacts>>>
    (synergy). Combining treatments may also enable using>>> lower doses>>>, thus
    limiting their>>> toxicity>>> or>>> delaying the onset of resistance>>>
77 Posts
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