Long-Acting Antibodies and Drugs as HIV Prevention Agents. David D. Ho, M.D.
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1 Long-Acting Antibodies and Drugs as HIV Prevention Agents David D. Ho, M.D.
2 the The HIV/AIDS pandemic rages on Key statistics from UNAIDS: 35M dead; 35M living with HIV 2.3M new infections a year or 6,300 a day
3 Features of gp120 that preclude the efficient neutralization of HIV by antibodies Schief et al, Curr Opin HIV AIDS 2009
4 Examples of broadly HIV-neutralizing monoclonal antibodies 10E8 3BNC117 or VRC % of infected affinity maturation PG9 or PGT145 PGT121, PGT128 or Burton et al, Science 2012
5 Demonstrated efficacy of pre-exposure prophylaxis (PrEP) using daily oral antiretroviral drugs in high-risk groups
6 Effectiveness (%) Effectiveness of PrEP correlates with subject adherence CAPRISA 004 (tenofovir gel, BAT-24 dosing) iprex (TDF/FTC) TDF2 (TDF/FTC) Partners PrEP (TDF) Partners PrEP (TDF/FTC) FEM-PrEP (TDF/FTC) Participants samples that had detectable drug levels (%) (Calculations based on analyses involving a subset of total trial participants) Pearson correlation = 0.86, p=0.003 VOICE (TDF) VOICE (TDF/FTC) VOICE (tenofovir gel, daily dosing) Source: Salim S. Abdool Karim
7 Overcoming the adherence problem with the use of long-acting anti-hiv agents - HIV-neutralizing bispecific antibodies with good potency and breadth - A long-acting integrase inhibitor, GSK744LA
8 Monoclonal antibodies that block HIV infection by targeting human CD4 or CCR5 Active & safe in humans (84) Active & safe in humans (272)
9 Examples of broadly HIV-neutralizing monoclonal antibodies 10E8 3BNC117 or VRC01 PGT121, PGT128 or PG9 or PGT145 Burton et al, Science 2012
10 Antiviral coverage of select monoclonal antibodies against a large panel of HIV strains
11 A library of anti-hiv CrossMabs Env 10E8 3BNC117 PGT128 PGT145 CD4/CCR5 Ibalizumab PRO140 Y. Huang & J. Yu
12 Potency (IC50) of four CrossMabs vs. their parental Abs Y. Huang & J. Yu
13 10E8/iMab with markedly improved breadth and potency Y. Huang & J. Yu
14 The activity of 10E8/iMab is better than co-administration of 10E8 and ibalizumab UG93-95 (R5/X4) G20 (T/F, R5) Inhibition (%) g/ml Inhibition (%) g/ml imab 10E8 10E8/iMab imab+10e8 (1:1) Y. Huang & J. Yu
15 Anchoring 10E8 to the cell membrane: CD4, CCR5 and HER2 HER2 Y. Huang & J. Yu
16 Anchoring 10E8 on HER2 does not improve antiviral activity Inhibition (%) T/F g/ml UG93-95 (Mix, A) E g/ml Pro140 10E8/P140 10E8/ HER2 T/F4 LAI-M 184V (B) Inhibition (%) g/ml g/ml R5 viruses X4 viruses
17 Anchoring 10E8 on CCR5 yields exceptional activity: 10E8/P140 is even more potent than 10E8/iMab IC50 Ab Conc. ( g/ml) IC50 Ab Conc. ( g/ml) E8/iMab 10E8/P Pro140 10E8/P140 10E8 *IC50<0.0001µg/ml: 25%
18 10E8/P140 CrossMab exhibits exceptional potency and breadth Y. Huang & J. Yu
19 GSK744 is a potent inhibitor of integrase-mediated strand transfer and HIV replication in patients GSK744 (a product of ViiV/GSK)
20 GSK744LA nanosuspension (200 mg/ml) Formulation properties High melting point Low water solubility Dosing properties High potency Low metabolic clearance Müller et al, Eur. J. Pharma. Biopharma. 2011
21 Pharmacokinetic evaluation of a single intramuscular GSK744LA injection in human volunteers Plasma GSK744 (µg/ml) mg 400 mg 800 mg 4X PAIC 90 1X PAIC Time (weeks) Data provided by ViiV/GSK
22 Repeated low-dose intrarectal challenges to evaluate GSK744LA as PrEP in 16 Indian rhesus macaques C. Andrews
23 GSK744LA is an effective PrEP agent in rhesus macaques 8/8 Untreated 0/8 Andrews et al, Science 2014
24 Repeated low-dose IR challenges to evaluate threshold GSK744 concentrations needed for protection in macaques = 1 control macaque begins challenge
25 One 50 mg/kg dose of GSK744LA protects macaques for at least five challenges First vrna detection 4X PAIC 90 1X PAIC 90 Andrews et al, Science 2014
26 GSK744 plasma concentrations >3X PAIC 90 result in 100% protection, while 1XPAIC 90 are 97% effective Andrews et al, Science 2014
27 GSK744LA: summary and path forward - Protective against intrarectal virus challenge at concentrations achievable with quarterly injections in humans - Also protective against intravaginal virus challenges in macaque models - Phase 2 clinical studies underway in the US - Phase 3 clinical studies anticipated in high-risk gay men as well as in heterosexual Africans 27
28 Aaron Diamond AIDS Research Center, The Rockefeller University Yaoxing Huang Jian Yu Ruijiang Song Craig Pace Chasity Andrews Neal Padte Kathrine Meyers Martin Markowitz ViiV/GSK Bill and Melinda Gates Foundation
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