US-based biopharmaceutical company Accent Therapeutics has dosed the first subject in an open-label Phase I/II trial of ATX-295, an oral kinesin family member 18A (KIF18A) inhibitor.
The dose-escalation and expansion trial is structured to assess the therapy’s safety profile at various dosage levels, evaluating its pharmacokinetics, preliminary efficacy, tolerability and pharmacodynamics.
Go deeper with GlobalData
Subjects with locally advanced or metastatic solid tumours, including high-grade serious ovarian cancer, are being enrolled in the trial.
The start of the trial comes after Accent’s first asset, ATX-559, entered clinical assessment near the end of last year.
ATX-295 is designed to target the mitotic kinesin motor protein KIF18A, which is crucial for cell division in certain tumours that exhibit chromosomal instability.
Accent noted that preclinical models have shown promising results, with the therapy inhibiting selective dose-dependent tumour growth in ovarian and triple-negative breast cancers.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe company has also received fast track designation from the US Food and Drug Administration (FDA) for ATX-295 to treat adults with advanced or metastatic platinum-resistant or refractory ovarian cancer.
As a selective inhibitor of DExH-box helicase 9 (DHX9), ATX-559 is intended for treating adults with unresectable/metastatic deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) colorectal cancer after treatment with a checkpoint inhibitor.
Accent Therapeutics’s chief medical officer Jason Sager said: “With the launch of our Phase I/II clinical trial of ATX-295, we now have two investigational drugs in the clinic, bringing us closer to achieving our mission of transforming cancer care.
“Additionally, receiving FDA fast track designation for both of our lead assets underscores the power of our approach and the potential for these investigational drugs to urgently address high unmet medical needs.”
Based in Massachusetts, Accent Therapeutics develops small-molecule therapies that target critical intracellular dependencies in various forms of cancer.
The company’s therapies are designed for both novel oncology targets and those without many existing treatment options.
