{"id":7074,"date":"2026-05-18T12:00:00","date_gmt":"2026-05-18T10:00:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=a2deb241659be21470171f0cb06d71d5"},"modified":"2026-05-18T12:00:00","modified_gmt":"2026-05-18T10:00:00","slug":"prokarium-reports-positive-interim-data-from-phase-1-1b-paradigm-1-trial-of-zh9-in-nmibc-patients-demonstrating-excellent-safety-and-encouraging-early-efficacy","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=7074","title":{"rendered":"Prokarium Reports Positive Interim Data from Phase 1\/1b PARADIGM-1 trial of ZH9 in NMIBC patients, Demonstrating Excellent Safety and Encouraging Early Efficacy"},"content":{"rendered":"<ul class=\"bwlistdisc\">\n<li>\n<i>ZH9 is very well tolerated with a favourable safety profile, and no dose-limiting toxicities or Grade \u22653 drug-related adverse events reported.<\/i><\/li>\n<li>\n<i>ZH9 demonstrates 91% freedom-from-relapse in NMIBC patients who have reached study end.<\/i><\/li>\n<li>\n<i>Company plans to run a larger phase 2 study across a range of patient populations spanning intermediate risk and high risk including CIS.<\/i><\/li>\n<\/ul><p>LONDON--(BUSINESS WIRE)--Prokarium, a clinical-stage biopharmaceutical company pioneering bacterial immunotherapies for the treatment of solid tumours, today announced safety and antitumour efficacy results from an interim review of the ongoing Phase 1\/1b PARADIGM-1 trial of ZH9 in non-muscle invasive bladder cancer (NMIBC) patients. These data were shared via an oral podium presentation at the American Urology Association (AUA26) Annual Meeting.<\/p><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260518901459\/en\/2805531\/5\/Prokarium_-_Main_Logo_-_for_white_background_%281%29.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260518901459\/en\/2805531\/22\/Prokarium_-_Main_Logo_-_for_white_background_%281%29.jpg\" \/><\/a><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260518901459\/en\/2805531\/5\/Prokarium_-_Main_Logo_-_for_white_background_%281%29.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260518901459\/en\/2805531\/21\/Prokarium_-_Main_Logo_-_for_white_background_%281%29.jpg\" \/><\/a><p>\nProkarium CMO, Dr Josefin-Beate Holz said <i>\u201cThese data demonstrate ZH9 as a universally applicable treatment for patients. As the treatment is very well tolerated and is showing impactful outcomes for early and BCG-non-responsive patients alike, it opens up the potential for ZH9 to be a transformative bladder saving treatment.\u201d<\/i><\/p><p>\n<i>\"There is a clear and urgent need to move beyond BCG. The current treatment burden\u2014requiring up to 18 catheterisations in the first year\u2014 detrimentally impacts real-world compliance and patient outcomes,\" <\/i>said Ibs Mahmood, CEO of Prokarium<i>. \"Patients deserve a therapy that is not only effective and safe, but also more convenient, and we believe ZH9, reducing this to just 4\u20135 administrations per year, could be a game changer.\u201d<\/i><\/p><p>\n<b>Interim data:<\/b><\/p><p>\nProkarium\u2019s PARADIGM-1 trial (NCT06181266) is a Phase 1\/1b study evaluating safety, tolerability and early efficacy of ZH9 in recurrent intermediate-risk and high-risk NMIBC patients.<\/p><ul class=\"bwlistdisc\">\n<li>\nOf 22 patients that received at least 1 dose of ZH9, 6 patients (27%) experienced an Adverse Event related to treatment with ZH9 all of which were mild or moderate and transient.<\/li>\n<li>\nNo grade 3 or higher toxicities, dose-limiting toxicities, or drug related serious adverse events were observed.<\/li>\n<li>\nZH9 demonstrated 91% freedom-from-relapse at 12 months in the heavily pretreated study population (10\/11 patients at 12m, per protocol completion).<\/li>\n<\/ul><p>\n<b>About Prokarium<\/b><\/p><p>\nProkarium is a pioneering clinical-stage biotech company leveraging synthetic biology to create next generation bacterial immunotherapies. This new class of immunotherapy is designed to deliver a broad and durable immune response with the potential to treat a wide range of cancers. The lead program, ZH9, is currently in Phase 1 clinical trials in the US as a monotherapy treatment for NMIBC. Prokarium is based in London, UK. For further information, visit <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.prokarium.com%2F&amp;esheet=54536083&amp;newsitemid=20260518901459&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.prokarium.com&amp;index=1&amp;md5=2041aba910d1aa3480f77a92bfb243c1\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.prokarium.com<\/a>.<\/p><p>\n<b>About ZH9<\/b><\/p><p>\nThe investigational immunotherapy, ZH9, is being developed as an intravesical treatment for the prevention of recurrence in non-muscle invasive bladder cancer. The PARADIGM-1 study (NCT06181266) has completed enrolment across multiple centers in the United States.<\/p><br\/> <b>Contacts<\/b> <br\/><p>\n<b>For enquiries, please contact:<\/b><br\/>Eugenie Eley\n<br\/><a  href=\"mailto:Eugenie.eley@prokarium.com\" rel=\"nofollow\" shape=\"rect\">Eugenie.eley@prokarium.com<\/a><br\/><a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.prokarium.com&amp;esheet=54536083&amp;newsitemid=20260518901459&amp;lan=en-US&amp;anchor=www.prokarium.com&amp;index=2&amp;md5=49ece8311d3fdac25b92c0983daaf857\" rel=\"nofollow\" shape=\"rect\">www.prokarium.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>ZH9 is very well tolerated with a favourable safety profile, and no dose-limiting toxicities or Grade \u22653 drug-related adverse events reported.<\/p>\n<p>ZH9 demonstrates 91% freedom-from-relapse in NMIBC patients who have reached study end.<\/p>\n<p>Company plans to &#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-7074","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/7074","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=7074"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/7074\/revisions"}],"predecessor-version":[{"id":7075,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/7074\/revisions\/7075"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7074"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7074"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7074"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}