Adagio Therapeutics summarizes ADG20 neutralizing activity against SARS-CoV-2 variants and outlines initiatives to address Omicron


Recent publications from several independent laboratories show that ADG20 has neutralizing activity with a strength comparable to other antibodies that retain activity against Omicron

More efforts underway to address Omicron and potential future SARS-CoV-2 variants

WALTHAM, Mass., January 12, 2022 (GLOBE NEWSWIRE) – Adagio Therapeutics, Inc., (Nasdaq: ADGI), a clinical-phase biopharmaceutical company focusing on the discovery, development and commercialization of antibody-based solutions to infectious diseases with pandemic potential , today summarized the latest results reported in three separate publications showing ADG20, its leading monoclonal antibody (mAb), has neutralizing activity against the Omicron (B.1.1.529) variant of SARS-CoV-2, and outlined initiatives for 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 in dialogue with the US Food and Drug Administration (FDA) regarding potential protocol updates for their global phase 2/3 clinical trials, including an increased dose of ADG20 for the potential prevention and treatment of COVID-19 due to the Omicron variant.

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

“What is crucial for assessing the potential clinical efficacy of SARS-CoV-2 mAbs is the neutralizing power of the mAb to a specific variant. While the results may show that ADG20 has reduced potency against Omicron compared to its high potency against all other concern variants, including Delta, the data support that ADG20 is among the few mAbs that demonstrate neutralizing activity against the Omicron variant and justify its continued development, Said Laura Walker, Ph.D., chief scientific officer and co-founder of Adagio.

This data is added to previously reported in vitro data from a series of preclinical studies demonstrating 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 lambda, Mu and Delta plus variants.

Updating clinical trial to address Omicron
Adagio continues to evaluate ADG20 in its EVADE and STAMP clinical trials. Adagio is in dialogue with the FDA on dosing strategy, including an increased dose of ADG20 and other protocol updates in light of the prevalence 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 who have previously received ADG20 will continue according to the original protocols.

Further efforts to address Omicron and future variants
In addition to its clinical trial updates, Adagio pursues several strategies to address both Omicron and potential future variants that may emerge. Taking advantage of its exclusive partnership with Adimab LLC, a global leader in antibody technology, Adagio explores the potential of constructing the ADG20 to further enhance binding to the Omicron variant to increase its neutralizing power against Omicron while maintaining its broad neutralization against other SARSs. CoV-2 variants of concern. In parallel, Adagio estimates hundreds of mAbs from its proprietary library of previously isolated SARS-CoV-2 antibodies for their neutralizing 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 expects preliminary results from its research in the first quarter of 2022.

“SARS-CoV-2 is a rapidly evolving virus, and at Adagio we are committed to adapting just as quickly. It is clear that no single product will fully address the evolving nature of the COVID-19 pandemic. “Based on both internal data and third-party results, we are convinced that ADG20 can be an important tool in the fight against this virus,” added Tillman Gerngross, Ph.D., co-founder and CEO director of Adagio.

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

About Adagio Therapeutics
Adagio (Nasdaq: ADGI) is a clinical-phase biopharmaceutical company focusing on the discovery, development and commercialization of antibody-based solutions to 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 technology features and is designed to provide patients and clinicians with the potential for a powerful combination of strength, breadth, durable protection (via half-life), manufacturability and affordability. Adagio’s portfolio of SARS-CoV-2 antibodies includes several non-competitive, broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured production capacity for the production of the ADG20 with third-party contract manufacturers to support the completion of clinical trials and initial commercial launches, ensuring the potential for wide accessibility for people worldwide, if approved or approved for use. For more information, please visit www.adagiotx.com.

Forward-looking statements
This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995. Words such as “anticipate”, “believe”, “expect”, “intend”, “projects” and “future” or similar terms are intended to identify forward-looking statement. Forward-looking statements include statements about, among other things, the timing, progress, and results of our preclinical studies and clinical trials with ADG20, including the commencement, modification, and termination of studies or trials and related preparatory work, including our plans to evaluate dosing regimens and other protocol updates. clinical trials, the period during which the results of our clinical trials and other studies and research activities 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 for treating the Omicron variant, including modification of clinical trial protocols; and other statements that are not historical facts. We may not achieve the plans, intentions or expectations outlined in our forward-looking statements and you should not rely unnecessarily 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 effects 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, predictability of clinical success of ADG20 based on neutralizing activity in preclinical studies, variation of results in models used to predict activity against SARS-CoV-2 variants of concern, activation or enrollment rates for clinical trial sites lower than expected, changes in expected or existing competition, changes in the regulatory environment and the uncertainty and timing of the regulatory approval process, including the outcome of our discussions with regulatory authorities regarding 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 submitted to the SEC. Such risks may be exacerbated by the effects of the COVID-19 pandemic. Forward-looking statements contained in this press release are made from this date, and Adagio assumes no obligation to update such information except as required by applicable law.

Contacts:
Media contact:
Dan Budwick, 1AB
[email protected]

Investor contact:
Monique Allaire, THRUST Strategic Communications
[email protected]

Adagio Therapeutics summarizes ADG20 neutralizing activity against SARS-CoV-2 variants and outlines initiatives to address Omicron

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