Senhwa Biosciences’ Pidnarulex (CX-5461) has been granted a Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of solid tumors with BRCA1/2, PALB2, and other gene mutations. In patients with solid tumors, specifically breast cancer or ovarian cancer, BRCA1/2, PALB2, and other Homologous Recombination (HR) gene mutations can be resistant to chemotherapy and PARP inhibitor treatments. BRCA1/2 and PALB2 genes help to repair damaged DNA. Mutations to these genes lead to an accumulation of defect cells unable to be repaired which can lead to an increased risk of developing breast cancer or ovarian cancer. Pidnarulex (CX-5461) uses a synthetic lethality approach by stabilizing the DNA G-quadraplex in cancer cells and effectively disrupting the cell’s replication fork. Addressing treatment-resistant tumors remains one of the leading unmet challenges in the oncology. Senhwa Biosciences develops next-generation DNA Damage Response therapies and anti-cancer drugs.

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