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with p53-Mutated Neoadjuvant Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Aileron Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aileron Therapeutics Announces Interim Data from Phase 1b Chemoprotection Trial of ALRN-6924 in Patients with p53-Mutated Non-Small Cell Lung Cancer (NSCLC) and Confirms Development Path for ALRN-6924 Focused on p53-Mutated Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Aileron Therapeutics","sponsor":"Not 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Find Clinical Drug Pipeline Developments & Deals for ALRN-6924
ALRN-6924 is an MDM2/MDMX inhibitor that leverages Aileron’s proprietary peptide drug technology. The primary endpoint of the Phase 1b open-label trial was duration and incidence of severe neutropenia in cycle 1.
The primary endpoints are duration and incidence of severe neutropenia (Grade 4) in cycle 1. Secondary endpoints include the chemoprotective effect of ALRN-6924 on chemotherapy-induced alopecia, as well as other hematologic and non-hematologic toxicities.
Enhancements to protocol, informed by recent ALRN-6924 data, are designed to improve the opportunity to demonstrate protection against chemotherapy-induced severe neutropenia, alopecia (hair loss) and potentially other toxicities in patients with p53-mutated breast cancer.
ALRN-6924, first-in-class MDM2/MDMX dual inhibitor, is designed to activate p53, which in turn upregulates p21, a known inhibitor of the cell replication cycle. ALRN-6924 is the only reported chemoprotective agent in clinical development to employ a biomarker strategy.
Non-clinical data demonstrated principle that ALRN-6924 can temporarily arrest cell cycle in human scalp hair follicles and their stem cells also ALRN-6924-induced cell cycle arrest protected hair follicles from paclitaxel-induced toxicity and irreversible stem cell damage.
A precision medicine-based chemoprotective agent, ALRN-6924 is designed to selectively activate p53 in normal cells, thereby upregulating p21, which pauses cell cycle in normal cells but not in p53-mutated cancer cells.
Initial findings from an ongoing study demonstrated that a 0.3 mg/kg dose of ALRN-6924 has been very well tolerated and resulted in p53-mediated induction of the cell cycle inhibitor p21 in normal bone marrow cells in healthy volunteers.
Aileron is developing ALRN-6924 as a novel medicine to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving chemotherapy’s effects against cancer cells.
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