Atavistik Bio has dosed the first subject in its Phase I clinical trial of ATV-1601, an allosteric selective AKT1 E17K inhibitor, designed to treat adults with solid tumours.
The trial uses a dose escalation and expansion phase, with the therapy as a single agent, followed by a similar phase in combination with fulvestrant at one location in the US.
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It is an open-label study and aims to assess the preliminary antitumor activity, tolerability, pharmacokinetics, and safety of the therapy in those with advanced or metastatic AKT1 E17K-mutant solid tumours.
ATV-1601will be assessed in conjunction with fulvestrant in individuals with AKT1 E17K-mutant hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Atavistik Bio CEO Bryan Stuart said: “Dosing the initial patient in our first-in-human study of ATV-1601 represents a significant milestone as we transition to a clinical stage biotechnology company and an important step forward in our efforts to develop innovative treatments for patients.
“As a selective allosteric AKT1 E17K inhibitor, ATV-1601 has generated a highly differentiated preclinical profile, which we believe has the potential to address significant unmet needs for patients. We look forward to evaluating ATV-1601 in the clinic and moving rapidly toward early proof-of-concept data for this programme.”
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By GlobalDataAccording to the company, the pan-AKT inhibitor is designed to prevent all three AKT isoforms: AKT1, AKT2, and AKT3.
Despite this, these inhibitors are often less effective for those with AKT1 E17K-driven mutant tumours and can lead to adverse events, resulting in the discontinuation of treatment or reduced doses in many individuals.
Developed using the company’s AMPS technology and integrated with the AI-enabled drug discovery engine, ATV-1601 is part of the company’s larger pipeline of in-house discovered allosteric oncology candidates.
