BCD-100 - first russian PD-1 inhibitor

  • 作者: Tyulyandin S1, Fedyanin M1, Semiglazova T2, Moiseenko V3, Odintsova S4, Alekseev B5, Ivanov R6, Shustova M6
  • 隶属关系:
    1. N.N.Blokhin National Medical Cancer Research Center of the Ministry of Health of the Russian Federation
    2. N.N.Petrov National Medical Cancer Research Center of the Ministry of Health of the Russian Federation
    3. Saint Petersburg Clinical Research and Practical Center for Specialized (oncological) Care
    4. Limited Liability Company “BioEq”
    5. National Medical Research Radiological Center of the Ministry of Health of the Russian Federation
    6. Joint-Stock Company “BIOCAD”
  • 期: 卷 19, 编号 3 (2017)
  • 页面: 5-12
  • 栏目: Articles
  • URL: https://journals.rcsi.science/1815-1434/article/view/27133
  • ID: 27133

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Purpose. To evaluate pharmacokinetics, pharmacodynamics, safety, immunogenicity and efficacy of intravenous infusions of BCD-100 (JSC “BIOCAD”, Russia) in increasing doses. Patients (materials) and methods. Patients with advanced malignant tumors of various localizations without severe somatic pathology were consistently included in cohorts receiving the BCD-100 drug in monotherapy at different doses (0.3, 1.0, 3.0 and 10 mg/kg) every 2 weeks for at least 85 days. Safety, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of the therapy were assessed. Results. 15 patients were included in the study. The vast majority of adverse events were represented by deviations in the results of laboratory tests of 1-2 grade, there was only one confirmed case of dose-limiting toxicity (autoimmune thyroiditis of 2 grade). Pharmaco kinetic parameters were standard for drug based on monoclonal antibodies of class IgG1. The saturation of PD-1 receptors by BCD-100 was high (90-100%) at all dose levels. 1 partial response to antitumor therapy and 3 stabilization cases according to irRC criteria were registered. conclusion. BCD-100 demonstrated a favorable profile of safety and immunogenicity, expected pharmacokinetic parameters allowing the drug to be administered once every 2 or 3 weeks, high pharmacodynamic parameters and the presence of antitumor activity.

作者简介

S Tyulyandin

N.N.Blokhin National Medical Cancer Research Center of the Ministry of Health of the Russian Federation

д-р мед. наук, проф., зам. дир., зав. отд-нием клинической фармакологии и химиотерапии 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23

M Fedyanin

N.N.Blokhin National Medical Cancer Research Center of the Ministry of Health of the Russian Federation

канд. мед. наук, ст. науч. сотр. отд-ния клинической фармакологии и химиотерапии 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23

T Semiglazova

N.N.Petrov National Medical Cancer Research Center of the Ministry of Health of the Russian Federation

д-р мед. наук, зав. отд. инновационных методов терапевтической онкологии и реабилитации, вед. науч. сотр. 197758, Russian Federation, Saint Petersburg, pos. Pesochnyi, ul. Leningradskaia, d. 68

V Moiseenko

Saint Petersburg Clinical Research and Practical Center for Specialized (oncological) Care

д-р мед. наук, проф., дир. 197758, Russian Federation, Saint Petersburg, pos. Pesochnyi, ul. Leningradskaia, d. 68 a, lit. A

S Odintsova

Limited Liability Company “BioEq”

канд. мед. наук, врач-онколог 197342, Russian Federation, Saint Petersburg, Krasnogvardeiskii per., d. 23, lit. Zh

B Alekseev

National Medical Research Radiological Center of the Ministry of Health of the Russian Federation

д-р мед. наук, проф., зам. дир. Института по научной работе 198515, Russian Federation, Obninsk, ul. Koroleva, d. 4

R Ivanov

Joint-Stock Company “BIOCAD”

PhD, вице-президент по разработкам и исследованиям 198515, Saint Petersburg, Petrodvortsovyi r-n, p. Strel'na, ul. Sviazi, 34, lit. A

M Shustova

Joint-Stock Company “BIOCAD”

дир. клинической разработки по направлению «Онкология» 198515, Saint Petersburg, Petrodvortsovyi r-n, p. Strel'na, ul. Sviazi, 34, lit. A

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