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    Home > Food News > Nutrition News > New approach to anti-HIV antibody therapy shows promise in phase I clinical trial

    New approach to anti-HIV antibody therapy shows promise in phase I clinical trial

    • Last Update: 2022-05-28
    • Source: Internet
    • Author: User
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    AAV vectors can be safely used in the body to deliver DNA into cells, and two AAV-based gene therapies are currently FDA-approved
    .
    In this clinical trial, an AAV vector designed by MGH researchers carried a genetic sequence known as a broadly neutralizing HIV-1 antibody, which blocks HIV's ability to bind to CD4, which is the key to HIV before it infects cells Targeted immune cell receptors

    .
    When injected into a patient, the AAV therapy (called AAV8-VRC07) enters the muscle cell, where the gene sequence is read and translated, producing a flood of broadly neutralizing antibodies (called VRC07), which are pumped out of the cell and in the Travel through the blood, looking for their targets

    .
    The result is a flood of antibodies circulating to block any interaction between HIV and the CD4 receptor on immune cells, essentially closing the door for HIV to enter the cell

    .

    The Phase 1 clinical trial enrolled eight HIV-infected adults who had been on stable antiretroviral therapy for at least 3 months
    .
    The investigators found that intramuscular injection of AAV8-VRC07 was safe and well tolerated

    .
    Measurable VRC07 was produced in the blood of all 8 individuals, with 3 having the highest VRC07 concentrations

    .
    In 6 individuals, these amounts remained stable near maximal concentrations over a follow-up period of up to 3 years

    .
    (The trial is ongoing, and some participants were not followed for as long as others

    .
    ) Three of the eight participants showed signs of anti-drug antibody responses to part of VRC07, which appeared to reduce two of them Generation of participants VRC07

    .

    "This work represents the first successful AAV-based production of monoclonal antibodies of any type by anyone," said co-author Alejandro B.
    Balazs, Ph.
    D.
    , who created the vector for use in the trial and is principal investigator at the Ragan Institute.
    MGH, MIT and Harvard, where his labs are continuing to develop the technology

    .
    "This is also the first time we have a way to generate antibodies that broadly neutralize HIV in humans," he said

    .

    The findings have broad clinical implications for the possible prevention or treatment of HIV and other infections, Balazs noted
    .
    "The findings demonstrate that the platform we designed is capable of producing long-term antibody expression with a single injection

    .
    Given our ability to encode any desired antibody into these vectors, we may be able to produce targets for infections ranging from malaria to COVID-19.
    effective preventive treatment for the disease,

    " he said
    .
    "This technology also has the potential to be applied to the delivery of other biological drugs to treat a wide range of diseases from autoimmunity to cancer

    .
    "

    The technique was originally developed by Balazs as a postdoc in the laboratory of Nobel laureate Dr.
    David Baltimore at Caltech

    .
    The NIH's Center for Vaccine Research supported the clinical study, which was conducted by the NIH Clinical Center

    .

    Additional study authors include Joseph P.
    Casazza, Evan M.
    Kyle, Sandeep Narpala, Galina V.
    Yamshchikov, Emily E.
    Coates, Cynthia S.
    Hendel Laura, Novik LaSonji a.
    Holman Ellie Thea T.
    Widge Preeti Margins, Ingelise Gordon, Martin R.
    Gaudinski, Michelle Conan-Cibotti, Bob C.
    Lin, Martha C.
    Nathan, Olga Trofymenko, Shinyi Telscher, Sarah ?h?Plummer, Diana Wycuff, William C.
    Adams, Janardan P.
    Pandey, Adrian McDermott, Mario Synonyms, Avery N.
    Sukienik Sijy 'Dell A, Jason G.
    .
    Created together by Britta Flach, Travis L.
    Terry, Misook Seung-chul Choi, Shi Wei, Xuejun Chen, Florence Kaltovich, Kevin O.
    Sanders, Judy A.
    Staniole A.
    Doria-Rose Richard M.
    Schwartz David Baltimore, Director Gary J.
    Nabel to Ben Richard A.
    Koup Barney S.
    Graham, Julie E.
    Ledgerwood, John R.
    Ma Sklar and VRC 603 Research Group

    .

    This work was supported by internal funding from the National Institute of Allergy and Infectious Diseases through the NIH Internal Research Program
    .

    Journal Reference :

    1. Joseph P.
      Casazza, Evan M.
      Cale, Sandeep Narpala, Galina V.
      Yamshchikov, Emily E.
      Coates, Cynthia S.
      Hendel, Laura Novik, LaSonji A.
      Holman, Alicia T.
      Widge, Preeti Apte, Ingelise Gordon, Martin R.
      Gaudinski, Michelle Conan-Cibotti, Bob C.
      Lin, Martha C.
      Nason, Olga Trofymenko, Shinyi Telscher, Sarah H.
      Plummer, Diane Wycuff, William C.
      Adams, Janardan P.
      Pandey, Adrian McDermott, Mario Roederer, Avery N.
      Sukienik, Sijy O’Dell, Jason G.
      Gall, Britta Flach, Travis L.
      Terry, Misook Choe, Wei Shi, Xuejun Chen, Florence Kaltovich, Kevin O.
      Saunders, Judy A.
      Stein, Nicole A.
      Doria-Rose, Richard M.
      Schwartz, Alejandro B.
      Balazs, David Baltimore, Gary J.
      Nabel, Richard A.
      Koup, Barney S.
      Graham, Julie E.
      Ledgerwood, John R.
      Mascola, Charla Andrews, Anita Arthur, Seemal F.
      Awan, Allison Beck , Eugeania Burch, Maria C.
      Burgos Florez, Nina M.
      Berkowitz, Eli A.
      Boritz, Kevin Carlton, Cora T.
      Cartagena, Christina Carter, Grace L.
      Chen, Pamela Costner, Jennifer Cunningham, Daniel C.
      Douek, Aba M.
      Eshun, Catina Evans, Renunda Hicks, Katherine V.
      Houser, Justine Jones, Brenda Larkin, Lam Le, Floreliz Mendoza, Stephen Migueles, John Misasi, Thuy A.
      Nguyen, Abidemi Ola, Karen Parker, Iris Pittman, La’ Shawn Requilman, Ro Shauna Rothwell, Gretchen L.
      Schieber, Jamie Saunders, Sandra Sitar, Colin Tran, Olga Trofymenko, Olga Vasilenko, Sana Waheed, Lingshu Wang, Xiaolin Wang, William Whalen, Pernell Williams, Richard L.
      Wu, Kathy Zephir.
      Floreliz Mendoza, Stephen Migueles, John Misasi, Thuy A.
      Nguyen, Abidemi Ola, Karen Parker, Iris Pittman, La’ Shawn Requilman, Ro Shauna Rothwell, Gretchen L.
      Schieber, Jamie Saunders, Sandra Sitar, Colin Tran, Olga Trofymenko, Olga Vasilenko, Sana Waheed, Lingshu Wang, Xiaolin Wang, William Whalen, Pernell Williams, Richard L.
      Wu, Kathy Zephir.
      Floreliz Mendoza, Stephen Migueles, John Misasi, Thuy A.
      Nguyen, Abidemi Ola, Karen Parker, Iris Pittman, La’ Shawn Requilman, Ro Shauna Rothwell, Gretchen L.
      Schieber, Jamie Saunders, Sandra Sitar, Colin Tran, Olga Trofymenko, Olga Vasilenko, Sana Waheed, Lingshu Wang, Xiaolin Wang, William Whalen, Pernell Williams, Richard L.
      Wu, Kathy Zephir.
      Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial .
      Nature Medicine , 2022; DOI: 10.
      1038/s41591-022-01762-x


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