{"id":418586,"date":"2021-01-21T08:11:09","date_gmt":"2021-01-21T13:11:09","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=418586"},"modified":"2021-01-21T08:11:09","modified_gmt":"2021-01-21T13:11:09","slug":"bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\/","title":{"rendered":"Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1"},"content":{"rendered":"<p>        <!--body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p>\nBio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1\n<\/p>\n<p>GUANGZHOU, China&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nBio-Thera Solutions, Ltd. (SHA: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT1308, a monoclonal antibody targeting PD-1 in cancer patient volunteers.\n<\/p>\n<p>\n\u201cPD-1 is a validated drug target. BAT1308 has demonstrated a very attractive preclinical profile.\u201d said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. &#8220;We have multiple immune-oncology (IO) assets in our pipeline targeting tumor infiltrating regulatory T cells (Tregs). We plan to explore combinations of BAT1308 with those IO assets targeting tumor infiltrating Tregs and other IO assets in our innovative pipeline to treat a broad range of cancers.\u201d\n<\/p>\n<p>\nThe Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT1308 is designed to assess the safety and tolerability of BAT1308 as a single agent. The study is expected to enroll subjects with advanced solid tumor. Key objectives in the study include determining maximum tolerated dose, pharmacokinetics and preliminary anti-tumor activity. Disease-specific expansion cohorts will be enrolled at the maximally tolerated or biologically relevant dose.\n<\/p>\n<p>\nBio-Thera Solutions is developing several additional innovative oncology assets directed at important IO targets, including TIGIT, CTLA4, OX40, CD47 and TGF\u03b2 and IO bispecifics targeting synergistic targets like PD-L1\/CD47.\n<\/p>\n<p><b>About Bio-Thera Solutions<\/b><\/p>\n<p>\nBio-Thera Solutions, Ltd., a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. A leader in next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and has one approved product, QLETLI, in China. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases. For more information, please visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bio-thera.com%2Fen%2F&amp;esheet=52365205&amp;newsitemid=20210121005310&amp;lan=en-US&amp;anchor=www.bio-thera.com%2Fen%2F&amp;index=1&amp;md5=b6bb6f92b86ececc9d831ccf274d4fbc\">www.bio-thera.com\/en\/<\/a> or follow us on Twitter (<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2Fbio_thera_sol&amp;esheet=52365205&amp;newsitemid=20210121005310&amp;lan=en-US&amp;anchor=%40bio_thera_sol&amp;index=2&amp;md5=bf98cc76d296e3396194714705577074\">@bio_thera_sol<\/a>) and wechat (Bio-Thera).\n<\/p>\n<p><b>Cautionary Note Regarding Forward-Looking Statements<\/b><\/p>\n<p>\nThis news release contains certain forward-looking statements relating to BAT1308 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing \u201ccould,\u201d \u201cmay,\u201d \u201cshould,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201canticipate,\u201d \u201cbelieve,\u201d \u201cplan,\u201d \u201cpromising,\u201d \u201cpotentially,\u201d or similar expressions. They reflect the company\u2019s current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high <i>in vitro<\/i> affinity may not translate to desired results <i>in vivo <\/i>or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company\u2019s financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company\u2019s views or otherwise.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210121005310r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20210121005310\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20210121005310\/en\/<\/a><\/span><\/p>\n<p>\nBio-Thera Solutions, Ltd.:<br \/>\n<br \/>Bert E. Thomas IV +1.410.627.1734<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:bethomas@bio-thera.com?subject=BAT1806%20Phase%20I%20Press%20Release\">bethomas@bio-thera.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> China Asia Pacific<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Biotechnology Health Pharmaceutical Clinical Trials Oncology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20210121005310\/en\/760455\/3\/New_Bio-Thera_Logo.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1 GUANGZHOU, China&#8211;(BUSINESS WIRE)&#8211; Bio-Thera Solutions, Ltd. (SHA: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT1308, a monoclonal antibody targeting PD-1 in cancer patient volunteers. \u201cPD-1 is a validated drug target. BAT1308 has demonstrated a very attractive preclinical profile.\u201d said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. &#8220;We have multiple immune-oncology (IO) assets in our pipeline targeting tumor infiltrating regulatory T cells (Tregs). We plan to explore combinations of BAT1308 with those IO assets targeting tumor infiltrating Tregs and other IO assets in our innovative pipeline to treat a &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1&#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-418586","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1 - 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\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1 GUANGZHOU, China&#8211;(BUSINESS WIRE)&#8211; Bio-Thera Solutions, Ltd. (SHA: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT1308, a monoclonal antibody targeting PD-1 in cancer patient volunteers. \u201cPD-1 is a validated drug target. BAT1308 has demonstrated a very attractive preclinical profile.\u201d said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. &#8220;We have multiple immune-oncology (IO) assets in our pipeline targeting tumor infiltrating regulatory T cells (Tregs). We plan to explore combinations of BAT1308 with those IO assets targeting tumor infiltrating Tregs and other IO assets in our innovative pipeline to treat a &hellip; Continue reading &quot;Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-01-21T13:11:09+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210121005310r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1\",\"datePublished\":\"2021-01-21T13:11:09+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\\\/\"},\"wordCount\":658,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20210121005310r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\\\/\",\"name\":\"Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1 - 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(SHA: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT1308, a monoclonal antibody targeting PD-1 in cancer patient volunteers. \u201cPD-1 is a validated drug target. BAT1308 has demonstrated a very attractive preclinical profile.\u201d said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. &#8220;We have multiple immune-oncology (IO) assets in our pipeline targeting tumor infiltrating regulatory T cells (Tregs). We plan to explore combinations of BAT1308 with those IO assets targeting tumor infiltrating Tregs and other IO assets in our innovative pipeline to treat a &hellip; Continue reading \"Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\/","og_site_name":"Market Newsdesk","article_published_time":"2021-01-21T13:11:09+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210121005310r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1","datePublished":"2021-01-21T13:11:09+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\/"},"wordCount":658,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210121005310r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/bio-thera-solutions-announces-initiation-of-phase-i-clinical-trial-for-bat1308-a-monoclonal-antibody-targeting-pd-1\/","name":"Bio-Thera Solutions Announces Initiation of Phase I Clinical Trial for BAT1308, a Monoclonal Antibody Targeting PD-1 - 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