On September 10, 2021 Aileron Therapeutics, a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported two upcoming poster presentations at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2021, which is being held September 16-21, 2021 (Press release, Aileron Therapeutics, SEP 10, 2021, View Source [SID1234587513]). In these posters, Aileron will present preliminary data from its ongoing Phase 1 study of ALRN-6924 in healthy volunteers and final data from its completed Phase 1b study of ALRN-6924 in patients with small cell lung cancer (SCLC) receiving second-line topotecan treatment. Aileron is developing ALRN-6924 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 attack on cancer cells, an emerging concept known as chemoprotection. ALRN-6924, a 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.
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"We are excited to share preliminary findings from our ongoing study of ALRN-6924 in healthy volunteers as well as final results from our completed Phase 1b study of ALRN-6924 in patients with small cell lung cancer at the upcoming ESMO (Free ESMO Whitepaper) Congress," said Manuel Aivado, M.D., Ph.D., President and CEO of Aileron. "These findings support the design of our ongoing randomized, double-blind, placebo-controlled study of ALRN-6924 in patients with non-small cell lung cancer and are helping us plan for future clinical studies of ALRN-6924 in multiple p53-mutated cancers and types of chemotherapy."
Aileron ESMO (Free ESMO Whitepaper) Poster Presentations
Title: A Phase 1b Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, for the Prevention of Chemotherapy-induced Myelosuppression
Abstract/Poster #: 1654P
Title: A Phase 1 Study of the Dual MDMX/MDM2 Inhibitor, ALRN 6924, in Healthy Volunteers
Abstract/Poster #: 1791P
Archived versions of Aileron’s ESMO (Free ESMO Whitepaper) poster presentations will be available under the Scientific Publications section of Aileron’s website at View Source
About the Phase 1 Study in Health Volunteers
Aileron is conducting a multi-part Phase 1 pharmacology study in healthy volunteers to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ALRN-6924. Aileron will present the findings from Parts 1 and 2 of the study at ESMO (Free ESMO Whitepaper). The objectives of these first two parts are to determine a dose of ALRN-6924 that initiates p53-mediated transcriptional regulation and yields transient cell cycle arrest via p21 induction in human bone marrow with minimal signal for apoptosis (Part 1), and to determine the time to onset, magnitude, and duration of bone marrow PD effects (Part 2). The study is ongoing, and Aileron anticipates presenting additional findings at a later date.
About the Phase 1b Study in Patients with p53-Mutated SCLC
In October 2020, Aileron presented positive clinical data from the Phase 1b trial in SCLC demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against severe neutropenia, anemia and thrombocytopenia in patients with p53-mutated SCLC treated with second-line topotecan. The final data set from this trial, which Aileron will present at ESMO (Free ESMO Whitepaper), includes results from 13 additional patients, including two new cohorts of seven patients receiving 0.3 mg/kg ALRN-6924 given six hours before topotecan; four patients receiving 0.2 mg/kg ALRN-6924 given 24 hours before topotecan; and two new patients receiving 0.3 mg/kg ALRN-6924 given 24 hours before topotecan. These data are in line with the proof-of-concept data previously presented and with Aileron’s expectation that administering ALRN-6924 at 0.3 mg/kg and 24 hours before topotecan is the optimal dose and schedule in this patient population.