Duke Street Bio receives FDA fast track designation for brain metastases treatment

Ella Day | July 8, 2025 | News story | Medical Communications, Research and Development |  Duke Street Bio, Oncology, US Food and Drug Administration, brain metastases, breast cancer, fast track designation 

Duke Street Bio, a biotech company based in London, UK, has announced that the US Food and Drug Administration (FDA) has granted fast track designation for DSB2455 for patients with brain metastases originating from primary triple-negative breast cancer tumours harbouring BRCA1/2 and/or homologous recombination repair alterations. This intends to treat serious conditions where high unmet medical need remains.

The candidate is a central nervous system-active selective PARP1 inhibitor. It has demonstrated brain penetrance and anti-tumour activity in pre-clinical models of homologous recombination-deficient cancers, including brain metastases.

The fast track designation expedites drug development, offering benefits such as frequent interactions with the FDA and the potential consideration for priority review or accelerated approval.

“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 tumours,” said Alan Wise, CEO 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,” added Dónal Landers, chief medical officer of Duke Street Bio.

Ella Day

8/7/25