Adcendo ApS Gains FDA Approval for Phase I Tiffany-01 Trial of ADCE-T02 IND Application

Adcendo, a biotechnology company headquartered in Copenhagen, Denmark, has announced that the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug (IND) application. This approval allows them to initiate a Phase I clinical study for ADCE-T02, a novel antibody-drug conjugate (ADC) targeting tissue factor in patients with advanced solid tumors. The study, named Tiffany-01, is set to explore the safety, pharmacokinetics, and preliminary efficacy of ADCE-T02 when administered as a monotherapy.

ADCE-T02 is distinguished by its use of a Topoisomerase I inhibitor-based linker/payload technology. This innovation targets tissue factor, an ADC target overexpressed in various solid tumors, which has been associated with a significant unmet medical need. The promising new treatment aims to offer an improved therapeutic window and better safety profile compared to existing treatments that target the same factor.

The ongoing Tiffany-01 trial is a first-in-human, Phase I, open-label study conducted across multiple centers. It focuses on determining the maximum tolerated dose and the recommended Phase II dose and schedule for ADCE-T02. The trial also aims to assess the safety and tolerability of the drug, along with its pharmacokinetics. The study is currently recruiting participants in Australia and plans to expand recruitment efforts to the United States in the coming months.

Dr. Lone Ottesen, Chief Medical Officer of Adcendo, emphasized the significance of this development, stating that the U.S. IND clearance marks a major milestone for both the ADCE-T02 program and the company. Dr. Ottesen expressed optimism about the potential for ADCE-T02 to overcome the limitations associated with current TF-targeting ADCs, which often suffer from a suboptimal side effect profile and limited therapeutic window. The innovative design of ADCE-T02, which utilizes an improved monoclonal antibody and advanced linker/payload technology, is expected to yield better clinical outcomes for patients.

Prof. Vinod Ganju, the Managing Director of Peninsula and Southeast Oncology (PASO) in Melbourne, Australia and Principal Investigator of the Tiffany-01 trial, expressed enthusiasm for working with Adcendo on this novel treatment. He highlighted the potential of ADCE-T02 to offer an improved safety profile and broader therapeutic window for patients with advanced solid tumors.

ADCE-T02 stands out in the realm of cancer therapeutics due to its unique features. The tissue factor it targets is strongly overexpressed in several cancers with significant unmet medical needs, such as cervical cancer, head and neck cancer, colorectal cancer, non-small cell lung cancer, and pancreatic ductal adenocarcinoma. The ADC's differentiated design is expected to minimize impact on the coagulation pathway and enhance the bystander effect, potentially improving response rates and overcoming resistance mechanisms.

Adcendo, the company behind ADCE-T02, is a clinical-stage biotechnology firm with operations in Boston, Massachusetts, in addition to its headquarters in Denmark. The company is focused on developing first-in-class ADCs for cancers with high unmet medical needs, leveraging a team of industry veterans with a proven track record in advancing innovative cancer therapies. By integrating novel targets and optimized linker-payload combinations, Adcendo aims to drive the development of next-generation cancer treatments.