ABIVAX’s ABX464 Phase IIa Data confirm HIV Reservoir Reduction in Oral Presentation at 8th International Workshop on HIV Persistence During Therapy

Regulatory News:

ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), a biotechnology company harnessing the immune system to develop a functional cure for HIV and treatments for inflammatory/autoimmune diseases and cancer, today announces results from the first cohort of its Phase IIa clinical trial, ABX464-005. The results show a statistically significant reduction (p<0.01) of the HIV viral reservoir in the blood of study participants with HIV. These data confirm the human HIV reservoir reduction by ABX464 seen in ABIVAX’s previous Phase IIa trial, ABX464-004. Moreover, new data on the anti-inflammatory effects of ABX464 on rectal tissue will be presented. These data will be presented in an oral plenary session at the 8th International Workshop on HIV Persistence During Therapy in Miami, FL.

The "HIV reservoir” is a group of immune cells in the body that are infected with HIV but are not impacted by currently marketed antiviral drugs. This is making it hard to put the infection into remission or achieve a cure. ABX464 is targeting the HIV reservoir in order to achieve remission and, eventually, a cure.

"These data from the ABX464-005 study are very exciting and suggest that ABX464 could potentially play a critical role in future HIV eradication or cure strategies,” said Dr Ross Cranston, presenter of the data and Principal Investigator of the study at Germans Trias i Pujol University Hospital Badalona in Barcelona, Spain. "Here we are reporting data from the first cohort after oral dosing for 28 days.”

In the first cohort, 11 study participants with HIV infection received 150mg ABX464 daily for 28 days in addition to their antiretroviral treatment. Blood samples and rectal biopsies were collected at pre-specified time intervals, allowing quantification of reductions in the viral reservoir and mucosal inflammation over time. The second ongoing cohort of 12 study participants are receiving 50mg of ABX464 daily for three months in addition to their antiretroviral treatment. Study participants undergo sampling at pre-specified intervals to quantify the change in HIV reservoir and level of inflammation over the course of the study in blood and also in rectal biopsy tissue, as the gut is probably the largest HIV reservoir in the human body.

Prof Bonaventura Clotet, Director of the Irsi Caixa Aids Research Institute and Head of the Infectious Disease Unit at Germans Trias i Pujol University Hospital Badalona in Barcelona, Spain, commented: "Following the data from ABX464-004 showing the first evidence that ABX464 could reduce the HIV reservoir in the blood, the analysis in our laboratory of samples from ABX464-005 is an important validation of the potential for ABX464 leading towards a functional cure. Our assay, which is more sensitive than the one used in a previous study, allowed us to show that ABX464 reduced HIV reservoir in blood and also to show that the effect is more robust than previously observed.”

Dr. Jean-Marc Steens, M.D., chief medical officer of ABIVAX, commented: "Our new data on the anti-inflammatory effects of ABX464 on rectal tissue are highly encouraging, and support the continued development of ABX464 for treatment of HIV, and inflammatory diseases like ulcerative colitis. The selection of our abstract by the program committee for an oral, plenary presentation at this prestigious conference is an important external validation of our work by the scientific and medical community. We are looking forward to discussing these results with the experts in the field in order to further position ABX464 as a key component of potential cure strategies.”

About ABIVAX (www.abivax.com)

ABIVAX is mobilizing the body’s natural immune machinery to treat patients with viral infections, autoimmune diseases and cancer. A clinical-stage company, ABIVAX leverages its antiviral and immune enhancing platforms to optimize candidates to cure HIV and treat inflammatory bowel diseases and liver cancer. 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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