Pharmacokinetic and pharmacodynamic study of a clinically effective anti‐CD2 monoclonal antibody
The humanized IgG1κ monoclonal antibody siplizumab and its rat parent monoclonal IgG2b antibody BTI‐322 are directed against the CD2 antigen. Siplizumab is species‐specific, reacting with human and chimpanzee cells but not with cells from any other species, including other non‐human primates. Becaus...
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| Veröffentlicht in: | Scandinavian journal of immunology 2020-01, Vol.91 (1), p.e12839-n/a |
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| container_title | Scandinavian journal of immunology |
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| creator | Sellberg, Felix Berglund, David Binder, Christian Hope, James Fontenot, Jane Griesemer, Adam Sykes, Megan Sachs, David H. Berglund, Erik |
| description | The humanized IgG1κ monoclonal antibody siplizumab and its rat parent monoclonal IgG2b antibody BTI‐322 are directed against the CD2 antigen. Siplizumab is species‐specific, reacting with human and chimpanzee cells but not with cells from any other species, including other non‐human primates. Because siplizumab treatment has recently shown great potential in clinical transplantation, we now present the results of our previous pharmacokinetic, pharmacodynamic and safety studies of both antibodies. Fourteen chimpanzees received 1‐3 doses of 0.143 to 5.0 mg/kg iv The effects were followed with flow cytometry on peripheral lymphocytes and staining of lymph nodes. Side effects were recorded. Serum antibody concentrations were followed. Across the doses, a rapid, transient depletion of CD2, CD3, CD4 and CD8 lymphocytes and NK cells was observed for both antibodies. Immune reconstitution was more rapid for BTI‐322 compared to siplizumab. Paracortical lymph node T cell depletion was moderate, estimated at 45% with doses of >0.6 mg/kg. Restoration of lymph node architecture was seen after two weeks to two months for all animals. All four subjects receiving BTI‐322 experienced AEs on the first dosing day, while the eight subjects dosed with siplizumab experienced few mild, transient AEs. Infusion with siplizumab and BTI‐322 resulted in rapid depletion of CD2+ cells in circulation and tissue. Siplizumab had a longer t1/2 and fewer AEs compared to BTI‐322. |
| doi_str_mv | 10.1111/sji.12839 |
| format | Article |
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Siplizumab is species‐specific, reacting with human and chimpanzee cells but not with cells from any other species, including other non‐human primates. Because siplizumab treatment has recently shown great potential in clinical transplantation, we now present the results of our previous pharmacokinetic, pharmacodynamic and safety studies of both antibodies. Fourteen chimpanzees received 1‐3 doses of 0.143 to 5.0 mg/kg iv The effects were followed with flow cytometry on peripheral lymphocytes and staining of lymph nodes. Side effects were recorded. Serum antibody concentrations were followed. Across the doses, a rapid, transient depletion of CD2, CD3, CD4 and CD8 lymphocytes and NK cells was observed for both antibodies. Immune reconstitution was more rapid for BTI‐322 compared to siplizumab. Paracortical lymph node T cell depletion was moderate, estimated at 45% with doses of >0.6 mg/kg. Restoration of lymph node architecture was seen after two weeks to two months for all animals. All four subjects receiving BTI‐322 experienced AEs on the first dosing day, while the eight subjects dosed with siplizumab experienced few mild, transient AEs. Infusion with siplizumab and BTI‐322 resulted in rapid depletion of CD2+ cells in circulation and tissue. Siplizumab had a longer t1/2 and fewer AEs compared to BTI‐322.</description><identifier>ISSN: 0300-9475</identifier><identifier>ISSN: 1365-3083</identifier><identifier>EISSN: 1365-3083</identifier><identifier>DOI: 10.1111/sji.12839</identifier><identifier>PMID: 31630416</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Animals ; antibodies ; Antibodies, Monoclonal - pharmacokinetics ; Antibodies, Monoclonal - therapeutic use ; Antibodies, Monoclonal, Humanized - pharmacokinetics ; Antibodies, Monoclonal, Humanized - therapeutic use ; antibodies/immunoglobulins ; Biomarkers ; Biopsy ; Cadmium ; CD2 antigen ; CD2 Antigens - antagonists & inhibitors ; CD3 antigen ; CD4 antigen ; CD8 antigen ; Chimpanzees ; Cytokines - blood ; Depletion ; Dosage ; experimental animals ; Female ; Flow cytometry ; Immune reconstitution ; Immunoglobulin G ; Immunoglobulin G - administration & dosage ; Immunoglobulin G - pharmacology ; immunoglobulins ; Immunophenotyping ; Killer Cells, Natural - immunology ; Killer Cells, Natural - metabolism ; Lymph nodes ; Lymphatic system ; Lymphocyte Depletion ; Lymphocytes ; Lymphocytes - immunology ; Lymphocytes - metabolism ; Lymphocytes T ; Male ; Medicin och hälsovetenskap ; molecules ; Monoclonal antibodies ; Natural killer cells ; Pan troglodytes ; Pharmacodynamics ; Pharmacokinetics ; Primates ; processes ; Rats ; Side effects ; solid organ transplantation ; subject ; Transplantation</subject><ispartof>Scandinavian journal of immunology, 2020-01, Vol.91 (1), p.e12839-n/a</ispartof><rights>2019 The Scandinavian Foundation for Immunology</rights><rights>2019 The Scandinavian Foundation for Immunology.</rights><rights>Copyright © 2020 The Foundation for the Scandinavian Journal of Immunology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5139-5cf04f1d5fa0c817c4588111eb755c3b645715fb4ffbdc0abf8587b6d595080f3</citedby><cites>FETCH-LOGICAL-c5139-5cf04f1d5fa0c817c4588111eb755c3b645715fb4ffbdc0abf8587b6d595080f3</cites><orcidid>0000-0001-7049-7348</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fsji.12839$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fsji.12839$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,780,784,885,1417,1433,4024,27923,27924,27925,45574,45575,46409,46833</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31630416$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-408474$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:142233428$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Sellberg, Felix</creatorcontrib><creatorcontrib>Berglund, David</creatorcontrib><creatorcontrib>Binder, Christian</creatorcontrib><creatorcontrib>Hope, James</creatorcontrib><creatorcontrib>Fontenot, Jane</creatorcontrib><creatorcontrib>Griesemer, Adam</creatorcontrib><creatorcontrib>Sykes, Megan</creatorcontrib><creatorcontrib>Sachs, David H.</creatorcontrib><creatorcontrib>Berglund, Erik</creatorcontrib><title>Pharmacokinetic and pharmacodynamic study of a clinically effective anti‐CD2 monoclonal antibody</title><title>Scandinavian journal of immunology</title><addtitle>Scand J Immunol</addtitle><description>The humanized IgG1κ monoclonal antibody siplizumab and its rat parent monoclonal IgG2b antibody BTI‐322 are directed against the CD2 antigen. Siplizumab is species‐specific, reacting with human and chimpanzee cells but not with cells from any other species, including other non‐human primates. Because siplizumab treatment has recently shown great potential in clinical transplantation, we now present the results of our previous pharmacokinetic, pharmacodynamic and safety studies of both antibodies. Fourteen chimpanzees received 1‐3 doses of 0.143 to 5.0 mg/kg iv The effects were followed with flow cytometry on peripheral lymphocytes and staining of lymph nodes. Side effects were recorded. Serum antibody concentrations were followed. Across the doses, a rapid, transient depletion of CD2, CD3, CD4 and CD8 lymphocytes and NK cells was observed for both antibodies. Immune reconstitution was more rapid for BTI‐322 compared to siplizumab. Paracortical lymph node T cell depletion was moderate, estimated at 45% with doses of >0.6 mg/kg. Restoration of lymph node architecture was seen after two weeks to two months for all animals. All four subjects receiving BTI‐322 experienced AEs on the first dosing day, while the eight subjects dosed with siplizumab experienced few mild, transient AEs. Infusion with siplizumab and BTI‐322 resulted in rapid depletion of CD2+ cells in circulation and tissue. Siplizumab had a longer t1/2 and fewer AEs compared to BTI‐322.</description><subject>Animals</subject><subject>antibodies</subject><subject>Antibodies, Monoclonal - pharmacokinetics</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized - pharmacokinetics</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>antibodies/immunoglobulins</subject><subject>Biomarkers</subject><subject>Biopsy</subject><subject>Cadmium</subject><subject>CD2 antigen</subject><subject>CD2 Antigens - antagonists & inhibitors</subject><subject>CD3 antigen</subject><subject>CD4 antigen</subject><subject>CD8 antigen</subject><subject>Chimpanzees</subject><subject>Cytokines - blood</subject><subject>Depletion</subject><subject>Dosage</subject><subject>experimental animals</subject><subject>Female</subject><subject>Flow cytometry</subject><subject>Immune reconstitution</subject><subject>Immunoglobulin G</subject><subject>Immunoglobulin G - administration & dosage</subject><subject>Immunoglobulin G - pharmacology</subject><subject>immunoglobulins</subject><subject>Immunophenotyping</subject><subject>Killer Cells, Natural - immunology</subject><subject>Killer Cells, Natural - metabolism</subject><subject>Lymph nodes</subject><subject>Lymphatic system</subject><subject>Lymphocyte Depletion</subject><subject>Lymphocytes</subject><subject>Lymphocytes - immunology</subject><subject>Lymphocytes - metabolism</subject><subject>Lymphocytes T</subject><subject>Male</subject><subject>Medicin och hälsovetenskap</subject><subject>molecules</subject><subject>Monoclonal antibodies</subject><subject>Natural killer cells</subject><subject>Pan troglodytes</subject><subject>Pharmacodynamics</subject><subject>Pharmacokinetics</subject><subject>Primates</subject><subject>processes</subject><subject>Rats</subject><subject>Side effects</subject><subject>solid organ transplantation</subject><subject>subject</subject><subject>Transplantation</subject><issn>0300-9475</issn><issn>1365-3083</issn><issn>1365-3083</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1ks1u1DAUhS0EosPAghdAkdiARFo7146dZTXlp6gSSPxsLduxwVMnHuKEKjsegWfkSXCbaZGQxhtbR985ur46CD0l-Jjkc5K2_phUApp7aEWgZiVgAffRCgPGZUM5O0KPUtpiTKDi8BAdAakBU1KvkP74XQ2dMvHS93b0plB9W-z2Wjv3qstaGqd2LqIrVGGC771RIcyFdc6a0f-02TP6P79-b86qoot9NCH2KtyoOmc8Rg-cCsk-2d9r9OXN68-bd-XFh7fnm9OL0jACTcmMw9SRljmFjSDcUCZE_p3VnDEDuqaME-Y0dU63BivtBBNc1y1rGBbYwRqVS266srtJy93gOzXMMiov99JlfllJeV3xJvPNQX43xPaf6dZIaFUB0LzpNXp10Hvmv57KOHyT0yQpFpTTjL9Y8Jz7Y7JplJ1PxoagehunJCvAHJqaAMno8__QbZyGvM9rCgipGwE4Uy8XygwxpcG6uwkIltedkLkT8qYTmX22T5x0Z9s78rYEGThZgCsf7Hw4SX56f75E_gWF18Li</recordid><startdate>202001</startdate><enddate>202001</enddate><creator>Sellberg, Felix</creator><creator>Berglund, David</creator><creator>Binder, Christian</creator><creator>Hope, James</creator><creator>Fontenot, Jane</creator><creator>Griesemer, Adam</creator><creator>Sykes, Megan</creator><creator>Sachs, David H.</creator><creator>Berglund, Erik</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7QR</scope><scope>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>7X8</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>DF2</scope><orcidid>https://orcid.org/0000-0001-7049-7348</orcidid></search><sort><creationdate>202001</creationdate><title>Pharmacokinetic and pharmacodynamic study of a clinically effective anti‐CD2 monoclonal antibody</title><author>Sellberg, Felix ; 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Siplizumab is species‐specific, reacting with human and chimpanzee cells but not with cells from any other species, including other non‐human primates. Because siplizumab treatment has recently shown great potential in clinical transplantation, we now present the results of our previous pharmacokinetic, pharmacodynamic and safety studies of both antibodies. Fourteen chimpanzees received 1‐3 doses of 0.143 to 5.0 mg/kg iv The effects were followed with flow cytometry on peripheral lymphocytes and staining of lymph nodes. Side effects were recorded. Serum antibody concentrations were followed. Across the doses, a rapid, transient depletion of CD2, CD3, CD4 and CD8 lymphocytes and NK cells was observed for both antibodies. Immune reconstitution was more rapid for BTI‐322 compared to siplizumab. Paracortical lymph node T cell depletion was moderate, estimated at 45% with doses of >0.6 mg/kg. Restoration of lymph node architecture was seen after two weeks to two months for all animals. All four subjects receiving BTI‐322 experienced AEs on the first dosing day, while the eight subjects dosed with siplizumab experienced few mild, transient AEs. Infusion with siplizumab and BTI‐322 resulted in rapid depletion of CD2+ cells in circulation and tissue. Siplizumab had a longer t1/2 and fewer AEs compared to BTI‐322.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>31630416</pmid><doi>10.1111/sji.12839</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-7049-7348</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Animals antibodies Antibodies, Monoclonal - pharmacokinetics Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized - pharmacokinetics Antibodies, Monoclonal, Humanized - therapeutic use antibodies/immunoglobulins Biomarkers Biopsy Cadmium CD2 antigen CD2 Antigens - antagonists & inhibitors CD3 antigen CD4 antigen CD8 antigen Chimpanzees Cytokines - blood Depletion Dosage experimental animals Female Flow cytometry Immune reconstitution Immunoglobulin G Immunoglobulin G - administration & dosage Immunoglobulin G - pharmacology immunoglobulins Immunophenotyping Killer Cells, Natural - immunology Killer Cells, Natural - metabolism Lymph nodes Lymphatic system Lymphocyte Depletion Lymphocytes Lymphocytes - immunology Lymphocytes - metabolism Lymphocytes T Male Medicin och hälsovetenskap molecules Monoclonal antibodies Natural killer cells Pan troglodytes Pharmacodynamics Pharmacokinetics Primates processes Rats Side effects solid organ transplantation subject Transplantation |
| title | Pharmacokinetic and pharmacodynamic study of a clinically effective anti‐CD2 monoclonal antibody |
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