Adcendo Achieves Milestone with FDA Clearance for ADCE-D01 Trial

FDA Clearance of ADCE-D01 Trial Marks Step Forward for Adcendo

Adcendo, a pioneering biotech company, has announced a significant milestone with the US Food and Drug Administration (FDA) clearing its Investigational New Drug (IND) application for the promising molecule ADCE-D01. This first-in-human clinical trial, known as the ADCElerate-01 Trial, aims to evaluate the safety and efficacy of this innovative antibody-drug conjugate (ADC) targeting uPARAP, which is notably overexpressed in various mesenchymal cancers, particularly soft tissue sarcomas (STS).

The Significance of ADCE-D01

ADCE-D01 is designed as a groundbreaking treatment targeting the uPARAP receptor, a receptor significantly involved in the pathology of mesenchymal cancers. Traditional therapies for metastatic soft tissue sarcoma often fall short, making the introduction of ADCE-D01 crucial for patients who desperately lack effective treatment options. This ADC is expected to demonstrate improved therapeutic outcomes for individuals suffering from advanced stages of these aggressive tumors.

Study Overview and Objectives

The Phase I/II ADCElerate-01 trial will enroll patients diagnosed with metastatic and/or unresectable STS to assess the safety, pharmacokinetics, and preliminary efficacy of ADCE-D01 as a standalone treatment. The primary focus of the study will be on determining the maximum tolerated dose and the overall safety profile of the drug, along with its recommended dosing schedules. Secondary objectives include detailed pharmacokinetics assessments and initial efficacy evaluations.

Expert Insights on ADCE-D01

Dr. Lone Ottesen, the Chief Medical Officer of Adcendo, emphasized the potential of uPARAP as a target for ADC therapy in mesenchymal cancers. She noted its high overexpression in various STS subtypes, alongside low expression in healthy tissues, making it an ideal candidate for targeted therapy. This IND clearance is not just a regulatory accomplishment; it carries significant implications for future cancer treatments and the patients who are in dire need of effective solutions.

Research and Development at Adcendo

In addition to ADCE-D01, Adcendo ApS is committed to developing a robust pipeline of first-in-class ADCs tailored for confrontations against various cancers that currently have limited treatment options. Earlier this year, the company secured a substantial funding boost, raising 98 million euros in a Series A extension financing round. These funds are earmarked to push their innovative therapies through clinical trials and into the hands of patients sooner.

Collaboration with Medical Experts

As part of the ADCElerate-01 trial, renowned experts such as Prof. Patrick Schöffski from the University Hospitals and KU Leuven have joined the team to take on the role of principal investigator. He expressed his enthusiasm regarding the unique biological profile of uPARAP and the promising pre-clinical data supporting ADCE-D01. Their collaborative effort aims to bring a transformative ADC treatment option to the forefront for patients battling soft tissue sarcoma.

About Adcendo ApS

Founded with a mission to reshape cancer therapies, Adcendo ApS remains resolute in their dedication to developing state-of-the-art antibody-drug conjugates aimed at addressing the dire needs in oncological healthcare. The company continues to collaborate with leading experts in the field, striving to make tangible impacts for patients globally.

Frequently Asked Questions

What does the FDA clearance of ADCE-D01 mean for patients?

The FDA clearance allows for the commencement of a clinical trial, offering patients with metastatic soft tissue sarcoma access to potentially groundbreaking therapy that targets their specific condition.

How does ADCE-D01 work?

ADCE-D01 targets the uPARAP receptor, which is overexpressed in various mesenchymal cancers, and aims to deliver therapeutic agents directly to the cancer cells while sparing healthy tissues.

What are the objectives of the ADCElerate-01 trial?

The trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of ADCE-D01 in patients with metastatic and/or unresectable soft tissue sarcoma.

Who are the key researchers involved in the trial?

Dr. Lone Ottesen, Chief Medical Officer of Adcendo, and Prof. Patrick Schöffski from KU Leuven are leading the trial efforts, focusing on advancing treatment options for patients.

What other developments are underway at Adcendo?

Adcendo is working on expanding its pipeline of first-in-class ADCs, driven by recent funding to accelerate research and clinical development of their innovative therapies.

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