ABIVAX Presents Full ABX464 Positive Phase 2A Clinical HIV Data at the HIV Cure and Reservoir Symposium

Regulatory News:

ABIVAX (Euronext Paris: FR0012333284 – ABVX) (Paris:ABVX) today announced that the full data from the ABX464-004 clinical study will be presented during an oral presentation at the 2^nd HIV Cure and Reservoir Symposium which will be held Sept. 11-12, 2017 in Ghent, Belgium. Top-line data from ABX464-004 were reported in May 2017. The presentation, to be given by Prof. Linos Vandekerckhove, M.D., PhD., will take place on Sept 12 from 1:55 to 2:10 pm at the OEHOE auditorium, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.

The presentation ‘’ABX464 decreases Total HIV DNA in PBMC´s when administered during 28 days to HIV-infected patients who are virologically suppressed’’ further confirms the preliminary trial results communicated previously. New data from integrated HIV DNA assays, a more sensitive DNA sequencing technique, confirmed the results obtained with initial assays measuring Total HIV DNA, showing that ABX464 substantially reduced the HIV blood reservoir in this Phase 2a clinical trial.

Professor Linos VandeKerckhove, M.D., Ph.D., head of the HIV Cure Research Center at Ghent University in the Department of Internal Medicine, said "The confirmation of the activity of ABX464 on the HIV reservoir measured by a second method – integrated HIV DNA – confirms our initial findings and encourages us to further explore the potential of this molecule.”

Jean-Marc Steens, M.D., chief medical officer of ABIVAX, added "These data further support ABX464’s potential to become a key functional cure component for HIV. The scientific endorsement by the HIV Cure and Reservoir Symposium is important for the recognition of the potential of this molecule to target the HIV reservoir, potentially leading towards a sustained viral remission.”

Prof. Hartmut Ehrlich, M.D., CEO of ABIVAX, commented "We are pleased about the opportunity created by the HIV Cure and Reservoir Symposium to present the full data from this important clinical trial to the scientific community. We are looking forward to the scientific discussion on the data, which will provide future guidance on the future development of ABX464.”

A separate Phase 2a clinical trial (ABX464-005) studying the effects of ABX464 on HIV reservoirs in blood and in gastrointestinal tissues is ongoing. In this previously announced study, patients in the first cohort are receiving ABX464 for 28 days in addition to their antiretroviral treatment. Rectal biopsies are being collected at certain intervals, allowing quantification of the viral reservoir and level of inflammation over time. Based on the results of the ABX464-004 study, ABIVAX has submitted a protocol amendment to extend the treatment period for the second cohort of patients to observe the longer-term effects of ABX464 on HIV reservoir suppression. Regulatory Authority and Ethics Committee approval have been received. Initial results from the first cohort of patients are expected later this month.

About ABIVAX (www.abivax.com)

ABIVAX is an innovative biotechnology company focused on targeting the immune system to eliminate viral disease. ABIVAX leverages three technology platforms for drug discovery: an anti-viral, an immune enhancement, and a polyclonal antibody platform. ABX464, its most advanced compound, is currently in Phase 2 clinical trials for providing a sustained viral remission or functional cure for patients with HIV/AIDS. It is a first-in-class oral small anti-viral molecule which blocks HIV replication through a unique mechanism of action and also has a strong anti-inflammatory effect. In addition, ABIVAX is advancing a clinical stage immune enhancer as well as multiple preclinical candidates against additional viral targets (e.g. Respiratory Syncytial Virus (RSV), Influenza and Dengue), and several of these compounds are planned to enter clinical development within the next 18 months. ABIVAX is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX).
More information on the company is available at www.abivax.com.

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