Aileron starts dosing in Phase I cancer trial of ALRN-6924

The multicenter, dose-escalation Phase I trial is designed to evaluate the safety and tolerability of ALRN-6924 as a single agent. ALRN-6924 is a potent and specific re-activator of wild type p53, a tumour suppressor protein.

Patients with advanced hematologic and solid malignancies that test positive for the presence of wild type p53, will be enrolled in the trial. The trial is also designed to provide for tumor specific expansion groups that will test the maximally tolerated or optimal biological dose.

Aileron Therapeutics president and chief executive officer Joseph Yanchik III said: "This clinical study represents a very ambitious undertaking for Aileron and is an exciting time for our team and collaborators.

"The ultimate goal of this trial is to demonstrate our ability to safely and effectively engage one of the most important targets in all of oncology, p53, and further establish the druggability of transcription factors that have been shown to be some of the most important but difficult-to-target oncogenic drivers.

"Per our stapled peptide platform, this study will demonstrate the first systemic administration of a cell-penetrating stapled peptide and will further establish the potential of this new class of medicines for a wide range of therapeutic areas."

The objectives of the trial include determining maximum tolerated dose, pharmacokinetics, pharmacodynamics and preliminary indications of anti-tumor activity.

ALRN-6924 is the first clinical drug candidate that binds equipotently and inhibits both p53 suppressors, MDM2 and MDMX, compared to other p53-targeting small molecule drugs in clinical development that only inhibit MDM2.