A Phase 1b Clinical Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, as a Chemoprotection Agent in Patients With TP53-Mutated, HER2 Negative Breast Cancer Receiving Neoadjuvant or Adjuvant Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)

This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with doxorubicin, docetaxel, and cyclophosphamide (TAC). Chemotherapy affects cells that are dividing, whether they are tumor cells or healthy cells (including, bone marrow cells, hair follicle cells, and epithelial cells lining the gastrointestinal tract). ALRN-6924 is designed to stop cell division in healthy cells but not in tumor cells because they have a mutation of the TP53 gene. When this happens, tumor cells will still be destroyed by the chemotherapy but healthy cells that are not dividing may be spared from chemotherapy damage and the patient should have less side effects.

Start Date09 Jan 2023

Sponsor / Collaborator

Rein Therapeutics, Inc.

NL-OMON52916

/ CompletedNot Applicable

A Phase 1 Pharmacology Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, in Healthy Volunteers. - CS0351-200052 Aileron

Start Date24 Nov 2020

Sponsor / Collaborator

Rein Therapeutics, Inc.

NCT04022876

/ TerminatedPhase 1

A Phase 1b Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, for the Prevention of Chemotherapy-induced Myelosuppression

This is a Phase 1b, multicenter, 2-part study of ALRN-6924 for the prevention of chemotherapy-induced side effects.
Part 1 SCLC is an open-label, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated ED SCLC undergoing 2nd-line treatment with topotecan. (Part 1 has completed enrollment).
Part 2 NSCLC is a randomized, double-blind, placebo-controlled, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated advanced NSCLC of adenocarcinoma histology receiving 1st-line treatment with carboplatin plus pemetrexed with or without immunotherapy.

Start Date03 Sep 2019

Sponsor / Collaborator

Rein Therapeutics, Inc.

100 Clinical Results associated with Sulanemadlin

100 Translational Medicine associated with Sulanemadlin

100 Patents (Medical) associated with Sulanemadlin

Literatures (Medical) associated with Sulanemadlin

01 Jun 2024·iScience

MDM2/MDMX inhibition by Sulanemadlin synergizes with anti-Programmed Death 1 immunotherapy in wild-type p53 tumors

Article

Author: Wermeling, Fredrik ; Partridge, Anthony W ; Nestor, Marika ; Kannan, Pavitra ; Jiang, Long ; Spiegelberg, Diana ; Ingelshed, Katrine ; Chandramohan, Arun ; Melssen, Marit M ; Lane, David P

Immunotherapy has revolutionized cancer treatment but its efficacy depends on a robust immune response in the tumor. Silencing of the tumor suppressor p53 is common in tumors and can affect the recruitment and activation of different immune cells, leading to immune evasion and poor therapy response. We found that the p53 activating stapled peptide MDM2/MDMX inhibitor Sulanemadlin (ALRN-6924) inhibited p53 wild-type cancer cell growth in vitro and in vivo. In mice carrying p53 wild-type CT26.WT tumors, monotherapy with the PD-1 inhibitor DX400 or Sulanemadlin delayed tumor doubling time by 50% and 37%, respectively, while combination therapy decreased tumor doubling time by 93% leading to an increased median survival time. Sulanemadlin treatment led to increased immunogenicity and combination treatment with PD-1 inhibition resulted in an increased tumor infiltration of lymphocytes. This combination treatment strategy could potentially turn partial responders into responders of immunotherapy, expanding the patient target group for PD-1-targeting immunotherapy.

27 Jul 2023·Journal of medicinal chemistryQ1 · MEDICINE

Discovery of Sulanemadlin (ALRN-6924), the First Cell-Permeating, Stabilized α-Helical Peptide in Clinical Development.

Q1 · MEDICINE

Article

Author: Vukovic, Vojislav ; Olson, Karen A ; Sutton, David ; Feyfant, Eric ; Elkin, Carl ; Aivado, Manuel ; Chang, Yong S ; Graves, Bradford ; Annis, D Allen ; Darlak, Krzysztof ; Guerlavais, Vincent ; Sawyer, Tomi K ; Carvajal, Luis ; Ren, Jian-Guo ; Packman, Kathryn ; Nash, Huw M ; Gangurde, Pranoti ; Vassilev, Lyubomir T ; Kesavan, Kamala

We report the discovery of sulanemadlin (ALRN-6924), the first cell-permeating, stabilized α-helical peptide to enter clinical trials. ALRN-6924 is a "stapled peptide" that mimics the N-terminal domain of the p53 tumor suppressor protein. It binds with high affinity to both MDM2 and MDMX (also known as MDM4), the endogenous inhibitors of p53, to activate p53 signaling in cells having a non-mutant, or wild-type TP53 genotype (TP53-WT). Iterative structure-activity optimization endowed ALRN-6924 with favorable cell permeability, solubility, and pharmacokinetic and safety profiles. Intracellular proteolysis of ALRN-6924 forms a long-acting active metabolite with potent MDM2 and MDMX binding affinity and slow dissociation kinetics. At high doses, ALRN-6924 exhibits on-mechanism anticancer activity in TP53-WT tumor models. At lower doses, ALRN-6924 transiently arrests the cell cycle in healthy tissues to protect them from chemotherapy without protecting the TP53-mutant cancer cells. These results support the continued clinical evaluation of ALRN-6924 as an anticancer and chemoprotection agent.

01 Jul 2023·Journal of the American Geriatrics Society

Cell cycle arrest: A breakthrough in the supportive care of older cancer patients

Review

Author: Balducci, Lodovico ; Falandry, Claire ; List, Alan

Abstract:

Background:

Age is a major risk factor for the acute and chronic complications of cancer chemotherapy. The current approach to the prevention of these complications is reactive and involves the reduction of the doses and the delay of treatment which may compromise the outcome. There is a limited number of antidotes to chemotherapy toxicity and these have complications of their own. Oldest old and frail patients are mostly excluded from life saving cancer treatment due to the risk of severe and even lethal complications.

Methods:

molecular biology has revealed that different checkpoints control the proliferative cycle of normal and neoplastic cells. Two new drugs, Trilaciclib and ALRN‐6924 may cause a temporary cell cycle arrest (CCA) of normal cells without blocking the proliferation of the neoplastic ones and render the normal cells temporarily invulnerable to the toxicity of chemotherapy. We reviewed the publications related to these drugs on the Medline, the published drug information and the presentations to major medical conferences.

Results:

In three randomized controlled phase II trials Trilaciclib proved effective in preventing neutropenia, thrombocytopenia and anemia in patients with non small cell lung cancer with non proficient RB1 gene. Forty‐five percent of patients were 65 and older and age did not prevent the effectiveness of the drug. Trilaciclib was approved by the FDA for the management of these patients. ALRN‐6924 appeared promising in preventing myelotoxicity in patients whose cancer had deleted or mutated TP53, but failed to show any significant activity in a randomized controlled study. The development of this drug is now on hold

Conclusions:

CCA is a novel proactive approach to the toxicity of chemotherapy of special interest to older patients. At the very least it may prevent all forms of myelotoxicity with a single agent, obviating the risk and cost of polypharmacy. It allows to avoid the complications of myelopoietic growth factors which include severe pain, stem cell competition, bone marrow exhaustion, and hematological malignancies. It may allow the treatment of frail patients with full chemotherapy doses. It is also reasonable to expect that may complications other common and sometimes lethal complications of chemotherapy such as stomatitis, esophagitis, diarrhea and dehydration.

News (Medical) associated with Sulanemadlin

07 Apr 2025

·www.prnewswire.com

Rein Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Rein advanced the clinical development of its lead asset, LTI-03, and aims to initiate a Phase 2 trial for the treatment of idiopathic pulmonary fibrosis (IPF) in the first half of 2025 Positive topline results from Cohort 2 (5 mg BID) of the Phase 1b clinical trial of LTI-03 in IPF patients demonstrated dose dependent effects in five biomarkers evaluated, with four biomarkers achieving statistical significance in the combined Cohort 1 and Cohort 2 data set AUSTIN, Texas, April 7, 2025 /PRNewswire/ -- Rein Therapeutics, Inc. (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today reported financial results for the fourth quarter and full year ended December 31, 2024 and provided a business update. "We've made significant clinical progress during 2024, culminating in promising safety and positive topline data from our Phase 1b trial of LTI-03 in IPF patients, which demonstrated early signs of therapeutic effect. LTI-03 has shown potential to improve lung function and potentially reverse the course of IPF, with its dual mechanism of action on both epithelial cells and fibroblasts gaining increasing support within the medical community," said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. "With our recent rebranding and renewed mission to combat fibrosis, we are excited to advance our pipeline. We are planning to initiate a Phase 2 study for LTI-03 in IPF in the first half of this year, where we will continue to evaluate the safety, tolerability and efficacy of this promising asset." Recent Clinical and Corporate Highlights and Upcoming Milestones Clinical Updates In November 2024, Rein announced positive topline data from Cohort 2 of the Phase 1b clinical trial evaluating the safety and tolerability of high dose LTI-03 (5 mg BID) and a set of exploratory biomarkers in patients diagnosed with IPF. Four biomarkers showed statistical significance in the combined Cohort 1 and Cohort 2 data set, and five demonstrated dose dependence, indicative of active pharmacodynamics. High dose LTI-03 continued to exhibit a favorable safety profile. A Phase 2 trial of LTI-03 for the treatment of IPF is anticipated to be initiated in the first half of this year, subject to funding. In October 2024, at the 22nd International Colloquium on Lung and Airway Fibrosis (ICLAF), Rein presented two abstracts highlighting preclinical and Phase 1b data for low dose LTI-03 (2.5 mg BID), reinforcing the potential of LTI-03 to improve lung function and reverse the course of IPF. Following inhaled administration of low dose LTI-03 in 12 patients over the course of 14 days, a positive trend was observed in biomarkers with evidence of reduced expression among multiple profibrotic proteins produced by basal-like cells and fibroblasts that contribute to the progression of IPF, including data from three biomarkers (collagen synthesis, inflammation, and fibrogenesis) that were statistically significant. Pre-clinical data further supported the potential therapeutic effectiveness of LTI-03 for IPF through precision cut lung slices (PCLS) performed ex-vivo. The studies demonstrated molecular activity in IPF PCLS explants indicative of fibrosis during five days in culture and LTI-03 broadly attenuated profibrotic proteins and pathways. Also in October 2024, the Company announced entry into an exclusive option agreement with Advancium Health Network for the acquisition of ALRN-6924, a clinical-stage oncology agent for retinoblastoma developed by the Company prior to its 2023 merger with Lung Therapeutics, Inc. Under the terms of the agreement, Rein received an upfront payment from Advancium for the exclusive option to acquire ALRN-6924 and related assets and could receive additional payments for development, regulatory and commercial milestones as well as sales royalties. Corporate Updates In January 2025, the Company rebranded to Rein Therapeutics, Inc. from Aileron Therapeutics, Inc. The new name, logo, website, and branding elements strategically aligns with the Company's sole focus to develop therapies in orphan pulmonary and fibrosis indications, including two Phase 2-ready clinical assets. The Company's common stock began trading under the Nasdaq ticker symbol "RNTX" effective January 13, 2025. Fourth Quarter and Full Year 2024 Financial Results Cash Position: Cash, cash equivalents, and investments on December 31, 2024, were $12.9 million, compared to $17.3 million on December 31, 2023. Research and Development (R&D) Expenses: R&D expenses for the quarter ended December 31, 2024, were $3.3 million, compared to $2.0 million for the quarter ended December 31, 2023. R&D expenses for the full-year 2024 were $14.2 million, compared to $4.0 million for the prior year. The increase in full year R&D expenses was primarily due to the termination of ALRN-6924 in 2023 and additional clinical programs acquired as part of the 2023 merger with Lung Therapeutics, Inc. General and Administrative (G&A) Expenses: G&A expenses for the quarter ended December 31, 2024, were $2.5 million compared to $5.3 million for the quarter ended December 31, 2023. G&A expenses for the full-year 2024 were $13.9 million, compared to $11.4 million for the prior year. The increase in full year G&A expenses was primarily due to increased headcount associated with the 2023 merger of Lung Therapeutics, Inc. and severance expense following the merger closure and increased facilities and other expenses as a result of the merger, offset by a decrease in professional fees. Net Loss: Net loss for the quarter ended December 31, 2024 was $41.0 million, compared to $7.3 million for the quarter ended December 31, 2023. The basic and diluted net loss per share for the quarter ended December 31, 2024, was $1.89 compared to a net loss per share of $1.54 for the quarter ended December 31, 2023. The increase in net loss in 2024 is mainly due to a non-cash impairment charge of $37.0 million related to aligning the carrying value of LTI-01 to the fair value. Excluding the non-cash charge, net loss per share for the fourth quarter ended December 31, 2024, was a loss of $0.26. The basic and diluted net loss per share for the full-year 2024 was $3.51, or an adjusted net loss per share of $1.53 excluding the non-cash impairment charge, compared to a net loss per share of $3.42 for the full-year 2023. About Rein Therapeutics Rein Therapeutics is a clinical-stage biopharmaceutical company advancing a novel pipeline of first-in-class therapies to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Rein's lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. Rein's second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the U.S. and E.U. and Fast Track Designation in the U.S. For more information, please visit the company's website at reintx.com, or follow them on LinkedIn and X. Forward-Looking Statements This press release may contain forward-looking statements of Rein Therapeutics, Inc. ("Rein", the "Company", "we", "our" or "us") within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to: the timing and expectation of a Phase 2 clinical trial of LTI-03; and future expectations, plans and prospects for the Company. We use words such as "anticipate," "believe," "estimate," "expect," "hope," "intend," "may," "plan," "predict," "project," "target," "potential," "would," "can," "could," "should," "continue," and other words and terms of similar meaning to help identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties related to: changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in the Company's drug discovery; preclinical and clinical development activities; the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, including in a Phase 2 trial of LTI-03, or that partial results of a trial will be indicative of the full results of the trial; the Company's ability to enroll patients in its clinical trials; and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the U.S. Food and Drug Administration and other regulatory authorities; investigational review boards at clinical trial sites and publication review bodies with respect to its development candidates; the Company's ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; competition; the Company's ability to obtain additional funding and the sufficiency of the Company's cash resources, after financing, to fund its planned activities for the periods anticipated and the Company's ability to manage unplanned cash requirements; and general economic and market conditions; as well as the risks and uncertainties discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2024, which is on file with the United States Securities and Exchange Commission (the "SEC") and in subsequent filings that the Company files with the SEC. These forward-looking statements should not be relied upon as representing the Company's view as of any date subsequent to the date of this press release, and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Rein Investor Relations & Media Contact: Argot Partners [email protected] 212-600-1902 SOURCE Rein Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 1Clinical ResultFinancial StatementOrphan Drug

16 Jan 2025

·www.fiercepharma.com

Aileron straps in for 2025 with a new name: Rein Therapeutics

Rebranding distances Rein Therapeutics, formerly Aileron Therapeutics, from the struggles that led to the merger with Lung Therapeutics. Aileron Therapeutics pulled a hard pivot in 2023, merging with Lung Therapeutics to gain a new pipeline and investor base. Now, the biotech has distanced itself from its premerger form by rebranding as Rein Therapeutics.Management said the new name, logo, website and branding elements reflect the company’s focus on developing “first-in-class treatments to rein in diseases.” The biotech’s lead drug candidate is a potential treatment for idiopathic pulmonary fibrosis (IPF) that it picked up through the merger with Lung. Rein shared phase 1b data on the asset in November and plans to start a phase 2 trial in the first half of 2025.Rebranding distances the biotech from the struggles that led to the merger with Lung, which left Aileron shareholders owning 14% of the combined company. Aileron had previously raised money from Eli Lilly, Novartis and Roche as a private company and went public in 2017, pricing its shares at $15 each in the IPO.However, a push to use ALRN-6924, a stapled peptide, to reactivate p53-mediated tumor suppression suffered setbacks. And an attempt to reposition the asset as a way to prevent chemotherapy-induced myelosuppression also ended in failure. By February 2023, Aileron was down to its last three employees, all of whom were working to find a deal to set the company on a new path. The team chose the Lung merger as the new path, shifting their focus away from cancer and toward IPF and other pulmonary diseases. Rein sees the IPF asset, LTI-03, as a potential blockbuster that could have a better safety profile than Boehringer Ingelheim’s Ofev. As well as the IPF candidate, the merger gave Aileron a phase-2b-ready treatment for loculated pleural effusions and a cystic fibrosis program.Finding funding for the programs remains an issue. Rein ended September with $17.7 million, a sum that management predicted would fund operations into June 2025.

IPOAcquisitionPhase 1Phase 2

14 Nov 2024

·www.prnewswire.com

Aileron Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights

Announced promising safety and positive biomarker data from Cohort 2 (5mg BID) of the Phase 1b clinical trial of LTI-03 in idiopathic pulmonary fibrosis (IPF) patients demonstrating dose dependent effects in five biomarkers evaluated compared to low dose LTI-03 Data from Cohort 2 of the Phase 1b clinical trial confirms results from Cohort 1, with four biomarkers achieving statistical significance in the combined Cohort 1 and Cohort 2 data set Planning is underway for a Phase 2 clinical trial AUSTIN, Texas, Nov. 14, 2024 /PRNewswire/ -- Aileron Therapeutics, Inc. ("Aileron") (NASDAQ: ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today reported financial results for the third quarter ended September 30, 2024, and provided a business update. "This past quarter has been one of significant progress for Aileron, as evidenced by our recent announcement of positive data from Cohort 2 of our Phase 1b clinical trial evaluating a higher dose of LTI-03 (5 mg BID) in patients with IPF, in which high dose LTI-03 demonstrated dose dependent effects in five biomarkers," said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. "We were highly encouraged that the combined data set from Cohort 1 and 2 achieved statistical significance in four out of eight biomarkers evaluated in the trial, which along with promising safety and tolerability data, reinforce the potential of LTI-03 to improve lung function and reverse the course of the disease." Third Quarter 2024 Highlights and Recent Updates Corporate Updates In October 2024, the Company announced entry into an exclusive option agreement with Advancium Health Network for the acquisition of ALRN-6924, a clinical-stage oncology agent developed by the Company prior to its 2023 merger with Lung Therapeutics, Inc., for retinoblastoma. Under the terms of the agreement, Aileron received a non-refundable fee from Advancium for the exclusive option to acquire ALRN-6924 and related assets. If Advancium exercises its option, Aileron will receive an exercise payment with potential for additional development, regulatory and commercial milestone payments and sales royalties. Pipeline In November 2024, Aileron announced positive topline data from Cohort 2 of the Phase 1b clinical trial evaluating the safety and tolerability of high dose LTI-03 (5 mg BID) and a set of exploratory biomarkers in patients diagnosed with idiopathic pulmonary fibrosis (IPF). In May, the Company reported positive biomarker data from Cohort 1 which evaluated low dose LTI-03 (2.5 mg BID). In August 2024, Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron, presented an oral presentation at the 8th Annual IPF Summit, entitled, "Biomarker Strategies in the Clinical Development of LTI-03 in IPF". Third Quarter 2024 Financial Results Cash Position: Cash and cash equivalents as of September 30, 2024, were $17.7 million, compared to $21.9 million as of June 30, 2024. The Company expects its existing cash and cash equivalents to be sufficient to fund operations into June 2025. Research and Development ("R&D") Expenses: R&D expenses for the quarter ended September 30, 2024, were $3.7 million, compared to less than $0.1 million for the quarter ended September 30, 2023. The increase of $3.7 million was primarily a result of the clinical programs acquired as part of the Company's acquisition of Lung Therapeutics, Inc. in October 2023 (the "Lung Acquisition"). During the quarter ended September 30, 2024, Aileron incurred expenses of $2.1 million on clinical trials, $1.0 million on manufacturing including $0.8 million write-offs due to the temporary delay of clinical development of LTI-01, and $0.1 million on regulatory and development consulting as well as $0.5 million on employee and related expenses associated with clinical programs acquired in the Lung Acquisition. General and Administrative ("G&A") Expenses: G&A expenses for the quarter ended September 30, 2024, were $2.3 million, compared to $2.0 million for the quarter ended September 30, 2023. The increase of $0.4 million was primarily due to increased employee and related expenses of $0.5 million as a result of increased headcount associated with the Lung Acquisition and severance expense recognized due to departure of former employees, and increased facilities and other expenses of $0.2 million, offset by decreased professional fees of $0.3 million as a result of less external consulting expenses during the quarter ended September 30, 2024 as compared to the quarter ended September 30, 2023. Net Loss: Net loss for the quarter ended September 30, 2024, was $5.8 million, compared to $1.8 million for the quarter ended September 30, 2023. The basic and diluted net loss per share for the quarter ended September 30, 2024 was $0.27 compared to $0.40 for the quarter ended September 30, 2023. About Aileron Therapeutics Aileron Therapeutics is a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Aileron's lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. LTI-03 completed a Phase 1b clinical trial for the treatment of idiopathic pulmonary fibrosis. Aileron's second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US. Forward-Looking Statements This press release may contain forward-looking statements of Aileron Therapeutics, Inc. ("Aileron", the "Company", "we", "our" or "us") within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to: the timing and expectation of a Phase 2 trial of LTI-03; future expectations, plans and prospects for the Company; the sufficiency of the Company's cash resources; the projected cash runway of the Company; and the potential commercial opportunity of LTI-03 and LTI-01. We use words such as "anticipate," "believe," "estimate," "expect," "hope," "intend," "may," "plan," "predict," "project," "target," "potential," "would," "can," "could," "should," "continue," and other words and terms of similar meaning to help identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties related to: changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in the Company's drug discovery; preclinical and clinical development activities; the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, including in a Phase 2 trial of LTI-03, or that partial results of a trial will be indicative of the full results of the trial; the Company's ability to enroll patients in its clinical trials; and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the U.S. Food and Drug Administration and other regulatory authorities; investigational review boards at clinical trial sites and publication review bodies with respect to the our development candidates; our ability to obtain, maintain and enforce intellectual property rights for our platform and development candidates; competition; the sufficiency of the Company's cash resources to fund its planned activities for the periods anticipated and the Company's ability to manage unplanned cash requirements; and general economic and market conditions; as well as the risks and uncertainties discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2023, and the Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, which are on file with the United States Securities and Exchange Commission (the "SEC") and in subsequent filings that the Company files with the SEC. These forward-looking statements should not be relied upon as representing the Company's view as of any date subsequent to the date of this press release, and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Investor Relations & Media Contact: Argot Partners [email protected] 212-600-1902 SOURCE Aileron Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Phase 2Clinical ResultFast TrackFinancial Statement

100 Deals associated with Sulanemadlin

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 2	United States	Rein Therapeutics, Inc.	03 Sep 2019
Non-Small Cell Lung Cancer	Phase 2	Bosnia and Herzegovina	Rein Therapeutics, Inc.	03 Sep 2019
Non-Small Cell Lung Cancer	Phase 2	Poland	Rein Therapeutics, Inc.	03 Sep 2019
Non-Small Cell Lung Cancer	Phase 2	Serbia	Rein Therapeutics, Inc.	03 Sep 2019
Non-Small Cell Lung Cancer	Phase 2	Spain	Rein Therapeutics, Inc.	03 Sep 2019
Chemotherapy-induced damage	Phase 2	Croatia	Rein Therapeutics, Inc.	14 Aug 2019
Advanced Malignant Solid Neoplasm	Phase 2	United States	Rein Therapeutics, Inc.	01 Oct 2014
Peripheral T-Cell Lymphoma	Phase 2	United States	Rein Therapeutics, Inc.	01 Oct 2014
Hematologic Neoplasms	Phase 2	-	Rein Therapeutics, Inc.	-
Hematologic Neoplasms	Phase 2	-	F. Hoffmann-La Roche Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04022876 (GlobeNewswire) Manual	Phase 1	Breast Cancer \| Non-Small Cell Lung Cancer p53-Mutated	20	Carboplatin+Pemetrexed Disodium Hydrate+ALRN-6924	xfcaifacxc(nkjaqeqoyw) = mcqkfirijs lvckfgpgaf (xgbhfanhym ) View more	Negative	29 Jun 2022
				Carboplatin+Pemetrexed Disodium Hydrate+Placebo	xfcaifacxc(nkjaqeqoyw) = ucyedjnkno lvckfgpgaf (xgbhfanhym ) View more
NCT04022876 (Corporate Publications) Manual	Phase 1	Bone marrow depression	44	Topotecan Hydrochloride+ALRN-6924	ujstnxegpn(nfmwkjqemh) = iklrnzvmmz tewhwawigs (rmfdxbpawk ) View more	Positive	16 Sep 2021
				Topotecan Hydrochloride	ujstnxegpn(nfmwkjqemh) = gmezvzwrfh tewhwawigs (rmfdxbpawk ) View more
NCT02264613 (Pubmed) Manual	Phase 1	Solid tumor \| Lymphoma TP53 Wild-type	71	ALRN-6924 (arm A)	yooracxcxk(botwazsnjt) = rcsljrkeqm rfeqogboib (dcwacarcmx )	Positive	22 Jul 2021
				ALRN-6924 (arm B)	kifjrjwngz(zikrdubjfy) = mskdkukkzo bjfryypkfp (iicpahjref )
NCT02909972 (ESMO2019) Manual	Phase 2	Neoplasms TP53 Wild-type \| MDM2 Amplification \| CDK4 Amplification	12	ALRN-6924+palbociclib	rkbpbkjnxz(cduykkvwce) = neutropenia, thrombocytopenia, leukopenia, increased ALT, pulmonary embolism, and fall zxrtdiuoto (bvknjkcfel )	Positive	28 Sep 2019
P6-20-11 (SABCS2019)	Not Applicable	Breast Cancer TP53 wild-type	-	ALRN-6924	zbnpcqzpsg(gmkxbyafaf) = akywekvgou bagdmvkwhk (qudzvbpelh )	Positive	15 Feb 2019
				Nab-paclitaxel	zbnpcqzpsg(gmkxbyafaf) = pejklmfqug bagdmvkwhk (qudzvbpelh )
NCT02264613 (ASCO2017)	Phase 1	Solid tumor \| Lymphoma	69	ALRN-6924 IV once weekly for 3 consecutive wks on a 28-day cycle	dnblteaihn(adcqcylolk) = DLTs were G3 fatigue at 3.1 mg/kg, and G3 hypotension, G3 alkaline phosphatase elevation, G3 anemia and G4 neutropenia at 4.4 mg/kg all in 5 pts in arm A. No G3/4 thrombocytopenia was observed. All DLTs resolved with dose hold. bpjqumlfzo (bgrtwolozf ) View more	Positive	30 May 2017

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis