Recent publications from several independent laboratories show that ADG20 has a neutralizing activity with a potency comparable to other antibodies and which remains active against Omicron
Several initiatives are underway to address Omicron and potential future variants of SARS-CoV-2
WALTHAM, Mass., Jan. 14, 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 presented in three separate publications that show that ADG20, its lead monoclonal antibody, has neutralizing activity against the Omicron variant (B.1.1.529) of SARS-CoV-2, and presented 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 for its global Phase 2/3 clinical trials, including a higher dose of ADG20 for prevention and treatment. potential treatments for COVID-19 resulting from the Omicron variant.
The neutralizing activity of ADG20 against Omicron
Studies in vitro recently published examined the neutralizing activity of large panels of monoclonal antibodies against the Omicron variant on authentic strains and pseudoviruses. The results of the three studies show that, among monoclonal antibodies in the late stages of clinical development or in the context of an application for emergency use authorization (EUA), ADG20 is one of the only ones to have demonstrated neutralizing activity against Omicron. Data from two authentic and separate neutralization assays against Omicron show that ADG20 had an inhibitory concentration median, a measure of neutralizing activity, approximately 0.4 to 1.1 µg/mL, which is comparable to the other two active monoclonal antibodies, sotrovimab and AZD7742.
“What is essential for evaluating the potential clinical efficacy of monoclonal antibodies against SARS-CoV-2 is the neutralizing activity of the monoclonal antibody against a variant specific. Although the results may show that ADG20 has reduced activity against Omicron compared to its high activity against all other variants of concern, including Delta, the data confirms that ADG20 is among the few monoclonal antibodies to demonstrate activity neutralizing agent against the Omicron variant and warrant its further development,” said Laura Walker, Ph.D., Chief Scientific Officer and Co-Founder of Adagio.
These results support the data in vitro previously reported from a variety of preclinical studies that have shown that ADG20 retains activity against other variants of concern, including Alpha, Beta, Delta, and Gamma, and that ADG20 retains neutralizing activity against a diverse set of circulating variants of SARS-CoV-2, including Lambda, Mu and Delta plus variants.
Omicron Clinical Trial Update
Adagio continues to evaluate 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 suspending enrollment of new patients in the 300mg dose group in both clinical trials as the company updates its protocols. Follow-up and monitoring of patients who previously received ADG20 continues according to the original protocols.
Further efforts to process Omicron and future variants
In addition to updating its clinical trials, Adagio is pursuing several strategies to address both Omicron and future variants that may potentially emerge. Leveraging its exclusive partnership with Adimab LLC, a world leader in antibody engineering, Adagio is exploring the possibility of modifying ADG20 to further enhance binding with the Omicron variant to enhance its neutralizing activity against Omicron while retaining its broad neutralization against other SARS-CoV-2 variants of concern. At the same time, Adagio is evaluating the neutralizing activity against Omicron of several hundred monoclonal antibodies from its proprietary library of previously isolated SARS-CoV-2 antibodies. These additional neutralizing monoclonal antibodies could be developed as a stand-alone product or as part of a combination approach. These efforts are ongoing, and the company expects to release preliminary findings from its research in the first quarter of 2022.
“SARS-CoV-2 is a rapidly evolving virus, and at Adagio we are determined to adapt as quickly as possible. It is becoming very clear that no single product will fully address the ever-changing nature of the COVID-19 pandemic, and that multiple preventive and therapeutic solutions are needed. Based on internal 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 the ADG20
ADG20, an investigational monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is being evaluated through global clinical trials for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed to provide potent and broad neutralizing capabilities of SARS-CoV-2 and other clade 1 sarbecoviruses to target a well-conserved epitope in the receptor binding domain. The ADG20 was also designed to provide an extended half-life for long lasting protection. Data in vitro 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 identified safety signals during a follow-up of at least three months in 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 antibody portfolio has been optimized with Adimab’s cutting-edge antibody engineering capabilities and is designed to provide patients and clinicians with an unparalleled potential combination of potency, breadth, protection durable (due to extended half-life), manufacturability, and affordability. Adagio’s SARS-CoV-2 antibody portfolio includes several non-competitive strong neutralizing antibodies with distinct ADG20-driven binding epitopes. Adagio has contracted manufacturing capabilities for the production of ADG20 with third-party contractors to support the completion of clinical trials and initial commercial launch, ensuring broad potential accessibility to populations worldwide , if its use is authorized or approved. For more information, visit our website 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 “anticipate”, “believe”, “expect to”, “intends”, “expects” and “in the future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding, among other things, the timing, progress and results of our preclinical studies and clinical trials with ADG20, including the initiation, modification and completion of studies or trials and related preparatory work, including our plans to assess dosing and other updates to our clinical trials, the period during which the results of our clinical trials and other studies and research activities will be available, and our research and development ; our ability to obtain and maintain regulatory approvals for our product candidates; our implementation of other strategies to counter the Omicron variant, including modification of our clinical trial protocols; and other statements that are not historical facts. 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 or implied by the forward-looking statements, including, without limitation, the impacts of the COVID-19 pandemic on our business, our clinical trials and our financial condition, unexpected safety or efficacy data observed in preclinical studies or clinical trials, the predictability of clinical success of ADG20 based on neutralizing activity in clinical trials preclinical, variability of results in models used to predict activity against SARS-CoV-2 variants of concern, clinical trial site activation or recruitment rates that are lower than predicted, changes in competition expected or existing, changes in the regulatory environment, and uncertainties and timing of the regulatory approval process, including the results of our discussions with regulatory authorities regarding our Phase 2/3 clinical trials. Other factors that could cause our actual results to differ materially from those expressed or implied by the forward-looking statements in this press release are described under the “Risk Factors” section of Adagio’s quarterly report on Form 10-Q for the quarter ended September 30, 2021 and in future reports that Adagio will file with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. The forward-looking statements contained in this press release are made as of this date, and Adagio disclaims any obligation to update such information except as required by applicable law.
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