On June 16, 2025 Duke Street Bio, a clinical-stage biotechnology company focused on precision oncology, reported 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 (Press release, Duke Street Bio, JUN 16, 2025, View Source [SID1234653916]).
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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.
The Fast Track designation is intended to facilitate the development of new therapies for serious conditions where there is significant unmet medical need. It allows for more frequent interactions with the FDA, eligibility for rolling review of an NDA, and potential consideration for Priority Review or Accelerated Approval.
"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."
About Fast Track Designation
The FDA’s Fast Track program is designed to accelerate the development and review of new drugs for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Companies granted this designation benefit from more frequent communication with the FDA and eligibility for rolling submissions and other expedited review processes.