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|Anti-tumor Activity Observed in Phase 1 Trial of Novel P53-Targeting Drug ALRN-6924|
First clinical data reported on a dual inhibitor of MDMX and MDM2,key suppressors of P53 function
Data reviewed in oral presentation at 2017 ASCO Annual Meeting
CHICAGO, IL—June 3, 2017—Aileron Therapeutics, a clinical-stage biopharmaceutical companydeveloping a novel class of therapeutics called stapled peptides, today announced safety andclinical activity data, including complete responses, partial responses and evidence of stabledisease, from its Phase 1, multi-center trial with ALRN-6924 in a variety of advanced cancers.ALRN-6924, a stapled peptide therapeutic, is believed to be the first product candidate shownto disrupt both MDMX- and MDM2-mediated inhibition of the wild type p53 tumor suppressorgene in clinical trials. The data were reviewed in an oral presentation at the 2017 ASCO AnnualMeeting by Funda Meric-Bernstam, M.D., Chair of the Department of Investigational CancerTherapeutics at The University of Texas MD Anderson Cancer Center.
Dr. Meric-Bernstam commented, "These results lend clinical support to the belief that thefunction of tumor suppressor gene p53, one of the most sought-after targets in oncology, isinhibited by MDMX and MDM2. What is encouraging about these early data with ALRN-6924 isthe duration of clinical activity observed--some lasting more than one year--and that thecompound appeared to be reasonably well tolerated in this population of previously treatedpatients with advanced solid tumors and lymphomas. Additional results from studies will lookat ALRN-6924, both as a single agent therapy as well as in combination with established canceragents."Study Results
The data presented from the Phase 1, multi-center, dose escalation trial included 71 patientswith a broad range of advanced blood and solid tumor cancers.
ALRN-6924 was well tolerated in patients in the study. The most common treatment-related,non-hematologic adverse events were GI symptoms, fatigue and headache. There was no Grade3/4 thrombocytopenia, and Grade 3/4 neutropenia was reported in less than 5% of patients.
Efficacy data was presented on 41 patients in the trial with a broad range of advanced bloodand solid tumor cancers who received a >3.2 mg/kg dose of ALRN-6924 per treatment cycle andwho did not have a mutation of the p53 gene. The 30 patients who were not included in theefficacy analysis either had a mutation of the p53 gene, received lower drug doses, ordiscontinued the study prior to disease evaluation.
Of the 41 patients, there were two complete responses (CR), two partial responses (PR), and 20with stable disease (SD). The disease control rate was 59% (24/41). One CR patient, both PRpatients and two SD patients have received ALRN-6924 for well over one year, theCRs and PRs are ongoing as of May 1, 2017 and patients continue to receivetreatment with ALRN-6924.
The Aileron abstract on ALRN-6924 was also selected for the Best of ASCO® program, aneducational initiative highlighting the year's most notable abstracts from the ASCO AnnualMeeting at various meetings around the globe this summer.