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style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:absolute;top:0;left:0;bottom:0;right:0"><img alt="Contagion Live" title="Contagion Live" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="fill" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:contain"/><noscript><img alt="Contagion Live" title="Contagion Live" sizes="100vw" srcSet="/_next/image?url=%2FMasterHead%2FcontagionLive_white.png&w=640&q=75 640w, /_next/image?url=%2FMasterHead%2FcontagionLive_white.png&w=750&q=75 750w, /_next/image?url=%2FMasterHead%2FcontagionLive_white.png&w=828&q=75 828w, /_next/image?url=%2FMasterHead%2FcontagionLive_white.png&w=1080&q=75 1080w, 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text-gray-400">bhagirathbhai-dholaria-mbbs</span></span></div><div class="flex justify-end gap-2"></div><div class="flex flex-col sm:flex-row"><div id="description-summary" class="py-2 text-sm text-gray-500 sm:w-[calc(100%-100px)]"><div class="blockText_blockContent__TbCXh"></div></div></div><h3 class="text-xl">Articles</h3><div class="flex flex-wrap w-full"><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div class="flex flex-1 md:col-span-2 " style="background-color:transparent;border-color:#F3F4F6;border-width:0;border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem"><a class=" md:flex-none w-full md:w-48 mt-2" href="/view/evaluating-allogeneic-car-t-p-bcma-allo1-multiple-myeloma"><div class=""><span style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;padding-top:100%"></span><img alt="Bhagirathbhai R. Dholaria, MD, an associate professor of medicine in malignant hematology & stem cell transplantation at Vanderbilt University Medical Center" title="Bhagirathbhai R. Dholaria, MD, an associate professor of medicine in malignant hematology & stem cell transplantation at Vanderbilt University Medical Center" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="responsive" class="shrink-0" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img alt="Bhagirathbhai R. Dholaria, MD, an associate professor of medicine in malignant hematology & stem cell transplantation at Vanderbilt University Medical Center" title="Bhagirathbhai R. Dholaria, MD, an associate professor of medicine in malignant hematology & stem cell transplantation at Vanderbilt University Medical Center" sizes="100vw" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F966ec042ea0449de0fc2f4a9fff69360426657e0-300x300.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 640w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F966ec042ea0449de0fc2f4a9fff69360426657e0-300x300.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=750&q=75 750w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F966ec042ea0449de0fc2f4a9fff69360426657e0-300x300.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=828&q=75 828w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F966ec042ea0449de0fc2f4a9fff69360426657e0-300x300.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75 1080w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F966ec042ea0449de0fc2f4a9fff69360426657e0-300x300.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1200&q=75 1200w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F966ec042ea0449de0fc2f4a9fff69360426657e0-300x300.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75 1920w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F966ec042ea0449de0fc2f4a9fff69360426657e0-300x300.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=2048&q=75 2048w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F966ec042ea0449de0fc2f4a9fff69360426657e0-300x300.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 3840w" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F966ec042ea0449de0fc2f4a9fff69360426657e0-300x300.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="responsive" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a><div class="flex-auto w-[200%] md:w-auto ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/evaluating-allogeneic-car-t-p-bcma-allo1-multiple-myeloma">Evaluating Allogeneic CAR-T P-BCMA-ALLO1 in R/R Multiple Myeloma</a></p><div class=" pl-4"><a class="text-sm text-sky-800" href="/authors/bhagirathbhai-dholaria-mbbs">Bhagirathbhai Dholaria, MBBS</a><span class="mr-1 ml-[1px]">;</span><a class="text-sm text-sky-800" href="/authors/noah-stansfield">Noah Stansfield</a></div><a href="/view/evaluating-allogeneic-car-t-p-bcma-allo1-multiple-myeloma"><span class="text-sm text-gray-500 pl-4">November 21st 2024</span><div class="mt-2 ml-4"></div><div class="flex flex-row gap-2"></div><p class=" mt-4 text-gray-800 pl-4">Bhagirathbhai R. Dholaria, MD, an associate professor of medicine in malignant hematology & stem cell transplantation at Vanderbilt University Medical Center, discussed interim data from the phase 1/1b clinical trial evaluating Poseida's CAR-T.</p><div class="pl-4"></div></a><div class="flex flex-col sm:flex-row pl-2 mt-4"></div></div></div></div></div></div><div class="mb-4 w-full h-full"><hr class="mt-1 w-full " style="border-top-width:1px;border-top-color:#F3F4F6"/><div class="w-full h-full" style="box-shadow:0px 0px 0 0 rgb(194, 194, 194, 1)"><div class="w-full md:w-auto md:flex md:flex-col md:items-center lg:items-start lg:flex-row mb-4 mt-3 p-4"><div class="flex flex-1 md:col-span-2 " style="background-color:transparent;border-color:#F3F4F6;border-width:0;border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem"><a class=" md:flex-none w-full md:w-48 mt-2" href="/view/dholaria-evaluating-allogeneic-car-t-p-bcma-allo1-multiple-myeloma"><div class=""><span style="box-sizing:border-box;display:block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;padding-top:56.19469026548673%"></span><img alt="Bhagirathbhai R. Dholaria, MD, an associate professor of medicine in malignant hematology & stem cell transplantation at Vanderbilt University Medical Center" title="Bhagirathbhai R. Dholaria, MD, an associate professor of medicine in malignant hematology & stem cell transplantation at Vanderbilt University Medical Center" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="responsive" class="shrink-0" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%"/><noscript><img alt="Bhagirathbhai R. Dholaria, MD, an associate professor of medicine in malignant hematology & stem cell transplantation at Vanderbilt University Medical Center" title="Bhagirathbhai R. Dholaria, MD, an associate professor of medicine in malignant hematology & stem cell transplantation at Vanderbilt University Medical Center" sizes="100vw" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F3cd84d3d78ca12e8794b228b70ddd6d12d1b525c-678x381.png%3Ffit%3Dcrop%26auto%3Dformat&w=640&q=75 640w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F3cd84d3d78ca12e8794b228b70ddd6d12d1b525c-678x381.png%3Ffit%3Dcrop%26auto%3Dformat&w=750&q=75 750w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F3cd84d3d78ca12e8794b228b70ddd6d12d1b525c-678x381.png%3Ffit%3Dcrop%26auto%3Dformat&w=828&q=75 828w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F3cd84d3d78ca12e8794b228b70ddd6d12d1b525c-678x381.png%3Ffit%3Dcrop%26auto%3Dformat&w=1080&q=75 1080w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F3cd84d3d78ca12e8794b228b70ddd6d12d1b525c-678x381.png%3Ffit%3Dcrop%26auto%3Dformat&w=1200&q=75 1200w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F3cd84d3d78ca12e8794b228b70ddd6d12d1b525c-678x381.png%3Ffit%3Dcrop%26auto%3Dformat&w=1920&q=75 1920w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F3cd84d3d78ca12e8794b228b70ddd6d12d1b525c-678x381.png%3Ffit%3Dcrop%26auto%3Dformat&w=2048&q=75 2048w, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F3cd84d3d78ca12e8794b228b70ddd6d12d1b525c-678x381.png%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 3840w" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F3cd84d3d78ca12e8794b228b70ddd6d12d1b525c-678x381.png%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75" decoding="async" data-nimg="responsive" style="border-top-left-radius:0rem;border-top-right-radius:0rem;border-bottom-left-radius:0rem;border-bottom-right-radius:0rem;position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%" class="shrink-0" loading="lazy"/></noscript></span></div></a><div class="flex-auto w-[200%] md:w-auto ml-2 flex-1"><p class="font-bold text-[1rem] pl-4 text-undefined" style="font-size:1rem"><a href="/view/dholaria-evaluating-allogeneic-car-t-p-bcma-allo1-multiple-myeloma">Bhagirathbhai R. 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style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:cover" class="shrink-0 object-cover" loading="lazy"/></noscript></span></div><div class="jsx-41d2ec0c9882d016 flex flex-col pb-3"><div class="jsx-41d2ec0c9882d016"><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500">Published: August 16th 2024</span><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500"> | Updated: August 19th 2024</span></div><div class="jsx-41d2ec0c9882d016 font-bold text-sm pb-1">Uptake of Nononcology Gene Therapy Remains Slow in Hematology</div></div></a><a class="jsx-41d2ec0c9882d016 recent-article" href="/view/phase-3-trial-seeks-to-continue-supporting-arsa-cel-gene-therapy-for-mld"><div class="jsx-41d2ec0c9882d016 min-h-[65px] min-w-[65px] max-w-[65px] mr-2 lg:mt-1"><span 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style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:cover"/><noscript><img alt="Phase 3 Trial Seeks to Continue Supporting Arsa-Cel Gene Therapy for MLD " title="Phase 3 Trial Seeks to Continue Supporting Arsa-Cel Gene Therapy for MLD " srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2Ff42cf5e88e95cf3ad2098e209fd9cf1ea8f9c5d8-1920x1080.png%3Ffit%3Dcrop%26auto%3Dformat&w=256&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2Ff42cf5e88e95cf3ad2098e209fd9cf1ea8f9c5d8-1920x1080.png%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2Ff42cf5e88e95cf3ad2098e209fd9cf1ea8f9c5d8-1920x1080.png%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:cover" class="shrink-0 object-cover" loading="lazy"/></noscript></span></div><div class="jsx-41d2ec0c9882d016 flex flex-col pb-3"><div class="jsx-41d2ec0c9882d016"><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500">Published: March 18th 2024</span><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500"> | Updated: June 3rd 2024</span></div><div class="jsx-41d2ec0c9882d016 font-bold text-sm pb-1">Phase 3 Trial Seeks to Continue Supporting Arsa-Cel Gene Therapy for MLD </div></div></a><a class="jsx-41d2ec0c9882d016 recent-article" href="/view/sarepta-dmd-gene-therapy-elevidys-sustained-benefit-updated-phase-3-data"><div class="jsx-41d2ec0c9882d016 min-h-[65px] min-w-[65px] max-w-[65px] mr-2 lg:mt-1"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27180%27%20height=%27100%27/%3e"/></span><img alt="Sarepta’s DMD Gene Therapy Elevidys Shows Sustained Benefit in Updated Phase 3 Data" title="Sarepta’s DMD Gene Therapy Elevidys Shows Sustained Benefit in Updated Phase 3 Data" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" class="shrink-0 object-cover" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:cover"/><noscript><img alt="Sarepta’s DMD Gene Therapy Elevidys Shows Sustained Benefit in Updated Phase 3 Data" title="Sarepta’s DMD Gene Therapy Elevidys Shows Sustained Benefit in Updated Phase 3 Data" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2Fe292d9fc799af049ac1bd0109419772a7b6fbdd4-1000x563.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=256&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2Fe292d9fc799af049ac1bd0109419772a7b6fbdd4-1000x563.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2Fe292d9fc799af049ac1bd0109419772a7b6fbdd4-1000x563.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:cover" class="shrink-0 object-cover" loading="lazy"/></noscript></span></div><div class="jsx-41d2ec0c9882d016 flex flex-col pb-3"><div class="jsx-41d2ec0c9882d016"><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500">Published: January 29th 2025</span><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500"> | Updated: February 17th 2025</span></div><div class="jsx-41d2ec0c9882d016 font-bold text-sm pb-1">Sarepta’s DMD Gene Therapy Elevidys Shows Sustained Benefit in Updated Phase 3 Data</div></div></a><a class="jsx-41d2ec0c9882d016 recent-article" href="/view/immunologic-ep-1-chemo-free-lymphoma-stephen-schuster"><div class="jsx-41d2ec0c9882d016 min-h-[65px] min-w-[65px] max-w-[65px] mr-2 lg:mt-1"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27180%27%20height=%27100%27/%3e"/></span><img alt="ImmunoLogic" title="ImmunoLogic" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" class="shrink-0 object-cover" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:cover"/><noscript><img alt="ImmunoLogic" title="ImmunoLogic" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F36c4ee5a012818308d0c2cd3ec0167a1682db9be-1401x1401.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=256&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F36c4ee5a012818308d0c2cd3ec0167a1682db9be-1401x1401.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F36c4ee5a012818308d0c2cd3ec0167a1682db9be-1401x1401.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:cover" class="shrink-0 object-cover" loading="lazy"/></noscript></span></div><div class="jsx-41d2ec0c9882d016 flex flex-col pb-3"><div class="jsx-41d2ec0c9882d016"><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500">Published: January 31st 2025</span><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500"> | Updated: February 17th 2025</span></div><div class="jsx-41d2ec0c9882d016 font-bold text-sm pb-1">ImmunoLogic, Episode 1: "Chemo-Free Lymphoma? Seriously?" With Stephen J. Schuster, MD</div></div></a><a class="jsx-41d2ec0c9882d016 recent-article" href="/view/porter-progress-cross-disciplinary-collaboration-cell-therapy-autoimmune-disease"><div class="jsx-41d2ec0c9882d016 min-h-[65px] min-w-[65px] max-w-[65px] mr-2 lg:mt-1"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27180%27%20height=%27100%27/%3e"/></span><img alt="David Porter, MD, the director of cell therapy and transplant at Penn Medicine" title="David Porter, MD, the director of cell therapy and transplant at Penn Medicine" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" class="shrink-0 object-cover" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:cover"/><noscript><img alt="David Porter, MD, the director of cell therapy and transplant at Penn Medicine" title="David Porter, MD, the director of cell therapy and transplant at Penn Medicine" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F8d8d8acfb0d5ca61348562090bc9b80c7b6d7442-696x393.png%3Ffit%3Dcrop%26auto%3Dformat&w=256&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F8d8d8acfb0d5ca61348562090bc9b80c7b6d7442-696x393.png%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F8d8d8acfb0d5ca61348562090bc9b80c7b6d7442-696x393.png%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:cover" class="shrink-0 object-cover" loading="lazy"/></noscript></span></div><div class="jsx-41d2ec0c9882d016 flex flex-col pb-3"><div class="jsx-41d2ec0c9882d016"><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500">Published: January 23rd 2025</span><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500"> | Updated: February 17th 2025</span></div><div class="jsx-41d2ec0c9882d016 font-bold text-sm pb-1">David Porter, MD, on Progress With Cross-Disciplinary Collaboration in Cell Therapy for Autoimmune Disease</div></div></a><a class="jsx-41d2ec0c9882d016 recent-article" href="/view/cgtlive-immunologic-video-podcast-joseph-fraietta-phd"><div class="jsx-41d2ec0c9882d016 min-h-[65px] min-w-[65px] max-w-[65px] mr-2 lg:mt-1"><span style="box-sizing:border-box;display:inline-block;overflow:hidden;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;position:relative;max-width:100%"><span style="box-sizing:border-box;display:block;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0;max-width:100%"><img style="display:block;max-width:100%;width:initial;height:initial;background:none;opacity:1;border:0;margin:0;padding:0" alt="" aria-hidden="true" src="data:image/svg+xml,%3csvg%20xmlns=%27http://www.w3.org/2000/svg%27%20version=%271.1%27%20width=%27180%27%20height=%27100%27/%3e"/></span><img alt="ImmunoLogic" title="ImmunoLogic" src="data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7" decoding="async" data-nimg="intrinsic" class="shrink-0 object-cover" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:cover"/><noscript><img alt="ImmunoLogic" title="ImmunoLogic" srcSet="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F36c4ee5a012818308d0c2cd3ec0167a1682db9be-1401x1401.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=256&q=75 1x, /_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F36c4ee5a012818308d0c2cd3ec0167a1682db9be-1401x1401.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75 2x" src="/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fgenetherapy%2F36c4ee5a012818308d0c2cd3ec0167a1682db9be-1401x1401.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=384&q=75" decoding="async" data-nimg="intrinsic" style="position:absolute;top:0;left:0;bottom:0;right:0;box-sizing:border-box;padding:0;border:none;margin:auto;display:block;width:0;height:0;min-width:100%;max-width:100%;min-height:100%;max-height:100%;object-fit:cover" class="shrink-0 object-cover" loading="lazy"/></noscript></span></div><div class="jsx-41d2ec0c9882d016 flex flex-col pb-3"><div class="jsx-41d2ec0c9882d016"><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500">Published: December 18th 2024</span><span class="jsx-41d2ec0c9882d016 text-sm text-gray-500"> | Updated: February 17th 2025</span></div><div class="jsx-41d2ec0c9882d016 font-bold text-sm pb-1">CGTLive® Presents: ImmunoLogic, A Video Podcast With Joseph Fraietta, PhD</div></div></a></div></div></div></div><div class="flex-none w-[300px] z-[9999] relative hidden md:block"><div style="top:70px;margin-top:44px" class="sticky custom-spacing"></div></div></div><div id="div-gpt-ad-pixel" style="width:1px;height:1px" class=""></div><noscript><iframe 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Alongside the number for lovo-cel, bluebird also pointed out that this year 4 patients have started on elivaldogene autotemcel (Lenti-D, Skysona), its marketed gene therapy for cerebral adrenoleukodystrophy, and 19 patients have started on betibeglogene autotemcel (beti-cel, Zynteglo), its marketed gene therapy for transfusion dependent thalassemia (TDT). As such, bluebird bio has reported 23 total cell collections for SCD/TDT gene therapies lovo-cel and beti-cel. 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Since Vertex has not clarified the breakdown of patients treated with exa-cel for each disease, direct comparison is difficult. 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News release. bluebird bio, Inc. August 14, 2024. Accessed August 15, 2024. https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-reports-second-quarter-2024-results-and-highlights\n2. Stock dive for bluebird as sickle cell gene therapy lags behind Vertex rival. News article. Anna Bratulic. FirstWord Pharma. August 14, 2024. Accessed August 15, 2024. https://firstwordpharma.com/story/5885598\n3. Vertex announces US FDA approval of CASGEVY™ (exagamglogene autotemcel) for the Treatment of Transfusion-Dependent Beta Thalassemia. News release. Vertex Pharmaceuticals Incorporated. January 16, 2024. Accessed August 15, 2024. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-approval-casgevytm-exagamglogene\n4. Vertex reports second quarter 2024 financial results. News release. Vertex Pharmaceuticals Incorporated. August 1, 2024. Accessed August 15, 2024. https://investors.vrtx.com/news-releases/news-release-details/vertex-reports-second-quarter-2024-financial-results\n5. Center for Inherited Blood Disorders Administers Country's First Gene Therapy Infusion to Treat Hemophilia A. News release. Center for Inherited Blood Disorders. January 11, 2024. Accessed August 15, 2024. https://firstwordpharma.com/story/5817834?from=article\n6. BioMarin Announces Updated Strategy for ROCTAVIAN® to Focus on U.S., Germany and Ital. News release. BioMarin Pharmaceutical Inc. August 5, 2024. Accessed August 15, 2024. https://investors.biomarin.com/news/news-details/2024/BioMarin-Announces-Updated-Strategy-for-ROCTAVIAN-to-Focus-on-U.S.-Germany-and-Italy/default.aspx\n7. FDA approves first gene therapy to treat adults with hemophilia B. News release. FDA. November 22, 2022. 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These patients had follow-up times ranging from 0.64 years to 12.19 years (median, 6.76).","_key":"e05ad2f88a430"},{"_type":"span","marks":["superscript"],"text":"3","_key":"20b2f78a1330"}],"_type":"block","style":"normal","_key":"a34ffba8617a"},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"“Metachromatic leukodystrophy, is a really important unmet need in the pediatric community. So, this is a disease that's rare, it affects about one in 40,000 children. And up until recently, we have had no curative treatment option for this,” Madeleine Powys, MBBS, Staff Specialist, Blood Transplant and Cell Therapies, The Children's Hospital at Westmead, told ","_key":"734e0726857e0"},{"_key":"37ba8124a9c6","_type":"span","marks":["em"],"text":"CGTLive"},{"_key":"d0ee2b87eef7","_type":"span","marks":[],"text":". \"Autologous hematopoietic stem cell gene therapy has offered really promising new hope for these patients.”"}],"_type":"block","style":"normal","_key":"02175956cae1"},{"children":[{"marks":["strong"],"text":"WATCH NOW: ","_key":"b7b5b71930ff","_type":"span"},{"marks":["cc2866c47d82"],"text":"Madeleine Powys, MBBS, on Lessons Learned With Libmeldy","_key":"e95a35599b5f","_type":"span"}],"_type":"block","style":"normal","_key":"25178411fea5","markDefs":[{"_type":"link","href":"https://www.cgtlive.com/view/madeleine-powys-mbbs-on-lessons-learned-with-libmeldy","_key":"cc2866c47d82","nofollow":false,"blank":true}]},{"_type":"block","style":"normal","_key":"bf4c75754420","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Arsa-cel is currently being evaluated in 6 participants enrolled in a phase 3 clinical trial (NCT04283227). The trial enrolled participants with documented biochemical and molecular diagnosis of MLD, including low ARSA activity and identification of 2 disease-causing ARSA alleles, with novel mutations analyzed and excluded as common polymorphisms, alongside specific genotype criteria. Symptomatic individuals must have onset between 7 and 17 years of age, or pre-symptomatic participants must be less than 17 years at treatment initiation and have a sibling with late-juvenile MLD variant, along with normal cognitive and motor function, with seizures or disease signs revealed by instrumental evaluations not being exclusionary if present alone, and compliance with contraceptive use requirements if applicable, with signed informed consent or assent provided by the participant or guardian.","_key":"d8fc24228c170"}]},{"markDefs":[],"children":[{"_type":"span","marks":[],"text":"The exclusion criteria for the study include documented HIV infection, malignant neoplasia except localized skin cancer or hereditary cancer syndrome unless successfully treated with no recurrence, myelodysplasia, acute myeloid leukemia, or serious hematological disorders, current enrollment in other interventional trials, prior allogeneic HSPC gene therapy or gene therapy, symptomatic herpes zoster unresponsive to treatment, active tuberculosis unless on antibiotic prophylaxis, acute or chronic stable Hepatitis B or positive Hepatitis C RNA test result unless specific conditions are met, end-organ dysfunction, severe infection not responsive to treatment, or other severe diseases deemed inappropriate for the study by the investigator. Additionally, testing for other transmissible infectious agents may be considered, and participants with elevated liver enzymes or bilirubin may be included after discussion and agreement with the medical monitor.","_key":"12d4c00d115a0"}],"_type":"block","style":"normal","_key":"da33a686d39a"},{"markDefs":[],"children":[{"text":"The study’s primary measures involve assessing the OTpbmsL-200 Arylsulfatase A (ARSA) activity levels in cerebrospinal fluid (CSF) and the neuronal metabolite ratio of N-acetyl-aspartate (NAA) to creatine (Cr) in white matter brain regions, both evaluated at 24 months post-treatment, with changes from baseline being monitored.","_key":"18df4b334f130","_type":"span","marks":[]}],"_type":"block","style":"normal","_key":"f3dd60b1e0bd"},{"style":"normal","_key":"daacc3a879df","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Secondary measures involve evaluating changes in ARSA activity levels in CSF and neuronal metabolite ratio in white matter brain regions, assessing ARSA levels in peripheral blood mononuclear cells (PBMCs) and specific subtypes, comparing neuronal metabolite ratios to baseline, siblings, or untreated controls, determining engraftment through lentiviral positivity in bone marrow progenitors and vector copy number in BM cells and PBMCs, assessing severity scale for brain MRI, neurocognitive function, full neurological clinical examination, gross motor function classification, nerve conduction velocity, Vineland Adaptive Behavior Scale, and monitoring conditioning regimen and non-conditioning-related adverse events up to 8 years post gene therapy, along with hematological reconstitution, infusion-related reactions, immune response, abnormal clonal proliferation, replication-competent lentivirus, and integration site analysis findings over time.","_key":"08a5d70bf46e0"}],"_type":"block"},{"markDefs":[{"_type":"link","href":"https://www.cgtlive.com/conferences/worldsymposium","_key":"261823a2ac93"},{"_key":"8d719dbd5e6b","nofollow":false,"blank":true,"_type":"link","href":"https://www.cgtlive.com/view/orchard-therapeutics-arsa-cel-restores-arsa-enzyme-activity-patients-late-juvenile-mld"}],"children":[{"_type":"span","marks":[],"text":"The","_key":"a0ac8a8dd60d0"},{"_type":"span","marks":["8d719dbd5e6b"],"text":" latest data from the phase 3 trial","_key":"07fefd2d7f1c"},{"_type":"span","marks":[],"text":" were presented at ","_key":"d4adcc094ddd"},{"text":"the 2024 WORLDSymposium","_key":"a0ac8a8dd60d1","_type":"span","marks":["261823a2ac93"]},{"_key":"a0ac8a8dd60d2","_type":"span","marks":[],"text":", held February 4-9, in San Diego, California, by Vera Gallo, MD, staff pediatrician, San Raffaele Telethon Institute for Gene Therapy. The data were from 5 patients with LJ MLD that had follow-up ranging from 3.2 to 21.3 months (median, 17.3). At the time of treatment, 3 patients had PS MLD and 2 had ES MLD. The group included a 2.7-year-old girl (PS), a 9.9-year-old boy (ES), a 15.2-year-old boy (PS), a 6.6-year-old girl (PS), and 10.9-year-old boy (ES) as of the December 2023 cutoff date."},{"_type":"span","marks":["superscript"],"text":"4","_key":"25d33dbc98cd"}],"_type":"block","style":"normal","_key":"44eb412f926f"},{"_type":"block","style":"normal","_key":"a1571d9737b9","markDefs":[],"children":[{"marks":[],"text":"\"This represents of course, the proof of principle that gene therapy with ex- vivo lentiviral gene therapy into stem cells can correct a lysosomal storage disorder (LSD)... and could be applicable to other LSDS. So we're working on new diseases to bring this approach of enzyme correction also to other LSDs,\" investigator Alessandro Aiuti, MD, PhD, deputy director, clinical research, and head, Clinical Research Unit, San Raffaele Telethon Institute for gene therapy, and Group leader, Pathogenesis and therapy, primary immunodeficiencies unit, and full professor, Università Vita Salute San Raffaele, and chief of clinic, Pediatric Immunohematology Unit, San Raffaele, told ","_key":"3db529a828200","_type":"span"},{"_type":"span","marks":["em"],"text":"CGTLive","_key":"9486e94b4706"},{"_type":"span","marks":[],"text":".","_key":"bdce5f7df09d"}]},{"style":"normal","_key":"e1b8afe3aaf6","markDefs":[],"children":[{"_key":"b3337bddd7dc0","_type":"span","marks":[],"text":"Data from these participants showed that they all had normal hematological reconstitution and engraftment that was consistent with arsa-cel outcomes seen in patients with early-onset MLD who have been treated in other settings. Time to neutrophil engraftment ranged from 26 to 42 days (median, 33) posttreatment and time to platelet engraftment ranged from 25 to 46 days (median, 26) posttreatment. ARSA activity reached supranormal levels in the PBMCs and in CD15+ cells and increased to normal levels in the CSF in 3 patients for whom central nervous system pharmacodynamic efficacy measures were available.At 90 days after administration of arsa-cel transduced bone marrow progenitors made up between 23.81% to 81.25% of bone marrow progenitors. At this time point, the PBMCs showed a median vector copy number (VCN) of 0.49 copies/cell and the CD15+ cells showed a median VCN of 0.82 copies/cell."},{"marks":["superscript"],"text":"4","_key":"8a181fcf9a73","_type":"span"}],"_type":"block"},{"_key":"cef68e74e418","markDefs":[],"children":[{"_type":"span","marks":[],"text":"In terms of safety, there were no serious adverse events (SAEs) deemed potentially related to arsa-cel. One nonserious AE deemed potentially related to the therapy, a case of erythematous rash, occurred in 1 patient. No SAEs deemed potentially related to the Busulfan conditioning regimen occurred; although cases of febrile neutropenia, cytopenia, and stomatitis were deemed to have potential relation to the regimen. An SAE of upper respiratory tract infection occurred in 1 patient. One patient with prolonged thrombocytopenia who had previously experienced treatment-failure with allogeneic transplant in the form of autologous reconstitution was administered thrombopoietin receptor agonist therapy for 5 months. No multilineage engraftment of transduced cells or malignancy occurred and there was no indication of clonal expansion or replication competent lentivirus.","_key":"80d5fcdb27980"},{"_type":"span","marks":["superscript"],"text":"4","_key":"0a6a6c49b779"}],"_type":"block","style":"normal"},{"style":"h6","_key":"72b0bb57c9f8","markDefs":[],"children":[{"_type":"span","marks":[],"text":"REFERENCES","_key":"3987f142a2e90"}],"_type":"block"},{"style":"h6","_key":"c38105a56665","markDefs":[],"children":[{"_type":"span","marks":[],"text":"1. FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy. News release. Orchard Therapeutics. March 18, 2024. Accessed March 18, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-children-metachromatic-leukodystroph\n2. Orchard Therapeutics announces acceptance of biologics license application for OTL-200 in MLD and receives priority review. News release. Orchard Therapeutics. September 18, 2023. Accessed September 18, 2023. https://ir.orchard-tx.com/news-releases/news-release-details/orchard-therapeutics-announces-acceptance-biologics-license\n3. Fumagalli F, Calbi V, De Mattia F, et al. Long-term clinical outcomes of atidarsageneautotemcel (autologous hematopoietic stem cell gene therapy) preserves cognitive and motor development in early-onset metachromatic leukodystrophy with up to 12 years follow-up. Presented at: WORLDSymposium, held February 4-9, in San Diego, California. Poster #92\n4. Gallo V, Calbi V, De Mattia F, et al. Lentiviral hematopoietic stem cell gene therapy (atidarsageneautotemcel) for late juvenile metachromatic leukodystrophy (MLD). Presented at: WORLDSymposium, held February 4-9, in San Diego, California. Poster #96","_key":"cf335e8687dd0"}],"_type":"block"}],"articleType":"News","contentCategory":{"_ref":"54fdc3d6-b776-4653-9c81-26acd95a8a7e","_type":"reference"},"is_visible":true,"_rev":"s4HNKQHudgS0rVzOmAznJS","title":"Phase 3 Trial Seeks to Continue Supporting Arsa-Cel Gene Therapy for MLD ","authors":[{"displayName":"Victoria Johnson","url":"victoria-johnson"}],"published":"2024-03-18T22:00:17.863Z","factCheckAuthors":null,"_type":"article","_createdAt":"2024-03-18T21:27:58Z","authorMapping":[{"_type":"reference","_key":"243d617b964c","_ref":"YxXi5DCehknTuOjGHyH0kO"}],"url":"phase-3-trial-seeks-to-continue-supporting-arsa-cel-gene-therapy-for-mld"},{"_updatedAt":"2025-02-04T16:17:45Z","body":[{"style":"normal","_key":"66b0e0a2e987","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Sarepta Therapeutics’ delandistrogene moxeparvovec-rokl (marketed as Elevidys), a marketed adeno-associated virus (AAV) vector-based gene therapy for patients with Duchenne muscular dystrophy (DMD), has shown sustained benefit in patients who are ambulatory who were treated in the phase 3 EMBARK clinical trial (NCT05096221; SRP-9001-301), according to new results from part 2 of the study.","_key":"3e78ac21bf70"},{"_type":"span","marks":["sup"],"text":"1","_key":"cd52003898fb"}],"_type":"block"},{"children":[{"_type":"span","marks":[],"text":"Among 59 patients in part 2 who crossed over to receive treatment with Elevidys after having received the placebo in part 1 of the study, a least square means (LSM) improvement of +2.34 points from baseline on the North Star Ambulatory Assessment (NSAA) in comparison to a matched external controlgroup (EC) at 52 weeks posttreatment (","_key":"837640fd01bb"},{"_type":"span","marks":["em"],"text":"P","_key":"28451adc5ba8"},{"text":" \u003c .0001). In addition, the patients treated with Elevidys in part 2 also showed an LSM –2.70 seconds improvement on Time to Rise (TTR) (","_key":"b2065625d0d7","_type":"span","marks":[]},{"_type":"span","marks":["em"],"text":"P","_key":"3cd7025e741e"},{"_key":"3dcc35fdd946","_type":"span","marks":[],"text":" \u003c .0001) and an LSM –1.07 seconds improvement on 10-meter walk/run (10MWR) ("},{"_type":"span","marks":["em"],"text":"P ","_key":"cb4b383f3ff5"},{"_type":"span","marks":[],"text":"= .0001) in comparison to a prespecified, propensity-weighted EC. Sarepta noted that the study remained blinded during the 52 weeks posttreatment period in part 2 and that the cross-over treated patients had an average age of 7.11 years, whereas the patients treated in part 1 of the study had had an average age of 5.98 years.","_key":"c4d9c17b4c2d"}],"_type":"block","style":"normal","_key":"ff825ea4aec7","markDefs":[]},{"_key":"c310e5ebd04a","markDefs":[],"children":[{"_key":"50ce3f58d948","_type":"span","marks":[],"text":"Sarepta also reported updated 2 year results from the 63 patients who originally received Elevidys in part 1 of EMBARK. At 2 years posttreatment, the patients treated with the gene therapy in EMBARK showed an LSM improvement of +2.88 points on NSAA ("},{"text":"P","_key":"fde03c45f5a8","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":" =. 0001), -2.06 seconds on TTR (","_key":"0706e358f40c"},{"_type":"span","marks":["em"],"text":"P","_key":"c6370e9ef652"},{"_type":"span","marks":[],"text":" = .0033), and –1.36 seconds on 10MWR (","_key":"c809b8dc39ba"},{"text":"P","_key":"2085f79ddcd5","_type":"span","marks":["em"]},{"_type":"span","marks":[],"text":" =.0028) in comparison to EC. The company pointed out that an increased difference from 1 year posttreatment to 2 years posttreatment on NSAA, TTR, and 10MWR was observed between patients treated with Elevidys in part 1 and the EC, suggesting a continued widening of the chasm in disease trajectory between patients who received the gene therapy and the natural history course of the disease.","_key":"80deb240bc31"}],"_type":"block","style":"normal"},{"_type":"block","style":"normal","_key":"9e528e715abe","markDefs":[],"children":[{"_type":"span","marks":[],"text":"Sarepta also noted that consistent and sustained expression of the microdystrophin encoded by Elevidys was observed in biopsies taken from patients treated in part 1 at 12 weeks posttreatment and 64 weeks posttreatment. With regard to safety, the company stated that no new safety signals have been reported.","_key":"a225455722ea"}]},{"children":[{"marks":[],"text":"“We’re very encouraged to see the results from part 2 of EMBARK as they further elucidate the impact Elevidys has on disease progression in a blinded, controlled study,” Louise Rodino-Klapac, PhD, the executive vice president, head of R\u0026D, and chief scientific officer of Sarapeta, said in a statement.","_key":"e0cf5390c059","_type":"span"},{"_type":"span","marks":["sup"],"text":"1","_key":"227d91178699"},{"_type":"span","marks":[],"text":" “Skeletal muscle MRI demonstrates the importance of preserving muscle, and the functional outcome results show disease stabilization sustained through 2 years after treatment. Over time, we continue to observe a statistically significant difference favoring Elevidys compared to a well-matched external control on NSAA and timed tests. The consistency and totality of evidence supporting a long-term and clinically meaningful treatment benefit with Elevidys continues to grow. We look forward to sharing more details with the clinical community in upcoming scientific forums.”","_key":"54f94a5a191d"}],"_type":"block","style":"normal","_key":"7375484de146","markDefs":[]},{"_key":"1c41a4f9afb8","markDefs":[{"_type":"link","href":"https://www.cgtlive.com/view/fda-approves-sareptas-dmd-gene-therapy-elevidys-expanded-indication","_key":"453655bec112"}],"children":[{"marks":[],"text":"The FDA originally approved Elevidys in June 2023 for ambulatory patients aged 4 through 5 years with DMD and a confirmed mutation in the ","_key":"9db0a89b6052","_type":"span"},{"marks":["em"],"text":"DMD","_key":"0046f4fa5ef5","_type":"span"},{"_key":"623fcaf65f46","_type":"span","marks":[],"text":" gene, excluding patients with any deletion in exon 8 and/or exon 9."},{"_type":"span","marks":["sup"],"text":"2","_key":"bca188044de3"},{"_type":"span","marks":[],"text":" The agency ","_key":"115cc90ead5a"},{"_key":"1743eb90bfa5","_type":"span","marks":["453655bec112"],"text":"expanded its indication"},{"_type":"span","marks":[],"text":" in June 2024 to include ambulatory patients (via traditional approval) and nonambulatory patients (via accelerated approval) with a confirmed mutation in the ","_key":"8124b2eb6b53"},{"_type":"span","marks":["em"],"text":"DMD","_key":"de7371c21cb4"},{"_key":"8f68605771d6","_type":"span","marks":[],"text":" gene who are 4 years of age or older and who do not have any deletion in exon 8 or exon 9 in the gene."},{"_type":"span","marks":["sup"],"text":"3","_key":"f48700a43baf"}],"_type":"block","style":"normal"},{"markDefs":[{"_type":"link","href":"https://www.cgtlive.com/view/brandsema-balancing-risks-rewards-muscular-dystrophy-gene-therapy","_key":"021bae2a4e98"}],"children":[{"_type":"span","marks":[],"text":"In September 2024, ","_key":"0803e4d22952"},{"_type":"span","marks":["em"],"text":"CGTLive®","_key":"594d9634ea64"},{"_type":"span","marks":[],"text":" ","_key":"53fb97eafa00"},{"marks":["021bae2a4e98"],"text":"spoke to John Brandsema, MD","_key":"a771a7d87ecc","_type":"span"},{"_type":"span","marks":[],"text":", a pediatric neurologist in the Division of Neurology at Children’s Hospital of Philadelphia, to get his view on the newly emerging landscape of care for DMD and experience that had been gained with Elevidys at the time. He emphasized the need for more long-term data, especially for older patients, as many patients treated thus far have been on the younger end of the spectrum.","_key":"5823eb9fb4ef"}],"_type":"block","style":"normal","_key":"729623bd5da7"},{"style":"normal","_key":"7b8943d9dcf6","markDefs":[],"children":[{"_key":"f4377cdb09f6","_type":"span","marks":[],"text":"“While the label is broad and is for everyone we don't necessarily have the data to back that up yet and that makes the conversation more nuanced,” Brandsema told "},{"_type":"span","marks":["em"],"text":"CGTLive","_key":"155ca75de260"},{"text":". “We also aren't sure about the durability of transgene expression. Muscle is a high turnover tissue, and therefore whether this is going to be a lifelong effect is still up in the air; although it does seem, from the early boys treated that there is a measurable difference in their trajectory years after the dose, up to 5 or 6 years at this point now.”","_key":"5da2b0996852","_type":"span","marks":[]}],"_type":"block"},{"style":"h6","_key":"845ff701b8db","markDefs":[],"children":[{"text":"REFERENCES\n1. Sarepta Therapeutics Announces Results from Part 2 of the EMBARK Study Demonstrating Sustained Benefits and Disease Stabilization in Ambulatory Individuals with Duchenne Muscular Dystrophy Following Treatment with ELEVIDYS. News release. Sarepta Therapeutics, Inc. January 27, 2025. Accessed January 29, 2025. https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-results-part-2-embark-study?_ga=2.44245095.2103940291.1738162169-1590731373.1738162169\n2. Sarepta Therapeutics Announces FDA Approval of ELEVIDYS, the First Gene Therapy to Treat Duchenne Muscular Dystrophy. News release. Sarepta Therapeutics. June 22, 2023. Accessed January 29, 2025. https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-fda-approval-elevidys-first-gene\n3. Sarepta Therapeutics Announces Expanded US FDA Approval of ELEVIDYS to Duchenne Muscular Dystrophy Patients Ages 4 and Above. News release. Sarepta Therapeutics, Inc. June 20, 2024. Accessed January 29, 2025. https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-us-fda-acceptance-efficacy?_ga=2.242068545.254033713.1708093077-1826905377.1708093076\n","_key":"ac5f039afa68","_type":"span","marks":[]}],"_type":"block"}],"url":"sarepta-dmd-gene-therapy-elevidys-sustained-benefit-updated-phase-3-data","thumbnail":{"_type":"mainImage","asset":{"_ref":"image-e292d9fc799af049ac1bd0109419772a7b6fbdd4-1000x563-jpg","_type":"reference"}},"ExcludeFromPubMedXML":false,"_type":"article","seoTag":["Duchenne Muscular Dystrophy","DMD","gene therapy"],"internalTag":["Duchenne Muscular Dystrophy","Sarepta Therapeutics","SRP-5051","vesleteplirsen","MOMENTUM","NCT04004065","hypomagnesemia","exon 51","gene therapy","DMD"],"taxonomyMapping":[{"_type":"taxonomy","_updatedAt":"2023-11-27T17:07:43Z","identifier":"neurology","parent":{"identifier":"topic","isMainTopic":true,"_createdAt":"2020-12-08T16:06:37Z","_type":"taxonomy","name":"Topic","_rev":"60drdzXgFuuRxJsEyE6his","_id":"8ea01556-869e-480b-83a7-58eca140415e","_updatedAt":"2023-01-19T14:52:23Z","parent":null},"cmeType":"per","_createdAt":"2020-12-08T16:07:23Z","name":"Neurology","_id":"721f499d-3ed3-4310-94c7-f646bad56dc2","perKeywordMapping":["Cardiology","Neurology","Health Equity Diversity \u0026 Inclusion"],"_rev":"USRhz6Ofj9athfco75TZJx","summary":[{"children":[{"text":"The ","_key":"8bdd6ce5e667","_type":"span","marks":[]},{"marks":["em"],"text":"CGTLive","_key":"d7e39fed968f","_type":"span"},{"_key":"5761d91435ea","_type":"span","marks":["superscript"],"text":"™"},{"marks":[],"text":" Neurology specialty topic page houses video interviews with key opinion leaders in the field of neurology about the latest relevant FDA actions, clinical guideline updates, and clinical trial findings related to cell therapies, gene therapies, and engineered and regenerative medicines developed for neurologic disorders and diseases. 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