#Denmark #Copenhagen #Adcendo ApS #ADCE-D01 #soft tissue sarcoma

Adcendo ApS Receives FDA Fast Track Designation for ADCE-D01 Treatment of Soft Tissue Sarcoma

Adcendo ApS, a Copenhagen-based biotech firm, has recently announced that its investigational drug, ADCE-D01, has been awarded Fast Track designation by the U.S. Food and Drug Administration (FDA). This distinction highlights the serious need for effective treatments in soft tissue sarcoma (STS), a particularly challenging form of cancer.

The Significance of ADCE-D01

ADCE-D01 represents a pioneering approach to cancer therapy as a first-in-class antibody-drug conjugate (ADC) that targets urokinase plasminogen activator receptor-associated protein (uPARAP). This receptor is notably overexpressed in various mesenchymal cancers, including multiple subtypes of STS. The drug is designed to deliver a Topoisomerase I inhibitor payload, specifically P1021, directly to tumor cells while minimizing damage to surrounding healthy tissue.

Preclinical studies have shown that ADCE-D01 exhibits robust anti-tumor activity against a range of mesenchymal tumor models, including STS, marking it as a promising therapeutic candidate. Furthermore, initial toxicology assessments in non-human primates have indicated a favorable safety profile, with no adverse effects tied specifically to the target.

Ongoing Clinical Trials

Currently, ADCE-D01 is being evaluated in a clinical trial named ADCElerate1—a Phase I/II multicenter, open-label study designed to assess the safety and tolerability of the drug as a monotherapy in patients with metastatic and/or unresectable STS. This study aims to not only gauge safety but also to scrutinize pharmacokinetics and preliminary efficacy.
The ADCElerate1 trial is actively enrolling participants in both the U.S. and Europe, supporting a growing effort to provide patients with more effective therapeutic options.

Insights from Adcendo’s Leadership

Dr. Lone Ottesen, Chief Medical Officer at Adcendo, stated, "Receiving this Fast Track designation is a crucial recognition of ADCE-D01's potential to address significant clinical needs in STS treatment. We believe our approach targeting uPARAP could radically change the treatment landscape and surpass current available therapies."

Moreover, Dr. Victoria Marsh, the Global Head of Regulatory Affairs at Adcendo, emphasized that this designation will allow for more frequent interactions with the FDA, likely expediting the development and regulatory review process for ADCE-D01, ultimately aiming for faster availability to patients.

About Adcendo ApS

Adcendo ApS is a clinical-stage biotechnology firm focused on creating innovative ADCs that target cancers with significant unmet medical needs. With its headquarters in Copenhagen and additional operations in Boston, Massachusetts, Adcendo is committed to advancing its pipeline of therapeutics through the integration of novel targets, optimized drug conjugate configurations, and strategic developmental strategies.

For more details about Adcendo and its exciting developments, visit their website at www.adcendo.com or follow them on LinkedIn.

Conclusion

The FDA's Fast Track designation for ADCE-D01 is a promising step towards enhancing treatment options for patients suffering from soft tissue sarcomas. The combination of innovative drug design and strategic regulatory support underscores Adcendo's commitment to pioneering next-generation cancer treatments that fulfill pressing medical needs.