ADCE-D01 / Adcendo - LARVOL DELTA

First-in-human (FIH) phase I/II study of ADCE-D01, a urokinase plasminogen activator receptor-associated protein (uPARAP)-targeted antibody-drug conjugate (ADC) carrying a topoisomerase 1 inhibitor payload, in patients with metastatic and/or unresectable soft tissue sarcoma (STS) (ESMO 2025) - P1/2 | "Phase 2 expansion cohorts will focus on selected STS subtypes, evaluating antitumor activity, durability, and further safety characterization. Exploratory objectives include tumor uPARAP expression and molecular response via circulating tumor DNA."

Clinical • First-in-human • Metastases • P1/2 data • Oncology • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Adcendo ApS Announces FDA Fast Track Designation Granted to ADCE-D01 for the Treatment of Soft Tissue Sarcoma (PRNewswire) - "ADCE-D01 is currently being evaluated in the ADCElerate1 clinical trial, 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."

Fast track • Soft Tissue Sarcoma

ADCElerate1: First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma (clinicaltrials.gov) - P1/2 | N=270 | Recruiting | Sponsor: Adcendo ApS | Initiation date: Mar 2025 ➔ Jun 2025

Trial initiation date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Adcendo ApS Announces First Patient Dosed in Phase I/II ADCElerate1 Trial of ADCE-D01 (PRNewswire) - "Adcendo...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 ADCElerate1 trial will enroll patients in the US and Europe."

Trial status • Soft Tissue Sarcoma

ADCElerate1: First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma (clinicaltrials.gov) - P1/2 | N=270 | Recruiting | Sponsor: Adcendo ApS | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

ADCE-D01: a first in class antibody drug conjugate against urokinase plasminogen activator receptor-associated protein (uPARAP) demonstrates excellent preclinical efficacy and tolerability (AACR 2025) - "A phase I/II clinical study of ADCE-D01 in patients with advanced STS is imminent. 1Barkholt et al., Cancer Res (2024), (6_Supplement): 6355; 2Evans et al., Mol Cancer Ther (2023); 3Lin et al., J Transl Med (2024)"

Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Mesothelioma • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Adcendo ApS to Present Data on its Clinical Stage ADCs ADCE-T02 and ADCE-D01 at the 2025 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "Adcendo ApS...will be presenting data on its two novel ADC programs ADCE-T02, targeting Tissue Factor, and ADCE-D01, targeting uPARAP, at the American Association for Cancer Research (AACR) Annual Meeting, held in Chicago, Illinois, from April 25th to April 30th, 2025."

Preclinical • Oncology • Solid Tumor

ADCElerate1: First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma (clinicaltrials.gov) - P1/2 | N=270 | Not yet recruiting | Sponsor: Adcendo ApS

New P1/2 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Adcendo ApS Completes Oversubscribed $135 Million Series B Financing to Advance First-in-class ADC Pipeline (PRNewswire) - "Adcendo...announced the successful closing of an oversubscribed $135 million Series B financing round. Proceeds from the fundraise will be used to advance, broaden, and accelerate the development of the Company's first-in-class ADC pipeline, including the ADCE-T02 (Tissue Factor ADC), ADCE-D01 (uPARAP ADC), ADCE-B05 and A0401 programs. The financing round was led by TCGX, with participation from new investors TPG Life Sciences Innovations, Orbimed Advisors, Venrock Healthcare Capital Partners, Surveyor Capital (a Citadel company), and Logos Capital, as well as all existing investors, including RA Capital Management, Novo Holdings, Pontifax Venture Capital, Dawn Biopharma, a platform controlled by KKR, HealthCap, Gilde Healthcare and Ysios Capital."

Financing • Oncology

Adcendo Announces US FDA Clearance of IND Application for Phase I/II First-in-Human ADCElerate-01 Trial of ADCE-D01 (uPARAP Receptor Targeting ADC) Trial in Patients With Metastatic and/or Unresectable Soft Tissue Sarcoma (STS) (PRNewswire) - "Adcendo...today announced that the US Food & Drug Administration (FDA) has provided clearance of the IND application for the Phase I/II study of ADCE-D01 in patients with metastatic and/or unresectable STS (the ADCElerate-01 Trial).... The primary objective of the study is to evaluate the safety and tolerability of ADCE-D01, to determine the maximum tolerated dose, as well as the recommended Phase II dose and schedule of ADCE-D01 monotherapy. 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 a CTIS submission planned in the EU during the coming months."

IND • New P1/2 trial • Soft Tissue Sarcoma

Adcendo ApS Announces Extension of Series A Financing to EUR 98M to Further Bolster its First-in-Class ADC Pipeline (PRNewswire) - "Adcendo ApS...today announces the successful completion of a second Series A extension financing, raising a total of 98M EUR...Adcendo plans to further bolster the development of its first-in-class ADC pipeline assets and expand the development strategy for its lead uPARAP program in soft tissue sarcoma and other mesenchymal cancers. In addition, the funding will be used to develop further discovery-stage, first-in-class ADC pipeline assets to Development Candidate Nomination and beyond."

Financing • Oncology • Soft Tissue Sarcoma • Solid Tumor

Adcendo ApS to Present Data on its Novel ADC Target uPARAP in Glioblastoma Multiforme at the American Association for Cancer Research Annual Meeting 2024 (PRNewswire) - "Adcendo ApS...will be presenting novel data on the expression of its novel ADC target uPARAP and the in vitro and in vivo activity of a uPARAP targeting ADC in glioblastoma multiforme (GBM) at the American Association for Cancer Research (AACR) Annual Meeting....The data demonstrate that uPARAP is strongly over-expressed in glioblastoma cells and that a uPARAP targeting ADC exhibits strong in vivo anti-tumor activity in a glioblastoma PDX model."

Preclinical • Glioblastoma

Adcendo ApS to Present Data on the Expression of the Novel ADC target uPARAP in Soft Tissue and Bone Sarcoma at the 2023 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "Adcendo ApS...will be presenting novel data evaluated in co-operation with the Laboratory of Experimental Oncology at KU Leuven/Leuven Cancer Institute on the expression of the novel ADC target uPARAP in Soft Tissue Sarcoma (STS) and Bone Sarcoma at the American Association for Cancer Research (AACR) Annual Meeting, being held in Orlando, Florida on the 14-19 April, 2023...The presentation entitled 'The urokinase plasminogen activator receptor-associated protein (uPARAP) is an attractive target for the development of antibody-drug conjugates (ADCs) for treatment of mesenchymal malignancies' demonstrates that uPARAP is strongly over-expressed by cancer cells in multiple soft-tissue & bone sarcoma subtypes, with limited expression in healthy tissues."

Clinical data • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Adcendo funding boosts antibody-drug conjugates development (PharmaTimes) - "Adcendo...has revealed that it has successfully completed vital funding. The series A extension financing raised a further €31m, following the €51m series round two years ago. Funds will be used to ensure the broad pan-sarcoma development of lead ADC candidate uPARAP and further progress a second ADC asset. The funding drive was led by Pontifax Venture Capital - a healthcare-focused venture capital firm - along with existing investors Ysios Capital and Novo Holdings."

Financing • Oncology • Sarcoma • Solid Tumor

Duality Biologics Announces License Agreement of its Next-generation ADC platform with Adcendo (PRNewswire) - "Duality Biologics...announced a license agreement with Adcendo ApS ('Adcendo'), a biotech company focused on the development of breakthrough ADCs for the treatment of underserved cancers. Under the terms of this agreement, Adcendo will be granted the license of Duality's proprietary DITAC (Duality Immune Toxin Antibody Conjugates) platform for its lead uPARAP-ADC program in mesenchymal cancers. Both parties are discussing to expand the license to cover additional targets selected by Adcendo. The DITAC platform is designed to generate ADCs with superior safety profiles, sustainable payload delivery and release in tumors, and efficient bystander killing of antigen low and negative cells."

Licensing / partnership • Oncology