COPENHAGEN, Denmark, April 20, 2026 /PRNewswire/ -- Adcendo ApS ("Adcendo"), a biotech company focused on the development of first- and best-in-class antibody-drug conjugates (ADCs) for the treatment of cancers with high unmet medical need, today announced multiple clinical and regulatory updates for the Company's pipeline of first- and best-in-class ADCs.
ADCE-T02 has advanced into cohort expansion portion of Tiffany-01 study. ADCE-T02 is a potential best-in-class Topo-I inhibitor-based ADC targeting tissue factor (TF), a clinically validated target overexpressed in a broad range of solid tumors (i.e., head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer and colorectal cancer, among others), with limited expression in normal tissues.
ADCE-T02 is currently being evaluated as a monotherapy in the Phase I Tiffany-01 (NCT06597721) clinical trial in patients with advanced solid tumors. The first patients have now been enrolled in the cohort expansion portion of Tiffany-01 across multiple solid tumor indications. The expansion cohorts are designed to evaluate two go-forward dose levels in a randomized setting, supporting dose optimization and enabling additional assessments of safety, anti-tumor activity, and durability of response. These data are expected to further clinical proof of concept and better inform the potential therapeutic profile of ADCE-T02 across multiple solid tumor indications.
An abstract highlighting new preclinical findings underpinning ADCE-T02 clinical development plans was selected for poster presentation at the American Association for Cancer Research (AACR) 2026 Annual Meeting. The abstract is available now in AACR's online itinerary planner. The poster, titled "ADCE-T02 - A clinical stage antibody drug conjugate targeting tissue factor demonstrates strong efficacy in preclinical models of head and neck squamous cell carcinoma" (Poulsen, et al) will be presented on April 22, 2026, from 9:00am to 12:00pm PT.
A manuscript highlighting additional ADCE-T02 preclinical data was selected for publication in the AACR journal Molecular Cancer Therapeutics. The manuscript, titled "ADCE-T02 - A Next Generation Antibody Drug Conjugate Targeting Tissue Factor Demonstrates Superior Preclinical Efficacy and Tolerability" (Poulsen, et al) is now available online here. The published manuscript highlights the unique design of ADCE-T02 facilitating a strong in vivo efficacy in a range of preclinical models and good tolerability in non-human primates, showing no evidence of ocular, skin and lung toxicity, peripheral nerve damage, or bleedings. These data further support the clinical development of ADCE-T02 as a novel TF-targeting ADC with a potentially superior therapeutic window.
ADCE-D01 granted Orphan Drug Designation by U.S. FDA. ADCE-D01 is a first-in-class ADC targeting uPARAP conjugated to the Topo- I inhibitor payload P1021. uPARAP is a novel endocytic receptor ADC target that is overexpressed in tumors of mesenchymal origin, such as sarcomas. ADCE-D01 recently received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of soft tissue sarcoma. This ODD follows the receipt of Fast Track Designation from the FDA which was received in Oct 2025. ADCE-D01 is currently being evaluated as a monotherapy in the Phase I ADCElerate1 (NCT06797999) clinical trial in patients with metastatic and/or unresectable soft tissue sarcoma (STS).
First patient dosed in the First-in-human Phase 1 trial of ADCE-B05 in the US. ADCE-B05 is a first-in-class ADC directed against a novel, undisclosed ADC target overexpressed in multiple tumors of squamous origin. ADCE-B05 is being evaluated as monotherapy in a first-in-human Phase I (NCT07362888) clinical trial enrolling patients across US and Australian sites.
Dr. Lone Ottesen MD, PhD, Chief Medical Officer of Adcendo, said: "We are extremely pleased about the significant progress made across all programs of our unique first- and best-in class ADC pipeline. Together with world leading clinical centers, we are enrolling patients with high unmet need cancers in three separate Phase 1 trials. With the proceeds from our recent Series C financing round, we will further accelerate our clinical programs, thereby getting closer to our vision to deliver new treatments to cancer patients with limited options."
About Adcendo ApS
Adcendo ApS is a clinical-stage biotechnology company headquartered in Copenhagen, Denmark, with operations in Boston, Massachusetts. The company is developing a pipeline of first- and potential best-in-class antibody-drug conjugates (ADCs) targeting cancers with high unmet medical needs Led by a team of experienced biopharma executives 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. Adcendo is currently advancing three ADCs: 1) ADCE-T02 targeting Tissue Factor, which is overexpressed in a broad range of solid tumors, including head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, colorectal cancer and non-small cell lung cancer; 2) ADCE-D01 targeting uPARAP, which is overexpressed in high unmet need cancers, including soft tissue sarcoma and other cancers of mesenchymal origin; and 3) ADCE-B05, for which the target is undisclosed, is currently being evaluated clinically in squamous cell solid tumors. For further information, please visit www.adcendo.com or follow us on LinkedIn.
About Orphan Drug Designation
Orphan Drug Designation is intended to support the development of therapies for rare diseases, defined as conditions affecting fewer than 200,000 people in the United States or fewer than 5 in 10,000 individuals in the European Union. These designations provide drug developers with potential benefits including tax credits for qualified clinical trials, exemptions from certain FDA fees for clinical trials, and the potential for seven years of market exclusivity following drug approval.
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