On September 24, 2024 Duke Street Bio Ltd, a precision medicine biotech developing next generation small molecule cancer therapies, reported that the European Medicines Agency (EMA) has granted approval to commence a clinical trial for its highly-selective PARP1 inhibitor, DSB2455 (Press release, Duke Street Bio, SEP 24, 2024, View Source [SID1234646835]). This potentially best-in-class, potent, highly selective and CNS-penetrant agent targets cancers that harbour homologous recombination deficiencies (HRD) including BRCA mutations. The safety profile of first generation non-selective PARP1/2 inhibitors has restricted their application, particularly in combination with chemotherapy and radiotherapy. By selectively inhibiting PARP1, we believe that DSB2455 has the potential to achieve a significantly enhanced therapeutic index, representing a significant advancement in precision medicine cancer treatment. Preliminary data indicate a strong safety profile and compelling efficacy in preclinical studies, paving the way to open our trial in the clinic.

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Alan Wise, CEO of Duke Street Bio, commented, "The approval of the DSB2455 First-in-Human clinical trial by the EMA is a testament to the therapeutic potential of our innovative approach in the DDR space. Duke Street Bio’s mission is to improve patient outcomes and bring new hope to individuals battling cancer. We believe that DSB2455 has the potential for improved efficacy and tolerability versus first-generation PARP inhibitors in patient populations where there is still significant unmet medical need."