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Combined therapy, that is, the utilization of several agents in the treatment of a patient, has become the norm in the treatment of cancer today. Some new medications today complete the traditional triad, such as >>>“targeted”>>> therapies that aim at>>> genes>>> or at >>>specific proteins in tumor cells>>>, medications that>>> “starve”>>> the tumors or prevent>>> their growth>>> and >>>immuno therapies>>> which uses the>>> immune system against tumors>>>, etc. As with traditional treatments, these new treatments have limitations or are faced with the>>> resistance>>> of tumors. They are thus also evaluated or approved in combination with reference treatments to increase their effectiveness.For the most common breast cancers, there are some very effective, targeted therapies and many women are cured from their breast cancer today. Yet, >>>15 to>>> 20%>>> of these patients have a>>> “triple-negative” (TNBC) >>>breast cancer, that is, without any hormonal or protein receptorin the>>> surface>>> of the cancer cells, likely to respond to a targeted therapy. These are very aggressive cancers with a high risk of >>>metastatic recurrence within 3 years>>> of diagnosis. The standard treatment is chemotherapy, with high toxicity risks. For this cancer with a poor prognosis and difficult to treat, >>>the combination of chemotherapy treatments that cause breaks in the DNA and a>>> compound like AsiDNA™>>>, which>>> prevents the repair of the DNA breaks>>>, is a clinical development pathway supported by the preclinical demonstration of a strong synergy of >>>AsiDNA™ with chemotherapy>>>, including in>>> non-mutated, resistant tumors such as triple-negative breast cancer.>>>
Press release Onxeo Reports Half-Year 2019 Financial Results and Provides Business Update • Finalization of DRIIV-1 Phase 1 study confirming AsiDNA™ activity and safety profile • Initiation of DRIIV-1b study of AsiDNA™ with chemotherapy, on track with preliminary results expected end H2 2019 and final results in H1 2020 • New optimized lead OX401 undergoing proof-of-concept preclinical studies • Cash position of €6.3 million at June 30, 2019 complemented by the Nice & Green equity line, providing financial visibility until Q3 2020 The full press release in PDF Paris (France), July 25, 2019 – 7.00 pm CEST - Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO - FR0010095596), (“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 reported its consolidated half-year financials, as of June 30, 2019, and provided a business update. Judith Greciet, Chief Executive Officer of Onxeo, said: “During the first half of 2019, we have achieved major progress in our developments that continue to enhance the value of our first-in-class lead drug candidate AsiDNA™ and our other R&D assets. With regards to AsiDNA™, the well-executed DRIIV-1 phase I study of AsiDNA™ in solid tumors provided positive results by meeting each of its core objectives and notably confirming both the activity and the tolerance of AsiDNA™. Based on these sound data, we have launched the first phase 1b study of AsiDNA™ in combination with a reference chemotherapy (carboplatin and paclitaxel) in patients suffering from eligible solid tumors. In parallel, we plan to initiate a second combination clinical study with a PARP inhibitor by year-end to assess the ability of AsiDNA™ to abrogate the acquired resistance to PARP inhibitors, a major limitation for their clinical use. We also recently expanded our pipeline with our new optimized lead OX401 that entered a proof-of-concept preclinical phase. OX401 is based on the same decoy agonist mechanism as AsiDNA™ and was designed to be a next-generation PARP inhibitor that does not induce resistance but triggers a strong immune response through the activation of the STING pathway. This new candidate is at the crossroads of DNA Damage Response and immuno oncology, the two most attractive domains in cancer treatment. By renewing our equity financing line with Nice & Green last June, we have secured the needed financial resources over at least the next 12 months to confidently move forward the developments of these two high potential candidates.” 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
HALF-YEAR 2019 HIGHLIGHTS, RECENT DEVELOPMENTS AND OUTLOOK AsiDNA™ - In early January 2019, reporting of the identification of biomarkers predicting the response to AsiDNA™, which could optimize its clinical development by selecting the most responsive patients to AsiDNA™, as well as making it eligible to personalized medicine approaches. - In April 2019, presentation of 5 posters at 2019 American Association for Cancer Research (AACR) Annual Meeting with supportive data on AsiDNA™ as a therapy with strong potential for cancer treatment. - In May 2019, announcement of final positive data from DRIIV-1 phase 1 study of AsiDNA™ in advanced solid tumors and initiation of DRIIV-1b, a phase 1b clinical study of AsiDNA™ in combination with chemotherapy in patients with solid tumors - DRIIV-1b study is progressing on track to deliver preliminary results in H2 2019 and final results in H1 2020, before pursuing with a phase 2 study. - The Company plans to start a combination study of AsiDNA ™ with a PARP inhibitor, no later than in the first half of 2020 to validate the abrogation of the acquired resistance to these treatments by AsiDNA ™. platON™ - At the end of June 2019, announcement of the pipeline expansion with an innovative & optimized lead compound, OX401, entering proof-of-concept preclinical phase. OX401 is the second candidate utilizing Onxeo's proprietary platform of decoy agonists, platON™, with differentiated and complementary properties to those of AsiDNA™. - In vivo results alone and in combination with cancer immunotherapies expected by early Q4 2019 Beleodaq® - On March 1, 2019, Spectrum Pharmaceuticals (SPPI) announced the completion of the sale of its portfolio of seven FDA-approved hematology/oncology products, including Beleodaq®, to Acrotech Biopharma L.L.C. On the basis of the information provided to date, the Company does not anticipate any significant impact of this transaction on activities and results from Beleodaq® for Onxeo. Corporate & Financing - Following the Ordinary General Meeting of May 22, 2019, Ms. Danièle Guyot-Caparros was appointed as the new Chair of the Board of Directors, taking over Mr. Joseph Zakrzewski whose term of office ended at the date of the General Meeting. She 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 good governance practices. – In early June 2019, Onxeo renewed the equity line with Nice & Green for a maximum amount of €10.2m, in order to secure sufficient financial resources to support the Company’s operations beyond the key milestones expected in the upcoming 12 months and to extend the cash runway until Q3 2020. – At the end of June 2019, the equity research company KEPLER CHEUVREUX has initiated the coverage of ONXEO with a “Buy” recommendation.
Hopen dat de koers gaat reageren:)
Ja, dat reageren is er wel geweest. Nu de low opzoeken?
Cumulative Antitumor Efficacy with a Low Probability of Acquired Resistance??? Author links open overlay panelWaelJdey*†‡1MariaKozlak*†1SergeyAlekseev*†SylvainThierry*†PaulineLascaux‡Pierre-MarieGirard*†FrançoiseBono‡MarieDutreixwww.sciencedirect.com/science/article...
Gaat het nog een keer stijgen of hoe zit dat?
RW1963 schreef op 17 augustus 2019 18:21 :
Gaat het nog een keer stijgen of hoe zit dat?
Het kabbelt nog wat door rond de huidige prijs en tevens wordt er telkens wat van de prijs afgeknabbeld. En op en dag schieten we weer even omhoog naar een paar euro om vervolgens weer zwakjes af te glijden......
Bodem? Omhoog: 65...74...82...89...1,05 ?
Onxeo to Attend Key Investor and Scientific Conferences The press release in PDF Paris (France), September 11, 2019 – 5.45 pm CEST - Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO - FR0010095596), (“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 management team will attend the following key investor and scientific conferences in the coming months: Investir Day October 15, 2019, Paris, France A new event providing shareholders and retail investors with the opportunity to meet and discuss with executives of listed companies. A masterclass session by Judith Greciet, CEO of Onxeo, is scheduled during the event. The Galien Medstartup 2019 October 24, 2019, in New York, NYC, United-States The Galien Foundation fosters, recognizes and rewards excellence in scientific innovation to improve the state of human health. Its vision is to be the catalyst for the development of the next generation of innovative treatment and technologies that will impact human health and save lives. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics October 26-30, 2019, in Boston, MA, United-States The premier international meeting featuring novel cancer therapeutics organized by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC). Direct Dirigeants event with Les Echos – Investir November 6, 2019, in Paris, France Presentation by Judith Greciet, CEO of Onxeo, to individual investors and shareholders. 2nd Annual DNA Damage Response Therapeutics SummitJanuary 29-31, 2019, in Boston, MA, United-States The Summit brings together the leading pharma and biotech companies accelerating the development of DNA repair pathway inhibitors, to optimize drug discovery, broaden patient population and generate greater efficacy. 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
Het ziet er niet naar uit dat dit ooit nog weer goed komt. Jammer geld.
Onxeo announces positive intermediate results from the first part of the DRIIV-1b study evaluating AsiDNA™ in combination with chemotherapy Stabilized disease without tumor progression for two of the three treated patients who are still receiving treatment with AsiDNA™ plus carboplatin Satisfactory tolerance allowing the continuation of the study Start of the second part of the study to evaluate AsiDNA™ in combination with carboplatin and paclitaxel, a reference treatment protocol for many cancers Preliminary results from this second part are expected at the end of the year
RW1963 schreef op 18 september 2019 14:49 :
Het ziet er niet naar uit dat dit ooit nog weer goed komt. Jammer geld.
Rustig afwachten:)
Une actualité riche ce matin dans le secteur des biotechs / medtechs, avec des résultats semestriels, des avancées de recherche et des recommandations d'analystes. AsiDNA en seconde phase. Onxeo obtient des résultats intermédiaires positifs sur la première partie de l'étude DRIIV-1b avec AsiDNA en association avec la chimiothérapie, sur trois patients. La seconde partie de l'étude, en combinaison avec carboplatine et paclitaxel chez des patients atteints de tumeurs solides métastasées éligibles à ce traitement, va démarrer. Dans la première partie de l'étude, le traitement n'a entraîné ni intoxication ni effets indésirables sévères. Deux des trois patients traités présentent un contrôle de la tumeur depuis la mise en place du traitement depuis plus de 4 et 5 mois. Le traitement est poursuivi jusqu’à progression éventuelle de la tumeur ou intolérance au carboplatine.
TA: Uit de dalende wig. Gapje: 0,634
Gap dicht. Terug in dalende wig.
Onxeo, Winner of the Innov'up Leader PIA Call for Projects, Receives Funding of €495,000 The winning project aims to develop a drug candidate in immuno-oncology from the platON™ platform Funding from the French State and the Île-de-France Region, operated by Bpifrance, consists of a grant of €330,000 and a repayable advance of €165,000
Is nu met 0,50 de low bereikt? Gaan we de weg terug naar 2,49? Het te volgen pad: 0,97...1,26...1,50...2,49?
rationeel schreef op 23 oktober 2019 14:51 :
Is nu met 0,50 de low bereikt?
Gaan we de weg terug naar 2,49?
Het te volgen pad:
0,97...1,26...1,50...2,49?
I hope so. Bij 2,49 heb ik zelfs ietsje winst ;-)
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