ALRN Aileron Therapeutics Inc.

1.41
+0.03  (+2%)
Previous Close 1.38
Open 1.35
52 Week Low 0.25
52 Week High 1.99
Market Cap $55,358,822
Shares 39,261,576
Float 38,013,696
Enterprise Value $32,654,659
Volume 873,712
Av. Daily Volume 1,127,152
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Upcoming Catalysts

Drug Stage Catalyst Date
ALRN-6924
Small Cell Lung Cancer (SCLC)
Phase 1/2
Phase 1/2
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ALRN-6924 and IBRANCE (palbociclib)
Solid tumors
Phase 2a
Phase 2a
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Drug Pipeline

Drug Stage Notes
ALRN-6924 and Cytarabine (Ara-C)
Acute myeloid leukemia (AML); Myelodysplastic syndrome (MDS)
Phase 1b
Phase 1b
Phase 1/1b trial ongoing.
ALRN-6924
Peripheral T-cell lymphoma (PTCL)
Phase 2a
Phase 2a
Noted that development to be discontinued - no pivotal trial.
ALRN-6924 and Paclitaxel
Breast cancer
Phase 1
Phase 1
Phase 1 has been initiated.

Latest News

    • Company continues to develop ALRN-6924 as novel chemoprotective medicine to protect patients from chemotherapy-induced toxicities and side effects
      -- Positive interim dose optimization data from proof-of-concept Phase 1b study, reported in second quarter 2020
    • Additional second quarter and recent highlights from Phase 1b proof-of-concept study include:
      -- Completed enrollment in dose optimization expansion cohort
      -- Initiated enrollment in schedule optimization part of the study
    • Final dose optimization data and preliminary schedule optimization data anticipated in fourth quarter 2020
    • Received $10.3 million in aggregate net proceeds in June 2020 from public offering of common stock

    WATERTOWN, Mass., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics…

    • Company continues to develop ALRN-6924 as novel chemoprotective medicine to protect patients from chemotherapy-induced toxicities and side effects

      -- Positive interim dose optimization data from proof-of-concept Phase 1b study, reported in second quarter 2020
    • Additional second quarter and recent highlights from Phase 1b proof-of-concept study include:

      -- Completed enrollment in dose optimization expansion cohort

      -- Initiated enrollment in schedule optimization part of the study
    • Final dose optimization data and preliminary schedule optimization data anticipated in fourth quarter 2020
    • Received $10.3 million in aggregate net proceeds in June 2020 from public offering of common stock

    WATERTOWN, Mass., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN) today reported business highlights and financial results for the second quarter ended June 30, 2020.

    "We continue to make important progress advancing our goal to deliver a novel chemoprotective medicine that can protect cancer patients against multiple serious, often life-threatening chemotherapy-induced side effects," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer of Aileron. "We're pleased with the preliminary data we reported in June from the dose optimization part of our ongoing Phase 1b proof-of-concept clinical trial of ALRN-6924 to protect against chemotherapy-induced bone marrow toxicities in small cell lung cancer patients undergoing treatment with topotecan. These data showed clinically meaningful protection against severe chemotherapy-induced anemia and thrombocytopenia. In addition, a signal of protection against Grade 4 neutropenia in the first treatment cycle was observed at the 0.3 mg/kg dose level."

    Dr. Aivado further commented, "Key inflection points for Aileron in the coming months include final Phase 1b dose optimization data in addition to preliminary data from the recently initiated schedule optimization part of the trial, both in the fourth quarter, as well as the initiation of our healthy volunteer study of ALRN-6924 in the third quarter. These milestones will further support and de-risk our plans to expand development of ALRN-6924 for multiple cancer types and various chemotherapies, to ultimately deliver this unique chemoprotective medicine to as many patients with p53-mutated cancers as possible, which could translate to approximately half of all cancer patients."

    Key Second Quarter and Recent Highlights

    Ongoing ALRN-6924 Proof-of-Concept Phase 1b Study

    Part one of study: dose optimization

    • Announced positive interim dose optimization results.   In June 2020, Aileron announced positive interim data from the open-label  dose optimization part of its ongoing Phase 1b clinical study of ALRN-6924. The study is evaluating ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to protect against chemotherapy-induced bone marrow toxicities in patients with p53-mutated small cell lung cancer (SCLC) who are being treated with topotecan.

    In the dose optimization part of the study, ALRN-6924 was administered at three dose levels (0.3, 0.6, and 1.2 mg/kg) 24 hours before each dose of topotecan.  Topotecan was administered days 1 through 5 every 21 days.

    As reported in June, treatment with ALRN-6924 resulted in a protective effect against severe chemotherapy-induced anemia and thrombocytopenia compared to historical controls. In addition, patients treated with 0.3 mg/kg ALRN-6924 met the protocol-defined criterion for reduction of NCI CTC Grade 3/4 neutropenia to ≤50% in the first treatment cycle, triggering a cohort expansion at this dose level, from six to 14 patients.   

    • Completed enrollment in dose optimization expansion cohort. Aileron recently announced completion of enrollment into the 0.3 mg/kg dose level cohort expansion, to reach a total of 14 patients treated at this dose and the 24-hour before topotecan schedule

    Part 2 of study: schedule optimization

    Initiated enrollment in schedule optimization part of study. In June 2020, Aileron announced that it began enrollment in the schedule optimization part of its ongoing Phase 1b clinical study. This part of the study is intended to determine whether ALRN-6924 given six hours before topotecan further enhances the protective effects observed when ALRN-6924 was given 24 hours before topotecan in the dose optimization part of the trial, as described above. Aileron plans to report final dose optimization data, including data from the dose optimization expansion cohort, in the fourth quarter of 2020. In addition, Aileron also plans to report preliminary schedule optimization data in the fourth quarter of 2020. Aileron will continue to carefully monitor the effect of the coronavirus pandemic on its clinical trial sites and the healthcare system, which may impact its planned data announcements.

    Planned Healthy Volunteer Study

    In the third quarter of 2020, Aileron plans to initiate enrollment in a healthy volunteer study to determine dosing schedules for ALRN-6924 that will support and further de-risk the company's long-term vision to provide a chemoprotective medicine for patients with p53-mutated cancer regardless of cancer type or chemotherapeutic drug.

    Corporate

    • Completed public offering of common stock. In June 2020, Aileron completed a public offering of common stock, priced at a public offering price of $1.10 per share, raising $10.3 million in aggregate net proceeds, including shares sold to the underwriter pursuant to its exercise of its option to purchase additional shares and after deducting underwriting discounts and commissions and offering expenses.

    Second Quarter 2020 Financial Results

    • Cash Position: Cash, cash equivalents and investments as of June 30, 2020 were $18.9 million, compared to $18.3 million as of December 31, 2019.
    • Research and Development Expenses: Research and development expenses for the quarter ended June 30, 2020 were $2.5 million, compared to $4.3 million for the quarter ended June 30, 2019. The decrease is primarily a result of a $1.2 million decrease in clinical development expenses attributed to the completion of patient dosing in our Phase 2a expansion cohort of the combination of ALRN-6924 and IBRANCE® (palbociclib) for the treatment of MDM2-amplified advanced solid tumors during the first quarter of 2020 and the effect of cost-saving measures implemented in 2019 and 2020.

       
    • General and Administrative Expenses: General and administrative expenses were $1.9 million for the quarter ended June 30, 2020, compared to $3.1 million for quarter ended June 30, 2019. The decreased expense in 2020 primarily reflects cost-saving initiatives that were implemented in March 2020 and lower administrative support-related costs in 2020 as compared to 2019.

       
    • Net Loss: Net loss was $4.4 million for the quarter ended June 30, 2020, compared to $7.2 million for the corresponding period in 2019.

    How ALRN-6924 Works to Protect Healthy Cells from Chemotherapy-Induced Damage

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

    Chemotherapy targets 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 (which give rise to red blood cells, white blood cells, and platelets), 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.

    ALRN-6924, an investigational first-in-class MDM2/MDMX dual inhibitor, is administered to cancer patients shortly before chemotherapy. ALRN-6924 is designed to selectively activate normal p53 protein in patients' healthy cells, temporarily and reversibly pausing cell cycling to shield 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 function in those cells. Therefore, cancer cells continue to cycle uninterrupted, remaining fully susceptible to destruction by chemotherapy.

    About Aileron Therapeutics

    At Aileron, we are focused on transforming the experience of chemotherapy for cancer patients, enabling them to fight cancer without the fear or burden of chemotherapy-induced side effects. We are advancing ALRN-6924, our first-in-class dual MDM2/MDMX inhibitor currently in clinical development, to provide a single medicine to protect multiple healthy cell types throughout the body from chemotherapy while ensuring chemotherapy continues to destroy cancer cells.

    In addition to potentially reducing or eliminating multiple side effects, ALRN-6924 may also improve patients' quality of life and help them better tolerate chemotherapy, potentially allowing patients to complete their treatment without dose reductions or delays. Our long-term vision is to provide chemoprotection for patients with p53-mutated cancers, which represents approximately 50% of cancer patients, regardless of cancer type or chemotherapeutic drug. Visit us at aileronrx.com to learn more.

    Forward-Looking Statements

    Statements in this press release about Aileron's future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the Company's strategy and clinical development plans. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to 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 whether Aileron's cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim data referenced in this release will be indicative of the final results of the trial; whether Aileron's product candidates will advance through the clinical trial process on a timely basis, or at all; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Aileron's product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; whether the coronavirus pandemic will have an impact on the timing of our clinical development, clinical supply and our operations; and other factors discussed in the "Risk Factors" section of Aileron's quarterly report on Form 10-Q for the period ended June 30, 2020, filed on August 5, 2020, and risks described in other filings that Aileron may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Aileron specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.

    Investor Contacts:

    Aileron Therapeutics

    Richard Wanstall, SVP Chief Financial Officer

    617-995-0900

    Hans C. Vitzthum

    LifeSci Advisors, LLC.

    617-430-7578

    Media Contact:

    Liz Melone

    617-256-6622



    Aileron Therapeutics, Inc.
    Balance Sheet Data
    (In thousands)
        
     June 30, 2020 December 31, 2019
        
    Cash, cash equivalents and investments$18,880  $18,278 
    Working capital$14,744  $13,711 
    Total assets$26,125  $26,473 
    Accumulated deficit$(209,273) $(198,135)
    Total stockholders' equity$16,654  $16,048 





    Aileron Therapeutics, Inc.
    Condensed Statement of Operations
    (In thousands, except share and per share data)
            
            
     Three Months Ended June 30, Six Months Ended June 30,
      2020   2019   2020   2019 
            
    Revenue$-  $-  $-  $- 
    Operating expenses:       
    Research and development 2,488   4,304   6,557   8,478 
    General and administrative 1,912   3,075   4,719   6,214 
    Total Operating expenses 4,400   7,379   11,276   14,692 
    Loss from operations (4,400)  (7,379)  (11,276)  (14,692)
    Gain on sale of property and equipment -   -   66   - 
    Interest income 10   207   72   307 
    Net loss (4,390)  (7,172)  (11,138)  (14,385)
    Net loss per share — basic and diluted$(0.14) $(0.26) $(0.38) $(0.68)
    Weighted average common shares outstanding—basic and diluted 31,221,139   27,526,065   29,515,749   21,206,269 
            

    Primary Logo

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  1. WATERTOWN, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN) today announced that Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer, will participate in two upcoming investor conferences this month.

    Thursday, August 6, 2020
    Event: William Blair Biotech Focus Conference 2020
    Time:  12:00 pm ET
    *Fireside chat

    Thursday, August 13, 2020
    Event: Canaccord Genuity 40th Annual Growth Conference
    Time:  4:30 pm ET
    *Company overview and business update presentation

    Live webcasts of these events will be available under the Investors and Media section of Aileron's website at https://investors.aileronrx.com/. A replay of the webcasts will be archived on Aileron's website for 30 days following the respective events…

    WATERTOWN, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN) today announced that Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer, will participate in two upcoming investor conferences this month.

    Thursday, August 6, 2020

    Event: William Blair Biotech Focus Conference 2020

    Time:  12:00 pm ET

    *Fireside chat

    Thursday, August 13, 2020

    Event: Canaccord Genuity 40th Annual Growth Conference

    Time:  4:30 pm ET

    *Company overview and business update presentation

    Live webcasts of these events will be available under the Investors and Media section of Aileron's website at https://investors.aileronrx.com/. A replay of the webcasts will be archived on Aileron's website for 30 days following the respective events.

    About Aileron Therapeutics

    At Aileron, we are focused on transforming the experience of chemotherapy for cancer patients, enabling them to fight cancer without the fear or burden of chemotherapy-induced side effects. We are advancing ALRN-6924, our first-in-class dual MDM2/MDMX inhibitor currently in clinical development, to provide a single medicine to protect multiple healthy cell types throughout the body from chemotherapy while ensuring chemotherapy continues to destroy cancer cells.

    In addition to potentially reducing or eliminating multiple side effects, ALRN-6924 may also improve patients' quality of life and help them better tolerate chemotherapy, potentially allowing patients to complete their treatment without dose reductions or delays. Our long-term vision is to provide chemoprotection for patients with p53-mutated cancers, which represents approximately 50% of cancer patients, regardless of cancer type or chemotherapeutic drug. Visit us at aileronrx.com to learn more. 

    Investor Contacts:

    Aileron Therapeutics

    Richard Wanstall, SVP Chief Financial Officer

    617-995-0900

    Hans C. Vitzthum

    LifeSci Advisors, LLC.

    617-430-7578

    Media Contact:

    Liz Melone

    617-256-6622

    Primary Logo

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    • Study is evaluating ALRN-6924 to protect against chemotherapy-induced bone marrow toxicities in patients with p53-mutated small cell lung cancer (SCLC) treated with topotecan

    • Previously reported positive interim data from dose optimization part of study demonstrated 0.3 mg/kg dose of ALRN-6924, now being evaluated in expansion cohort, resulted in most robust chemoprotective effects

    • Data readouts anticipated in Q4 2020:  Final dose optimization data, including data from expansion cohort as well as pharmacodynamic biomarker and tumor efficacy data; preliminary data from recently initiated schedule optimization part of study

    WATERTOWN, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN) announced today that it has completed…

    • Study is evaluating ALRN-6924 to protect against chemotherapy-induced bone marrow toxicities in patients with p53-mutated small cell lung cancer (SCLC) treated with topotecan



    • Previously reported positive interim data from dose optimization part of study demonstrated 0.3 mg/kg dose of ALRN-6924, now being evaluated in expansion cohort, resulted in most robust chemoprotective effects



    • Data readouts anticipated in Q4 2020:  Final dose optimization data, including data from expansion cohort as well as pharmacodynamic biomarker and tumor efficacy data; preliminary data from recently initiated schedule optimization part of study

    WATERTOWN, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN) announced today that it has completed enrollment in the dose optimization expansion cohort of its ongoing open-label Phase 1b clinical study of ALRN-6924. Aileron is focused on transforming the experience of chemotherapy for cancer patients by developing and delivering a novel chemoprotective medicine to protect against multiple chemotherapy-induced side effects. The proof-of-concept Phase 1b study is evaluating ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to prevent chemotherapy-induced bone marrow toxicities, such as severe anemia, thrombocytopenia and neutropenia, in patients with p53-mutated small cell lung cancer (SCLC) who are being treated with topotecan. The protocol for this study consists of a phase 1b and a randomized, controlled phase 2; the Phase 1b has two parts: dose optimization and schedule optimization.

    "We're very encouraged by the data we reported from the dose optimization part of the Phase 1b in June demonstrating ALRN-6924's potential to shield multiple healthy cell types from chemotherapy-induced damage without limiting the effect of chemotherapy on cancer cells," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "Per the interim findings, the 0.3 mg/kg dose of ALRN-6924 achieved the most robust and consistent chemoprotective effects of the three dose levels evaluated. The chemoprotection results were further supported by pharmacodynamic biomarker results also observed in the interim analysis."

    Dr. Aivado continued, "We look forward to reporting the final results of the dose optimization part of the Phase 1b, including findings from the 0.3 mg/kg expansion cohort, as well as preliminary results from the recently initiated schedule optimization part of the Phase 1b, in Q4 of this year. We believe that the results from the Phase 1b, along with results from a healthy volunteer study that we plan to initiate in Q3 of this year, will further support and de-risk our plans to develop ALRN-6924 as a chemoprotective agent for patients with multiple cancer types who are treated with various chemotherapies."

    In June 2020, Aileron announced positive interim data from the dose optimization part of the Phase 1b study demonstrating that treatment with ALRN-6924 resulted in protective effects against severe chemotherapy-induced anemia and thrombocytopenia in patients across three dose levels (0.3, 0.6, and 1.2 mg/kg) relative to historical controls. In addition, patients treated with 0.3 mg/kg ALRN-6924 also met the protocol-defined criterion for reduction of NCI CTC Grade 3/4 neutropenia to ≤50% in the first treatment cycle, triggering a cohort expansion at this dose level, from six to 14 patients.

    As previously guided, in the fourth quarter of 2020, Aileron plans to report final Phase 1b dose optimization data, including data from the dose optimization expansion cohort as well as pharmacodynamic biomarker and tumor efficacy data, in addition to preliminary Phase 1b schedule optimization data. Additionally, in the third quarter or 2020, Aileron plans to initiate enrollment in a healthy volunteer study to determine dosing schedules for ALRN-6924 that will support and further de-risk the company's long-term vision to provide a chemoprotective medicine for patients with a p53-mutation regardless of cancer type or chemotherapeutic drug. Aileron will continue to carefully monitor the effect of the coronavirus pandemic on its clinical trial sites and the healthcare system, which may impact its planned data announcements.

    About the Dose Optimization Expansion Cohort Design

    In the dose optimization expansion cohort, which has completed planned enrollment of eight patients, ALRN-6924 is being administered at a 0.3 mg/kg dose level 24 hours before each dose of topotecan. Topotecan is being administered days 1 through 5 every 21 days.

    How ALRN-6924 Works to Protect Healthy Cells from Chemotherapy-Induced Damage

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

    Chemotherapy targets 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 (which give rise to red blood cells, white blood cells, and platelets), 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.  

    ALRN-6924, an investigational first-in-class MDM2/MDMX dual inhibitor, is administered to cancer patients shortly before chemotherapy. ALRN-6924 is designed to selectively activate normal p53 protein in patients' healthy cells, temporarily and reversibly pausing cell cycling to shield 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 function in those cells. Therefore, cancer cells continue to cycle uninterrupted, remaining fully susceptible to destruction by chemotherapy.

    About Aileron Therapeutics

    At Aileron, we are focused on transforming the experience of chemotherapy for cancer patients, enabling them to fight cancer without the fear or burden of chemotherapy-induced side effects. We are advancing ALRN-6924, our first-in-class dual MDM2/MDMX inhibitor currently in clinical development, to provide a single medicine to protect multiple healthy cell types throughout the body from chemotherapy while ensuring chemotherapy continues to destroy cancer cells.

    In addition to potentially reducing or eliminating multiple side effects, ALRN-6924 may also improve patients' quality of life and help them better tolerate chemotherapy, potentially allowing patients to complete their treatment without dose reductions or delays. Our long-term vision is to provide chemoprotection for patients with p53-mutated cancers, which represents approximately 50% of cancer patients, regardless of cancer type or chemotherapeutic drug. Visit us at aileronrx.com to learn more. 

    Forward-Looking Statements

    Statements in this press release about Aileron's future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the Company's strategy and clinical development plans. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to 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 whether Aileron's cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim data referenced in this release will be indicative of the final results of the trial; whether Aileron's product candidates will advance through the clinical trial process on a timely basis, or at all; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Aileron's product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; whether the coronavirus pandemic will have an impact on the timing of our clinical development, clinical supply and our operations; and other factors discussed in the "Risk Factors" section of Aileron's quarterly report on Form 10-Q for the period ended March 31, 2020, filed on May 11, 2020, and risks described in other filings that Aileron may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Aileron specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.

    Investor Contacts:

    Aileron Therapeutics

    Richard Wanstall, SVP Chief Financial Officer

    617-995-0900

    Hans C. Vitzthum

    LifeSci Advisors, LLC.

    617-430-7578

    Media Contact:

    Liz Melone

    617-256-6622

    Primary Logo

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  2.  -- Novel approach leverages the ability of intracellular p53 protein to induce cell cycle arrest in healthy cells to prevent severe toxicities driven by chemotherapy's off-target effects --

     – In p53-mutant cancers, ALRN-6924 is designed to shield healthy cells from chemotherapy while preserving cancer cells' susceptibility to chemotherapy –

     – p53 mutations occur in approximately 50% of all cancer patients; potential for ALRN-6924 to transform treatment paradigm for cancer patients undergoing chemotherapy --
    -
    -- Company plans to report topline data from the schedule optimization and final data from the dose optimization parts of Phase 1b/2 study in Q4 2020 –

    WATERTOWN, Mass., June 29, 2020 (GLOBE NEWSWIRE) --  Aileron Therapeutics (NASDAQ…

     -- Novel approach leverages the ability of intracellular p53 protein to induce cell cycle arrest in healthy cells to prevent severe toxicities driven by chemotherapy's off-target effects --

     – In p53-mutant cancers, ALRN-6924 is designed to shield healthy cells from chemotherapy while preserving cancer cells' susceptibility to chemotherapy –

     – p53 mutations occur in approximately 50% of all cancer patients; potential for ALRN-6924 to transform treatment paradigm for cancer patients undergoing chemotherapy --

    -

    -- Company plans to report topline data from the schedule optimization and final data from the dose optimization parts of Phase 1b/2 study in Q4 2020 –

    WATERTOWN, Mass., June 29, 2020 (GLOBE NEWSWIRE) --  Aileron Therapeutics (NASDAQ:ALRN), a biotechnology company advancing a novel chemoprotective therapy for cancer patients, announced today that it has enrolled the first patient in the open-label Phase 1b schedule optimization part of its ongoing Phase 1b/2 clinical trial, evaluating ALRN-6924's potential to protect patients against chemotherapy-induced toxicities. Patients in this open-label trial have p53-mutated extensive disease small cell lung cancer (SCLC) and are being treated with second-line topotecan following administration of ALRN-6924. The schedule optimization part of the trial is intended to determine whether ALRN-6924 given six hours before topotecan further enhances the protective effect of ALRN-6924 against severe hematological adverse events observed when ALRN-6924 was given 24 hours before topotecan in the dose optimization part of the trial, as reported by Aileron earlier this month.

    "Following our recent announcement of positive interim data from the Phase 1b dose optimization part of this ongoing Phase 1b/2 study, we are pleased to reach another key milestone in our advancement of ALRN-6924 to potentially transform the treatment paradigm for cancer patients undergoing chemotherapy," said Manuel Aivado, M.D., Ph.D., President & CEO of Aileron Therapeutics.

    Dr. Aivado explained, "Chemotherapy remains a critical cornerstone treatment for millions of cancer patients. Unfortunately, in the process of killing cancer cells, chemotherapy inadvertently harms healthy cells, too. This leads to a multitude of common, damaging, severe toxicities. We treat healthy cells ahead of chemotherapy to prevent those toxicities, importantly, without interrupting chemotherapy's potent onslaught against cancer cells. ALRN-6924 could dramatically improve patients' quality of life by improving their tolerance to chemotherapy."   

    ALRN-6924's novel mechanism of action leverages the innate ability of intracellular p53 protein to induce cell cycle arrest in healthy cells to prevent toxicities driven by chemotherapy's off-target effects in bone marrow and potentially other tissues and organs. In patients with p53-mutant cancers, which represent approximately 50% of all cancer patients, ALRN-6924 is designed to shield healthy cells from chemotherapy while preserving the susceptibility of cancer cells to chemotherapy. 

    About the Phase 1b/2 Study

    The ongoing Phase 1b/2 study is designed to identify an optimal dose and schedule of ALRN-6924 administration to reduce chemotherapy toxicities such as severe anemia, thrombocytopenia, and neutropenia caused by topotecan in patients with small cell lung cancer. There are two parts to the Phase 1b study: (i) dose optimization and (ii) schedule optimization.

    1. In the dose optimization part, which enrolled 18 patients, ALRN-6924 was administered at three dose levels (0.3, 0.6, and 1.2 mg/kg) 24 hours before each dose of topotecan on days 1 through 5 of every 21-day treatment cycle. An expansion cohort of the dose optimization part of the trial at the 0.3 mg/kg dose level is ongoing.



      Aileron announced positive interim findings from this part of the trial in June 2020. ALRN-6924 demonstrated a protective effect against severe chemotherapy-induced anemia and thrombocytopenia across all dose levels as compared to historical controls. In addition, patients treated with 0.3 mg/kg ALRN-6924 met the protocol-defined criteria for reduction of NCI CTC Grade 3/4 neutropenia to ≤50% in the first treatment cycle triggering the expansion cohort in up to eight patients.



    2. In the schedule optimization part, ALRN-6924 is being administered at two dose levels (0.3 and 0.6 mg/kg) 6 hours before each dose of topotecan on days 1 through 5 of every 21-day treatment cycle. Aileron expects to enroll approximately 20 patients in this part of the study.             

    "We were highly encouraged by the strong chemoprotective effect of ALRN-6924 seen in the dose optimization part of this study as previously reported, as it reinforces our belief that ALRN-6924 can selectively induce cell cycle arrest to protect cancer patients from the toxic side effects of chemotherapy," said Vojo Vukovic, M.D., Ph.D., Chief Medical Officer of Aileron. "The schedule optimization part of the trial is intended to inform whether ALRN-6924 given six hours before topotecan can further enhance the protective effects we have observed when giving our drug 24 hours before topotecan."

    Phase 1b/2 Trial - Next Steps

    While enrollment in the 6-hour dosing schedule is underway, Aileron is continuing to enroll patients in the expansion cohort of its 0.3mg/kg dose level using the 24-hour schedule.

    As previously reported, the company plans to report topline data from the schedule optimization and final data from the dose optimization parts of the trial in the fourth quarter of 2020. Aileron expects that these results will enable the company to determine a recommended ALRN-6924 dose and schedule for subsequent trials.

    Aileron is carefully monitoring the effect of the coronavirus pandemic on its clinical trial sites and the healthcare system, which may impact the future timing of the trial and the company's planned data announcements.

    About ALRN-6924

    ALRN-6924 is a first-in-class dual MDM2/MDMX inhibitor that is currently being evaluated in a Phase 1b/2 clinical trial as a chemoprotective agent to protect against chemotherapy-related toxicities.

    About Aileron

    Aileron is a clinical-stage biopharmaceutical company advancing a proprietary platform of cell-permeating alpha-helical peptides. The stabilized helical structure of our peptides allows the design of cell-permeating therapeutic agents with large molecular surfaces for optimal target binding properties, resulting in drug candidates like ALRN-6924. Our current focus is to improve the standard of care for patients with cancer by developing safe and effective therapies that leverage our proprietary peptide platform. For more information, visit www.aileronrx.com, and for more information about our clinical trials please visit www.clinicaltrials.gov.

    Forward-Looking Statements

    Statements in this press release about Aileron's future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the Company's strategy and clinical development plans. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to 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 whether Aileron's cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; whether Aileron's product candidates will advance through the clinical trial process on a timely basis, or at all; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Aileron's product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; whether the coronavirus pandemic will have an impact on the timing of our clinical development, clinical supply and our operations; and other factors discussed in the "Risk Factors" section of Aileron's quarterly report on Form 10-Q for the period ended March 31, 2020, filed on May 11, 2020, and risks described in other filings that Aileron may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Aileron specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.

    Investor Contacts:

    Aileron Therapeutics

    Richard Wanstall, SVP Chief Financial Officer

    617-995-0900

    Hans C. Vitzthum

    LifeSci Advisors, LLC.

    617-430-7578

     

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  3. WATERTOWN, Mass., June 10, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN) announced today the closing of its underwritten public offering of its common stock, including the exercise by the underwriter of their option to purchase an additional 1,071,149 shares at the public offering price of $1.10 per share. The exercise of the option to purchase additional shares brought the total number of shares of common stock sold by Aileron to 10,162,059 shares and increased the amount of gross proceeds to $11.2 million, before deducting underwriting discounts and commissions and offering expenses payable by Aileron.

    Aileron expects to use the net proceeds from the offering, together with its existing cash, cash equivalents and short-term…

    WATERTOWN, Mass., June 10, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN) announced today the closing of its underwritten public offering of its common stock, including the exercise by the underwriter of their option to purchase an additional 1,071,149 shares at the public offering price of $1.10 per share. The exercise of the option to purchase additional shares brought the total number of shares of common stock sold by Aileron to 10,162,059 shares and increased the amount of gross proceeds to $11.2 million, before deducting underwriting discounts and commissions and offering expenses payable by Aileron.

    Aileron expects to use the net proceeds from the offering, together with its existing cash, cash equivalents and short-term investments, to fund clinical development of ALRN-6924 as a chemoprotective agent and for working capital as well as other general corporate purposes.

    William Blair & Company, L.L.C. acted as sole book-running manager for the offering.

    The shares were offered pursuant to an effective shelf registration statement that was filed with the Securities and Exchange Commission (SEC) on July 1, 2019 and declared effective by the SEC on July 15, 2019.

    This offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, or by calling (800) 621-0687, or emailing .

    This release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

    About Aileron

    Aileron is a clinical-stage biopharmaceutical company advancing a proprietary platform of cell-permeating alpha-helical peptides. The stabilized helical structure of the Company's peptides allows the design of cell-permeating therapeutic agents with large molecular surfaces for optimal target binding properties, such as the Company's lead product candidate ALRN-6924. The Company's focus is to improve the standard of care for patients with cancer by developing safe and effective therapies that leverage the Company's proprietary peptide platform.

    Investor Contacts:

    Aileron Therapeutics

    Richard Wanstall, SVP Chief Financial Officer

    617-995-0900

    Hans C. Vitzthum

    LifeSci Advisors, LLC.

    617-430-7578

    Primary Logo

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