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Abstract also selected for inclusion in the Best of ASCO® Program

P53 stapled peptide product candidate ALRN-6924 granted orphan drug designation from FDA for treatment of acute myeloid leukemia

CAMBRIDGE, MA—May 18, 2017—Aileron Therapeutics, a clinical-stage biopharmaceutical company advancing a novel class of therapeutics called stapled peptides, today announced that the Company's abstract for ALRN-6924, its lead stapled peptide product candidate targeting p53, was selected for an oral presentation at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, June 2 – 6, 2017.

"We are excited to unveil at ASCO the clinical data on ALRN-6924 from our Phase 1 All-comers trial, showing a favorable safety profile and promising anti-tumor activity in advanced solid tumors and lymphomas," said Joseph A. Yanchik III, President and Chief Executive Officer of Aileron Therapeutics. "P53 inactivation is essential for the formation of virtually all cancers and has long been a focus of research due to its central role in preventing cancer initiation and progression. As the first clinical compound we're aware of that disrupts both primary proteins known to suppress p53's anti-cancer function, we believe ALRN-6924 presents a new strategy in targeting this important mechanism and may represent a new approach to restoring a patient's natural defense against a wide variety of cancers."

Data from a Phase 1, multi-center, two-arm trial of ALRN-6924 in patients with solid tumors and lymphomas will be reviewed by Funda Meric-Bernstam, M.D., Chair of the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center, on Saturday June 3. The presentation during ASCO will include updated clinical data from what is covered in the abstract.

The Aileron abstract on ALRN-6924 was selected for the Best of ASCO® program, an educational initiative highlighting, the year's most notable abstracts from the ASCO Annual Meeting at various meetings around the globe this summer.

ASCO 2017 Oral Presentation Details
Presentation Title: Phase I trial of a novel stapled peptide ALRN-6924 disrupting MDMX- and MDM2-mediated inhibition of WT p53 in patients with solid tumors and lymphomas
Abstract Number: 2505
Session Name: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Date: Saturday, June 3, 2017
Presentation Time: 2:39 PM - 2:51 PM CDT (3:39 PM - 3:51 PM EDT)

Orphan Designation for ALRN-6924
Aileron also announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for ALRN-6924 for the treatment of acute myeloid leukemia (AML). ALRN-6924 is currently being tested in clinical trials for the treatment of AML.

About ALRN-6924
ALRN-6924 is a first-in-class product candidate designed to reactivate wild type p53 tumor suppression by disrupting the interactions between the two primary p53 suppressor proteins, MDMX and MDM2. Aileron believes ALRN-6924 is the first and only product candidate in clinical development that can equipotently bind to and disrupt the interaction of MDMX and MDM2 with p53. Based on preclinical data and preliminary evidence of safety and anti-tumor activity in its ongoing clinical trials, there may be a significant opportunity to develop ALRN-6924 as a monotherapy or combination therapy for a wide variety of solid and liquid tumors. ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of AML, advanced myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma (PTCL). For information about its clinical trials, please visit www.clinicaltrials.gov.

About Aileron
Aileron is a clinical-stage biopharmaceutical company advancing stapled peptides, a novel class of therapeutics for cancers and other diseases. Stapled peptides are chemically stabilized alpha helical peptides that are modified to improve their stability and cell penetrability while maintaining high affinity for large protein surfaces. Our goal is to use our proprietary stapled peptide drug platform to create first-in-class therapeutics, like ALRN-6924, that may be able to address historically undruggable targets and complex mechanisms that underlie many diseases with high unmet medical need. Our platform enables us to chemically stabilize and improve the performance and activity of a broad range of alpha-helical peptides that we believe can potentially activate and inhibit key cellular functions that are otherwise difficult to target with existing drug technologies, including small molecules and monoclonal antibodies. For more information, visit www.aileronrx.com.

Contact:
BMC Communications
Brad Miles, 646-513-3125
bmiles@bmccommunications.com