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About Aileron Therapeutics Inc.
Aileron Therapeutics Inc. (NASDAQ: ALRN) is a clinical-stage biopharmaceutical company dedicated to advancing a novel pipeline of first-in-class medicines that address significant unmet medical needs in orphan pulmonary, fibrotic, and oncology indications. With a strong foundation in peptide therapeutics, Aileron is at the forefront of developing innovative therapies designed to improve patient outcomes in challenging and underserved medical conditions.
Core Product Pipeline
LTI-03: Aileron's lead product candidate, LTI-03, is a synthetic peptide with a dual mechanism of action targeting alveolar epithelial cell survival and inhibition of profibrotic signaling. Currently in clinical development, LTI-03 has shown promise in treating idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. The therapy's unique approach aims to not only slow disease progression but potentially restore healthy lung function.
LTI-01: Another key asset in Aileron's pipeline, LTI-01, is a proenzyme developed for loculated pleural effusions. Having completed Phase 1b and Phase 2a clinical trials, LTI-01 has received Orphan Drug Designation in both the U.S. and EU, as well as Fast Track Designation in the U.S., underscoring its potential to address critical unmet needs in this condition.
ALRN-6924: Previously a lead oncology candidate, ALRN-6924 is a clinical-stage therapy that reactivates the tumor-suppressing protein p53 by targeting MDMX and MDM2. This innovative approach has positioned ALRN-6924 as the first and only clinical-stage drug targeting MDMX, with potential applications in rare cancers like retinoblastoma.
Market Position and Competitive Edge
Aileron Therapeutics operates in the highly specialized fields of peptide-based therapeutics and orphan disease indications. By focusing on first-in-class therapies, the company differentiates itself from competitors through its innovative mechanisms of action and targeted approach to high-need patient populations. Its strategic focus on orphan diseases, supported by Orphan Drug and Fast Track designations, positions it to capitalize on regulatory incentives and market exclusivity.
Industry Significance
As a pioneer in peptide therapeutics, Aileron Therapeutics is contributing to the advancement of treatments for complex diseases with limited existing options. Its commitment to addressing unmet medical needs in IPF, fibrosis, and oncology aligns with broader industry trends emphasizing innovation in rare and life-threatening diseases. With a robust clinical pipeline and a focus on leveraging cutting-edge science, Aileron is poised to make a meaningful impact on patient care and the biopharmaceutical landscape.
Aileron Therapeutics (Nasdaq: ALRN) announced that CEO Manuel Aivado will participate in a fireside chat at the William Blair Biotech Focus Conference 2022. The chat will be available on-demand starting July 11, 2022. Management will also meet in-person at the conference on July 12, 2022. Aileron focuses on chemoprotection oncology, aiming to make chemotherapy safer and more effective. Their lead product, ALRN-6924, is designed to protect healthy cells from chemotherapy while targeting cancer cells, particularly in patients with p53-mutated cancers, which encompass about 50% of cancer patients.
Aileron Therapeutics (ALRN) announced interim data from its Phase 1b trial focused on ALRN-6924 for NSCLC. Patients treated with ALRN-6924 completed 93% of the first four chemotherapy cycles compared to 78% on placebo, indicating a potential bias on the primary endpoint. The interim analysis showed 56% of cycles on ALRN-6924 were free of severe hematologic toxicities, compared to 50% for placebo. Aileron plans to halt further enrollment in the NSCLC trial and refocus on a Phase 1b breast cancer trial, applying insights from the NSCLC study to enhance the new protocol.
Aileron Therapeutics (Nasdaq: ALRN) has initiated a Phase 1b clinical trial for ALRN-6924, aimed at preventing chemotherapy-induced neutropenia and other toxicities in patients with p53-mutated breast cancer undergoing treatment with doxorubicin, cyclophosphamide, and docetaxel (AC+D). This regimen causes severe side effects, including neutropenia in 75% of patients. The trial will enroll 30 patients, with initial interim results expected in 4Q2022. Aileron highlights its innovative approach targeting p53-mutated cancers, which affects nearly 1 million U.S. patients annually.
BOSTON, May 17, 2022 (GLOBE NEWSWIRE) -- Aileron Therapeutics (Nasdaq: ALRN) announced that CEO Manuel Aivado will present at the H.C. Wainwright Global Investment Conference on May 25, 2022, at 1:30 p.m. ET in Miami, FL. The event will be accessible via a live webcast on the company’s website, with a replay available for 30 days thereafter.
Aileron focuses on chemoprotection in oncology, aiming to enhance chemotherapy safety and effectiveness. Their lead product, ALRN-6924, is a dual inhibitor designed to protect healthy cells from chemotherapy damage while targeting cancer cells.
Aileron Therapeutics (Nasdaq: ALRN) has announced a virtual KOL investor event scheduled for May 19, 2022, at 4:00 pm ET. The event will feature presentations from CEO Manuel Aivado and key opinion leaders, discussing the potential of ALRN-6924 as a precision medicine to mitigate chemotherapy-induced toxicities. Key topics include new data on ALRN-6924’s protective effects on hair follicles, updates on ongoing clinical trials for p53-mutated cancers, and planned data readouts for 2022. A live webcast will be available on the company's website.
Aileron Therapeutics (Nasdaq: ALRN) announced promising non-clinical findings regarding ALRN-6924, a dual inhibitor of MDM2/MDMX, which showed the potential to protect hair follicles from chemotherapy-induced damage. Specifically, ALRN-6924 was found to cause cell cycle arrest in human scalp hair follicles, which may prevent alopecia commonly associated with taxane-based chemotherapy like paclitaxel. Highlighted in a late-breaking presentation at the Society for Investigative Dermatology meeting, these results reinforce Aileron's strategy to enhance chemotherapy safety for patients with p53-mutated cancers.
Aileron Therapeutics (Nasdaq: ALRN) reported first-quarter 2022 results, with a net loss of $8.4 million, compared to $7.0 million in Q1 2021. The company has $38.1 million in cash, expected to fund operations into Q4 2023. Aileron is advancing its Phase 1b clinical trial of ALRN-6924 for advanced p53-mutated non-small cell lung cancer (NSCLC), with interim results anticipated in June 2022, and topline results projected for 4Q 2022. A second trial for p53-mutated ER+/HER2- breast cancer is set to begin in 2Q 2022. The company will host a virtual investor event on May 19, 2022.
Aileron Therapeutics (Nasdaq: ALRN) has appointed Christopher Zergebel as the new Vice President of Program Management and Clinical Operations, expanding its management team. With over 20 years of oncology experience, Zergebel aims to enhance operational excellence as Aileron develops ALRN-6924, a chemoprotective agent for p53-mutated cancers. The ongoing clinical trial for ALRN-6924 in non-small cell lung cancer is set to release interim data in June 2022, while enrollment for a breast cancer trial is anticipated in Q2 2022.
Aileron Therapeutics (Nasdaq: ALRN) reported its financial results for Q4 and the year ended December 31, 2021. The company aims to advance its chemoprotection strategy for patients with p53-mutated cancers, with several milestones expected in 2022, including interim data from Phase 1b trials for non-small cell lung cancer (NSCLC) and neoadjuvant breast cancer. As of December 31, 2021, Aileron had $45.9 million in cash, anticipated to fund operations through Q4 2023. However, the net loss for 2021 increased to $26.2 million, reflecting higher R&D expenses due to clinical activities.
Aileron Therapeutics (Nasdaq: ALRN) announced that CEO Manuel Aivado will present a company overview at the 2022 Virtual Growth Conference hosted by Maxim Group LLC from March 28th to 30th. Aileron focuses on developing chemoprotection therapies to enhance chemotherapy safety and efficacy. Their lead product, ALRN-6924, is a first-in-class dual inhibitor designed to activate p53, targeting patients with p53-mutated cancers. This innovative approach aims to protect healthy cells during chemotherapy, potentially improving patient quality of life and treatment tolerability.