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July 2017; 4 (4) ArticleOpen Access

Safety/tolerability of the anti-semaphorin 4D antibody VX15/2503 in a randomized phase 1 trial

Christopher LaGanke, Lawrence Samkoff, Keith Edwards, Lily Jung Henson, Pavle Repovic, Sharon Lynch, Lael Stone, David Mattson, Aaron Galluzzi, Terrence L. Fisher, Christine Reilly, Laurie A. Winter, John E. Leonard, Maurice Zauderer
First published June 16, 2017, DOI: https://doi.org/10.1212/NXI.0000000000000367
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  • Figure 1
    Figure 1 Disposition of study participants enrolled in the single ascending dose phase 1 study of VX15/2503

    This flow diagram depicts the disposition of the participants in this single-dose, dose-escalation study of intravenously administered VX15/2503. Forty participants were treated with VX15/2503 and 10 with placebo; none discontinued the study. The median infusion time for all patients was 60 minutes, with durations ranging from 45 to 170 minutes.

  • Figure 2
    Figure 2 Semi-log plot of mean VX15/2503 serum concentrations vs time after a single infusion

    Mean serum VX15/2503 concentrations are shown vs scheduled sampling days. Data shown are for antibody-treated patients in each of the 5 dose cohorts; samples from placebo-treated subjects were assayed but not reported because of the absence of antibody in these samples. Sampling times were end of infusion, 4 and 8 hours on days 1 2, 4, 8, 15, 29, 43, 57, 71, 85, 155, and 190; time points beyond day 29 were successively applied to cohorts 2 through 5. Data shown represent mean values ± SD. Serum assays were performed in triplicate using a validated method.15,16

  • Figure 3
    Figure 3 Mean percent cellular SEMA4D saturation vs time after VX15/2503 administration

    Percent VX15/2503 saturation of cSEMA4D on peripheral T lymphocytes is shown for antibody-treated participants in each dose cohort. The scheduled sampling times for each dose cohort were as described in the legend of figure 2. Data shown represent mean values ± SE; flow cytometric assays were performed in triplicate and data analyzed as previously described.16,20 T-cell saturation values below 20% were considered unsaturated; mean predose saturation values ranged between 0.7% and 18%.

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