Adcendo's ADCE-D01 Receives FDA Clearance for Phase I/II Soft Tissue Sarcoma Trial
Key Insights
Adcendo (search)'s ADCE-D01, a first-in-class antibody-drug conjugate (ADC) targeting uPARAP (search), has received FDA clearance for a Phase I/II trial in metastatic and/or unresectable soft tissue sarcoma (search) (STS (search)).
The ADCElerate-01 trial will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ADCE-D01 as a monotherapy in STS (search) patients.
uPARAP (search), the target of ADCE-D01, is highly overexpressed in mesenchymal cancers like STS (search), making it an attractive target for ADC development.
Adcendo (search), a biotech company focused on antibody-drug conjugates (ADCs), has received FDA clearance for its Investigational New Drug (IND) application for ADCE-D01. This clearance allows Adcendo to initiate a Phase I/II clinical trial, named ADCElerate-01, to evaluate the drug's safety, pharmacokinetics, and preliminary efficacy in patients with metastatic and/or unresectable soft tissue sarcoma (search) (STS (search)). The trial will be conducted across multiple centers in the US and Europe.
ADCElerate-01 Trial Design
ADCElerate-01 is designed as a first-in-human, multicenter, open-label, dose escalation and expansion study. The primary objective is to assess the safety and tolerability of ADCE-D01, determine the maximum tolerated dose (MTD), and establish the recommended Phase II dose and schedule when administered as a monotherapy. Secondary objectives include characterizing the pharmacokinetics of ADCE-D01 and evaluating its preliminary efficacy in STS (search) patients.
uPARAP as a Target in Soft Tissue Sarcoma
ADCE-D01 is an ADC that targets the urokinase plasminogen activator receptor associated protein (uPARAP (search)), also known as Endo180. uPARAP is a recycling endocytic receptor involved in collagen homeostasis and turnover. It exhibits limited expression in healthy tissues but is highly upregulated in various mesenchymal cancers, including STS (search), bone sarcoma, gastrointestinal stromal tumors (GIST (search)), mesothelioma, and glioblastoma (search). This expression profile makes uPARAP an attractive target for ADC development in these cancers.
Dr. Lone Ottesen, Chief Medical Officer of Adcendo (search), emphasized the significance of uPARAP (search) as a target: "uPARAP is a highly attractive target for the development of an ADC in mesenchymal cancers including soft tissue sarcoma (search), as it is highly overexpressed in multiple STS (search) subtypes, has unique internalization properties and shows only very low expression in healthy tissues."
Clinical Need in Soft Tissue Sarcoma
Soft tissue sarcomas are a heterogeneous group of malignancies that arise from mesenchymal tissues. Patients with metastatic STS (search) face limited treatment options and a poor prognosis. Current treatment modalities, including surgery, radiation therapy, and chemotherapy, often fail to provide long-term disease control, underscoring the need for novel therapeutic strategies.
Professor Patrick Schöffski, Head of the Department of General Medical Oncology at the University Hospitals and the Laboratory of Experimental Oncology at KU Leuven, and Principal Investigator of the ADCElerate-01 trial, commented on the potential impact of ADCE-D01: "Patients with metastatic soft tissue sarcoma (search) have very limited treatment options and an extremely poor prognosis... ADCs have already significantly altered the therapeutic landscape for many solid tumor indications, and we are excited to be working with Adcendo (search) to develop a potential pan-sarcoma ADC for our STS (search) patients."
Adcentrx's ADRX-0405 Receives FDA IND Clearance for Advanced Solid Tumors
In related news, Adcentrx Therapeutics (search) announced FDA clearance of its IND application for ADRX-0405, a next-generation ADC targeting STEAP1 (search) for the treatment of advanced solid tumors. A Phase 1a/b trial is planned to investigate the agent in patients with advanced solid tumors, including metastatic castration-resistant prostate cancer (search). ADRX-0405 utilizes Adcentrx’s i-Conjugation technology and has demonstrated promising preclinical results.