On October 9, 2025 Adcendo ApS ("Adcendo"), a biotech company focused on the development of first and best-in-class antibody-drug conjugates (ADCs) for the treatment of cancers with high unmet medical need, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ADCE-D01 for the treatment of soft tissue sarcoma (STS) (Press release, ADCendo, OCT 9, 2025, View Source [SID1234656545]).
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ADCE-D01 is a first-in-class ADC targeting urokinase plasminogen activator receptor-associated protein (uPARAP) conjugated to the Topoisomerase I inhibitor payload P1021. uPARAP is a novel endocytic ADC target that is overexpressed in tumors of mesenchymal origin, such as sarcomas. Preclinically, ADCE-D01 shows strong anti-tumor activity in a range of mesenchymal tumor models including STS and is well tolerated in non-human primate toxicology studies with a favorable safety profile and no evidence of target-specific toxicity.
ADCE-D01 is currently being evaluated in the ADCElerate1 clinical trial, a first-in-human Phase I/II multicenter, open-label, dose escalation and expansion study evaluating ADCE-D01 as a monotherapy in patients with metastatic and/or unresectable STS. The primary objective of the study is to evaluate the safety and tolerability of ADCE-D01. The secondary objectives are to characterize the pharmacokinetics and to evaluate the preliminary efficacy of ADCE-D01. The study is recruiting in the US (NCT06797999) and in Europe. (EUCT number: 2024-516900-41-00).
Dr. Lone Ottesen, Chief Medical Officer of Adcendo, said: "This Fast Track designation is an important recognition of the potential of our uPARAP-targeting drug candidate and marks another meaningful milestone for Adcendo. We are committed to further advancing ADCE-D01 and believe that our uPARAP-targeting approach has the potential to transform the sarcoma treatment landscape and overcome the limitations experienced with existing therapies."
Dr. Victoria Marsh, Global Head of Regulatory at Adcendo, said: "With this Fast Track designation the development of ADCE-D01 will now benefit from more frequent interactions with the FDA. Increased FDA engagement will support and expedite the future regulatory review of ADCE-D01 with the aim of making ADCE-D01 available to patients sooner".