Duke Street Bio receives FDA fast track designation for PARP1-selective inhibitor with CNS activity

Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need

Duke Street Bio, a clinical-stage biotechnology company focused on precision oncology, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DSB2455, its next-generation, CNS-active selective PARP1 inhibitor, for the treatment of patients with brain metastases originating from primary triple-negative breast cancer (TNBC) tumors harboring BRCA1/2 and/or homologous recombination repair (HRR) alterations.

DSB2455 is a potentially best-in-class agent within the PARP1-selective inhibitor space, offering a differentiated profile that may expand therapeutic possibilities in hard-to-treat indications. The compound is a next-generation, highly PARP1-selective inhibitor with demonstrated brain penetrance and potent anti-tumour activity in preclinical models of homologous recombination-deficient cancers, including brain metastases.

“Receiving Fast Track designation for DSB2455 represents an important milestone in our mission to develop more targeted and effective therapies for patients with limited treatment options,” said Alan Wise, Chief Executive Officer of Duke Street Bio. “Next-generation PARP1-selective inhibitors such as DSB2455 are expected to offer a wider therapeutic window than earlier PARP inhibitors, potentially enabling broader use both as monotherapy and in combination with other anti-cancer agents across a range of tumors.”

“DSB2455’s ability to achieve therapeutically relevant concentrations in the CNS represents a key differentiator,” added Dónal Landers, Chief Medical Officer of Duke Street Bio. “This could offer a new treatment option for patients with secondary HRD brain metastases, where clinical need remains high and current therapeutic choices are limited.”