Aileron Therapeutics Commences Enrollment in a Phase 2a Expansion Cohort for ALRN-6924 in Combination with Pfizer’s IBRANCE® (palbociclib) in Patients with MDM2-Amplified Cancers
“We are excited to launch this Phase 2a expansion cohort, expanding on our ALRN-6924 clinical trial combination program,” said
About the Phase 2a MDM2-amplified Expansion Cohort
This Phase 2a expansion cohort is intended to assess the preliminary activity and safety of ALRN-6924 in combination with palbociclib. The trial is expected to enroll up to 25 MDM2-amplified cancer patients with advanced solid tumors that test positive for the presence of wild-type p53. The objectives of the trial include determining the overall response rate and other parameters of efficacy, as well as evaluating the safety and tolerability of the combination. Aileron expects to present preliminary data in the second half of 2019 at a medical conference.
ALRN-6924 is a first-in-class, stabilized cell-permeating peptide that mimics the p53 tumor suppressor protein to disrupt the interaction with both p53-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 each other, with CDK4 very frequently co-amplified in patients with MDM2-amplified cancers who will be enrolled in this trial. This co-amplification provides the mechanistic rationale and suggests a potential patient benefit from combining the MDM2/MDMX-inhibitor, ALRN-6924, with the CDK4/6-inhibitor, palbociclib2.
1. 2018 San Antonio Breast Cancer Symposium abstract #1129, “The Stapled Peptide ALRN-6924, a Dual Inhibitor of MDMX and MDM2, and the CDK4/6 Inhibitors Palbociclib, Ribociclib, or Abemaciclib Synergistically Enhance Each Other’s in vitro and in vivo Anticancer Activity"
2. Laroche-Clary et al.
ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of solid and hematological cancers, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). For information about Aileron’s clinical trials, please visit www.clinicaltrials.gov.
Aileron is a clinical-stage biopharmaceutical company advancing a proprietary platform of cell-permeating alpha-helical peptides that address the most important intracellular targets in oncology and other therapeutic areas. The stabilized helical structure of our peptides allows the design of cell-permeating therapeutic agents with large molecular surfaces for optimal target binding properties, resulting in unique drugs like ALRN-6924. Our current focus is to improve the standard of care for patients with solid tumors and hematological malignancies by developing safe and effective therapies that leverage our proprietary peptide platform. For more information, visit www.aileronrx.com, and for more information about our clinical trials please visit www.clinicaltrials.gov.
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Source: Aileron Therapeutics, Inc.