Aileron Therapeutics provided a business update and outlined the company's strategic priorities for 2022. Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with p53-mutated cancers to reduce or eliminate chemotherapy-induced side effects. Nearly 1 million patients each year are diagnosed with a p53-mutated cancer in the US alone, and Aileron employs a precision medicine approach to exclusively treat those patients with p53-mutated cancers who are receiving chemotherapy.

ALRN-6924 is designed to selectively protect these patients' healthy cells from chemotherapy without protecting cancer cells. This novel concept is known as selective chemoprotection. The reduction or elimination of multiple chemotherapy-induced side effects is expected to enhance tolerability of chemotherapy, which is expected to result in fewer dose reductions and delays of chemotherapy, and that is expected to improve efficacy of chemotherapy.

Aileron plans to initiate a new clinical trial in 1H22 to evaluate ALRN-6924 to protect against chemotherapy-induced bone marrow and other toxicities in ER+/HER2- breast cancer patients treated with a doxorubicin + cyclophosphamide and docetaxel chemotherapy regimen, also known as ‘AC-D'. The Phase 1b trial will enroll up to 30 patients in a parallel group design trial with a dose expansion cohort. Aileron will provide more details on the planned neoadjuvant breast cancer trial design at the time of trial initiation.

Aileron is currently enrolling patients in the US and EU with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. As previously guided, Aileron anticipates reporting interim results on 20 patients in 2Q22, and topline results on 60 patients in 4Q22. Aileron has dosed the first 10 patients in the trial and plans to conduct a blinded safety evaluation on these patients after one cycle in 1Q22, as previously guided.

Aileron is continuing to progress its ongoing Phase 1 pharmacology study which 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. The company presented initial data from the study in 2021, confirming the drug's novel p53 biomarker-driven mechanism of action, as well as its pharmacodynamic effects, including time to onset, magnitude and duration. The aim of the study is to develop a universal dosing regimen for ALRN-6924 for use as a chemoprotection agent across a range of chemotherapies and p53-mutated cancers.

Aileron anticipates reporting additional findings from the study this year.