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Abivax

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  1. forum rang 4 Bioteg71 14 mei 2020 07:44
    ABX464 inhibits replication of SARS-CoV-2 (COVID-19) in reconstituted human respiratory epithelium model
    ABX464 is the only drug candidate with a potential triple action for COVID-19 treatment: antiviral, anti-inflammatory and tissue repair
    ******
    ABX464, as assessed by RTqPCR, inhibits in vitro viral replication of SARS-CoV-2 (COVID-19)

    Simultaneously, Abivax receives ANSM and CPP clearance[1] to test ABX464 as promising
    COVID-19 therapeutic candidate in Phase 2b/3, randomized,
    1,034 patient, miR-AGE clinical trial

    COVID-19 patients die from acute respiratory failure resulting from viral replication inducing pulmonary hyper-inflammation or longer-term fibrosis

    ABX464 is the sole drug candidate with such promising triple activity, inhibition of SARS-CoV-2 replication shown in vitro, inflammation reduction and tissue repair shown in ulcerative colitis patients

    ABX464 would meet U.S. NIH/NIAID COVID-19 strategic priorities for novel drugs: antiviral, anti-inflammatory, tissue repair, oral administration, convenient once-daily administration

    ******

    PARIS, France, May 14, 2020 – 06:00 a.m. (CET) – Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announces today that ABX464 inhibits replication of SARS-CoV-2 in an in vitro reconstituted human respiratory epithelium model, as assessed by Transepithelial electrical resistance and RTqPCR. ABX464 has already been shown to be an effective drug candidate in a severe inflammatory disease, ulcerative colitis. miR-124 specific upregulation by ABX464 can explain the triple effect of the drug candidate on inhibiting viral replication, down-regulation of cytokines that induce inflammation and tissue repair.

    The breakthrough scientific data Abivax is reporting today make ABX464 a unique potential treatment for COVID-19 patients. Given the current pandemic and patient’s excessive inflammatory response to viral replication as the primary cause of acute respiratory distress syndrome (ARDS) and death of COVID-19 patients, ABX464 with its convenient oral administration and its potential unique triple mode of action, will be urgently tested in a European clinical trial as a potential new treatment to:

    - Prevent and reduce inflammation, as already demonstrated in another severe inflammatory disease, ulcerative colitis. Indeed, ABX464 has been shown to upregulate miR-124[2], a “natural brake” of inflammation. miR-124 down-regulates the multiple chemo- and cytokines involved in the COVID-19 cytokine storm, including TNF alpha, IL-1 beta, G-CSF, IL-6, MCP-1 and IL-17.

    - Reduce viral replication, mediated by RNA quality control and miR-124 induced inhibition of dynamin 2, a key component necessary for viral replication.

    - Promote tissue repair and decrease pulmonary fibrosis.


    By binding to the Cap Binding Complex (CBC), ABX464 allows the splicing of a non-coding RNA, LncRNA 205, to produce miR-124, a potent anti-inflammatory microRNA that prevents the translation of multiple chemo- and cytokines as mentioned above. Furthermore, the replication of SARS-CoV-2 requires dynamin 2, a GTPase responsible for vesicle scission and cell penetration of the virus. Dynamin 2 is a target gene of miR-124 and downregulated by miR-124 upregulation.

    Antiviral experiments were performed at the International Research Center specialized in infectiology at Claude-Bernard-Lyon-1 University, VirPath laboratory.

    Manuel Rosa-Calatrava, Ph.D., VirPath Co-director at the International Center for Infectiology Research in Lyon, France said: “Although in vitro results cannot predict clinical benefits in patients, this antiviral effect against SARS-CoV-2 with ABX464 obtained in our laboratory is very promising, in addition to the known anti-inflammatory properties. ABX464’s antiviral effect and protection of tissue integrity are significant as they are based on a physiologic in vitro reconstituted human pulmonary epithelium model and not on the more basic monkey kidney Vero E6 cells model”.

    Philippe Pouletty, M.D., Chairman of Abivax and CEO of Truffle Capital said: “When we patented the anti-SARS-CoV-2 effect of ABX464, based on our research on its mechanism of action and coronavirus physiopathology, we were very cautious about the ability to demonstrate an antiviral effect in such a stringent human pulmonary epithelium model. We wish to thank the VirPath team that was able to do this rapidly and rigorously.”

    Prof. Hartmut Ehrlich, M.D., CEO of Abivax added: “Our demonstration of the antiviral effect of ABX464 against SARS-CoV-2 further strengthens the rationale for initiating the miR-AGE clinical study, making ABX464 a promising drug candidate to be investigated clinically. With the recent approval of the miR-AGE clinical trial by ANSM (the French regulatory authorities) and the ethics committee, we will soon start patient recruitment to find out whether this triple activity of ABX464 can be translated into clinical benefits for patients diagnosed with COVID-19.”

    This potential triple role of ABX464 is extremely promising, and it is the only drug candidate in the world today to show such a complementarity. In addition, convenient ABX464 daily oral dosing allows early treatment of patients in or out of hospital, to potentially act on viral replication, cytokine production, pulmonary tissue repair, before severe complications occur.

    ******

    About Abivax

    Abivax, a clinical stage biotechnology company, is mobilizing the body’s natural immune machinery to treat patients with autoimmune diseases, viral infections, and cancer. Abivax is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 to treat severe inflammatory diseases, and ABX196 to treat hepatocellular carcinoma.

    More information on the company is available at www.abivax.com. Follow us on Twitter @ABIVAX.

    About Truffle Capital

    Established in 2001, Truffle Capital is an independent European Venture Capital company, specializing in breakthrough technologies in life sciences (BioTech and MedTech) and in FinTech and InsurTech fields. Truffle Capital’s mission is to support the creation and development of young innovative companies able to become tomorrow’s leaders. More information: www.truffle.com – Twitter: @trufflecapital
  2. [verwijderd] 14 mei 2020 10:42
    quote:

    poil-1 schreef op 27 december 2019 13:32:


    Ik kocht ooit een pakket aandelen Galapagos aandelen die ik met winst verkocht heb. Maar ik durf soms niet te kijken of Galapagos al 200 noteert ;)
    Dat gaat mij niet nog een keer overkomen. Dit pakket Abivax blijft op de plank.
    Groet, poil



    Abivax volgens Der Aktionär:
    Geduld loont
    “Abivax is ook van plan verschillende antivirale verbindingen te testen tegen Covid-19. Abivax is een van de meest veelbelovende biotech small-caps in Europa. De reset biedt risicobewuste beleggers de mogelijkheid om het Abivax-aandeel toe te voegen aan de langetermijndeposito ', schreef DER AKTIONÄR in nummer 14/2020 en raadde aan om de hete aandelen te kopen tegen prijzen van ongeveer EUR 13,60.

    Inmiddels omzet 330K
    Abivax SA 22,70 5,58 32,59 % 10:41:43

    Succes en blijf ze vasthouden. Amerika komt nog, poil
  3. [verwijderd] 14 mei 2020 13:15
    www.4investors.de/nachrichten/mobile/...

    Bijna 45 procent plus is momenteel voor het Abivax-aandeel in Tradegate-handel. Het Franse biotechbedrijf zet de koerssprong vandaag op gang met een bericht over nieuwe wetenschappelijke gegevens over de Covid-19-medicijnkandidaat ABX464, die veel aandacht trekt in de corona-crisis: “Met behulp van RTqPCR (virus-RNA-analyse met behulp van kwantitatieve real-time PCR), werd aangetoond dat ABX464 de in vitro virusreplicatie van SARS-CoV-2 (COVID-19) aantoonbaar remt ”, meldt het bedrijf. ABX464 wordt ontwikkeld voor de behandeling van ernstige ontstekingsziekten zoals colitis ulcerosa.

    In de huidige fase van de tests moet u echter nog steeds voorzichtig zijn en kunnen de resultaten niet noodzakelijkerwijs worden overgedragen op mensen. "Hoewel in vitro resultaten het klinische voordeel voor patiënten niet kunnen voorspellen, is de antivirale activiteit van ABX464 tegen SARS-CoV-2 die we in ons laboratorium zagen, samen met de bekende ontstekingsremmende eigenschappen van de stof, veelbelovend," zegt Manuel Rosa-Calatrava, mededirecteur van VirPath bij het Centre International de Recherche en Infectiologie (CIRI) in Lyon. "Het antivirale en weefselbeschermende effect van ABX464 is significant omdat het gebaseerd is op een fysiologisch, gereconstitueerd menselijk longepitheelcelmodel en niet op het vereenvoudigde Vero-E6-niercelmodel van apen", zegt Rosa-Calatrava.

    Abivax werkt nu aan het bevestigen van de gegevens in klinische onderzoeken. Het biotechbedrijf heeft nu goedkeuring gekregen van zowel het Franse Geneesmiddelen Bureau (ANSM) als de ethische commissie voor een fase 2b / 3 klinische proef met ABX464 voor de behandeling van Covid-19-patiënten. Abivax is van plan 1.034 patiënten in te schrijven voor de klinische proef. "Omdat de pathogenese van COVID-19 complex is, moeten we voorzichtig zijn met het mogelijke succes van de miR-AGE-studie", zegt Philippe Pouletty, Abivax-voorzitter en CEO van Truffle Capital. "We hebben voldoende ABX464-capsules op voorraad om ongeveer 50.000 patiënten te behandelen en kunnen binnen enkele maanden ABX464 produceren voor meer dan een miljoen patiënten", zegt Hartmut Ehrlich, CEO van het bedrijf.
    Abivax: aandeelhouderswaarde wordt "een essentieel criterium" voor de Evotec-partner

    Met ABX464 heeft de Franse Evotec-partner Abivax een zeer interessant actief ingrediënt tegen ontstekingsziekten zoals colitis ulcerosa in zijn portfolio. Ondanks sterke prijsstijgingen zien analisten nog steeds een hoog prijspotentieel voor het biotechaandeel. Ondertussen staat het bedrijf voor belangrijke vervolgstappen.

    Groet, poil
  4. forum rang 4 Bioteg71 14 mei 2020 17:57
    Abivax verdient veel meer aandacht. Ik durf wel te stellen dat het bedrijf enorm is ondergewaardeerd. Molecuul ABX464 is breed inzetbaar met prima resultaten tot dusver. Als analisten en grote investeerders dit gaan inzien spuit de koers omhoog. Er staan nog geen 13 miljoen aandelen uit.
  5. grounds for hope ? 14 mei 2020 20:23
    Ze (we) hadden pech dat dit prachtig hoopgevend nieuws op een bloedrode beursdag uitkwam.

    Ik ben wat teleurgesteld door het koersverloop. Maar de Fransen zijn nog geterroriseerd na het genfit debacle van eergisteren, en kiezen momenteel liever eieren voor hun geld.

    Ja Abivax heeft een enorm potentieel. Onno, je zocht toch een leuke overnamekandidaat ?
  6. forum rang 4 Bioteg71 15 mei 2020 23:02
    €36 million non-dilutive funding from Bpifrance for ABIVAX’ ABX464 Covid-19 program
    ******

    Funding covers 1,034-patient placebo-controlled ABX464 Phase 2b/3 COVID-19

    miR-AGE trial, manufacturing scale-up and additional development costs related to the potential filing of ABX464 Marketing Authorization Applications

    ABX464’s triple effect well suited for COVID-19 treatment evaluation in clinical trial: antiviral, anti-inflammatory and tissue repair

    ABX464 miR-AGE Phase 2b/3 trial was approved by ANSM and Ethical Committee CPP and is expected to enroll first patients soon

    Additional European regulatory approvals in process

    ******

    PARIS, France, May 15, 2020 – 10:30 p.m. (CEST) – Abivax SA (Euronext Paris: FR0012333284 – ABVX), a late stage clinical biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announces today that Bpifrance (Copil, SGPI) approved a €36 million non-dilutive funding (€20.1. million grant, and €15.9 million loan refundable upon success) for its Phase 2b/3 trial of ABX464 in high-risk patients with COVID-19 as well as manufacturing scale-up and additional clinical and other development costs.

    Philippe Pouletty, M.D., Founder and Chairman of the Board of Abivax and CEO of Truffle Capital, said: “We are very pleased to announce this approval of a €36 million non-dilutive funding for the COVID-19 miR-AGE Phase 2b/3 study and ABX464 pharmaceutical and clinical development program, to potentially provide a novel treatment option for patients with COVID-19. We would like to thank Bpifrance, the Secrétariat Général pour l’Investissement and their outstanding teams that worked hard with Abivax to speed-up their in-depth evaluation and decision process. Our gratitude also goes to ANSM, the ethics committee, clinicians and our partners that joined in this special effort. Our goal is to now implement the 1,034 patients ABX464 miR-AGE trial as rapidly as possible and, if we get positive results, bring with no delay ABX464 to the market and manufacture sufficient drug product for patients.”

    Prof. Hartmut Ehrlich, M.D., CEO of Abivax, said: “The orally available ABX464, with its unique mechanism of action resulting in a triple effect - antiviral, anti-inflammatory, tissue repair - may have the potential to improve the outcome for patients with COVID-19. Now, with funding for the clinical and development program in place, we are rapidly initiating this rigorously designed clinical trial to hopefully translate the promising features of ABX464 into tangible clinical benefits for the patients. If miR-AGE is successful, we will work with regulators to make ABX464 available as quickly as possible, including rapid manufacturing scale-up. In parallel, we continue the ABX464 Phase 2b trial for ulcerative colitis, Phase 2a for rheumatoid arthritis, and the preparation of a Phase 2b trial for Crohn’s disease. Securing this financing from Bpifrance is a first major step towards funding Abivax for the next 18-24 months, preferably non-dilutive.”

    Bpifrance is the investment bank of the French state, supporting entrepreneurial activities that are in the public interest. The financing will allow to fund the consortium led by Abivax (including Nice University Hospital) in order to conduct the ABX464 COVID-19 miR-AGE clinical study, as well as ABX464 manufacturing scale-up and additional clinical and other development costs. The provision of funding is planned to take place over a period of one year, including expenditures since February 1, 2020, to be implemented as soon as the administrative steps have been completed. The funding consists of €20.1 million in grants and €15.9 million in refundable loans, which Abivax would repay after ABX464 reaches commercial stage. Specific agreements with regards to this financing will be finalized between Abivax and Bpifrance in the coming weeks.

    Abivax recently announced clearance by the French regulatory authorities (ANSM) and the ethics committee to conduct the randomized, double-blind and placebo-controlled miR-AGE trial in 1,034 elderly or high-risk COVID-19 patients. About 50 French and European clinical study sites are expected to investigate the clinical benefits of Abivax’ lead development candidate ABX464.

    ABX464 is a small molecule with a unique mechanism of action, upregulating a microRNA, miR-124, with antiviral, anti-inflammatory and tissue repair properties, and with convenient once-daily oral dosing. With its triple effect, the molecule is uniquely positioned to potentially limit replication of SARS-CoV-2 virus, prevent and treat the cytokine storm, hyper-inflammation, and acute respiratory failure syndrome as well as potentially limit long-term lung injury. ABX464 is the only molecule known to have this triple effect. However, given the complexity and rapid development of COVID-19 disease, there is no certainty that any medical benefit can be shown in the miR-AGE trial.

    The oral dosage form of ABX464 enables the inclusion of hospitalized and, importantly, non-hospitalized COVID-19 patients into the clinical trial, and high-risk patients will be treated early following diagnosis. The design of the miR-AGE trial should ensure the generation of scientifically and medically valid conclusions. Provided patient recruitment can be achieved and the trial is successful, MAA (market authorization application) filings will be done in France, Europe and globally.

    ******

    About Abivax

    Abivax, a clinical stage biotechnology company, is mobilizing the body’s natural immune machinery to treat patients with autoimmune diseases, viral infections, and cancer. Abivax is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 to treat severe inflammatory diseases, and ABX196 to treat hepatocellular carcinoma.

    More information on the company is available at www.abivax.com. Follow us on Twitter @ABIVAX.
  7. grounds for hope ? 16 mei 2020 17:54
    hier zijn we toch vertrokken, .....

    Ze hebben hun financiering vast !!!!!
    Okay, liever had ik een partner gezien, maar wat nog niet is kan nog komen.
    Ze hebben gisteren een OPA (aankoopaanbieding)
    geweigerd, een bod dat interessant was voor de aandeelhouders (dixit Philippe Pouletty).

    Ze willen het onderzoek van de Covid19 liever zelf doen.
    Momenteel hebben ze een voorraad voor 50.000 behandelingen. Met hun industriele partners hebben ze de capaciteit om 1 million dossissen binnen de 6 maanden te maken.
    Aan een faire prijs van 1.000€ per patient, reken maar ....

    ALS, INDIEN, de molecule ABX464 doeltreffend zou zijn voor Covid19, dan gaan we naar 100€....
    Ondertussen, met al dat goed nieuws, zou 30€ volgende week haalbaar zijn.




  8. forum rang 4 Bioteg71 16 mei 2020 18:02
    quote:

    grounds for hope ? schreef op 16 mei 2020 17:54:


    hier zijn we toch vertrokken, .....


    Ze hebben gisteren een OPA (aankoopaanbieding)
    geweigerd, een bod dat interessant was voor de aandeelhouders (dixit Philippe Pouletty).




    Hoi Grounds for hope.

    Hoe kom je aan die info, of stond dat ergens?

    Dit is een financiering alleen voor COVID-19. Voor financiering andere indicaties krijgen we tzt nog info. Partnering dus ?
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