Duke Street Bio Receives EMA Approval for First-in-Human Trial of PARP1 Inhibitor DSB2455

• Duke Street Bio has been granted EMA approval to begin a clinical trial for DSB2455, a highly-selective PARP1 inhibitor.
• DSB2455 targets cancers with homologous recombination deficiencies, including BRCA mutations, potentially improving treatment outcomes.
• Preclinical data suggests DSB2455 has a strong safety profile and compelling efficacy, offering a potential advancement in cancer treatment.
• The trial aims to address the unmet medical need in patient populations where first-generation PARP inhibitors have limitations.

Duke Street Bio Ltd has announced that the European Medicines Agency (EMA) has approved the commencement of a first-in-human clinical trial for its highly-selective PARP1 inhibitor, DSB2455. This approval marks a significant step forward in developing next-generation small molecule cancer therapies with improved efficacy and tolerability.

Targeting HRD Cancers with Enhanced Selectivity

DSB2455 is designed to target cancers harboring homologous recombination deficiencies (HRD), including those with BRCA mutations. Unlike first-generation PARP1/2 inhibitors, DSB2455 selectively inhibits PARP1, potentially leading to a significantly enhanced therapeutic index. The non-selective nature of earlier PARP inhibitors has often restricted their use, particularly in combination with chemotherapy and radiotherapy, due to safety concerns.

Preclinical Data and Clinical Potential

Preliminary data from preclinical studies indicate that DSB2455 has a strong safety profile and demonstrates compelling efficacy. These findings pave the way for the clinical trial, which will assess the drug's safety, tolerability, and preliminary efficacy in patients with HRD cancers. Alan Wise, CEO of Duke Street Bio, stated, "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... 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."

Addressing Unmet Needs in Cancer Treatment

Duke Street Bio aims to improve patient outcomes and bring new hope to individuals battling cancer. By selectively inhibiting PARP1, DSB2455 has the potential to overcome the limitations of first-generation PARP inhibitors and offer a more effective and tolerable treatment option for patients with HRD cancers. The company is dedicated to advancing precision medicine through groundbreaking research and innovative treatments that reprogram tumor biology by targeting the underlying genetic and immune pathways that fuel tumor growth.