#FDA #Denmark #Copenhagen #Adcendo ApS #ADCE-D01

Adcendo ApS Secures FDA Fast Track Approval for Revolutionary Cancer Treatment

On October 9, 2025, Adcendo ApS, a pioneering biotechnology firm based in Copenhagen, Denmark, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its innovative drug candidate, ADCE-D01. This designation is a critical step in advancing the treatment of soft tissue sarcoma (STS), a type of cancer known for its aggressive and often high unmet medical needs.

Understanding ADCE-D01

ADCE-D01 represents a novel first-in-class antibody-drug conjugate (ADC) that targets urokinase plasminogen activator receptor-associated protein (uPARAP). This protein is significantly overexpressed in multiple sarcoma subtypes, making it a prime target for effective cancer therapies. Conjugated with the Topoisomerase I inhibitor known as P1021, ADCE-D01 is engineered to deliver potent anti-tumor effects directly to the cancer cells while minimizing damage to surrounding healthy tissues.

Preclinical studies reveal ADCE-D01's robust anti-tumor activity against various mesenchymal tumor models, including soft tissue sarcoma. Additionally, toxicology evaluations in non-human primate subjects indicate a favorable safety profile for this ADC, which only adds to the excitement surrounding its potential use in humans.

Current Clinical Trials

Currently under investigation, ADCE-D01 is being evaluated in the ADCElerate1 clinical trial—a multicenter Phase I/II study that is open-label and designed for dose escalation and expansion. This trial specifically aims to assess the drug's safety and tolerability when utilized as a monotherapy for patients with metastatic and/or unresectable STS. The study is actively recruiting participants both in the United States (NCT06797999) and Europe (EUCT number 2024-516900-41-00).

Dr. Lone Ottesen, Chief Medical Officer at Adcendo, stated, “The FDA’s Fast Track designation underscores the promise of ADCE-D01 and represents a significant milestone for our company. We are dedicated to the ongoing development of this uPARAP-targeting approach, which we believe has the potential to revolutionize the current treatment landscape for sarcomas.”

Engaging with the FDA

The Fast Track designation ensures that Adcendo will have enhanced communication with the FDA throughout the development process. This close interaction is expected to expedite the regulatory review of ADCE-D01, facilitating quicker access to this innovative treatment for patients who desperately need novel therapies.

Dr. Victoria Marsh, Global Head of Regulatory Affairs at Adcendo, expressed her enthusiasm, stating, “With this designation, ADCE-D01’s development will benefit from more frequent communications with the FDA, supporting a streamlined regulatory review and ultimately leading to faster patient availability.”

Adcendo ApS’s Mission

Founded with the mission to develop first and best-in-class ADCs for cancers with substantial unmet medical needs, Adcendo leverages its talented team and innovative technologies to bolster its pipeline. By integrating cutting-edge research with strategically designed therapies, Adcendo is poised to contribute significantly to cancer treatment advancements.

For ongoing updates about Adcendo's progress and its groundbreaking developments, you can visit their official website or follow them on LinkedIn.

Conclusion

The FDA’s Fast Track designation for ADCE-D01 showcases the potential of this revolutionary treatment to make a tangible difference in the lives of patients suffering from soft tissue sarcoma. As Adcendo navigates the path towards bringing this therapy to market, the company stands at the forefront of a crucial evolution in cancer care, committed to transforming the future of sarcoma treatments.