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

Aileron 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

Aileron 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

Aileron 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 ; Spiegelberg, Diana ; Jiang, Long ; 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

15 Apr 2024

·www.biospace.com

Aileron Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Topline results from Phase 1b study of LTI-03, a novel Caveolin-1-related peptide in development for the treatment of idiopathic pulmonary fibrosis, expected to be reported in the third quarter of 2024 Cash runway expected to fund operations and key milestones into the fourth quarter of 2024 AUSTIN, Texas, April 15, 2024 (GLOBE NEWSWIRE) -- Aileron Therapeutics, Inc. (“Aileron”, the “Company”, “we”, “our” or “us”) (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 fourth quarter and full year ended December 31, 2023 and provided a business update. “We ended the year in a solid position after the successful completion of our merger with Lung Therapeutics, which provided a focused pipeline of promising clinical-stage candidates for life-threatening lung conditions, coupled with a strengthened balance sheet from the successful closure of a $18.4 million financing,” said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. “We anticipate 2024 as a pivotal year of execution as we continue to progress our lead product candidate, LTI-03. We expect to report topline results from the ongoing Phase 1b study of LTI-03 in the third quarter of this year. LTI-03 and its potential dual mechanism of action on both epithelial cells and fibroblasts is gaining support from the medical community, and we look forward to building upon encouraging preclinical data that LTI-03 has the potential to protect healthy lung epithelial cells and to reduce pro-fibrotic signaling.” Recent Business Highlights and Upcoming Milestones Corporate Updates In October 2023, Aileron acquired Lung Therapeutics, Inc. (“Lung”), shifting the Company’s disease focus to advance a pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis diseases. The Company’s lead clinical programs include LTI-03 for idiopathic pulmonary fibrosis (IPF) and LTI-01 for loculated pleural effusion (LPE). Immediately following the closing of Aileron’s acquisition of Lung (“Lung Acquisition”), the Company entered into a definitive agreement for the sale of shares of its Series X non-voting convertible preferred stock and warrants to purchase shares of Aileron common stock in a private placement to a group of accredited investors led by Bios Partners, the majority stockholder of Lung prior to the Lung Acquisition, and including Nantahala Capital, as well as additional undisclosed investors. The private placement resulted in gross proceeds to Aileron of approximately $18 million before deducting placement agent fees and other offering expenses. In March 2024, the Company announced the appointment of Brian Windsor, Ph.D., as President and Chief Executive Officer and to the Board of Directors. Dr. Windsor previously served as Aileron’s Chief Operating Officer and President, and Chief Executive Officer and director of Lung. Pipeline In February 2024, Aileron hosted a pulmonary care expert panel to discuss the potential implications of LTI-03 for IPF, featuring pulmonary care experts Fernando J. Martinez, M.D., M.S., Chief of the Pulmonary and Critical Care Medicine Division at Weill Cornell Medicine; Tejaswini Kulkarni, M.D., M.P.H., Associate Professor of Pulmonology, Allergy and Critical Care Medicine and Director of the Interstitial Lung Disease Program at University of Alabama at Birmingham Medicine; and Andreas Günther, M.D., Senior Physician of Pulmonology and Intensive Care Medicine and Chief Physician of Pulmonology and Internal Intensive Care Medicine at Agaplesion Evang. Central Hesse Hospital and Professor of Interstitial and Rare Lung Diseases at Justus Liebig University. A replay of the event can be accessed at . LTI-03: a novel Caveolin-1-related (Cav1) peptide with a dual mechanism targeting both alveolar epithelial cell survival as well as inhibition of profibrotic signaling LTI-03 is currently in a randomized, double-blind, placebo-controlled Phase 1b clinical trial in IPF patients. Aileron expects to report topline results from this trial in the third quarter of 2024. LTI-01: a PAI-1 resistant plasmin activated proenzyme for loculated pleural effusions LTI-01 has been evaluated in Phase 1b and Phase 2a clinical trials in patients with infected, non-draining LPEs and is ready for Phase 2b. LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US. Fourth Quarter and Full Year 2023 Financial Results Cash Position: Cash, cash equivalents, and investments on December 31, 2023, were $17.3 million, compared to $21.2 million on December 31, 2022. Based on its current operating plan, the Company expects its existing cash, cash equivalents, and investments will fund operations into the fourth quarter of 2024. Research and Development (R&D) Expenses: R&D expenses for the quarter ended December 31, 2023, were $2.0 million, compared to $2.4 million for the quarter ended December 31, 2022. R&D expenses decreased primarily due to the termination of R&D activities related to ALRN-6924. R&D expenses for the full-year 2023 were $4.0 million, compared to $18.0 million for the prior year. General and Administrative (G&A) Expenses: G&A expenses for the quarter ended December 31, 2023, were $5.3 million compared to $2.3 million for the quarter ended December 31, 2022. G&A expenses increased due to the integration and operating activities of Lung. G&A expenses for the full-year 2023 were $11.4 million, compared to $9.7 million for the prior year. Net Loss: Net loss for the quarter ended December 31, 2023, was $7.3 million, compared to $4.5 million for the quarter ended December 31, 2022. The basic and diluted net loss per share for the quarter ended December 31, 2023 was $1.54 compared to $1.00 for the quarter ended December 31, 2022. The basic and diluted net loss per share for the full-year 2023 was $3.42 compared to $6.02 for the full-year 2022. 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. Currently, LTI-03 is being evaluated in 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 within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to: the timing and expectation of the topline results of the Phase 1b study of LTI-03; future expectations, plans and prospects for the Company following the merger transaction between the Company and Lung that closed in the fourth quarter of 2023 (the “Merger”); the sufficiency of the Company’s cash resources; the projected cash runway of the Company; the status and plans for clinical trials, including the timing of data; future product development; 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 the ability to recognize the anticipated benefits of the Merger; 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; 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 Company’s development candidates; our ability to obtain, maintain and enforce intellectual property rights for our platform and development candidates; our potential dependence on collaboration partners; competition; uncertainties as to 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, which is on the United States Securities and Exchange Commission and in subsequent filings that the Company files with the Securities and Exchange Commission. 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 aileron@argotpartners.com 212-600-1902 Aileron Therapeutics, Inc. Balance Sheet Data (Unaudited) (In thousands) December 31, 2023 December 31, 2022 Cash, cash equivalents and investments $ 17,313 $ 21,242 Working capital 13,881 18,489 Total assets 106,008 22,007 Accumulated deficit (288,517 ) (272,785 ) Total stockholders' equity 6,887 18,623 Aileron Therapeutics, Inc. Condensed Statement of Operations (Unaudited) (In thousands, except share and per share data) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Revenue $ - $ - $ - $ - Operating expenses: Research and development 1,972 2,402 3,991 17,967 General and administrative 5,330 2,301 11,357 9,680 Restructuring and other (12 ) - 928 - Total Operating expenses 7,290 4,703 16,276 27,647 Loss from operations (7,290 ) (4,703 ) (16,276 ) (27,647 ) Other income (expense), net (49 ) 156 544 318 Net loss (7,339 ) (4,547 ) (15,732 ) (27,329 ) Net loss per share — basic and diluted $ (1.54 ) $ (1.00 ) $ (3.42 ) $ (6.02 ) Weighted average common shares outstanding—basic and diluted 4,769,483 4,541,167 4,598,715 4,539,318

Phase 1Phase 2Fast TrackFinancial StatementExecutive Change

22 Feb 2023

·www.fiercebiotech.com

Ailing Aileron enters endgame as breast cancer data trigger layoffs and search for a buyer

Aileron Therapeutics’ remaining three staff members will work with Ladenburg Thalmann & Co. to find a strategic alternative. Aileron Therapeutics’ unraveling has entered its endgame. An early look at phase 1b data persuaded the biotech to call it quits on development of its sole drug candidate—and lay off most of its remaining staff to hunker down while searching for an exit. In 2017, Aileron raised $56 million in an IPO to fund clinical development of ALRN-6924, a stapled peptide that it originally pitched as a way to reactivate p53-mediated tumor suppression. Almost six years later, the biotech has finally given up on ALRN-6924, throwing in the towel after its pivot to focus on the prevention of chemotherapy-induced myelosuppression failed to bear fruit. Aileron decided to terminate the phase 1b chemoprotection breast cancer clinical trial and stop further development of ALRN-6924 after taking a look at initial data from the study. The analysis revealed people experienced grade 4 neutropenia and alopecia after receiving ALRN-6924 and chemotherapy. The finding suggests ALRN-6924 has failed to work as Aileron hoped. The biotech designed the study to show the candidate protects multiple healthy cell types from chemotherapy without protecting cancer cells. To test that hypothesis, Aileron selected the incidence of grade 2 alopecia and grade 4 neutropenia, common side effects of chemotherapy, as two of its endpoints. In light of the disappointing data, Aileron has decided to lay off six of its remaining nine staff over the coming weeks. The step continues the long-running reduction of the biotech’s head count. Aileron ended 2018 with 23 full-time employees but thinned its ranks over the following two years. The remaining three staff will work with financial services company Ladenburg Thalmann & Co. to find a strategic alternative for the biotech. An acquisition, merger, business combination or sale of assets are all theoretically on the table. Aileron ended September with $25.5 million in the bank. Beyond that, the biotech has a Nasdaq listing, a peptide drug technology and ALRN-6924 to offer to potential buyers.

Phase 1IPOPDCFinancial StatementClinical Result

21 Feb 2023

·pipelinereview.com

Aileron Therapeutics Announces Termination of Phase 1b Breast Cancer Chemoprotection Trial and Exploration of Strategic Alternatives

BOSTON, MA, USA I February 21, 2023 I Aileron Therapeutics (Nasdaq: ALRN) today announced that a review of initial data from its Phase 1b chemoprotection trial of ALRN-6924 in patients with p53-mutated breast cancer showed that patients in the trial experienced severe neutropenia (Grade 4) and alopecia. The primary endpoint of the Phase 1b open-label trial, which was evaluating ALRN-6924 in patients with breast cancer receiving neoadjuvant or adjuvant treatment with docetaxel, doxorubicin, and cyclophosphamide, or “TAC” chemotherapy, was duration and incidence of severe neutropenia in cycle 1. Incidence of chemotherapy-induced alopecia (hair loss) was a secondary endpoint. Based on these findings, Aileron has decided to terminate the Phase 1b breast cancer trial and further development of ALRN-6924. Aileron also announced that it is exploring a range of strategic alternatives to maximize shareholder value. The company has engaged Ladenburg Thalmann & Co., Inc. to act as a strategic advisor for this process. Strategic alternatives that are being evaluated may include, but are not limited to, an acquisition, a merger, a business combination, a sale of assets or other transactions. There is no set timetable for this process and there can be no assurance that this process will result in Aileron pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms. Aileron does not intend to comment further on this process unless or until its Board of Directors has approved a definitive course of action or it is determined that other disclosure is appropriate. Aileron has determined to reduce its remaining workforce from 9 to 3 full-time employees in the coming weeks. The company plans to retain the remaining employees to assist in executing the strategic alternatives review process. “We are very disappointed by these initial findings from our breast cancer trial, given the significant unmet need of cancer patients who must endure a wide range of chemotherapy-induced side effects and given the activity we had observed in our clinical trial in small cell lung cancer patients receiving topotecan chemotherapy. I would like to extend a heartfelt thanks to our patients, investigators and clinical trial staff and scientific advisors, as well as all others who have supported this trial and our efforts to advance ALRN-6924 as a chemoprotective agent. I would also like to thank our talented and truly dedicated Aileron team who have worked so diligently to advance ALRN-6924,” said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron Therapeutics. “We certainly hoped for a much different outcome for patients, but it is imperative that we now shift our focus toward conserving our resources as we explore strategic alternatives to maximize shareholder value.” About ALRN-6924 ALRN-6924 is an MDM2/MDMX inhibitor that leverages Aileron’s proprietary peptide drug technology. Aileron originally initiated development of ALRN-6924 as an anti-cancer agent to restore p53-dependent tumor suppression in p53 wild-type tumors, evaluating ALRN-6924 as an anti-cancer agent in 196 patients in multiple clinical trials, including a single-agent Phase 1 trial in solid tumor and lymphoma patients [1]; a single-agent Phase 2a trial for the treatment of peripheral T-cell lymphoma (PTCL) [2]; a single-agent and Ara-C-combination Phase 1/1b trial for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) [3]; and a Phase 2a combination trial of ALRN-6924 and palbociclib in patients with tumors harboring MDM2 amplifications [4]. In these trials, ALRN-6924 was generally well-tolerated, with evidence of single-agent anti-tumor activity including complete and partial responses. Aileron has also conducted three clinical trials of ALRN-6924 as a chemoprotective agent in p53-mutated small cell lung cancer [5], non-small cell lung cancer, and breast cancer. Aileron has a strong intellectual property portfolio in the U.S. and internationally and maintains exclusive worldwide rights to ALRN-6924 as well as the company’s proprietary peptide drug technology. The company is based in Boston, Mass. Visit aileronrx.com to learn more. References [1] M. N. Saleh et al., Phase 1 Trial of ALRN-6924, a Dual Inhibitor of MDMX and MDM2, in Patients with Solid Tumors and Lymphomas Bearing Wild-type TP53. Clin Cancer Res 27 , 5236-5247 (2021). [2] A. R. Shustov et al., Preliminary Results of Stapled Peptide ALRN-6924, a Dual Inhibitor of MDMX and MDM2, in Two Phase IIa Dose Expansion Cohorts in Relapsed/Refractory TP53 Wild-Type Peripheral T-Cell Lymphoma. Blood 132 , 1623-1623 (2018). [3] D. A. Sallman et al., Phase 1/1b Study of the ALRN-6924 As Monotherapy or in Combination with Cytarabine for the Treatment of Relapsed/Refractory AML and Advanced MDS with TP53 Wild-Type. Blood 132 , 4066-4066 (2018). [4] F. Meric-Bernstam et al., A phase IIa clinical trial combining ALRN-6924 and palbociclib for treatment of patients with tumors harboring wild-type p53 and MDM2 amplification or MDM2/CDK4 co-amplification. Annals of Oncology 30 , v179-v180 (2019). [5] Z. Andric et al., “A phase Ib/II study of the dual MDMX/MDM2 inhibitor, ALRN-6924, for the prevention of chemotherapy-induced myelosuppression.” Annals of Oncology 32 , S1166 (2021) SOURCE: Aileron Therapeutics

Phase 1Phase 2Clinical Result

100 Deals associated with Sulanemadlin

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 2	US	Aileron Therapeutics, Inc.	03 Sep 2019
Non-Small Cell Lung Cancer	Phase 2	BA	Aileron Therapeutics, Inc.	03 Sep 2019
Non-Small Cell Lung Cancer	Phase 2	PL	Aileron Therapeutics, Inc.	03 Sep 2019
Non-Small Cell Lung Cancer	Phase 2	RS	Aileron Therapeutics, Inc.	03 Sep 2019
Non-Small Cell Lung Cancer	Phase 2	ES	Aileron Therapeutics, Inc.	03 Sep 2019
Chemotherapy-induced damage	Phase 2	HR	Aileron Therapeutics, Inc.	14 Aug 2019
Advanced Malignant Solid Neoplasm	Phase 2	US	Aileron Therapeutics, Inc.	01 Oct 2014
Peripheral T-Cell Lymphoma	Phase 2	US	Aileron Therapeutics, Inc.	01 Oct 2014
Hematologic Neoplasms	Phase 2	-	Aileron Therapeutics, Inc.	-
Hematologic Neoplasms	Phase 2	-	F. Hoffmann-La Roche Ltd.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

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	dqbwkuwuoe(wwkjfoeshj) = nkfeuycgiq kjlemnlgdb (swzdrnqumt ) View more	Negative	29 Jun 2022
				Carboplatin+Pemetrexed Disodium Hydrate+Placebo	dqbwkuwuoe(wwkjfoeshj) = ifxylgeiba kjlemnlgdb (swzdrnqumt ) View more
NCT04022876 (Corporate Publications) Manual	Phase 1	Bone marrow depression	44	Topotecan Hydrochloride+ALRN-6924	tbykolcgxx(dgdyekudbb) = ktwnfvzkji dvchcbpvut (gqbrmyolch ) View more	Positive	16 Sep 2021
				Topotecan Hydrochloride	tbykolcgxx(dgdyekudbb) = iocwslouwy dvchcbpvut (gqbrmyolch ) View more
NCT02264613 (Pubmed) Manual	Phase 1	Solid tumor \| Lymphoma TP53 Wild-type	71	ALRN-6924 (arm A)	jqxkehmjlv(xyetrzmnvt) = lrjcpgbuyg nwncnnihmu (pwtsjsmhqx )	Positive	22 Jul 2021
				ALRN-6924 (arm B)	suzmtvqowa(qugltnjkde) = yiikfgrdcy dvyxnzvzcx (scwtvqydbw )
NCT02909972 (ESMO2019) Manual	Phase 2	Neoplasms TP53 Wild-type \| MDM2 Amplification \| CDK4 Amplification	12	ALRN-6924+palbociclib	arhywuzgql(mlnsfayswo) = neutropenia, thrombocytopenia, leukopenia, increased ALT, pulmonary embolism, and fall qizkpyajlp (qyorkalcce )	Positive	28 Sep 2019
NCT02264613 (ASCO2017)	Phase 1	Solid tumor \| Lymphoma	69	ALRN-6924 IV once weekly for 3 consecutive wks on a 28-day cycle	ixiutgvgtv(pmosjieayy) = 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. wnexnpjlsi (gmuwirjsvf ) View more	Positive	30 May 2017

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