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Abivax

1. grounds for hope ? 15 juni 2020 22:06

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   • grounds for hope ?

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   ....... En parallèle, Abivax se prépare déjà à d’éventuelles
   autorisations de mise sur le marché et à la commercialisation mondiale d’ABX464 pour le traitement des patients
   COVID-19 à haut risque. »
   
   Dit is toch weeral groot nieuws ....
   
   
2. grounds for hope ? 15 juni 2020 22:06

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   ABIVAX OBTIENT UN FINANCEMENT NON-DILUTIF DE LA SOCIETE
   GENERALE DE 5 MILLIONS D’EUROS SOUS FORME DE PGE
   ******
   Le prêt apporte un financement supplémentaire au financement non-dilutif de
   36 millions d’euros accordé par Bpifrance en mai 2020
   Les activités opérationnelles et les programmes d’études cliniques en cours d’Abivax sont
   entièrement financés jusqu’au début de 2021
   D’autres possibilités de financement non-dilutifs sont en cours d'évaluation
   ******
   PARIS, France, le 15 juin 2020 – 18h00 (CEST) – Abivax SA (Euronext Paris : FR0012333284 – ABVX), société de
   biotechnologie au stade clinique qui mobilise le système immunitaire afin de développer de nouveaux
   traitements contre les maladies inflammatoires, le cancer et les maladies virales, annonce aujourd’hui qu’elle a
   obtenu un financement non-dilutif de 5 millions d'euros de la Société Générale sous forme d’un prêt garanti par
   l’Etat français (PGE).
   Le prêt de 5 millions d’euros est structuré sous forme de PGE (Prêt Garanti par l’État) avec une maturité initiale
   de 12 mois au taux de 0,25% et une option d’extension de 5 ans. Ce prêt non-dilutif étend la trésorerie d’Abivax
   jusqu’au début de 2021.
   Le Professeur Hartmut Ehrlich, Directeur Général d’Abivax, déclare : « Le financement accordé par Bpifrance est
   désormais complété par celui de la Société Générale, et permet à Abivax de maintenir un rythme de
   développement rapide de ses programmes d’études cliniques en cours et prévus. Le recrutement des patients
   avance bien et est conforme à nos attentes concernant nos essais avec ABX464, à savoir la Phase 2b dans la
   rectocolite hémorragique et la Phase 2a dans la polyarthrite rhumatoïde, ainsi que pour notre essai de Phase 1/2
   avec ABX196 dans le carcinome hépatocellulaire. Le premier patient de l’étude COVID-19 avec ABX464 sera
   bientôt inclus – laquelle est menée en Europe ainsi qu’au Brésil et possiblement dans d’autres pays en Amérique
   latine, où la pandémie n’a pas encore atteint son pic. En parallèle, Abivax se prépare déjà à d’éventuelles
   autorisations de mise sur le marché et à la commercialisation mondiale d’ABX464 pour le traitement des patients
   COVID-19 à haut risque. »
   Didier Blondel, Directeur Financier d’Abivax, ajoute : « Au-delà des 36 millions d’euros octroyés par Bpifrance,
   ce financement de 5 millions d’euros de la Société Générale étend notre trésorerie jusqu’au début de 2021. À
   court terme, pour pouvoir réaliser l’intégralité de nos objectifs et pour maintenir nos plans et délais de
   développement, Abivax vise à obtenir au moins 30 millions d'euros de financement supplémentaire. Nous
   entretenons des discussions régulières avec un certain nombre de parties prenantes pour évaluer ces possibilités
   de financement supplémentaires, pour lesquelles nous continuons à nous concentrer sur des options nondilutives. »
   *
3. Bioteg71 16 juni 2020 20:50

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   Op de site van Abivax staat de nieuwste corporate presentation van gisteren maandag 15 juni 2020
   Zie www.abivax.com/investors/
   
   Uit die presentatie twee interessante zaken, die nieuw zijn tov eerdere presentaties
   
   blz. 27: Abivax partnering en/of Nasdaq listing Q2 2021. Vooral Nasdaq listing zou ik goede zet vinden
   blz. 28: koersdoelen van € 24,70 t/m € 41
   
4. Wil Helmus 17 juni 2020 11:04

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   Bedankt voor het delen Bioteg71!
5. Wil Helmus 18 juni 2020 19:39

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   De Franse regering heeft zes projecten geselecteerd voor een totaalbedrag van 78 miljoen euro ter bestrijding van Covid

   Bijlage:
6. Bioteg71 18 juni 2020 21:21

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   quote:

   Wil Helmus schreef op 18 juni 2020 19:39:

   De Franse regering heeft zes projecten geselecteerd voor een totaalbedrag van 78 miljoen euro ter bestrijding van Covid
   

   Toch weer mooi nieuws, alles is meegenomen.
7. Bioteg71 22 juni 2020 20:14

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   abivax.gcs-web.com/news-releases/news...
   
   Abivax provides business update on most recent achievements and announces positive results of annual ordinary and extraordinary general meeting
   ******
   
   Brazilian Health Regulatory Agency approves Phase 2b/3 study miR-AGE
   of ABX464 in COVID-19 patients
   
   miR-AGE study has been approved by French and German regulators, and most recently by the British and Italian regulatory authorities
   
   French government announced the selection of six COVID-19 projects to finance with a total of 78m EUR, with Abivax to receive 36m EUR
   
   Final agreements for the 36m EUR funding have been signed with Bpifrance
   
   Patient enrollment in ulcerative colitis Phase 2b trial post COVID-19 getting back on track,
   with 113 of 232 randomized to date
   
   All resolutions presented during the general meeting were adopted
   
   ******
   
   PARIS, France, June 22, 2020 – 07:00 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, today provides an update on its most recent clinical and financial achievements and developments and announces the positive results of the annual ordinary and extraordinary general meeting held on June 19, 2020.
   
   The Brazilian Health Regulatory Agency (ANVISA - Agência Nacional de Vigilância Sanitária) approved the randomized, double-blind and placebo-controlled miR-AGE trial in high-risk COVID-19 patients. The study, already approved in France and Germany, will now be expanded to Brazil, where the number of new infections is still increasing rapidly. Approval for the miR-AGE trial has also been granted by the British Medicines and Healthcare Products Regulatory Agency (MHRA) and the Italian Medicines Agency (AIFA), with approval in Spain expected shortly.
   
   Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, said: “By expanding the miR-AGE study to Brazil, currently the pandemic’s most active country, we hope to be able to provide an efficient therapeutic option for the treatment of high-risk COVID-19 patients. We are also advancing the approval process in additional Latin American countries that are heavily affected by the rapid expansion of the pandemic. In parallel, patient recruitment is progressing according to our expectations for our ongoing clinical trials with ABX464, i.e. the Phase 2b in ulcerative colitis and Phase 2a in rheumatoid arthritis, as well as the US Phase 1/2 trial with ABX196 to treat hepatocellular carcinoma.”
   
   Prof. Jorge Kalil, M.D., Ph.D., Head of Immunology at the University Hospital in Sao Paulo and miR-AGE overall study coordinator in Brazil, added: “We are eager to start the miR-AGE trial in Brazil and to test this innovative and promising drug candidate for the benefit of all countries and patients affected by the COVID-19 pandemic, which is still globally present. We hope to see a positive effect from the early treatment with ABX464 in reducing the severity of the disease by inhibiting viral replication, preventing hyper-inflammation and thus the potential deadly acute respiratory distress syndrome and also by limiting potential long-term lung injury in patients.”
   
   Philippe Pouletty, M.D., Chairman of the Board of Abivax, said: “We are proud that Abivax’s ABX464 was selected by the French government as a promising drug candidate for treatment of COVID-19. We wish to thank Bpifrance, the Secrétariat Général pour l’Investissement (SGPI) and the French government for their backing and support of Abivax. At the same time, while we are confident that ABX464 may have a positive impact by reducing the severity of COVID-19 sequelae, we remain prudent on expectations for the miR-AGE trial given the complexities surrounding treatment of COVID-19 disease. Progressing ABX464 development in chronic inflammatory diseases remains Abivax’s corporate priority.”
   
   With regards to the financial situation of the Company, the final agreements with Bpifrance, the investment bank of the French state, have been signed following the French government’s selection of six development projects for a potent COVID-19 treatment. These projects will be financed with a total of 78m EUR by the French state, of which Abivax will receive 36m EUR in non-dilutive funding for its 1,034-patient ABX464 Phase 2b/3 COVID-19 (miR-AGE) trial, manufacturing scale-up as well as additional development costs related to other ABX464 studies for the potential filing of ABX464 Marketing Authorization Applications (MAA).
   
   Abivax recently also announced a further 5m EUR non-dilutive financing from Société Générale in the form of a loan guaranteed by the French state (PGE - Prêts Garantis par l’Etat).
   
   Didier Blondel, Chief Financial Officer of Abivax, said: “With the official signing of the final contracts with Bpifrance and the loan recently granted by Société Générale, Abivax’s cash resources will fully finance the corporate objectives and current development plans until early 2021. We currently plan to continue to focus on sourcing additional non-dilutive financing options for the longer term.”
   
   The Company also announces today that it held its annual ordinary and extraordinary general meetings on June 19, 2020 behind closed doors, under the chairmanship of Dr. Philippe Pouletty, Chairman of the Board of Directors and without the physical presence of its shareholders due to COVID-19 social distancing practices.
   
   All resolutions presented by the Board of Directors were adopted, including the compensation policy applicable to the Chief Executive Officer and the directors. Details of the voting results on all resolutions will be available on the company website.
   
   
   
   ******
   
   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_.
8. Wil Helmus 1 juli 2020 18:34

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   2021 wordt een spannend jaar voor Abivax. Weet iemand of we dit jaar nog nieuws kunnen verwachten?
   
   The ongoing Phase 2b clinical trial with ABX464 in ulcerative colitis remains an Abivax top priority. Given the COVID-19 crisis and related emergency situations in many hospitals, patient recruitment is now expected to be completed by the end of 2020 and first high-level results are expected in Q2 2021.
   
   The Phase 2a clinical study with ABX464 in rheumatoid arthritis should complete recruitment in 2020 with first high-level results expected in early Q1 2021.
   
   For Abivax’s ongoing clinical trial with ABX196 to treat patients with hepatocellular carcinoma, the first data of the escalation phase of the study will probably be available during H1 2021.
9. Bioteg71 2 juli 2020 08:36

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   Abivax treats first patient in Phase 2b/3 ABX464 Covid-19 clinical trial
   ******
   
   First patient treated in “miR-AGE” trial at University Hospital Center in Nice (CHU Nice)
   
   50 study sites and 1,034 high-risk patients to participate in the European and
   Latin American placebo-controlled trial
   
   ABX464 works via unique triple action: antiviral, anti-inflammatory and tissue repair
   
   Easy, once daily oral administration allows inclusion of hospitalized as well as non-hospitalized COVID-19 patients
   
   Results from this study expected by year-end
   
   ******
   
   PARIS, France, July 02, 2020 – 07:30 a.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 the first patient has been treated in its Phase 2b/3 study of ABX464 in COVID-19 patients at the University Hospital Center in Nice, France (CHU Nice).
   
   The randomized, double-blind, placebo-controlled miR-AGE study investigates the effect of early treatment (at point of diagnosis) in 1,034 COVID-19 elderly or high-risk patients. The main goal of the trial is to measure the potential of ABX464 to limit viral replication as well as the severe inflammation that leads to acute respiratory distress syndrome (ARDS). Abivax has already received clearance for the study from the regulatory authorities in France and Germany as well as in the UK, Italy and Brazil and expects authorization to follow in Spain and additional Latin American countries with high infection rates, including Mexico, Chile and Peru in due course.
   
   Prof. Hartmut Ehrlich, M.D., CEO of Abivax, said: “We are pleased that the first patient in our miR-AGE trial has been treated and that recruitment and treatment at further sites in Europe and Latin America can now proceed swiftly. After the approval of the regulators in Brazil, additional regulatory approvals in Latin American countries, where the epidemic has still not reached its peak, are expected to follow soon. We expect first top-line results from miR-AGE by the end of the year. Enrollment in our other clinical trials is now back on track with more than half (122/232) of the patients randomized in the ulcerative colitis Phase 2b trial and with recruitment in the Phase 2a trial in rheumatoid arthritis and the US Phase 1/2 trial in hepatocellular carcinoma progressing as well. With non-dilutive funding provided by Bpifrance and Société Générale, Abivax’s projects are fully financed until early 2021 and discussions for further, preferably non-dilutive financial options are ongoing.”
   
   “The treatment of the first patient in the miR-AGE trial is an important milestone for Abivax,” added Philippe Pouletty, M.D., Chairman of the Board of Abivax and CEO of Truffle Capital. “While further study centers in Europe are being initiated, we also continue to expand the trial in additional Latin American countries. The already available regulatory and national ethics committee clearance in Brazil make a recruitment start in July realistic, as we are only missing the local ethics approvals. Furthermore, the ongoing preparation of filing in Mexico, Chile and Peru are very important, as the pandemic is still very active in these countries. While we are confident that ABX464 may have a positive impact by reducing the severity of COVID-19 sequelae, we remain prudent on expectations for the miR-AGE trial given the complexities surrounding treatment of COVID-19 disease. Progressing ABX464 development in chronic inflammatory diseases remains Abivax’s corporate priority.”
   
   Eric Cua, M.D., Infectiologist at the University Hospital Center (CHU) of Nice, said: “As the principal investigator at the CHU in Nice, I am glad that the first patient has been treated and I am very much looking forward to evaluating whether early treatment with ABX464 will have a positive effect in COVID-19 patients. ABX464’s unique triple mode of action could potentially limit the replication of SARS-CoV-2 virus, prevent and treat the cytokine storm or hyper-inflammation – and the ensuing acute respiratory failure syndrome – as well as limit long-term lung injury through tissue repair. Due to ABX464’s easy, once-daily oral administration, we can include hospitalized as well as non-hospitalized COVID-19 patients in this trial. We hope that the findings in this placebo controlled and randomized trial bring us one step closer to a potent treatment for this disease in order to protect especially high-risk patients and avoid tense situations in hospitals and intensive care units in the future.”
   
   ABX464 has already demonstrated impressive efficacy in a Phase 2a trial in another severe inflammatory disease, ulcerative colitis (UC). In this trial, specifically, potent anti-inflammatory effects and tissue healing were observed. The results in UC patients together with the unique molecular mechanism of action of ABX464 support the rationale to use the drug candidate to treat the cytokine storm and hyper-inflammation syndrome observed in COVID-19 patients. Hyper-inflammation in the lung is the primary cause of the respiratory distress and potential death in COVID-19 patients.
   
   ABX464’s molecular action has been shown to upregulate a micro-RNA, miR-124, which is a “physiological brake” on inflammation. It works by down-regulating 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. In addition, unlike other potent anti-inflammatory agents that specifically target single cytokines, ABX464 has not been associated with increased vulnerability to opportunistic infections or a damping down of the immune system.
   
   Furthermore, in previous clinical testing ABX464 has been shown to have antiviral effects against HIV and it is the first therapeutic candidate ever in development that reduced HIV reservoirs in patients. More recently, ABX464 demonstrated a marked antiviral effect, inhibiting SARS-CoV-2 (COVID-19) replication in reconstituted human respiratory epithelium model.
   
   Financing for this Phase 2b/3 trial, as well as manufacturing scale-up, additional clinical and other development costs is provided by the French investment bank Bpifrance, with 36 million EUR in non-dilutive funding. In addition, Abivax recently received 5 million EUR in non-dilutive financing from Société Générale in the form of a loan guaranteed by the French state. Abivax’s operations and ongoing clinical study programs are fully financed until early 2021.
   
   ******
   
   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_.
10. Bioteg71 2 juli 2020 10:36

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    Inmiddels bijna op € 23,- en een freeze. Momenteel relatief veel omzet. Apart dat het nu opeens wel losgaat....
12. Bioteg71 3 juli 2020 11:17

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    twitter.com/EuroMed_Awards
    
    Mediscience Awards
    @EuroMed_Awards
    ·
    14 u
    Huge congratulations to the 4 outstanding companies shortlisted for the Best Technology Award this year
    @Abivax_
    , #argenx,
    @OxfordBiomedica
    and
    @RenalytixAI
    . Read more about the innovation behind these group's technologies at mediscience-event.co.uk/awards/shortl... #shortlisted #besttech
13. Bioteg71 3 juli 2020 11:19

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    www.mediscience-event.co.uk/awards/sh...
14. Wil Helmus 3 juli 2020 20:28

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    quote:

    Bioteg71 schreef op 3 juli 2020 11:19:

    www.mediscience-event.co.uk/awards/sh...
    

    Ik heb het idee dat Abivax nu redelijk onbekend is. Zou mooi zijn als ze winnen. Zorgt voor meer naamsbekendheid in Europa. Dan ook nog even een notering aan de nasdaq, kunnen ze in Amerika ook overstag;-)
15. Wil Helmus 4 juli 2020 11:04

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    Ik lees op twitter dat Abivax voor een 28 daagse behandeling tegen corona €1,000 in Europa en $4,000 in de US gaat vragen. Indien blijkt dat het primaire doel van ABX464 bereikt wordt, namelijk virale replicatie en ernstige ontsteking beperken, dan is the sky the limit voor dit aandeel. Eind dit jaar weten we meer....
16. Wil Helmus 16 juli 2020 17:53

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    Paar interessante tweets van German biotech:
    
    $ABVX has an extremely versatile and valuable substance in ABX464. It is well known that ABX464 has anti-inflammatory and antiviral effects via upregulation of miR-124. However, it is also interesting that miR-124 inhibits tumor growth and sensitizes tumors for chemotherapy.
    
    2/n
    
    As I have seen in my routine searches of the European patent database, Abivax $ABVX has investigated the anti-tumor mechanism of ABX464 and filed a patent for it.
    More about this later.
17. de tuinman 22 juli 2020 16:18

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    quote:

    Bioteg71 schreef op 16 juni 2020 20:50:

    Op de site van Abivax staat de nieuwste corporate presentation van gisteren maandag 15 juni 2020
    Zie www.abivax.com/investors/
    
    Uit die presentatie twee interessante zaken, die nieuw zijn tov eerdere presentaties
    
    blz. 27: Abivax partnering en/of Nasdaq listing Q2 2021. Vooral Nasdaq listing zou ik goede zet vinden
    blz. 28: koersdoelen van € 24,70 t/m € 41
    
    

    ?????
    
    26 man/vrouw personeel?
    10 miljoen cash?
    
    Hoe kunnen ze ooit die pipeline verder ontwikkelen?
18. Wil Helmus 22 juli 2020 18:22

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    Dit is toch een tegenvaller. Alles moet wijken voor hun covid trial?
    $abvx #abx464 #uc dose finding study completion 9m later, now june2021, us sites finally starting recruitment
    
    t.co/5OianJmujI
19. Bioteg71 23 juli 2020 07:56

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    quote:

    Wil Helmus schreef op 22 juli 2020 18:22:

    Dit is toch een tegenvaller. Alles moet wijken voor hun covid trial?
    $abvx #abx464 #uc dose finding study completion 9m later, now june2021, us sites finally starting recruitment
    
    t.co/5OianJmujI
    

    Dit was al enige tijd bekend hoor, zie ook investor presentatie van 2 juli. Vertraging heeft ook te maken met het tijdelijk stopzetten van werven kandidaten fase 2b ivm covid-19. Daar hebben andere bedrijven ook last van (gehad).
20. Wil Helmus 23 juli 2020 11:19

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    quote:

    Bioteg71 schreef op 23 juli 2020 07:56:

    [...]
    
    Dit was al enige tijd bekend hoor, zie ook investor presentatie van 2 juli. Vertraging heeft ook te maken met het tijdelijk stopzetten van werven kandidaten fase 2b ivm covid-19. Daar hebben andere bedrijven ook last van (gehad).
    

    Heb ik gemist. Wel vreemd omdat ze eerder aangegeven hebben dat UC hun prioriteit blijft. Dan maar hopen dat ABX464 tegen Covid en succes wordt. Ze lijken hiervan zelf nogal overtuigd, aangezien ze eerder aangegeven hebben dan de overname van Abivax is afgeketst omdat ze perse door wilden met dit onderzoek. En omdat covid nu blijkbaar meer prioriteit heeft dan UC.
21. Wil Helmus 26 juli 2020 08:49

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    Van twitter (even door Google translate grhaald):
    
    Karine Lacombe Specialist in infectieziekten en hoofd van de afdeling infectieziekten van het ziekenhuis Paris Saint Antoine:
    
    Hallo dokter, sinds een paar dagen horen we, naast uw onderzoek naar plasma, over onderzoeken met 2 hoopvolle geneesmiddelen: SNG001 en ABX464, wat denkt u ervan? Dankjewel.
    
    Goedenavond, twee ontstekingsremmende moleculen die op immuniteit inwerken, één in aerosol (SNG001), de andere in tablet (ABX464), al getest bij andere pathologieën. Het is nog te vroeg om te zeggen dat het op grote schaal werkt, het belooft veel in vroege proeven!