Aileron Enters Clinical Trial Collaboration with Pfizer

Aileron Therapeutics announced that it has entered into a clinical trial collaboration with Pfizer to evaluate the combination of Aileron’s ALRN-6924 and Pfizer’s palbociclib, also known as IBRANCE, in MDM2-amplified cancers. Overexpression of MDM2 in cancer is typically a driver of tumor proliferation. Aileron expects this Phase 1B trial to start enrolling patients with solid tumors in the first quarter of 2019. Pfizer will provide drug supply in support of the trial.

ALRN-6924 is a first-in-class, stabilized cell-permeating peptide that mimics the p53 tumor suppressor protein to disrupt the interaction with both its endogenous inhibitors, MDMX and MDM2. For p53 wild-type tumors, ALRN-6924 can restore p53-dependent tumor suppression. Palbociclib is an oral inhibitor of cell cycle check-point regulators CDK4/6. The MDM2 and CDK4 genes are located on chromosome 12 in close proximity to one-another, with CDK4 very frequently co-amplified in the MDM2-amplification-positive patients to be enrolled in this trial. This co-amplification further suggests a potential patient benefit from combining the MDM2/MDMX-inhibitor ALRN-6924 with the CDK4/6-inhibitor palbociclib1.

“We are excited about this combination trial with Pfizer’s palbociclib,” stated Manuel Aivado, MD, PhD, President and Chief Executive Officer of Aileron. “The combination of ALRN-6924 and palbociclib demonstrated enhanced antitumor activity and meaningfully delayed tumor growth in animal models over single agents alone. We believe the combination of these two drugs represents a complementary attack on the proliferation of cancer cells that may benefit patients with a variety of different cancers.”