On September 16, 2025 Cebiotex reported that CEB-01, its lead product for local post-surgical cancer treatment, has been granted Orphan Drug Designation (ODD) status by the EMA for the treatment of pancreatic cancer (PC), a disease with one of the lowest survival rates and few effective treatment options (Press release, Cebiotex, SEP 16, 2025, View Source [SID1234655995]). In this context, CEB-01 implant offers the possibility for localized drug delivery to improve postoperative local control. While CEB-01 is not intended to replace existing treatment methods, its development aims to serve as a complementary therapy within the current standard of care.
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"Our goal is to integrate CEB-01 alongside surgery and adjuvant chemotherapy, enhancing the local control of residual disease at the surgical site, where recurrence often begins, and ultimately improving survival outcomes.", explains Toni Pérez, Chief Medical Officer of Cebiotex.
Receiving ODD from the EMA is a critical milestone in Cebiotex mission to address an unmet medical need for this rare and life-threatening condition by offering new alternatives to patients facing PC.
Anna Huguet, Regulatory Manager at Cebiotex, commented: "The granted ODD acknowledges the therapeutic potential of CEB-01 to address an existing unmet medical need in PC. It will facilitate CEB-01 development through scientific and regulatory support from EMA including fee reductions and drug development incentives that will support the path towards CEB-01 authorization. Importantly, it also means that CEB-01 is eligible for up to 10 years of market exclusivity in the EU upon authorization, further enhancing its attractiveness for long-term investment and development."