{"id":43142,"date":"2026-02-06T12:00:00","date_gmt":"2026-02-06T12:00:00","guid":{"rendered":"http:\/\/www.prnasia.com\/story\/archive\/4882432_CN82432_0"},"modified":"2026-02-06T12:00:00","modified_gmt":"2026-02-06T12:00:00","slug":"delonix-bioworks-announces-ind-clearance-for-dx-104-a-novel-engineered-menb-omv-vaccine-candidate-in-china-and-australia","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=43142","title":{"rendered":"Delonix Bioworks Announces IND Clearance for DX-104, a Novel Engineered MenB OMV Vaccine Candidate, in China and Australia"},"content":{"rendered":"\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SHANGHAI<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Feb. 6, 2026<\/span><\/span> \/PRNewswire\/ &#8212;<b> Delonix Bioworks<\/b>, a clinical-stage biotechnology company developing next-generation bacterial vaccines, <span id=\"spanHghlt1d20\">recently<\/span> announced that its Group B meningococcal (MenB) vaccine candidate, DX-104, has received Investigational New Drug (IND) clearance from <span class=\"xn-location\">China&#8217;s<\/span> National Medical Products Administration (NMPA). This follows the successful completion of Clinical Trial Notification (CTN) procedures and ethics committee approval in <span class=\"xn-location\">Australia<\/span> in <span class=\"xn-chron\">January 2026<\/span>. Delonix plans to initiate Phase I clinical trials in the near term to evaluate the safety and immunogenicity of DX-104 in human subjects.<\/p>\n<p>Invasive meningococcal disease (IMD) is a life-threatening bacterial infection that disproportionately impacts infants, adolescents, and young adults. Serogroup B has emerged as a predominant cause of IMD globally, accounting for approximately 50% of cases with a rising prevalence trend. While vaccines like GSK&#8217;s Bexsero&reg; and Pfizer&#8217;s Trumenba&reg; have established the commercial and clinical value of MenB prevention\u2014with Bexsero recording approximately <span class=\"xn-money\">$1.58 billion<\/span> in sales in 2025\u2014significant global gaps in access and strain coverage remain.<\/p>\n<p>DX-104 is an engineered MenB vaccine candidate developed using Delonix&#8217;s proprietary <b>OMV Plus&reg; platform<\/b>. The platform leverages precisely engineered outer membrane vesicles (OMVs) with intrinsic adjuvant properties to optimize immunogenicity. In preclinical studies, DX-104 induced robust serum bactericidal antibody (SBA) responses without the need for external adjuvants. Furthermore, DX-104 has achieved commercial-scale production with high batch-to-batch consistency, ensuring a reliable global supply chain as the candidate advances toward potential commercialization.<\/p>\n<p>&quot;The dual regulatory clearances in <span class=\"xn-location\">China<\/span> and <span class=\"xn-location\">Australia<\/span> mark a transformative milestone for Delonix Bioworks as we transition into a clinical-stage company,&quot; said <b>Qiubin Lin, CEO and Founder of Delonix Bioworks<\/b>. &quot;This is a crucial step in our global strategy to deploy engineered bacterial vaccines that are designed to be highly immunogenic, well-tolerated, and scalable. We are committed to addressing the urgent unmet medical needs of patients worldwide.&quot;<\/p>\n<p><b>About Delonix Bioworks<br \/><\/b>Delonix Bioworks is a clinical-stage biotechnology company at the forefront of developing next-generation genetically engineered bacterial vaccines. Leveraging its proprietary <b>OMV Plus&reg; platform<\/b>, the company produces high-yield, cost-effective, and precisely engineered outer membrane vesicles (OMVs) designed for superior antigen presentation and immunogenicity. Delonix is dedicated to advancing a robust pipeline of first-in-class and best-in-class programs addressing critical unmet needs, including vaccines for <i>Meningococcal B<\/i>, <i>pertussis<\/i>, <i>gonorrhoeae<\/i>, and <i>K. pneumoniae<\/i>.<\/p>\n<p>For more information, please visit <b><a href=\"https:\/\/delonixbio.com\/\" target=\"_blank\" rel=\"nofollow noopener\" style=\"color: #0000FF\">https:\/\/delonixbio.com\/<\/a><\/b> or contact <a href=\"mailto:BD@delonixbio.com\" target=\"_blank\" rel=\"nofollow noopener\" style=\"color: #0000FF\">BD@delonixbio.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>SHANGHAI, Feb. 6, 2026 \/PRNewswire\/ &#8212; Delonix Bioworks, a clinical-stage biotechnology company developing next-generation bacterial vaccines, recently announced that its Group B meningococcal (MenB) vaccine candidate, DX-104, has received Investigational New Drug (IND) clearance from China&#8217;s National Medical Products Administration (NMPA). This follows the successful completion of Clinical Trial Notification (CTN) procedures and ethics committee [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-43142","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Delonix Bioworks Announces IND Clearance for DX-104, a Novel Engineered MenB OMV Vaccine Candidate, in China and Australia - My Blog<\/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:\/\/transmediavictoria.net.au\/?p=43142\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Delonix Bioworks Announces IND Clearance for DX-104, a Novel Engineered MenB OMV Vaccine Candidate, in China and Australia - My Blog\" \/>\n<meta property=\"og:description\" content=\"SHANGHAI, Feb. 6, 2026 \/PRNewswire\/ &#8212; Delonix Bioworks, a clinical-stage biotechnology company developing next-generation bacterial vaccines, recently announced that its Group B meningococcal (MenB) vaccine candidate, DX-104, has received Investigational New Drug (IND) clearance from China&#8217;s National Medical Products Administration (NMPA). 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