{"id":31682,"date":"2025-09-06T04:42:00","date_gmt":"2025-09-05T21:42:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=31682"},"modified":"2025-09-06T04:42:00","modified_gmt":"2025-09-05T21:42:00","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:\/\/thaipropertynews.com\/feeds\/?p=31682","title":{"rendered":"Senhwa Biosciences CX-5461 Secures NCI Support to Advance into MYC-Driven Lymphoma, Driving Cross-Cancer and Global Licensing Value"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

TAIPEI<\/span> and SAN DIEGO<\/span><\/span>, Sept. 5, 2025<\/span><\/span> \/PRNewswire\/ — 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<\/span>\/2 clinical trial in patients with B-cell lymphoma subtypes that harbors MYC gene aberrations.<\/p>\n

\n<\/div>\n

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

MYC as a Cancer Driver \u2013 Genetic Aberrants in Nearly One-Third of Patients<\/b><\/p>\n

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,\u00a0notably 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

First-in-Class G4 Targeting Therapy Against Hard-to-Treat Lymphomas<\/b><\/p>\n

CX-5461 is the world’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’s clinical partner Peter MacCallum Cancer Center (PMCC) in Australia<\/span>, CX-5461 delivered promising results in patients with B-cell lymphoma.<\/p>\n

“From preclinical models to\u00a0haematologic malignancies study, CX-5461 has demonstrated potential efficacy in MYC gene-driven tumors. With FDA’s clearance for this Phase 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,” said Jason Huang<\/span>, Chief Medical Officer of Senhwa.<\/p>\n

B-cell Lymphoma Market Potential Exceeds USD 10 Billion<\/span> <\/b><\/p>\n

According to BioSpace, the global B-cell lymphoma therapeutics market reached USD 4.9 billion<\/span> in 2024, and is projected to grow to 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

With its differentiated mechanism of action and precision oncology potential, CX-5461 could significantly enhance Senhwa’s global licensing value and emerge as a next-generation standard of care in B-cell lymphoma treatment.<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

TAIPEI<\/span> and SAN DIEGO<\/span><\/span>, Sept. 5, 2025<\/span><\/span> \/PRNewswire\/ — 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<\/span>\/2 clinical trial in patients with B-cell lymphoma subtypes that harbors MYC gene aberrations.<\/p>\n

\n<\/div>\n

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

MYC as a Cancer Driver \u2013 Genetic Aberrants in Nearly One-Third of Patients<\/b><\/p>\n

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,\u00a0notably 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

First-in-Class G4 Targeting Therapy Against Hard-to-Treat Lymphomas<\/b><\/p>\n

CX-5461 is the world’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’s clinical partner Peter MacCallum Cancer Center (PMCC) in Australia<\/span>, CX-5461 delivered promising results in patients with B-cell lymphoma.<\/p>\n

“From preclinical models to\u00a0haematologic malignancies study, CX-5461 has demonstrated potential efficacy in MYC gene-driven tumors. With FDA’s clearance for this Phase 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,” said Jason Huang<\/span>, Chief Medical Officer of Senhwa.<\/p>\n

B-cell Lymphoma Market Potential Exceeds USD 10 Billion<\/span> <\/b><\/p>\n

According to BioSpace, the global B-cell lymphoma therapeutics market reached USD 4.9 billion<\/span> in 2024, and is projected to grow to 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

With its differentiated mechanism of action and precision oncology potential, CX-5461 could significantly enhance Senhwa’s global licensing value and emerge as a next-generation standard of care in B-cell lymphoma treatment.<\/p>\n

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