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Boyko O.V.

Russian National Medical Research University named after N.I. Pirogov;
Neuro-Clinic LLC (Yusupov Hospital)

Boyko A.N.

Russian National Medical Research University named after N.I. Pirogov;
Neuro-Clinic LLC (Yusupov Hospital)

Yakovlev P.A.

JSC 'BIOCAD', Saint Petersburg, Russia

Zinkina-Orikhan A.V.

JSC «BIOCAD», St. Petersburg, Russia

Kotov S.V.

Vladimirsky Moscow Regional Clinical Research Institute

Lin’kova Yu.N.

JSC «BIOCAD», St. Petersburg, Russia

Prakhova L.N.

N.P. Bechtereva Institute of the Human Brain, Saint Petersburg, Russia

Totolyan N.A.

Pavlov First St. Petersburg State Medical University

Shchur S.G.

Filatov Moscow City Clinical Hospital No. 15

Ivanov R.A.

JSC BIOCAD, Saint Petersburg, Russia

Results of a phase 1 clinical study of anti-CD20 monoclonal antibody (BCD-132): pharmacokinetics, pharmacodynamics and safety

Authors:

Boyko O.V., Boyko A.N., Yakovlev P.A., Zinkina-Orikhan A.V., Kotov S.V., Lin’kova Yu.N., Prakhova L.N., Totolyan N.A., Shchur S.G., Ivanov R.A.

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Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2019;119(10‑2): 87‑95

DOI: 10.17116/jnevro201911910287

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Table of contents

RESULTS OF A PHASE 1 CLINICAL STUDY OF ANTI-CD20 MONOCLONAL ANTIBODY (BCD-132): PHARMACOKINETICS, PHARMACODYNAMICS AND SAFETY
RESULTS OF A PHASE 1 CLINICAL STUDY OF ANTI-CD20 MONOCLONAL ANTIBODY (BCD-132): PHARMACOKINETICS, PHARMACODYNAMICS AND SAFETY

To cite this article:

Boyko OV, Boyko AN, Yakovlev PA, et al. . Results of a phase 1 clinical study of anti-CD20 monoclonal antibody (BCD-132): pharmacokinetics, pharmacodynamics and safety. S.S. Korsakov Journal of Neurology and Psychiatry. 2019;119(10‑2):87‑95. (In Russ.)
https://doi.org/10.17116/jnevro201911910287

Подписка 2026 Журнал неврологии и психиатрии им. С.С. Корсакова. Спецвыпуски (S.S. Korsakov Journal of Neurology and Psychiatry (special issues))
 
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Abstract:

Objective. To study the pharmacokinetics, pharmacodynamics, and immunogenicity of two intravenous dosing regimens of the new anti-B-cells drug BCD-132 (JSC BIOCAD, Russia) at ascending doses in patients with remitting multiple sclerosis. Material and methods. Twenty-four patients with multiple sclerosis were sequentially randomized in the multicenter open-label uncontrolled multicohort phase I study (3+3 design) and assigned to 4 cohorts (8 groups). Patients in each cohort received an intravenous infusion of BCD-132 at a predefined dose ranging from 100 to 1000 mg based on the planned algorithm of dose escalation if no dose-limiting toxicities occurred. Results. The assessment of the number of cells positive for the main B-cell antigens over time demonstrated a direct effect of BCD-132 on B lymphocytes when used at a wide range of doses (100 to 1000 mg) in patients with remitting multiple sclerosis. No significant variation of the number of T-cells was observed, which clearly proves strict specificity of BCD-132 exclusively to B lymphocytes. Conclusion. BCD-132 has an expected pharmacodynamic effect of long-term depletion of CD19+ and CD20+ B lymphocytes and an acceptable safety profile when used to treat patients with remitting multiple sclerosis at all tested doses.

Keywords:

multiple sclerosis
anti-CD20 monoclonal antibody
CD19+ B cells
CD20+ B cells
B lymphocytes

Authors:

Boyko O.V.

Russian National Medical Research University named after N.I. Pirogov;
Neuro-Clinic LLC (Yusupov Hospital)

Boyko A.N.

Russian National Medical Research University named after N.I. Pirogov;
Neuro-Clinic LLC (Yusupov Hospital)

Yakovlev P.A.

JSC 'BIOCAD', Saint Petersburg, Russia

Zinkina-Orikhan A.V.

JSC «BIOCAD», St. Petersburg, Russia

Kotov S.V.

Vladimirsky Moscow Regional Clinical Research Institute

Lin’kova Yu.N.

JSC «BIOCAD», St. Petersburg, Russia

Prakhova L.N.

N.P. Bechtereva Institute of the Human Brain, Saint Petersburg, Russia

Totolyan N.A.

Pavlov First St. Petersburg State Medical University

Shchur S.G.

Filatov Moscow City Clinical Hospital No. 15

Ivanov R.A.

JSC BIOCAD, Saint Petersburg, Russia

Close metadata

References:

  1. Nourbakhsh B, Mowry EM. Multiple sclerosis risk factors and pathogenesis. Continuum (Minneap Minn). 2019;25(3):596-610.
  2. Khachanova NV, Davidovskaya MV, Boyko AN. Multiple sclerosis: from pathogenensis to therapy. In: Selected Lectures on Neurology. Pod red. Guseva E.I. M. 2019.
  3. Li R, Patterson KR, Bar-Or A. Reassessing B cell contributions in multiple sclerosis. Nat Immunol. 2018;19(7):696-707. https://doi.org/10.1038/s41590-018-0135-x
  4. Arneth BM. Impact of B cells to the pathophysiology of multiple sclerosis. J Neuroinflammation. 2019;16(1):128. https://doi.org/10.1186/s12974-019-1517-1
  5. Martin R, Sospedra M, Rosito M, Engelhardt B. Current multiple sclerosis treatments have improved our understanding of MS autoimmune pathogenesis. Eur J Immunol. 2016;46(9):2078-2090. https://doi.org/10.1002/eji.201646485
  6. Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376(3):221-234. https://doi.org/10.1056/NEJMoa1601277
  7. Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus placebo in primary progressive Multiple Sclerosis. N Engl J Med. 2017;376(3):209-220. https://doi.org/10.1056/NEJMoa1606468
  8. Forsthuber TG, Cimbora DM, Ratchford JN, Katz E, Stüve O. B cell-based therapies in CNS autoimmunity: differentiating CD19 and CD20 as therapeutic targets. Ther Adv Neurol Dis. 2018;11:1-13. https://doi.org/10.1177/1756286418761697
  9. Pereira N, Chan KF, Lin PC, Song Z. The «less-is-more» in therapeutic antibodies: Afucosylated anti-cancer antibodies with enhanced antibody-dependent cellular cytotoxicity. MAbs. 2018;10(5):693-711. https://doi.org/10.1080/19420862.2018.1466767
  10. Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O’Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011;69(2):292-302. https://doi.org/10.1002/ana.22366
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