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news.Adcendo has secured fast track designation from the US Food and Drug Administration (FDA) for ADCE-D01 to treat soft tissue sarcoma (STS).
Preclinical data indicate that ADCE-D01 exhibits anti-tumour activity in mesenchymal tumour models, including STS. Credit: CDC on Unsplash.
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ADCE-D01 is an antibody-drug conjugate (ADC) designed to target the urokinase plasminogen activator receptor-associated protein (uPARAP).
Preclinical data indicate that ADCE-D01 exhibits anti-tumour activity in mesenchymal tumour models, including STS.
The candidate has demonstrated good tolerability in non-human primate toxicology trials, showing a favourable safety profile with no signs of target-specific toxicity.
ADCE-D01 is currently under assessment in the first-in-human Phase I/II multicentre, open-label ADCElerate1 study involving dose escalation and expansion. This monotherapy is being tested in patients with metastatic and unresectable STS.
The study’s primary objective is to assess the safety and tolerability of ADCE-D01.
Secondary objectives include characterising the pharmacokinetics of the candidate and evaluating its preliminary efficacy.
Recruitment for the study is taking place in Europe and the US.
Adcendo chief medical officer Dr Lone Ottesen said: “This fast track designation is an important recognition of the potential of our uPARAP-targeting drug candidate and marks another meaningful milestone for Adcendo.
“We are committed to further advancing ADCE-D01 and believe that our uPARAP-targeting approach has the potential to transform the sarcoma treatment landscape and overcome the limitations experienced with existing therapies.”
Adcendo regulatory global head of Dr Victoria Marsh said: “With this fast track designation the development of ADCE-D01 will now benefit from more frequent interactions with the FDA.
“Increased FDA engagement will support and expedite the future regulatory review of ADCE-D01 with the aim of making ADCE-D01 available to patients sooner.”
