The Phase I/IIa clinical study will assess ATRN-119 as a monotherapy for the treatment of advanced solid tumour patients. Credit: Atlas of Pulmonary Pathology/ Flickr (Creative Commons).

Aprea Therapeutics, a portfolio company of Karolinska Development, has dosed the first participant in a Phase I/IIa clinical study of ATRN-119.

The open-label, multi-centre, dose-escalation, and expansion clinical study has been designed for evaluating ATRN-119 as a monotherapy in advanced solid tumours patients.

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Its initial part will assess the pharmacokinetics, tolerability, recommended Phase II dose, and analyse the patient biomarkers.

The trial’s Phase IIa expansion part will further assess ATRN-119’s efficacy and tolerability as a monotherapy.

The findings from the trial are expected during this year.

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Karolinska Development CEO Viktor Drvota said: “The dosing of the first patient in the clinical Phase I/IIa trial of ATRN-119 marks an important milestone in Aprea Therapeutics’ efforts to develop a pipeline of drug candidates that inhibit DNA repair in tumours.

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“The drug candidate differs from other ATR inhibitors and has shown a potent effect on a variety of cancer cell lines in preclinical studies, and we look forward to following the results from the study during the year.”   

The new macrocyclic ATR inhibitor, ATRN-119, has been designed for affecting the proteins that are involved in the tumours’ ability to repair the damage in their DNA.

It is currently being assessed as a monotherapy, as well as in combination with standard therapy to treat malignant solid tumours.

In May last year, Aprea Therapeutics added ATRN-119 to its project portfolio through the purchase of US-based private biopharmaceutical company Atrin Pharmaceuticals.

In 2021, the company had announced that the US Food and Drug Administration (FDA) placed a clinical hold on the clinical trial of eprenetapopt (APR-246) to treat lymphoid malignancies.