ADGI Adagio Therapeutics Inc.

6.29
-0.15  -2%
Previous Close 6.44
Open 6.11
52 Week Low 4.92
52 Week High 78.82
Market Cap $699,772,941
Shares 111,251,660
Float 64,017,030
Enterprise Value $33,450,941
Volume 3,109,894
Av. Daily Volume 9,974,981
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Drug Pipeline

Drug Stage Notes
ADG20 - (EVADE)
COVID-19 (prevention)
Phase 2/3
Phase 2/3
Phase 2/3 trial data suggest the 300 mg IM regimen has a projected ability to rapidly exceed target serum concentrations in the majority of simulated patients and to maintain potentially effective concentrations for up to 12 months, noted September 29, 2021. EUA submission due in 3Q 2022. Pediatric trial to be initiated in mid-2022. Phase 2/3 trial enrollment paused pending alignment with FDA, noted January 13, 2022.
ADG20 - (STAMP)
COVID-19 (treatment)
Phase 2/3
Phase 2/3
Phase 2/3 data compiled to date suggest that the 300 mg IM regimen has a projected ability to rapidly achieve and maintain target concentrations at key tissue sites of viral replication, including the ability to attain near complete and durable SARS-CoV-2 receptor occupancy across a range of baseline viral loads, noted September 29, 2021. Phase 2/3 enrollment paused pending alignment with FDA, noted January 13, 2022.
ADG 20
Healthy Volunteers
Phase 1
Phase 1
Phase 1 study data from a six-month evaluation time point confirmed the extended half-life, which approached 100 days based on data from the 300 mg IM dose that was given as a single injection, noted September 29, 2021.

Latest News

  1. Recent Publications by Several Independent Laboratories Show ADG20 Has Neutralizing Activity with Potency Comparable to Other Antibodies that Retain Activity Against Omicron

    Multiple Efforts Underway to Address Omicron and Potential Future SARS-CoV-2 Variants

    WALTHAM, Mass., Jan. 12, 2022 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc., (NASDAQ:ADGI), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today summarized recent findings reported in three separate publications that show ADG20, its lead monoclonal antibody (mAb), has neutralization activity against the Omicron (B.1.1.529) variant of SARS-CoV-2, and outlined…

    Recent Publications by Several Independent Laboratories Show ADG20 Has Neutralizing Activity with Potency Comparable to Other Antibodies that Retain Activity Against Omicron

    Multiple Efforts Underway to Address Omicron and Potential Future SARS-CoV-2 Variants

    WALTHAM, Mass., Jan. 12, 2022 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc., (NASDAQ:ADGI), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today summarized recent findings reported in three separate publications that show ADG20, its lead monoclonal antibody (mAb), has neutralization activity against the Omicron (B.1.1.529) variant of SARS-CoV-2, and outlined initiatives to address current and future SARS-CoV-2 variants of concern. Adagio is evaluating ADG20 in its global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19. Adagio is engaging with the U.S. Food and Drug Administration (FDA) regarding potential protocol updates to its global Phase 2/3 clinical trials, including an increased dose of ADG20 for the potential prevention and treatment of COVID-19 resulting from the Omicron variant.

    ADG20 Neutralizing Activity Against Omicron

    Recently published in vitro studies examined the neutralization potencies of large panels of mAbs against the Omicron variant in both authentic and pseudovirus assays. Findings across all three studies show that among mAbs in late-stage clinical development or with Emergency Use Authorization (EUA), ADG20 is one of only a few mAbs that demonstrated neutralizing activity against Omicron. Across two distinct authentic neutralization assays against Omicron, the data show that ADG20 had an IC50, a measurement of neutralization potency, of approximately 0.4 to 1.1 µg/mL, which is comparable with the two other active mAbs, sotrovimab and AZD7742.

    "What is critical to assessing potential clinical effectiveness of SARS-CoV-2 mAbs is the neutralization potency by the mAb against a specific variant. While findings may show that ADG20 has reduced potency against Omicron when compared to its high potency against all other variants of concern, including Delta, the data support that ADG20 is among the few mAbs to demonstrate neutralizing activity against the Omicron variant and warrants its continued development," said Laura Walker, Ph.D., chief scientific officer and co-founder of Adagio.

    These data add to previously reported in vitro data from a variety of preclinical studies that showed that ADG20 retains activity against other variants of concern including Alpha, Beta, Delta and Gamma, and that ADG20 retains neutralizing activity against a diverse panel of circulating SARS-CoV-2 variants, including the Lambda, Mu and Delta plus variants.

    Clinical Trial Update to Address Omicron

    Adagio is continuing evaluation of ADG20 in its EVADE and STAMP clinical trials. Adagio is engaging with the FDA on dosing strategy, including an increased dose of ADG20 and other protocol updates in light of the spread of the Omicron variant. Adagio is pausing the enrollment of new patients in the 300 mg dose arm in both clinical trials as the company updates its protocols. Follow-up and monitoring of patients previously administered ADG20 are continuing per the original protocols.

    Additional Efforts to Address Omicron and Future Variants

    In addition to its clinical trial updates, Adagio is pursuing multiple strategies to address both Omicron and potential future variants that may emerge. Leveraging its exclusive partnership with Adimab LLC, a global leader in antibody engineering, Adagio is exploring the potential to engineer ADG20 to further improve binding to the Omicron variant to enhance its neutralization potency against Omicron while retaining its broad neutralization against other SARS-CoV-2 variants of concern. In parallel, Adagio is assessing several hundred mAbs from its proprietary library of previously isolated SARS-CoV-2 antibodies for their neutralization potency against Omicron. Such an additional neutralizing mAb could be developed as a stand-alone product or as part of a combination approach. These efforts are underway, and the company anticipates preliminary findings from its research in the first quarter of 2022.

    "SARS-CoV-2 is a quickly evolving virus, and at Adagio, we are committed to adapting just as quickly. It is abundantly clear that no single product will fully address the evolving nature of the COVID-19 pandemic, and that multiple preventative and therapeutic solutions are needed. Based on both in-house data and third-party findings, we are confident that ADG20 can be an important tool in the fight against this virus," added Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio.

    About ADG20

    ADG20, an investigational monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is being evaluated in global clinical trials for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed to possess high potency and broad neutralization activity against SARS-CoV-2 and additional clade 1 sarbecoviruses by targeting a highly conserved epitope in the receptor binding domain. ADG20 was further engineered to provide an extended half-life for durable protection. In vitro data from a variety of preclinical studies have shown that ADG20 retains neutralizing activity against all known SARS-CoV-2 variants of concern. In a Phase 1 trial, ADG20 was well-tolerated with no safety signals identified through a minimum of three months follow-up across all cohorts. ADG20 has not been approved for use in any country, and safety and efficacy have not yet been established.

    About Adagio Therapeutics

    Adagio (NASDAQ:ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, including COVID-19 and influenza. The company's portfolio of antibodies has been optimized using Adimab's industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with the potential for a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio's portfolio of SARS-CoV-2 antibodies includes multiple non-competing, broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers to support the completion of clinical trials and initial commercial launch, ensuring the potential for broad accessibility to people around the world, if authorized or approved for use. For more information, please visit www.adagiotx.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of ADG20, including the initiation, modification and completion of studies or trials and related preparatory work, including our plans to evaluate dosing regimens and other protocol updates in our clinical trials, the period during which the results of our clinical trials and other studies and research activities will become available, and our research and development programs; our ability to obtain and maintain regulatory approvals for our product candidates; our pursuit of other strategies to address the Omicron variant, including modification of clinical trial protocols; and other statements that are not historical fact. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, the impacts of the COVID-19 pandemic on our business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, the predictability of clinical success of ADG20 based on neutralizing activity in pre-clinical studies, variability of results in models used to predict activity against SARS-CoV-2 variants of concern, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, and the uncertainties and timing of the regulatory approval process, including the outcome of our discussions with regulatory authorities concerning our Phase 2/3 clinical trials. Other factors that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in Adagio's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and in Adagio's future reports to be filed with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic.  Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.

    Contacts:

    Media Contact:

    Dan Budwick, 1AB

    Investor Contact:

    Monique Allaire, THRUST Strategic Communications



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  2. WALTHAM, Mass., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc., (NASDAQ:ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today announced that Tillman Gerngross, Ph.D., chief executive officer of Adagio, is scheduled to present at the 40th Annual J.P. Morgan Healthcare Conference on Thursday, January 13, 2022 at 7:30 a.m. ET.

    A live webcast will be available in the investor section of the company's website at investors.adagiotx.com and will be archived for 60 days following the presentations.

    About Adagio Therapeutics

    Adagio (NASDAQ:ADGI) is a clinical-stage biopharmaceutical company focused…

    WALTHAM, Mass., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc., (NASDAQ:ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today announced that Tillman Gerngross, Ph.D., chief executive officer of Adagio, is scheduled to present at the 40th Annual J.P. Morgan Healthcare Conference on Thursday, January 13, 2022 at 7:30 a.m. ET.

    A live webcast will be available in the investor section of the company's website at investors.adagiotx.com and will be archived for 60 days following the presentations.

    About Adagio Therapeutics

    Adagio (NASDAQ:ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, including COVID-19 and influenza. The company's portfolio of antibodies has been optimized using Adimab's industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with the potential for a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio's portfolio of SARS-CoV-2 antibodies includes multiple non-competing, broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers to support the completion of clinical trials and initial commercial launch, if authorized or approved by regulatory authorities, ensuring the potential for broad accessibility to people around the world. For more information, please visit www.adagiotx.com.

    Contacts:

    Media Contact:

    Dan Budwick, 1AB

    Investor Contact:

    Monique Allaire, THRUST Strategic Communications

      



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  3. BOSTON, Dec. 17, 2021 /PRNewswire/ -- Omega Funds, a leading international healthcare venture capital firm focused on delivering impactful medicines to patients, today announced it has closed its seventh and largest fund with $650 million in limited partner capital commitments. The new fund, Omega Fund VII, L.P. ("Fund VII"), was oversubscribed, exceeding the firm's targeted raise of $500 million, and included strong support from both new and existing limited partners. With Fund VII, the firm will continue to execute on its strategy of creating and investing in life sciences companies in the US and Europe that target severe, unmet medical needs. Since its inception in 2004, Omega Funds has raised close to $2 billion to invest in exceptional…

    BOSTON, Dec. 17, 2021 /PRNewswire/ -- Omega Funds, a leading international healthcare venture capital firm focused on delivering impactful medicines to patients, today announced it has closed its seventh and largest fund with $650 million in limited partner capital commitments. The new fund, Omega Fund VII, L.P. ("Fund VII"), was oversubscribed, exceeding the firm's targeted raise of $500 million, and included strong support from both new and existing limited partners. With Fund VII, the firm will continue to execute on its strategy of creating and investing in life sciences companies in the US and Europe that target severe, unmet medical needs. Since its inception in 2004, Omega Funds has raised close to $2 billion to invest in exceptional entrepreneurs developing innovative products across multiple therapeutic areas, including oncology, immunology, rare diseases, and precision medicine.

    "We appreciate the trust from both our longstanding and new investors and their support of our differentiated model, which leverages our broad investment toolkit and data-driven approach to target transformative innovation," said Otello Stampacchia, Ph.D., Founder and Managing Director of Omega Funds. "We look forward to contributing our conviction-building processes and network connectivity, in addition to capital, to the many entrepreneurs and founders intent on transforming existing standards of care for severe diseases. We believe this is the most exciting time to invest in healthcare, due to the accelerating pace of development in biotechnology and the fact that the COVID-19 pandemic has led to many novel discoveries about the human immune system."

    Fund VII builds upon the success of Omega Funds' $438M Fund VI and previous funds, which have supported portfolio companies that have brought 46 new products to market. The firm's investments have contributed to 39 successful portfolio company public listings and 35 portfolio company exits via M&A. Omega Funds' recent public offerings and exits include Theseus Pharmaceuticals (NASDAQ:THRX), Adagio Therapeutics (NASDAQ:ADGI), Icosavax (NASDAQ:ICVX), Imago BioSciences (NASDAQ:IMGO), Ikena Oncology (NASDAQ:IKNA), Nuvation Bio (NYSE:NUVB), Sana Biotechnology (NASDAQ:SANA), Prevail Therapeutics (acquired by Eli Lilly) and Kronos Bio (NASDAQ:KRON).

    Fund VII is stage-agnostic and is expected to be deployed across companies in the U.S. and Europe. Similar to past funds, Fund VII investments will include a variety of investment approaches, from company creation to early venture rounds and later-stage financings.

    "We are delighted to announce with the closing of Fund VII, the addition of Mike Powell as Executive Partner and the promotion of Francesco Draetta to Partner" added Dr. Stampacchia. "We have thoughtfully built our investment team to have the diverse capabilities required to successfully identify, support and construct biotech companies that can bring novel therapies to patients. We look forward to Francesco's continued contribution and Mike's complimentary additions to the team."

    Mike Powell, Ph.D., joined Omega Funds in August 2021 from Sofinnova Investments, where he served as Managing General Partner since 1997. Previously, he was Group Leader at Genentech, where his focus was on drug delivery, CMC, and formulation of both small molecule and protein drug entities. He was previously Board President of the AIDS Vaccine Advocacy Coalition, and past advisor to the Institute for One World Health, the International AIDS Vaccine Initiative (IAVI), and the Bill and Melinda Gates Foundation. Dr. Powell is currently an Adjunct Associate Professor in the Department of Pharmaceutical Chemistry at the University of Kansas, and also serves on the Board of Trustees at Washington University in St. Louis. Dr. Powell has authored or co-authored 90 peer-reviewed publications, numerous book chapters, and the textbook, Vaccine Design. He holds a PhD in Physical Chemistry from the University of Toronto, and completed his postdoctoral studies in BioOrganic Chemistry at the University of California.

    Francesco Draetta, CFA, CAIA, began his career at Omega Funds, as an Analyst from 2008 to 2012, and then rejoined in 2016 as a Principal. He focuses on private company investments and  fundraising for the firm. Mr. Draetta currently serves on the board of Chord Therapeutics and is Chief Financial Officer of Omega Alpha SPAC (NASDAQ:OMEG). Prior to rejoining Omega, Mr. Draetta was part of the investment team at Brookside Mezzanine Partners and at Commonfund Capital. Mr. Draetta graduated cum laude from the Isenberg School of Management at the University of Massachusetts Amherst with a BBA in Finance and Operations Management.

    About Omega Funds

    Founded in 2004, Omega Funds is a leading international venture capital firm that creates and invests in life sciences companies that target our world's most urgent medical needs. Omega focuses on identifying and supporting companies through value inflection points across the full arc of innovation, from company formation through clinical milestones and commercial adoption. Omega Funds' portfolio companies have brought 46 products to market in multiple therapeutic areas, including oncology, rare diseases, precision medicine and others. Please visit www.omegafunds.com for additional information.

    Media Contact:

    Michael Beyer

    The Harbinger Group

    Tel: 312-961-2502

    E-mail:

    Omega Contact:

    Katie Kerfoot

    Tel: 857-332-4495

    E-mail:

    Cision View original content:https://www.prnewswire.com/news-releases/omega-funds-closes-oversubscribed-650-million-fund-vii-to-invest-in-transformative-life-science-companies-301446687.html

    SOURCE Omega Funds

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  4. WALTHAM, Mass., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc., (NASDAQ:ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today provided an update following external in vitro analyses to evaluate neutralizing activity of ADG20 against the Omicron SARS-CoV-2 variant. The in vitro data generated through both authentic and pseudovirus testing of the Omicron variant show a greater than 300-fold reduction in neutralizing activity of ADG20 against Omicron. Additional analyses are ongoing, and the company plans to engage with regulatory and government agencies to assess the role ADG20 can play for the…

    WALTHAM, Mass., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc., (NASDAQ:ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today provided an update following external in vitro analyses to evaluate neutralizing activity of ADG20 against the Omicron SARS-CoV-2 variant. The in vitro data generated through both authentic and pseudovirus testing of the Omicron variant show a greater than 300-fold reduction in neutralizing activity of ADG20 against Omicron. Additional analyses are ongoing, and the company plans to engage with regulatory and government agencies to assess the role ADG20 can play for the prevention and treatment of COVID-19, particularly as the industry's understanding of the epidemiology and impact of Omicron and potential new variants develops.

    "Due to the highly conserved and immunorecessive nature of the epitope recognized by ADG20, we anticipated that ADG20 would retain neutralizing activity against Omicron, consistent with activity observed in in vitro models with all other known variants of concern," said Tillman Gerngross, Ph.D., chief executive officer of Adagio. "While the individual mutations present in the Omicron receptor binding domain were not associated with escape from ADG20 in the context of an original strain of the virus, new data show that the combination of mutations present in the Omicron spike protein led to a reduction in ADG20 neutralization that was not suggested by prior data. The continued prevalence of the Delta variant in the U.S. and other countries, evolution of SARS-CoV-2 variants and potential future coronaviruses means a multitude of therapies and approaches are needed. With an expert team committed to advancing antibody solutions that combat this unprecedented pandemic and a strong balance sheet, we're conducting additional analyses to assess the optimal path forward with ADG20 as both a prophylactic and treatment option for COVID-19."

    ADG20 is an investigational monoclonal antibody (mAb) product candidate designed to provide broad and potent neutralizing activity against SARS-CoV-2, including variants of concern, for the prevention and treatment of COVID-19 with potential duration of protection for up to one year with a single injection. In previously disclosed in vitro studies, ADG20 retained activity against prior variants of concern including Alpha, Beta, Delta and Gamma. In addition, in vitro data demonstrated retained neutralizing activity of ADG20 against a diverse panel of circulating SARS-CoV-2 variants, including the Lambda, Mu and Delta plus variants. The safety and efficacy of ADG20 have not been established, and ADG20 is not authorized or approved for use in any country.

    Adagio is currently evaluating ADG20 in global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19. Based on the in vitro findings related to Omicron, Adagio plans to pause patient recruitment in its Phase 2/3 COVID-19 treatment trial at clinical sites in South Africa, where Omicron has emerged as the dominant variant. Adagio is evaluating next steps for its ADG20 program.

    In vitro analyses were also conducted on ADG10, a second mAb in development, which showed minimal neutralizing activity against the Omicron variant in both authentic and pseudovirus neutralization assays.

    About Adagio Therapeutics

    Adagio (NASDAQ:ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, including COVID-19 and influenza. The company's portfolio of antibodies has been optimized using Adimab's industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with the potential for a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio's portfolio of SARS-CoV-2 antibodies includes multiple non-competing, broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers to support the completion of clinical trials and initial commercial launch, ensuring the potential for broad accessibility to people around the world. For more information, please visit www.adagiotx.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of ADG20, including the timing of future program updates and the initiation, modification and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; the additional and ongoing analyses to evaluate the activity of ADG20 against the Omicron variant and the potential of ADG20 to play a role as both a prophylactic and a treatment option for COVID-19; the risk/benefit profile of our product candidates to patients; and the adequacy of our cash, cash equivalents and marketable securities. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, the impacts of the COVID-19 pandemic on our business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, and the uncertainties and timing of the regulatory approval process. Other factors that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in Adagio's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and in Adagio's future reports to be filed with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.

      
    Contacts: 
    Media Contact:Investor Contact:
    Dan Budwick, 1ABMonique Allaire, THRUST Strategic Communications
      



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  5. Additional in vitro studies to determine neutralization activity of ADG20 against Omicron are ongoing

    ADG20 EUA submissions planned for prevention and treatment of COVID-19 in mid-2022

    Inventory build continues in anticipation of EUA in second half of 2022, with 4 million doses available for distribution over the next two years

    WALTHAM, Mass., Nov. 29, 2021 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc., (NASDAQ:ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today provided information related to the potential of its lead SARS-CoV-2 antibody, ADG20, to address the Omicron SARS-CoV-2 variant, and other…

    Additional in vitro studies to determine neutralization activity of ADG20 against Omicron are ongoing

    ADG20 EUA submissions planned for prevention and treatment of COVID-19 in mid-2022

    Inventory build continues in anticipation of EUA in second half of 2022, with 4 million doses available for distribution over the next two years

    WALTHAM, Mass., Nov. 29, 2021 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc., (NASDAQ:ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today provided information related to the potential of its lead SARS-CoV-2 antibody, ADG20, to address the Omicron SARS-CoV-2 variant, and other known variants of concern. ADG20 is an investigational monoclonal antibody (mAb) product candidate designed to provide broad and potent neutralizing activity against SARS-CoV-2, including variants of concern, for the prevention and treatment of COVID-19 with potential duration of protection for up to one year in a single injection.

    "The continued global scale of the COVID-19 pandemic has led to increased levels of immune pressure on the virus, which is driving the emergence of variants containing mutations associated with escape from common classes of neutralizing antibodies induced by natural infection or vaccination. Unlike most antibodies currently available under EUA, ADG20 has been shown to target an epitope that is highly conserved among clade I sarbecoviruses and that is not readily targeted by the endogenous neutralizing antibody response," said Laura Walker, Ph.D., co-founder and chief scientific officer of Adagio. "Due to the highly conserved and immunorecessive nature of the epitope recognized by ADG20, we expect that ADG20 will retain activity against Omicron, as we have observed in in vitro models with all other variants of concern identified previously. Further, none of the mutations present in the spike protein of the Omicron variant have been associated with escape from ADG20 neutralization.   ADG20 was engineered for potent and broadly neutralizing activity in anticipation of both the rapid antigenic evolution of SARS-CoV-2 and the emergence of future SARS-like viruses with pandemic potential."

    "ADG20 was uniquely designed to combine breadth, potency and duration of protection against SARS-CoV-2 for up to one year in a single injection. We did this anticipating that SARS-CoV-2 would continue to evolve and potentially render some early therapies and vaccines obsolete," said Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio. "Our global clinical trials are advancing with potential EUA submissions in mid-2022 for both prevention and treatment of COVID-19. We continue to engage with the FDA and other regulatory bodies and governmental agencies to discuss potential acceleration of development plans and the need for a portfolio of therapeutic solutions to combat the COVID-19 pandemic."

    Given the significant potential health crisis resulting from the emergence of Omicron, Adagio is undertaking a number of activities to support ADG20's utility in addressing this newly emerged variant of concern, including:

    • Conducting in vitro studies to evaluate the expected binding and neutralizing activity of ADG20 against Omicron. Initial data from these studies is anticipated by the end of the year; and
    • Recruiting patients in Adagio's Phase 2/3 COVID-19 treatment trial, known as STAMP, across several clinical sites in South Africa (along with ongoing clinical trial efforts globally) in an effort to generate clinical data for ADG20 against infections due to the Omicron variant.

    Based on the data being generated, Adagio plans to engage with health authorities and government agencies to accelerate development and supply of ADG20 to combat SARS-CoV-2 and its variants of concern.

    ADG20 and Variants of Concern

    The neutralizing antibody response induced by SARS-CoV-2 infection and vaccination is dominated by three classes of receptor binding domain (RBD)-directed antibodies (Class 1, Class 2 and Class 3), which often share common escape mutations. The newly emerged Omicron (B.1.1.529) variant identified in South Africa contains mutations associated with resistance to a large proportion of these commonly elicited antibodies, which may be due to immune pressure on these antigenic sites. Data for most antibodies available under EUA or in late-stage clinical development show they target one of these three dominant antigenic regions within the RBD.

    In vitro studies have shown that ADG20 binds to a highly conserved epitope within the RBD that is not targeted by any of the common classes of neutralizing antibodies induced by SARS-CoV-2 infection and vaccination. Thus, unlike many other clinical-stage antibodies, which were isolated from COVID-19 patients and recognize epitopes that are also targeted by endogenous neutralizing antibodies, there is limited immune pressure on the ADG20 binding site. The ADG20 epitope has remained conserved in 99.99% of the nearly 4 million full length SARS-CoV-2 viral sequences deposited in the GISAID database as of October 15, 2021, and, as shown in in vitro studies, ADG20 retains activity against prior variants of concern including Alpha, Beta, Delta, and Gamma. For the Omicron variant, none of the mutations present in the spike protein are associated with escape from ADG20 neutralization. Based on published epitope mapping and structural studies, Adagio anticipates that ADG20 will retain neutralizing activity against the Omicron variant whereas other mAb products may lose substantial activity against this variant.

    Previously disclosed in vitro data demonstrated retained neutralizing activity of ADG20 against a diverse panel of circulating SARS-CoV-2 variants, including the recently emerged Lambda, Mu and Delta plus variants. Notably, findings from these in vitro studies showed that ADG20 demonstrated potent neutralizing activity against all SARS-CoV-2 variants of concern tested, including those with reduced susceptibility to mAb products currently available under EUA or in late-stage development.

    About ADG20

    ADG20, an investigational monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is advancing through global clinical trials for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed and engineered to possess high potency and broad neutralization activity against SARS-CoV-2 and additional clade 1 sarbecoviruses by targeting a highly conserved epitope in the receptor binding domain. ADG20 was further engineered to provide an extended half-life for durable protection. ADG20 has demonstrated potent neutralizing activity against the original SARS-CoV-2 virus, SARS-CoV-2 variants of concern Alpha, Beta, Delta, and Gamma, other SARS-CoV-2 variants to date, and additional SARS-like viruses in preclinical studies. ADG20 is administered in clinical trials by a single intramuscular injection. To date, ADG20 has been well-tolerated in a Phase 1 trial with no safety signals identified through a minimum of three months follow-up across all cohorts. ADG20 has not been approved for use in any country, and safety and efficacy have not yet been established.

    About Adagio Therapeutics

    Adagio (NASDAQ:ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, including COVID-19 and influenza. The company's portfolio of antibodies has been optimized using Adimab's industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with the potential for a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio's portfolio of SARS-CoV-2 antibodies includes multiple non-competing, broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers to support the completion of clinical trials and initial commercial launch, ensuring the potential for broad accessibility to people around the world. For more information, please visit www.adagiotx.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of ADG20, including the timing of our planned EUA submissions, initiation, modification and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; the expected neutralizing activity of ADG20 against the Omicron variant; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients, including in specific populations, with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our expectations regarding the scope of any approved indication for ADG20; and the risk/benefit profile of our product candidates to patients; our manufacturing capabilities and strategy, including plans for doses available in the near future; and our ability to successfully commercialize our product candidates. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, the impacts of the COVID-19 pandemic on our business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, and the uncertainties and timing of the regulatory approval process. Other factors that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in Adagio's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and in Adagio's future reports to be filed with the SEC, including Adagio's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. Such risks may be amplified by the impacts of the COVID-19 pandemic.  Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.

    Contacts:

    Media Contact:

    Dan Budwick, 1AB

    Investor Contact:

    Monique Allaire, THRUST Strategic Communications



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