Adcendo’s ADCE-D01 Receives FDA Fast Track Designation for Soft Tissue Sarcoma
Friday, October 10, 2025
Adcendo ApS, a biotechnology company developing antibody-drug conjugates (ADCs) for cancers with high unmet medical need, has announced 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).
ADCE-D01 is a first-in-class ADC targeting urokinase plasminogen activator receptor-associated protein (uPARAP) and is linked to the Topoisomerase I inhibitor payload P1021. uPARAP is overexpressed in tumours of mesenchymal origin, such as sarcomas. Preclinical studies have shown that ADCE-D01 demonstrates strong anti-tumour activity across mesenchymal tumour models, including STS, and is well tolerated in non-human primates with a favourable safety profile and no target-specific toxicity.
The drug is currently being evaluated in the ADCElerate1 clinical trial, a first-in-human Phase I/II multicentre, open-label study assessing ADCE-D01 as a monotherapy in patients with metastatic or unresectable STS. The trial aims to assess safety and tolerability, while also examining pharmacokinetics and preliminary efficacy. Recruitment is ongoing in the US (NCT06797999) and Europe (EUCT number: 2024-516900-41-00).
Fast Track designation is expected to facilitate more frequent interactions with the FDA, supporting a faster regulatory review process and potentially allowing earlier patient access to ADCE-D01.
Source: prnewswire.com
