{"id":829887,"date":"2025-03-26T08:03:23","date_gmt":"2025-03-26T12:03:23","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/vaximm-ag-an-osr-company-announces-results-from-phase-2a-trial-of-vxm01-and-avelumab-combination-therapy-in-glioblastoma\/"},"modified":"2025-03-26T08:03:23","modified_gmt":"2025-03-26T12:03:23","slug":"vaximm-ag-an-osr-company-announces-results-from-phase-2a-trial-of-vxm01-and-avelumab-combination-therapy-in-glioblastoma","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/vaximm-ag-an-osr-company-announces-results-from-phase-2a-trial-of-vxm01-and-avelumab-combination-therapy-in-glioblastoma\/","title":{"rendered":"Vaximm AG, an OSR Company, Announces Results from Phase 2a Trial of VXM01 and Avelumab Combination Therapy in Glioblastoma"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<p>\n        <b>Results from Phase 2a Trial demonstrate a good safety and tolerability profile of VXM01 and Avelumab Combination Therapy in Glioblastoma, supporting further investigation of VXM01<\/b>\n      <\/p>\n<p>\n        <span class=\"legendSpanClass\"><br \/>\n          <span class=\"xn-location\">BASEL, Switzerland<\/span><br \/>\n        <\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">March 26, 2025<\/span><\/span> \/PRNewswire\/ &#8212; Vaximm AG, a subsidiary of OSR Holdings, Inc. and a pioneering biotechnology company focused on developing innovative immunotherapies, today announced final data from the successful conclusion of its\u00a0open-label\u00a0Phase 2a clinical trial\u00a0assessing the safety\u00a0and tolerability of VXM01, an investigational\u00a0oral anti-VEGFR-2 vaccine, in combination with avelumab (PD-L1 inhibitor) in patients with recurrent glioblastoma (GBM).\u00a0The trial was part of a collaboration with Merck KGaA, Darmstadt, <span class=\"xn-location\">Germany<\/span>.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/2393302\/OSR_Holdings_logo_Logo.html\" target=\"_blank\" rel=\"nofollow\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/2393302\/OSR_Holdings_logo_Logo.jpg\" title=\"OSR Holdings logo (PRNewsfoto\/OSR Holdings)\" alt=\"OSR Holdings logo (PRNewsfoto\/OSR Holdings)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<p>Key<b>\u00a0results<\/b>\u00a0and observations:<\/p>\n<ul type=\"disc\">\n<li>The VXM01-avelumab combination therapy was generally well-tolerated, with the majority of safety events being mild to moderate in severity. These safety and tolerability data are in-line with previously reported data on\u00a0avelumab alone with no additional safety signals for the combination of VXM01 and avelumab.<\/li>\n<li>No serious adverse events (SAEs)\u00a0were attributed to VXM01, while\u00a09 of 11 (81.8%) were related to the target disease, underscoring the well manageable safety profile of this combination therapy in a frail patient population.\u00a0<\/li>\n<li>The non-resected patient cohort showed a 12.0% objective response rate (ORR). 12.0% of these patients showed a partial remission and 4.0% had stable disease. This suggests that, with further investigation, VXM01 in combination with PD-L1 inhibition (e.g. avelumab) could offer meaningful clinical benefit for this challenging patient population. In resected patients, the overall survival (OS) ranged from 2.2 to 46.5 months, highlighting the variability in response and the need for additional studies to determine optimal treatment regimens for specific subgroups of GBM patients.<\/li>\n<li>Despite the small size of this open-label trial (n=25), the observed median time to progression of 2.7 months (95% CI: 2.7 \u2013 2.7, range \u00a00.3 &#8211; 22.1 months), and median OS of 11.1 months (95% CI: 8.5 \u2013 16.3, range \u00a03.8- 38.2 months), are encouraging initial results in the context of prognosis for patients with recurrent glioblastoma, \u00a0reported to have a median PFS of 1.5 to 6 months and median OS of 2 to 9\u00a0months.<b>(Birzu et al. 2020)<\/b><\/li>\n<li>Decreased tumor size was observed in responding patients independent of tumor size at baseline, supporting the expectation that VXM01 vaccine treatment may be effective in patients with larger sized tumors as well as patients with early-stage cancer or very small tumors.<\/li>\n<li>Exploratory biomarker investigations identified potential predictive and\u00a0pharmacodynamic biomarkers of a VXM01-mediated tumor response \u00a0<\/li>\n<\/ul>\n<p>\n        <b>Moving Forward:<\/b>\n      <\/p>\n<p>The reported safety and tolerability data, together with early indications for the potential relevance of a VXM01dependent, VEGFR-2 specific immune response in GBM therapy warrant further study.<\/p>\n<p>&#8220;The completion of this Phase 2a study is a significant milestone for Vaximm AG, as it provides strong evidence that VXM01, in combination with\u00a0avelumab is generally well-tolerated in patients with recurrent glioblastoma,&#8221; said Dr. <span class=\"xn-person\">Constance Hoefer<\/span>, CEO of Vaximm AG. &#8220;We are encouraged by these early results and the potential to improve outcomes for patients with this aggressive cancer. We remain committed to advancing VXM01 as a key therapeutic candidate for the treatment of glioblastoma, other cancers and\u00a0other\u00a0diseases where VXM01 may have\u00a0positive\u00a0impact on treatment outcomes&#8221;\u00a0<\/p>\n<p>\n        <b>About VXM01<\/b><br \/>\n        <b>:<\/b>\n      <\/p>\n<p>VXM01 is an oral T-cell immunotherapy that is designed to activate T-cells to attack the tumor vasculature and, in several tumor types, attack cancer cells directly. It is based on a live attenuated, safe, orally available bacterial vaccine strain, which is modified to carry vascular endothelial growth factor receptor-2 (VEGFR2) as the target gene. VXM01 stimulates the patient&#8217;s immune system to activate VEGFR2-specific, cytotoxic T-cells (so-called killer cells). These immune killer cells then actively destroy cells in the tumor vasculature, leading to an increased infiltration of various immune cells into the tumor. In several tumor types, including brain cancer, VEGFR2 is highly over-expressed on the cancer cells themselves. In preclinical studies, a murine analog VXM01 vaccine showed broad anti-tumor activity in different tumor types. This activity was linked to a VEGFR2-specific T-cell response and was accompanied by the destruction of the tumor vasculature and increased immune cell infiltration. In a Phase I double-blind, randomized, placebo-controlled study in 71 patients with advanced pancreatic cancer, VXM01 appeared to be safe and well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival. Clinical activity in terms of objective responses and survival has been observed in recurrent glioblastoma.<\/p>\n<p>\n        <b>About Vaximm AG:<\/b>\n      <\/p>\n<p>Vaximm AG is a pioneering biotechnology company focused on developing innovative immunotherapies. Through innovative approaches, Vaximm aims to unlock the potential of cancer vaccines and immune-oncology therapies to address the unmet needs of patients suffering from various types of cancer. For more information about Vaximm, please visit\u00a0<u><a href=\"http:\/\/www.vaximm.com\/\" target=\"_blank\" rel=\"nofollow\">www.vaximm.com<\/a><\/u>.\u00a0\u00a0<\/p>\n<p>\n        <b>About OSR Holdings Inc:<\/b>\n      <\/p>\n<p>OSR Holdings, Inc. (NASDAQ: OSRH) is a global healthcare company dedicated to advancing healthcare outcomes and improving the quality of life for people and their families. OSR aims to build and develop a robust portfolio of innovative and potentially transformative therapies and healthcare solutions. Its current operating businesses (through three wholly-owned\u00a0subsidiaries) include (i)\u00a0developing oral immunotherapies for the treatment of cancer (&#8220;Vaximm&#8221;), (ii)\u00a0developing design-augmented\u00a0biologics for age-related\u00a0and other degenerative diseases (&#8220;Darnatein&#8221;) and (iii)\u00a0neurovascular intervention medical device and systems distribution in Korea (&#8220;RMC&#8221;). \u00a0OSR&#8217;s vision is to acquire and operate a portfolio of innovative healthcare\u00a0related companies globally.<\/p>\n<p>\n        <b>Contact:<\/b>\n      <\/p>\n<p>Vaximm AG<br \/>Email: <a href=\"mailto:ir@osr-holdings.com\" target=\"_blank\" rel=\"nofollow\">ir@osr-holdings.com<\/a>\u00a0<br \/>Website:\u00a0<u><a href=\"http:\/\/www.vaximm.com\/\" target=\"_blank\" rel=\"nofollow\">www.vaximm.com<\/a><\/u><\/p>\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=CN50346&amp;sd=2025-03-26\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"https:\/\/www.prnewswire.com\/news-releases\/vaximm-ag-an-osr-company-announces-results-from-phase-2a-trial-of-vxm01-and-avelumab-combination-therapy-in-glioblastoma-302411928.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/vaximm-ag-an-osr-company-announces-results-from-phase-2a-trial-of-vxm01-and-avelumab-combination-therapy-in-glioblastoma-302411928.html<\/a><\/p>\n<p>SOURCE  OSR Holdings Inc.<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=CN50346&amp;Transmission_Id=202503260716PR_NEWS_USPR_____CN50346&amp;DateId=20250326\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire Results from Phase 2a Trial demonstrate a good safety and tolerability profile of VXM01 and Avelumab Combination Therapy in Glioblastoma, supporting further investigation of VXM01 BASEL, Switzerland , March 26, 2025 \/PRNewswire\/ &#8212; Vaximm AG, a subsidiary of OSR Holdings, Inc. and a pioneering biotechnology company focused on developing innovative immunotherapies, today announced final data from the successful conclusion of its\u00a0open-label\u00a0Phase 2a clinical trial\u00a0assessing the safety\u00a0and tolerability of VXM01, an investigational\u00a0oral anti-VEGFR-2 vaccine, in combination with avelumab (PD-L1 inhibitor) in patients with recurrent glioblastoma (GBM).\u00a0The trial was part of a collaboration with Merck KGaA, Darmstadt, Germany. Key\u00a0results\u00a0and observations: The VXM01-avelumab combination therapy was generally well-tolerated, with the majority of safety events being mild to moderate in severity. These &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/vaximm-ag-an-osr-company-announces-results-from-phase-2a-trial-of-vxm01-and-avelumab-combination-therapy-in-glioblastoma\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Vaximm AG, an OSR Company, Announces Results from Phase 2a Trial of VXM01 and Avelumab Combination Therapy in Glioblastoma&#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-829887","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>Vaximm AG, an OSR Company, Announces Results from Phase 2a Trial of VXM01 and Avelumab Combination Therapy in Glioblastoma - 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\/vaximm-ag-an-osr-company-announces-results-from-phase-2a-trial-of-vxm01-and-avelumab-combination-therapy-in-glioblastoma\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Vaximm AG, an OSR Company, Announces Results from Phase 2a Trial of VXM01 and Avelumab Combination Therapy in Glioblastoma - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire Results from Phase 2a Trial demonstrate a good safety and tolerability profile of VXM01 and Avelumab Combination Therapy in Glioblastoma, supporting further investigation of VXM01 BASEL, Switzerland , March 26, 2025 \/PRNewswire\/ &#8212; Vaximm AG, a subsidiary of OSR Holdings, Inc. and a pioneering biotechnology company focused on developing innovative immunotherapies, today announced final data from the successful conclusion of its\u00a0open-label\u00a0Phase 2a clinical trial\u00a0assessing the safety\u00a0and tolerability of VXM01, an investigational\u00a0oral anti-VEGFR-2 vaccine, in combination with avelumab (PD-L1 inhibitor) in patients with recurrent glioblastoma (GBM).\u00a0The trial was part of a collaboration with Merck KGaA, Darmstadt, Germany. Key\u00a0results\u00a0and observations: The VXM01-avelumab combination therapy was generally well-tolerated, with the majority of safety events being mild to moderate in severity. 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Key\u00a0results\u00a0and observations: The VXM01-avelumab combination therapy was generally well-tolerated, with the majority of safety events being mild to moderate in severity. 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