ALRN-6924
We are implementing a clinical development strategy designed to maximize our opportunity to bring biomarker-driven, selective chemoprotection to all patients with p53-mutated cancer regardless of cancer type or chemotherapy.
We continue to advance our randomized, double-blind, placebo-controlled Phase 1b clinical trial of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with advanced p53-mutated NSCLC.
We plan to enroll a total of 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. Patients will be randomized 1:1 to receive carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or placebo for at least four 21-day treatment cycles.
Our planned data readouts include interim results on 20 patients in 2Q 2022, and topline results on 60 patients in 4Q 2022.
Please visit the NSCLC trial listing on clinicaltrials.gov.
In May 2022, we initiated a Phase 1b clincal trial to evaluate the safety, tolerabliity and protective effect of ALRN-6924 againt chemotherapy-induced bone marrow toxicities and other toxicities in patients with p53-mutated neoadjuvant breast cancer undergoing treatment with doxorubicin plus cyclophosphamide and docetaxel (AC+D). Anticipated to enroll 30 patients, the trial involves a parallel group design with a dose expansion cohort. Patients will receive doxorubicin plus cyclophosphamide (AC) on Day 1 of each 3-week cycle for 4 cycles, and then docetaxel (D) on Day 1 of each 3-week cycle for 4 cycles. In part 1 (Dose Evaluation), a control group of 8 patients with p53-wild type breast cancer (i.e., non-p53-mutated) will receive AC+D without ALRN-6924. Patients with p53-mutated breast cancer on the same AC+D regimen will be randomized to concurrently receive ALRN-6924 at 0.3 mg/kg ALRN-6924 (n=6) or at 0.6 mg/kg ALRN-6924 (n=6). ALRN-6924 is given as IV infusion on study days 0, 1 (day of chemotherapy) and 2. In Part 2 (Dose Expansion), 10 patients will receive the same AC+D regimen and the ALRN-6924 dose selected in Part 1.
We plan to report initial interim results from the breast cancer trial in the 4Q 2022.
We presented final results from our completed Phase 1b trial in patients with p53-mutated SCLC receiving second-line topotecan at the European Society for Medical Oncology (ESMO) Congress 2021. Following the interim proof-of-concept data presented in October 2020 from this study, these final results reinforced ALRN-6924’s ‘triple-play’ reduction in neutropenia, thrombocytopenia and anemia caused by chemotherapy, as well as a reduction in febrile neutropenia, platelet transfusions and red blood cell transfusions.
We presented preliminary results from our ongoing Phase 1 pharmacology study of ALRN-6924 in healthy volunteers at the International Society for Experimental Hematology (ISEH) 2021 Scientific Meeting and ESMO 2021. These preliminary results confirmed 0.3 mg/kg as the optimal dose for ALRN-6924 and confirmed the drug’s novel p53 biomarker-driven mechanism of action, as well as its pharmacodynamic effects, including time to onset, magnitude and duration.
The healthy volunteer study is evaluating ALRN-6924’s induction of p21-induced cell cycle arrest in healthy, normal bone marrow cells and other cell types in healthy volunteers receiving ALRN-6924.
We anticipate reporting additional findings from this study in the 2H 2022.
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