Adcendo’s candidate targets uPARAP, which exhibits a limited expression profile in healthy tissues but is highly upregulated in multiple mesenchymal cancers. Credit: Shutterstock / grandbrothers

Adcendo’s antibody-drug conjugate (ADC) candidate will enter a Phase I/II study after receiving Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA).

The Danish immune-oncology company’s planned ADCElerate-01 trial will be a multi-centred, first-in-human, Phase I/II dose escalation study of ADCE-D01 as a monotherapy in patients with metastatic and unresectable soft tissue sarcoma (STS). ADCE-D01 targets endocytic receptor uPARAP (Endo180).

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Adcendo’s chief medical officer Dr Lone Ottesen commented: “uPARAP is a highly attractive target for the development of an ADC in mesenchymal cancers including STS, as it is highly overexpressed in multiple STS subtypes, has unique internalisation properties and shows only very low expression in healthy tissues.

“The IND clearance of ADCE-D01 is an important milestone for our programme and our company. We look forward to initiating patient enrolment for this study and working with our investigators to evaluate the therapeutic utility of this drug in STS patients as soon as possible,” Ottesen continued.

The Phase I study will evaluate the safety and tolerability of ADCE-D01, determine the maximum tolerated dose and recommended Phase II dose, and determine the dosing schedule. Secondary objectives of Phase I will include characterising the pharmacokinetics (PK) and early signs of efficacy.

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Adcendo plans to recruit patients for the study in the US and Europe.

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The company recently inked a deal potentially worth over $1bn with China-based Multitude for its tissue factor-targeting ADC candidate ADCE-T02.

In 2023, Adcendo concluded an €82m ($89.6m) Series A funding round to develop its ADC pipeline and entered a deal with Duality Biologics, granting it a licence to Duality’s Duality Immune Toxin Antibody Conjugates (DITAC) linker/payload platform for its lead uPARAP-ADC mesenchymal cancers programme.

In related antibody conjugate news, the FDA recently lifted a hold on Avidity’s lead antibody oligonucleotide conjugate, del-desiran, in the Phase I/II MARINA trial (NCT05027269).

ADCs have been a keen area of interest in recent months, with the likes of MSD and Pfizer presenting data on trials involving ADCs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in May.

October 2023 saw MSD enter an agreement with Daiichi Sankyo to develop and commercialise three of its DXd ADC candidates, potentially spending up to $22bn on the partnership.