Aileron Therapeutics Announces Proof-of-Concept Data for ALRN-6924 to be Featured in Late-Breaking Presentation at EORTC-NCI-AACR Annual Symposium

On October 12, 2020 Aileron Therapeutics (Nasdaq: ALRN) reported that proof-of-concept data from the company’s Phase 1b study of ALRN-6924 will be featured in a late-breaking poster presentation during the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Annual (ENA 2020) Symposium on Molecular Targets and Cancer Therapeutics, being held virtually October 24 – 25, 2020 (Press release, Aileron Therapeutics, OCT 12, 2020, View Source [SID1234568326]).

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The abstract entitled, "Prevention of Chemotherapy-induced Myelosuppression in SCLC patients treated with the Dual MDM2/MDMX inhibitor ALRN-6924," (LBA96) will be presented starting Saturday, October 24, on the ENA 2020 website.

The data to be presented is from Aileron’s Phase 1b study, which is evaluating ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to prevent chemotherapy-induced toxicities, such as severe anemia, neutropenia and thrombocytopenia, in patients with p53-mutated small cell lung cancer (SCLC) who are being treated with the chemotherapy topotecan. In June 2020, Aileron announced positive interim data from this study.

"Chemotherapy, which remains the backbone of treatment for millions of cancer patients, is associated with toxicities and side effects – ranging from unpleasant to life-threatening, and sometimes fatal. Current supportive care drugs try to manage these side effects, but often unsuccessfully and with associated toxicities of their own. Aileron has the potential to bring much-needed innovation to this area of cancer care, improving patients’ quality of life as well as their tolerance for chemotherapy," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron Therapeutics.

Dr. Aivado continued, "ALRN-6924 is the first and only chemoprotective agent to utilize a biomarker strategy by treating patients with p53-mutated cancers. In these patients, ALRN-6924 is designed to selectively shield healthy non-p53-mutated cells while chemotherapy can continue targeting p53-mutated cancer cells. We believe that our novel mechanism of action has the potential to introduce a transformative paradigm of proactive prevention of hematological and non-hematological chemotherapy-induced side effects. Importantly, our approach is designed to give oncologists access to a chemoprotective agent that will not reduce the efficacy of chemotherapy."

Aileron’s long-term vision is to bring chemoprotection to all patients with p53-mutated cancers, which represent at least 50% of cancer patients, regardless of cancer type or chemotherapy.

Aileron Investor Call

Aileron will host a virtual investor call and webcast to discuss the new data as well as the company’s clinical development strategy to expand chemoprotection to patients with p53-mutated cancers. The event will take place on Monday, October 26 at 8:30 a.m. ET. Details will be provided closer to the event at View Source

How ALRN-6924 Works to Protect Healthy Cells from Chemotherapy

ALRN-6924 is being developed by Aileron as a novel chemoprotective medicine to selectively protect healthy cells in patients with cancers that harbor p53-mutations to reduce or eliminate chemotherapy-induced side effects.

Chemotherapy preferentially acts on cells that are cycling, or undergoing the process of cell division. In cancer cells, the cell cycle is unchecked, which leads to uncontrolled cell proliferation, a hallmark of cancer. Certain types of healthy cells also naturally need to cycle, such as bone marrow cells, hair follicle cells, skin cells, and cells lining the oral cavity and the gastrointestinal tract. As a result, chemotherapy targets and kills both cycling healthy cells and cycling cancer cells. This, in turn, leads to a spectrum of chemotherapy-induced side effects, from unpleasant to life-threatening and fatal.

ALRN-6924, an investigational first-in-class MDM2/MDMX dual inhibitor, is administered prior to chemotherapy to patients with p53-mutant cancers. ALRN-6924 is designed to activate normal p53 protein in patients’ healthy cells, temporarily and reversibly pausing cell cycling to selectively shield the patients’ healthy cells from chemotherapy. The protection is limited to healthy cells, as ALRN-6924 cannot work in p53-mutated cancer cells given that p53 has lost its function in those cells. Therefore, cancer cells continue to cycle uninterrupted and remain fully susceptible to destruction by chemotherapy.