Aileron Therapeutics Initiates Phase I Cancer Study of ALRN-6924 in Advanced Hematologic and Solid Malignancies with Wild Type p53

Aileron Therapeutics, Inc., a clinical-stage biopharmaceutical companyhas announced that the first cancer patients have been dosed in a Phase I clinical trial of ALRN-6924.

ALRN-6924 is a potent and specific re-activator of wild type p53, a tumour suppressor protein that has been long referred to as “the guardian of the genome.”  P53 represents one of the most sought after oncology drug targets by clinical oncologists due to its central role in preventing the initiation and progression of most liquid and solid tumours.  ALRN-6924 is the first clinical drug candidate that binds equipotently and inhibits both of the p53 suppressor proteins, MDM2 and MDMX, in contrast to other p53-targeting small molecule drugs in clinical development that only inhibit MDM2. 

“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,” said Joseph A. Yanchik III, President and CEO of Aileron Therapeutics.

“It is estimated that over 10 million people are living with a cancer that has wild type p53 signaling inactivated.  Our ability to directly engage the full mechanism with ALRN-6924 could have unprecedented impact not only in treating a broad range of liquid and solid tumours that test positive for wild type p53, but our drug could also expand the efficacy of many current therapies that rely on a functional p53 pathway,” said Dr Manuel Aivado, Chief Medical Officer of Aileron Therapeutics.  “With the Phase I study well underway, we expect to have a steady flow of important insights into the safety and activity of ALRN-6924 in patients throughout the year.”