{"id":39606,"date":"2025-09-05T08:46:00","date_gmt":"2025-09-05T08:46:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4766460_HK66460_0"},"modified":"2025-09-05T08:46:00","modified_gmt":"2025-09-05T08:46:00","slug":"senhwa-biosciences-cx-5461-secures-nci-support-to-advance-into-myc-driven-lymphoma-driving-cross-cancer-and-global-licensing-value","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=39606","title":{"rendered":"Senhwa Biosciences CX-5461 Secures NCI Support to Advance into MYC-Driven Lymphoma, Driving Cross-Cancer and Global Licensing Value"},"content":{"rendered":"<div id=\"dvContent\" readability=\"100\">\n<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1933477\/Senhwa_Logo_Logo_Logo.jpg?p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">TAIPEI<\/span> and <span class=\"xn-location\">SAN DIEGO<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Sept. 5, 2025<\/span><\/span> \/PRNewswire\/ &#8212; Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has granted IND clearance for its innovative drug candidate Pidnarulex(CX-5461) ina Phase <span class=\"xn-money\">1b<\/span>\/2 clinical trial in patients with B-cell lymphoma subtypes that harbors MYC gene aberrations.<\/p>\n<p>Given that nearly 30% of all cancers are associated with MYC oncogene overexpression, the clinical development of CX-5461 is generating significant anticipation. If the trial delivers positive results, CX-5461 could become the first pan-cancer therapy specifically targeting MYC-driven tumors, unlocking substantial licensing opportunities and market potentials for Senhwa.<\/p>\n<p><b>MYC as a Cancer Driver \u2013 Genetic Aberrants in Nearly One-Third of Patients<\/b><\/p>\n<p>MYC is recognized as a critical oncogene, with gene amplification or related alterations present in approximately 28% of tumors across multiple cancer types, including lung, breast, liver, lymphoma, prostate, and endometrial cancers. MYC functions as a transcription factor,&nbsp;notably enhancing glycolysis and biosynthetic pathways to meet the energy and biomass demands of rapidly proliferating cancer cells, which accelerates malignant growth, increases recurrence rates, and reduces overall survival.<\/p>\n<p><b>First-in-Class G4 Targeting Therapy Against Hard-to-Treat Lymphomas<\/b><\/p>\n<p>CX-5461 is the <b>world&#8217;s first and most advanced G-quadruplex (G4) stabilizer<\/b> in clinical development. Preclinical studies have demonstrated its ability to suppress MYC expression and inhibit tumor progression. Moreover, in a blood cancer trial conducted by Senhwa&#8217;s clinical partner Peter MacCallum Cancer Center (PMCC) in <span class=\"xn-location\">Australia<\/span>, CX-5461 delivered promising results in patients with B-cell lymphoma.<\/p>\n<p>&#8220;From preclinical models to&nbsp;haematologic malignancies study, CX-5461 has demonstrated potential efficacy in MYC gene-driven tumors. With FDA&#8217;s clearance for this Phase <span class=\"xn-money\">1b<\/span>\/2 trial, we are excited to broaden its potential application from refractory lymphomas to multiple cancer indications in the future, offering patients a truly groundbreaking treatment option,&#8221; said <span class=\"xn-person\">Jason Huang<\/span>, Chief Medical Officer of Senhwa.<\/p>\n<p><b>B-cell Lymphoma Market Potential Exceeds <span class=\"xn-money\">USD 10 Billion<\/span> <\/b><\/p>\n<p>According to BioSpace, the global B-cell lymphoma therapeutics market reached <span class=\"xn-money\">USD 4.9 billion<\/span> in 2024, and is projected to grow to <span class=\"xn-money\">USD 8.9 billion<\/span> by 2035, representing a steady CAGR of 5.79% over the next decade. Demand for innovative targeted therapies is particularly strong among relapsed and refractory lymphoma patients, underscoring an unmet medical need.<\/p>\n<p>With its differentiated mechanism of action and precision oncology potential, CX-5461 could significantly enhance Senhwa&#8217;s global licensing value and emerge as a next-generation standard of care in B-cell lymphoma treatment.<\/p>\n<\/p><\/div>\n<p>Source: Senhwa Biosciences, Inc.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>TAIPEI and SAN DIEGO, Sept. 5, 2025 \/PRNewswire\/ &#8212; Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has granted IND clearance for its innovative drug candidate Pidnarulex(CX-5461) ina Phase 1b\/2 clinical trial in patients with B-cell lymphoma subtypes that harbors MYC gene aberrations. Given [&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-39606","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>Senhwa Biosciences CX-5461 Secures NCI Support to Advance into MYC-Driven Lymphoma, Driving Cross-Cancer and Global Licensing Value - 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=39606\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Senhwa Biosciences CX-5461 Secures NCI Support to Advance into MYC-Driven Lymphoma, Driving Cross-Cancer and Global Licensing Value - My Blog\" \/>\n<meta property=\"og:description\" content=\"TAIPEI and SAN DIEGO, Sept. 5, 2025 \/PRNewswire\/ &#8212; Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has granted IND clearance for its innovative drug candidate Pidnarulex(CX-5461) ina Phase 1b\/2 clinical trial in patients with B-cell lymphoma subtypes that harbors MYC gene aberrations. 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