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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Oct 10
- 1 min read
09/10/2025
Adcendo's ADCE-D01 received the FDA fast track designation for the treatment of STS (Ref)
The US FDA granted the fast track designation to Adcendo's ADCE-D01 (uPARAP-targeting ADC) for the treatment of soft tissue sarcoma (STS).
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 Phase 1/2 ADCElerate1 trial as a monotherapy in patients with metastatic and/or unresectable STS
Dr. Lone Ottesen, CMO, Adcendo: "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, Adcendo: "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".
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