Senhwa Biosciences announced on September 5 that its innovative drug candidate Pidnarulex (CX-5461) has received support from the U.S. National Cancer Institute (NCI), entering the second five-year cancer research program. The U.S. FDA has also granted approval for a Phase 1b/2 clinical trial targeting specific B-cell lymphoma subtypes with MYC gene abnormalities.
Senhwa Biosciences stated that nearly 30% of cancers exhibit overexpression of the MYC oncogene, generating high expectations for CX-5461’s clinical development. If trial results are positive, CX-5461 could become the first cross-cancer innovative therapy targeting MYC gene abnormalities, unlocking significant licensing and market potential for the company.
The MYC gene is recognized as a critical oncogene, with approximately 28% of cancer patients exhibiting MYC amplification or mutation, spanning lung, breast, liver, lymphoma, prostate, and endometrial cancers. MYC protein functions as a transcription factor, promoting the expression of multiple glycolysis-related enzymes, accelerating cancer cell metabolism and proliferation, leading to rapid tumor growth, higher recurrence risk, and reduced overall survival.
CX-5461 is the world’s first and fastest-developing anticancer drug stabilizing G-quadruplex (G4) DNA structures. Preclinical studies have demonstrated its ability to inhibit MYC expression and block tumor proliferation. Clinical trials in hematologic cancers conducted in collaboration with Australian partner PMCC have shown positive efficacy in B-cell lymphoma patients.
Senhwa Biosciences Chief Medical Officer, Dr. Pin-Yan Huang, noted that CX-5461 has demonstrated potential efficacy against MYC-driven tumors from preclinical studies through hematologic cancer trials. The FDA-approved clinical trial is expected to expand the therapy’s scope from refractory lymphomas to additional cancer types, offering patients breakthrough treatment options.
According to BioSpace, the global B-cell lymphoma treatment market reached US$4.9 billion in 2024 and is projected to grow to US$8.9 billion by 2035, with a compound annual growth rate (CAGR) of 5.79%. The demand for innovative therapies among relapsed and refractory patients is particularly high, creating a clear market gap.
Senhwa Biosciences stated that if CX-5461 demonstrates efficacy, it could be licensed and is expected to become a key drug leading a new generation of B-cell lymphoma treatments.
Resource: 美國NCI支持 生華科CX-5641將啟動MYC異常淋巴瘤1b／2期臨床試驗
