ABX-464 is being developed by Abivax, in collaboration with the Cuban Center for Genetic Engineering and Biotechnology (CIGB), for the treatment of HIV. ABX-464, has demonstrated the potential to address indications in two disease areas: treatment of inflammation in ulcerative colitis and reduction of the viral reservoir in HIV. ABX-464 is an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory activity in preclinical trials and in a completed Phase 2a proof-of-concept study to treat lesions in ulcerative colitis. It also inhibited HIV replication through an entirely new mechanism of action, and has completed three Phase 2a clinical trials. ABX-464 inhibits HIV-1 replication in stimulated peripheral blood mononuclear cells (PBMCs) with an IC50 ranging between 0.1 uM and 0.5 uM. In two Phase 2a clinical trials, ABX464-004 and ABX464-005, ABX-464 demonstrated up to 50% reduction of HIV-DNA in peripheral blood mononuclear cells after 28 days of combination treatment with anti-retroviral therapy. This unique mode of action and the preclinical data to-date suggest that ABX-464 has the potential to: Reduce or eliminate the viral reservoirs in patients with HIV Induce long term control of the viral load, Prevent the emergence of HIV mutants that are resistant to treatment after six months of treatment in vitro Be less frequently administered. When evaluated in a Phase 2a Proof-of-Concept study, ABX464-101, ABX-464 demonstrated both safety and statistically significant efficacy based on both clinical and endoscopic endpoints with 35% of the patients achieving a clinical remission (placebo: 11%) and 50% of patients achieving mucosal healing (placebo: 11%), (p=0.034) Because of its ability to greatly upregulate production of a unique RNA splicing product and anti-inflammatory agent, miR-124, ABX-464’s mechanism of action is unique and has shown promise in clinical trials in its ability to bring patients to remission and heal inflammatory lesions in ulcerative colitis.

CMX157 is a lipid (1-0-hexadecyloxypropyl) conjugate of the acyclic nucleotide analog tenofovir (TFV) with activity against both wild-type and antiretroviral drug-resistant HIV strains, including multidrug nucleoside/nucleotide analog-resistant viruses. CMX157 was designed to mimic lysophosphatidylcholine to take advantage of natural lipid uptake pathways and to achieve high intracellular concentrations of the active antiviral, with the aim of increasing the effectiveness of TFV against wild-type and mutant HIV. CMX157 demonstrated potential to effectively suppress replication of multiNRTI-resistant (MNR) HIV that cannot be treated with any currently available NRTIs, including TDF. It is in phase II clinical trial for HIV infections in USA and phase Ib portion of the phase I/II trial for Hepatitis B in Thailand (PO).