Abivax

Abivax SA (Euronext: ABVX) is a clinical-stage, publicly traded biotechnology company harnessing the immune system to develop novel treatments against inflammatory diseases, viral diseases and cancer. The company is headquartered in Paris, France [1] and closely cooperates with the CNRS Collaborative Laboratory in Montpellier, France.

Abivax
Euronext: ABVX
IndustryBiotechnology, Pharmaceutical
Founded2013
FounderPhillipe Pouletty, M.D.
Headquarters
Paris
,
France
Key people
Prof. Hartmut Ehrlich, M.D. CEO
Number of employees
27
Websiteabivax.com

Founding and IPO

Abivax has been founded in December 2013 in Paris under the leadership of Truffle Capital[2] by Phillipe Pouletty, co-founder and Chairman of the Board.

In 2015, Abivax launched its initial public offering on the stock market Euronext[3] in Paris, raising EUR 57.7m, a record[4] amount for a French biotechnology company on the Euronext in Paris.

Initially, Abivax focused on the development of a novel treatment in HIV with lead drug candidate ABX464.[5] As the molecule showed a strong anti-inflammatory effect in preclinical models,[6] Abivax decided to conduct a Phase 2a clinical study in ulcerative colitis, an inflammatory bowel disease (IBD).[7] Based on the promising results of this clinical study in ulcerative colitis,[8] the Company decided to shift its focus towards the treatment of chronic inflammatory diseases.

Pipline

ABX464 in inflammatory diseases

Abivax focuses on the treatment of inflammatory diseases, namely ulcerative colitis (UC), Crohn’s disease (CD), rheumatoid arthritis (RA) and also COVID-19, where the hyper-inflammation syndrome[9] is known to be the cause of the severe form of the disease. Its lead drug candidate, ABX464, is an oral, first-in-class, small molecule[10] that has demonstrated safety and tolerability[11] as well as profound anti-inflammatory activity in preclinical as well as clinical trials in UC and HIV.[12]

ABX464 for the treatment of ulcerative colitis

ABX464 is currently being tested in a clinical Phase 2b trial[13] in patients with moderate-to-severe ulcerative colitis, composed of an induction and a maintenance study, conducted in 15 European countries, Canada and the US. The previously conducted Phase 2a induction and maintenance studies in UC generated very promising results with regard to safety and tolerability as well as durable efficacy of ABX464 after the second year of treatment.[14]

ABX464 for the treatment of Crohn’s disease

Based on the good safety profile and promising efficacy results obtained for ABX464 in UC and due the clinical similarities of CD and UC, Abivax has been encouraged by its KOLs to initiate a pivotal Phase 2b/3 trial for the treatment of CD.[15]

ABX464 for the treatment of rheumatoid arthritis

In addition to the clinical observations in UC patients, Abivax generated promising pre-clinical data from collagen-induced arthritis animal models[16] that were the basis for moving into the ongoing Phase 2a clinical trial in rheumatoid arthritis.[17] The study investigates the safety and tolerability of ABX464 in combination with methotrexate in patients with moderate-to-severe active RA. Patients enrolled in the study had an inadequate response to methotrexate or/and to one or more anti-tumor necrosis factor alpha (TNFα) therapies.

ABX464 for the treatment of COVID-19

Due to the lack of an effective vaccine or treatment option[18] and based on the potentially beneficial effect of ABX464 to reduce the severity of COVID-19 disease and to prevent acute respiratory distress syndrome (ARDS),[19] Abivax decided to expand its clinical trial program to treat COVID-19 high-risk patients. The Company has initiated a Phase 2b/3 clinical trial[20] to test the potentially beneficial antiviral, anti-inflammatory and tissue repair properties of ABX464 in this indication.

ABX196 for the treatment of hepatocellular carcinoma

ABX196 is Abivax’s second drug candidate currently in clinical development. ABX196 has been developed as a synthetic agonist of iNKT cells,[21] demonstrating immune enhancing effects in cancer models.[22] Together with the Scripps MD Anderson Cancer Center in San Diego, California, and the MD Anderson Cancer Center in Houston, Texas, Abivax is currently conducting a Phase 1/2 clinical trial[23] of ABX196 to treat patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.[24]

Abivax research activities

Abivax is conducting all R&D work in Montpellier[25] where half of the company’s staff is based at its collaborative laboratory. The scientists in Montpellier closely collaborate with the French National Center for Scientific Research (CNRS), the Institut Curie and the University of Montpellier.[26]

References
  1. "Abivax SA". www.bloomberg.com. Retrieved 2018-11-29.
  2. "Truffle Capital creates therapeutic vaccines developer Abivax". www.cosmeticsbusiness.com.
  3. "Abivax s'introduit sur Euronext Paris | euronext.com".
  4. Bayre, Guillaume (June 23, 2015). "Abivax inscrit un nouveau record par le montant levé sur Euronext Paris".
  5. "Treatment of the First HIV Positive Patient in ABIVAX's Phase IIa Clinical Trial With ABX464". www.prnewswire.com.
  6. "Analyst Report" (PDF). www.genesta-finance.com. 31 May 2018. Retrieved 2020-10-23.
  7. "ABX464 as a Treatment for Ulcerative Colitis". HCPLive.
  8. "Positive results for ABX464 as an oral treatment ulcerative colitis | Coloproctology News". www.coloproctologynews.net.
  9. Manson, Jessica J.; Crooks, Colin; Naja, Meena; Ledlie, Amanda; Goulden, Bethan; Liddle, Trevor; Khan, Emon; Mehta, Puja; Martin-Gutierrez, Lucia; Waddington, Kirsty E.; Robinson, George A.; Santos, Liliana Ribeiro; McLoughlin, Eve; Snell, Antonia; Adeney, Christopher; Loeff, Ina Schim van der; Baker, Kenneth F.; Duncan, Christopher J. A.; Hanrath, Aidan T.; Lendrem, B. Clare; Soyza, Anthony De; Peng, Junjie; J'Bari, Hajar; Greenwood, Mandy; Hawkins, Ellie; Peckham, Hannah; Marks, Michael; Rampling, Tommy; Luintel, Akish; Williams, Bryan; Brown, Michael; Singer, Mervyn; West, Joe; Jury, Elizabeth C.; Collin, Matthew; Tattersall, Rachel S. (1 October 2020). "COVID-19-associated hyperinflammation and escalation of patient care: a retrospective longitudinal cohort study". The Lancet Rheumatology. 2 (10): e594–e602. doi:10.1016/S2665-9913(20)30275-7. PMC 7442426. PMID 32864628.
  10. "Abivax begins patient enrolment in clinical trial of ABX464 to treat HIV - Clinical Trials Arena". www.clinicaltrialsarena.com.
  11. Rutsaert, Sofie; Steens, Jean-Marc; Gineste, Paul; Cole, Basiel; Kint, Sam; Barrett, P Noel; Tazi, Jamal; Scherrer, Didier; Ehrlich, Hartmut J; Vandekerckhove, Linos (2019). "Safety, tolerability and impact on viral reservoirs of the addition to antiretroviral therapy of ABX464, an investigational antiviral drug, in individuals living with HIV-1: a Phase IIa randomised controlled study". Journal of Virus Eradication. 5 (1): 10–22. doi:10.1016/S2055-6640(20)30273-9. PMC 6362909. PMID 30800421.
  12. Chebli, Karim; Papon, Laura; Paul, Conception; Garcel, Aude; Campos, Noëlie; Scherrer, Didier; J. Ehrlich, Hartmut; Hahne, Michael; Tazi, Jamal (December 2017). "The Anti-Hiv Candidate Abx464 Dampens Intestinal Inflammation by Triggering Il-22 Production in Activated Macrophages". Scientific Reports. 7 (1): 4860. Bibcode:2017NatSR...7.4860C. doi:10.1038/s41598-017-04071-3. PMC 5501810. PMID 28687795.
  13. Clinical trial number NCT03760003 for "Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis" at ClinicalTrials.gov
  14. "ABIVAX: Abivax reports long-lasting two-year efficacy and safety data from ABX464 ulcerative colitis Phase 2a maintenance study | live".
  15. "Abivax posts ulcerative colitis data, commits to phase 2b". FierceBiotech.
  16. "ABX464 in Phase 2a Trials for RA".
  17. Clinical trial number NCT03813199 for "Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis" at ClinicalTrials.gov
  18. Gallagher, James (25 September 2020). "Coronavirus vaccine: When will we have one?". BBC News.
  19. "COVID-19 Treatment Candidate ABX464 Shows Promise In Vitro". Contagion Live.
  20. Clinical trial number NCT04393038 for "ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19 (Mir-Age)" at ClinicalTrials.gov
  21. "NCI Drug Dictionary". National Cancer Institute. February 2, 2011.
  22. "ABX196 – 1stOncology™: Cancer Intelligence Service".
  23. Clinical trial number NCT03897543 for "ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma" at ClinicalTrials.gov
  24. "Abivax Includes First Patient in U.S. Phase 1/2 Clinical Trial of ABX196 to Treat Hepatocellular Carcinoma". BioSpace.
  25. pharma, Industrie (December 1, 2016). "Jeune société innovante : Abivax s'organise autour de trois plateformes" – via www.industriepharma.fr. Cite journal requires |journal= (help)
  26. "Biotech - ABIVAX". Centre de recherche de l'Institut Curie.
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