{"id":508781,"date":"2021-07-01T08:04:23","date_gmt":"2021-07-01T12:04:23","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-multiple-advancements-of-4-1bb-bispecific-antibody-portfolio\/"},"modified":"2021-07-01T08:04:23","modified_gmt":"2021-07-01T12:04:23","slug":"i-mab-announces-multiple-advancements-of-4-1bb-bispecific-antibody-portfolio","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-multiple-advancements-of-4-1bb-bispecific-antibody-portfolio\/","title":{"rendered":"I-Mab Announces Multiple Advancements of 4-1BB Bispecific Antibody Portfolio"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<ul type=\"disc\">\n<li>\n          <i>First patient dosed in U.S. phase 1 clinical trial of TJ-CD4B\/ABL111 in patients with advanced or metastatic solid tumors<\/i>\n        <\/li>\n<li>\n          <i><br \/>\n            <span class=\"xn-location\">China<\/span> sites to join the dose expansion part of the study to accelerate <\/i><br \/>\n          <i>TJ-<\/i><br \/>\n          <i>CD4B\/ABL111 development<\/i>\n        <\/li>\n<li>\n          <i>Results of TJ-L14B\/ABL503 preclinical studies accepted for publication in Journal <\/i><br \/>\n          <i>for <\/i><br \/>\n          <i>ImmunoTherapy of Cancer <\/i>\n        <\/li>\n<\/ul>\n<p>\n        <span class=\"xn-location\">SHANGHAI<\/span> and <span class=\"xn-location\">GAITHERSBURG, MD<\/span>., <span class=\"xn-chron\">July 1, 2021<\/span> \/PRNewswire\/ &#8212; I-Mab (the &#8220;Company&#8221;) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, today announced multiple advancements in its 4-1BB bispecific antibody portfolio. Stimulation of 4-1BB is a promising therapeutic strategy for improving the current immunotherapy for cancers. I-Mab&#8217;s lead bi-specific antibody assets TJ-CD4B\/ABL111 and TJ-L14B\/ABL503, both jointly developed with ABL Bio, Inc. (Kosdaq: 298380), are undergoing clinical development in <span class=\"xn-location\">the United States<\/span>.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/1433981\/logo_Logo.html\" target=\"_blank\" rel=\"nofollow noopener\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/1433981\/logo_Logo.jpg\" title=\"(PRNewsfoto\/I-Mab)\" alt=\"(PRNewsfoto\/I-Mab)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<p>TJ-CD4B\/ABL111 is the only clinical-stage bispecific antibody that binds to Claudin 18.2 (CLDN18.2)-expressing cancer cells and co-stimulatory molecule 4-1BB on immune cells to elicit a localized and combined immune response against solid tumors. Preclinical studies have demonstrated superior CLDN18.2-dependent immune activation with TJ-CD4B\/ABL111 compared to 4-1BB monoclonal antibodies. The anti-tumor activity is achieved locally at the tumor site with no hepatotoxicity or systemic side effects that are commonly seen with 4-1BB monoclonal antibodies when used alone. Studies have also demonstrated a memory response that can resist tumor rechallenge for a long-lasting treatment effect.<\/p>\n<p>A U.S. phase 1 clinical trial of TJ-CD4B\/ABL111 in advanced or metastatic solid tumors (NCT04900818) has been initiated with the first patient being dosed on <span class=\"xn-chron\">June 29, 2021<\/span>. The phase 1 clinical study is a multi-center dose escalation and dose expansion study. To accelerate TJ-CD4B\/ABL111 development, <span class=\"xn-location\">China<\/span> sites will join the dose expansion part of the study. Patients with gastric cancer, esophageal adenocarcinoma and pancreatic cancer in <span class=\"xn-location\">China<\/span> will be enrolled later this year.<\/p>\n<p>TJ-L14B\/ABL503 is another novel bispecific antibody uniquely designed to activate 4-1BB signalling in the presence of PD-L1, while simultaneously blocking PD-1\/PD-L1 signalling. Preclinical studies have demonstrated superior anti-tumor activity for TJ-L14B\/ABL503 compared to equimolar doses of 4-1BB and PD-L1 monoclonal antibodies single agents alone or in combination. The data suggest that TJ-L14B\/ABL503 induced anti-tumor response was protective against tumor rechallenge in animal studies. These results have now been accepted for publication by the <i>Journal for ImmunoTherapy of Cancer<\/i> (JITC), titled &#8220;Novel anti-4-1BB X PD-L1 bispecific antibody augments anti-tumor immunity through tumor-directed T-cell activation and checkpoint blockade.&#8221; A phase 1 clinical trial for TJ-L14B\/ABL503 was initiated in the U.S. earlier in <span class=\"xn-chron\">April 2021<\/span> in patients with locally advanced or metastatic solid tumors (NCT04762641).<\/p>\n<p>&#8220;As the next-wave of innovation in immuno-oncology, bispecific antibodies could be a promising solution to cancers that are resistant to the existing standard of care,&#8221; said Dr. <span class=\"xn-person\">Joan Shen<\/span>, CEO of I-Mab. &#8220;With the rapid development of our bispecific antibody portfolio, we are excited to progress one of the world&#8217;s first echelon of 4-1BB bispecific antibodies in the clinic.&#8221; <\/p>\n<p>\n        <b>About TJ-CD4B\/ABL111 <\/b>\n      <\/p>\n<p>TJ-CD4B, also known as ABL111, is a Claudin 18.2 and 4-1BB bispecific antibody capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to be activated only upon tumor engagement whilst silent elsewhere. TJ-CD4B effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both Claudin 18.2 antibody and 4-1BB antibody while it avoids or minimizes liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. TJ-CD4B is being developed under collaboration between I-Mab and ABL. <\/p>\n<p>\n        <b>About TJ-L14B\/ABL503<\/b>\n      <\/p>\n<p>Being developed jointly with ABL, TJ-L14B\/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL&#8217;s &#8216;Grabody-T&#8217; bispecific antibody platform technology, TJ-L14B\/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination.<\/p>\n<p>\n        <b>About I-Mab<\/b>\n      <\/p>\n<p>I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company&#8217;s mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab&#8217;s globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&amp;D capability and global licensing partnerships, based on the Company&#8217;s unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&amp;D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in <span class=\"xn-location\">Shanghai<\/span> (headquarters), <span class=\"xn-location\">Beijing<\/span>, <span class=\"xn-location\">Hangzhou<\/span> and <span class=\"xn-location\">Hong Kong<\/span> in <span class=\"xn-location\">China<\/span>, and <span class=\"xn-location\">Maryland<\/span> and <span class=\"xn-location\">San Diego<\/span> in <span class=\"xn-location\">the United States<\/span>. For more information, please visit\u00a0<a target=\"_blank\" href=\"http:\/\/ir.i-mabbiopharma.com\/\" rel=\"nofollow noopener\">http:\/\/ir.i-mabbiopharma.com<\/a>\u00a0and follow I-Mab on\u00a0<a target=\"_blank\" href=\"https:\/\/www.linkedin.com\/company\/i-mab\/\" rel=\"nofollow noopener\">LinkedIn<\/a>,\u00a0<a target=\"_blank\" href=\"https:\/\/twitter.com\/IMabBiopharma\" rel=\"nofollow noopener\">Twitter<\/a>\u00a0and\u00a0<a target=\"_blank\" href=\"https:\/\/mp.weixin.qq.com\/s\/_s634aizyQPuq1Vgf-hLGA\" rel=\"nofollow noopener\">WeChat<\/a>.<\/p>\n<p>\n        <b>I-Mab Forward Looking Statements<\/b>\n      <\/p>\n<p>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJ-CD4B\/TJ-L14B\u00a0clinical trials, the potential implications of clinical data for patients, and the advancement by I-Mab and ABL, and anticipated clinical development, regulatory milestones and commercialization of TJ-CD4B\/TJ-L14B.\u00a0Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to the ability of I-Mab and ABL to demonstrate the safety and efficacy of TJ-CD4B\/TJ-L14B; the clinical results for the drug candidate, which may not support further development or NDA\/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the drug candidate; the ability to achieve commercial success for the drug candidate, if approved; I-Mab&#8217;s ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab&#8217;s reliance on third parties to conduct drug development, manufacturing and other services; I-Mab&#8217;s limited operating history and I-Mab&#8217;s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company&#8217;s clinical development, commercial and other operations, as well as those risks more fully discussed in the &#8220;Risk Factors&#8221; section in I-Mab&#8217;s most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab&#8217;s subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.<\/p>\n<p>\n        <b>For more information, please contact:<\/b>\n      <\/p>\n<p>\n        <b>I-Mab<br \/><\/b>Jielun Zhu, Chief Financial Officer<br \/>E-mail: <a target=\"_blank\" href=\"mailto:jielun.zhu@i-mabbiopharma.com\" rel=\"nofollow noopener\">jielun.zhu@i-mabbiopharma.com<\/a><br \/>Office line: +86 21 6057 8000<\/p>\n<p>\n        <span class=\"xn-person\">Gigi Feng<\/span>, Chief Communications Officer<br \/>E-mail: <a target=\"_blank\" href=\"mailto:gigi.feng@i-mabbiopharma.com\" rel=\"nofollow noopener\">gigi.feng@i-mabbiopharma.com<\/a><br \/>Office line: +86 21 6057 5709<\/p>\n<p>\n        <b>Investor Inquiries:<br \/><\/b>The Piacente Group, Inc.<br \/><span class=\"xn-person\">Emilie Wu<\/span><br \/>E-mail: <a target=\"_blank\" href=\"mailto:emilie@thepiacentegroup.com\" rel=\"nofollow noopener\">emilie@thepiacentegroup.com<\/a><br \/>Office line: + 86 21 6039 8363<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder2\"><\/div>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=CN30477&amp;sd=2021-07-01\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"https:\/\/www.prnewswire.com\/news-releases\/i-mab-announces-multiple-advancements-of-4-1bb-bispecific-antibody-portfolio-301323961.html\">https:\/\/www.prnewswire.com\/news-releases\/i-mab-announces-multiple-advancements-of-4-1bb-bispecific-antibody-portfolio-301323961.html<\/a><\/p>\n<p>SOURCE  I-Mab<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=CN30477&amp;Transmission_Id=202107010800PR_NEWS_USPR_____CN30477&amp;DateId=20210701\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire First patient dosed in U.S. phase 1 clinical trial of TJ-CD4B\/ABL111 in patients with advanced or metastatic solid tumors China sites to join the dose expansion part of the study to accelerate TJ- CD4B\/ABL111 development Results of TJ-L14B\/ABL503 preclinical studies accepted for publication in Journal for ImmunoTherapy of Cancer SHANGHAI and GAITHERSBURG, MD., July 1, 2021 \/PRNewswire\/ &#8212; I-Mab (the &#8220;Company&#8221;) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, today announced multiple advancements in its 4-1BB bispecific antibody portfolio. Stimulation of 4-1BB is a promising therapeutic strategy for improving the current immunotherapy for cancers. I-Mab&#8217;s lead bi-specific antibody assets TJ-CD4B\/ABL111 and TJ-L14B\/ABL503, both jointly developed with ABL Bio, Inc. (Kosdaq: &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-multiple-advancements-of-4-1bb-bispecific-antibody-portfolio\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;I-Mab Announces Multiple Advancements of 4-1BB Bispecific Antibody Portfolio&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-508781","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>I-Mab Announces Multiple Advancements of 4-1BB Bispecific Antibody Portfolio - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-multiple-advancements-of-4-1bb-bispecific-antibody-portfolio\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"I-Mab Announces Multiple Advancements of 4-1BB Bispecific Antibody Portfolio - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire First patient dosed in U.S. phase 1 clinical trial of TJ-CD4B\/ABL111 in patients with advanced or metastatic solid tumors China sites to join the dose expansion part of the study to accelerate TJ- CD4B\/ABL111 development Results of TJ-L14B\/ABL503 preclinical studies accepted for publication in Journal for ImmunoTherapy of Cancer SHANGHAI and GAITHERSBURG, MD., July 1, 2021 \/PRNewswire\/ &#8212; I-Mab (the &#8220;Company&#8221;) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, today announced multiple advancements in its 4-1BB bispecific antibody portfolio. Stimulation of 4-1BB is a promising therapeutic strategy for improving the current immunotherapy for cancers. I-Mab&#8217;s lead bi-specific antibody assets TJ-CD4B\/ABL111 and TJ-L14B\/ABL503, both jointly developed with ABL Bio, Inc. 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-multiple-advancements-of-4-1bb-bispecific-antibody-portfolio\/","og_locale":"en_US","og_type":"article","og_title":"I-Mab Announces Multiple Advancements of 4-1BB Bispecific Antibody Portfolio - Market Newsdesk","og_description":"PR Newswire First patient dosed in U.S. phase 1 clinical trial of TJ-CD4B\/ABL111 in patients with advanced or metastatic solid tumors China sites to join the dose expansion part of the study to accelerate TJ- CD4B\/ABL111 development Results of TJ-L14B\/ABL503 preclinical studies accepted for publication in Journal for ImmunoTherapy of Cancer SHANGHAI and GAITHERSBURG, MD., July 1, 2021 \/PRNewswire\/ &#8212; I-Mab (the &#8220;Company&#8221;) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, today announced multiple advancements in its 4-1BB bispecific antibody portfolio. Stimulation of 4-1BB is a promising therapeutic strategy for improving the current immunotherapy for cancers. I-Mab&#8217;s lead bi-specific antibody assets TJ-CD4B\/ABL111 and TJ-L14B\/ABL503, both jointly developed with ABL Bio, Inc. 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