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Senhwa Biosciences, Inc., a clinical-stage biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted IND clearance for its innovative drug candidate Pidnarulex (CX-5461) in a phase 1b/2 clinical trial in patients with B-cell lymphoma subtypes that harbours MYC gene aberrations.
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 tumours, unlocking substantial licensing opportunities and market potentials for Senhwa.
MYC is recognized as a critical oncogene, with gene amplification or related alterations present in approximately 28% of tumours across multiple cancer types, including lung, breast, liver, lymphoma, prostate, and endometrial cancers. MYC functions as a transcription factor, 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.
CX-5461 is the world’s first and most advanced G-quadruplex (G4) stabilizer in clinical development. Preclinical studies have demonstrated its ability to suppress MYC expression and inhibit tumour progression. Moreover, in a blood cancer trial conducted by Senhwa’s clinical partner Peter MacCallum Cancer Center (PMCC) in Australia, CX-5461 delivered promising results in patients with B-cell lymphoma.
“From preclinical models to haematologic malignancies study, CX-5461 has demonstrated potential efficacy in MYC gene-driven tumours. With FDA’s clearance for this phase 1b/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, chief medical officer of Senhwa.
According to BioSpace, the global B-cell lymphoma therapeutics market reached USD 4.9 billion in 2024, and is projected to grow to USD 8.9 billion 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.
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.
Senhwa Biosciences Inc. was established in 2012 and listed on the Taipei Exchange on April 24, 2017. The company aims to transform the model for new drug development by focusing on human efficacy. Senhwa believes that its dedication to science and rigorous processes will enable Senhwa to achieve remarkable milestones.
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