Auron Therapeutics has dosed the first subject in the multicentre Phase I trial of the orally available lysine acetyltransferase 2A (KAT2A) and lysine acetyltransferase 2B (KAT2B) degrader, AUTX-703, targeting individuals with advanced haematologic malignancies.
The open-label, first-in-human trial is designed to evaluate AUTX-703’s tolerability, pharmacodynamics, safety, preliminary clinical activity, and pharmacokinetics.
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It specifically targets individuals with relapsed or refractory acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS).
The trial is structured in two parts: Part A, which is a dose escalation part, aims to establish the maximum tolerated dose and/or recommended Phase II dose while the dose optimisation segment, Part B, will further assess the selected dosages for their safety, efficacy, pharmacokinetics, and pharmacodynamics.
The trial has nine locations across the US.
Auron Therapeutics CEO Kate Yen said: “The initiation of our first Phase 1 trial marks a significant milestone for Auron in our transition to a clinical-stage company.
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By GlobalData“This achievement reflects the strength of our scientific platform and the dedication of our team in advancing a novel therapeutic approach targeting KAT2A/B, the epigenetic regulators that play a central role in driving cellular plasticity. By modulating this key mechanism, we aim to overcome one of the fundamental barriers to durable cancer treatment.”
Discovered and developed using the company’s AURIGIN platform, AUTX-703 is under development for treating several types of tumours.
Through the AURIGIN platform, the company recognised KAT2A/B as crucial drivers of cell plasticity and disease progression.
Auron noted that it has validated the target in multiple disease models, including AML, neuroendocrine prostate cancer (NEPC), and small cell lung cancer (SCLC).
In preclinical studies, the therapy has shown a dose-dependent survival benefit in a primary AML model.
With two investigational new drug applications cleared, AUTX-703 has advanced into the Phase I study.
The US Food and Drug Administration has also granted fast-track designation to the therapy for the treatment of relapsed/refractory AML.
