On April 11, 2018 Aileron Therapeutics (NASDAQ:ALRN), the clinical stage leader in the field of stapled peptide therapeutics for cancers and other diseases, reported the publication of nonclinical results in Science Translational Medicine demonstrating the anti-cancer potential of ALRN-6924 in models of Acute Myeloid Leukemia (AML) (Press release, Aileron Therapeutics, APR 11, 2018, View Source;p=RssLanding&cat=news&id=2342163 [SID1234525472]). ALRN-6924 is designed to reactivate p53-mediated tumor suppression by targeting the two primary p53 suppressor proteins, MDM2 and MDMX. ALRN-6924 is being evaluated in Phase 1 and Phase 2 clinical trials in patients with AML, myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma (PTCL).

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In AML, blood-forming stem cells in the bone marrow produce abnormal red and white blood cells as a result of damage to DNA. P53, a natural tumor suppressor, is inactive in AML, allowing cancer cells to grow unimpeded. Reactivating p53 with ALRN-6924 appears to slow or stop the growth of both mature and immature cancer cells. As demonstrated by the researchers at Albert Einstein in their nonclinical studies, treatment with ALRN-6924 increased the median survival rate in an animal model of human AML (mice transplanted with human leukemia cells) from 50 to about 150 days. In addition, about 40% of the animals were cured, meaning they were tumor-free at one year.

"These data further support our belief that p53’s function may be more effectively restored when both MDMX and MDM2 are blocked. ALRN-6924, a stapled peptide therapeutic shown to inhibit both protein targets, has the potential to deliver on the long-held promise that restoring apoptosis through the p53 pathway may be critical in treating certain cancers," said Manuel Aivado, M.D., Ph.D., Chief Medical and Scientific Officer of Aileron.

"This is a very striking response. Most experimental drugs for leukemia in our experience achieve an increase in survival of only a few days in these preclinical models. Even more importantly, ALRN-6924 effectively cured about 40 percent of the treated mice," said study leader Ulrich Steidl, M.D., Ph.D., Professor of the Departments of Cell Biology and of Medicine and the Diane and Arthur B. Belfer Faculty Scholar in Cancer Research at Albert Einstein College of Medicine, and Associate Chair for Translational Research in Oncology at Montefiore.

The study in Science Translational Medicine is titled, "Dual inhibition of MDMX and MDM2 as a Therapeutic Strategy in Leukemia."

About ALRN-6924
ALRN-6924 is a first-in-class product candidate designed to reactivate wild type p53 tumor suppression by disrupting the interactions between the two primary p53 suppressor proteins, MDMX and MDM2. Aileron believes ALRN-6924 is the first and only product candidate in clinical development that can equipotently bind to and disrupt the interaction of MDMX and MDM2 with p53. Based on preclinical data and preliminary evidence of safety and anti-tumor activity in its ongoing clinical trials, there may be a significant opportunity to develop ALRN-6924 as a monotherapy or combination therapy for a wide variety of solid and liquid tumors. ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma (PTCL). For information about its clinical trials, please visit www.clinicaltrials.gov.