Adcendo ApS Announces First Patient Dosed in Phase I/II ADCElerate1 Trial of ADCE-D01

• ADCE-D01 is a first-in-class antibody-drug conjugate (ADC) targeting uPARAP, an endocytic receptor highly overexpressed in mesenchymal cancers including multiple soft tissue sarcoma subtypes
  
  
• The ADCElerate1 trial will enroll patients in the US and Europe

COPENHAGEN, Denmark, June 10, 2025 /PRNewswire/ -- Adcendo, a clinical-stage biotech company pioneering the development of first and best-in-class ADCs for cancers with a high unmet medical need, today announced that the first patient has been dosed in the Phase I/II ADCElerate1 clinical trial evaluating ADCE-D01 in patients with metastatic and/or unresectable soft tissue sarcoma (STS). The patient was dosed at The Memorial Sloan Kettering Cancer Center in New York.

ADCElerate1 (NCT06797999) is 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 will recruit in the US and Europe with the European clinical trial application recently approved (EUCT number: 2024-516900-41-00).

Dr. Lone Ottesen, Chief Medical Officer of Adcendo, said: "The dosing of the first patient in the ADCElerate1 study is a major milestone for both Adcendo and for the uPARAP program and we are excited to evaluate ADCE-D01's potential benefit for patients with advanced STS. uPARAP is a highly attractive target for the development of an ADC in mesenchymal cancers, as it is highly overexpressed in multiple STS subtypes, has unique internalization properties, and shows only very low expression in healthy tissues."

Professor Robert Maki, MD, PhD, Sarcoma Oncologist and Early Drug Development Specialist at the Department Musculoskeletal Cancers and Condition, in the Memorial Sloan Kettering Cancer Center, New York, NY, commented: "We are very pleased to be working with Adcendo to develop ADCE-D01 for the many advanced STS patients who currently have very limited treatment options. ADCs have already made a significant impact across the therapeutic landscape, and we are pleased to be able to bring this exciting treatment modality to our sarcoma patients."

About ADCE-D01

ADCE-D01 is an antibody-drug conjugate (ADC) targeting the uPARAP receptor. uPARAP is a continuously recycling endocytic receptor involved in collagen homeostasis. uPARAP exhibits a restricted expression profile in healthy tissues but is highly upregulated in multiple mesenchymal cancers, including STS, bone sarcoma, GIST, as well as mesothelioma and glioblastoma. ADCE-D01 is a first-in-class pan-mesenchymal cancer targeting ADC in phase 1/2 clinical development.

About Adcendo

Adcendo is a clinical-stage biotechnology company headquartered in Copenhagen, Denmark, with operations in Boston, Massachusetts. The company is developing a pipeline of first-in-class antibody-drug conjugates (ADCs) targeting cancers with high unmet medical needs. Led by a team of industry veterans with a track record of advancing multiple ADCs to approval, Adcendo integrates novel targets, optimized linker-payload combinations, and a rationally designed development strategy to drive next-generation cancer therapies. For further information, please visit www.adcendo.com or follow the company on LinkedIn.

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