Business Wire

Adagio Therapeutics Announces ADG20 Phase 1 Data and Initiation of Global Phase 2/3 Clinical Trial of ADG20 for the Prevention of COVID-19

Share

Adagio Therapeutics, Inc., a biotechnology company developing highly differentiated antibodies to broadly neutralize coronaviruses, today announced that the first patient has been treated in the company’s Phase 2/3 pivotal trial evaluating ADG20 for the prevention of COVID-19, known as the EVADE trial. Trial initiation is supported by positive preliminary data from the company’s ongoing Phase 1 trial in healthy volunteers. EVADE will be conducted globally at more than 100 sites, including in regions where there is a high prevalence of SARS-CoV-2 variants of concern, and will evaluate the ability of a single, intramuscular dose of ADG20 to prevent COVID-19 in both pre- and post-exposure settings.

The initiation of the EVADE trial is supported by blinded data from Adagio’s ongoing first-in-human, randomized, placebo-controlled Phase 1 clinical trial. The Phase 1 trial was designed to evaluate the safety, tolerability, pharmacokinetics and serum SARS-CoV-2 neutralizing antibody levels of various ADG20 dose regimens. Preliminary data demonstrate that a single intramuscular injection of ADG20 is well tolerated at doses up to 600 mg, and the initial pharmacokinetic profile support a prolonged serum half-life, which has the potential to afford up to 12 months of protection against COVID-19. In addition, initial ADG20 serum virus neutralizing activity against authentic SARS-CoV-2 is similar to peak serum neutralizing antibody titers reported for mRNA COVID-19 vaccine recipients.

“We are pleased with the strength of our initial clinical data and with the initiation of the EVADE trial to assess the efficacy of ADG20 in two key settings for the prevention of symptomatic COVID-19,” said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. “Based on its potent and broad activity and extended duration of effect in preclinical models, we believe that ADG20 has the potential to provide both rapid protection in the face of a known, recent exposure to an individual with SARS-CoV-2 infection as well as durable protection over several months, including for individuals who are unlikely to have a sufficiently protective immune response to vaccines. We appreciate the enthusiasm expressed by our investigators and their support in advancing this differentiated antibody therapy.”

“COVID-19 continues to be a significant health crisis, and with the recurring emergence of new variants across the globe, we believe a broadly neutralizing therapy that could be given for both treatment and prevention will be necessary,” said Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio.

The EVADE trial is a global, multi-center, double-blind, placebo-controlled clinical trial evaluating ADG20 in two independent cohorts. The first cohort (post-exposure prophylaxis) is designed to assess the safety and efficacy of ADG20 compared to placebo for the prevention of COVID-19 after exposure to an individual with laboratory confirmed SARS-CoV-2 infection. The second cohort (pre-exposure prophylaxis) is designed to assess the efficacy and safety of ADG20 compared to placebo in individuals who are at increased risk for SARS-CoV-2 infection due to occupational, housing or recreational situations, and in individuals who are at increased risk of poor vaccine response, including individuals with compromised immune systems or other co-morbidities. After evaluation of data from the first 200 adult participants in the Phase 2 portion of the trial, enrollment may be opened to adolescents and pregnant women in Phase 3. The primary efficacy endpoint in both cohorts is the prevention of laboratory confirmed, symptomatic COVID-19. For more information on the EVADE trial, please visit clinicaltrials.gov.

The clinical development program for ADG20 includes two additional trials: the ongoing Phase 1 clinical trial of ADG20 in healthy volunteers and the ongoing STAMP trial evaluating ADG20 as a treatment for high-risk individuals with mild or moderate COVID-19 (see clinicaltrials.gov).

About ADG20

ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is being developed 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 against SARS-CoV-2 and additional clade 1 sarbecoviruses, by targeting a highly conserved epitope in the receptor binding domain. ADG20 displays potent neutralizing activity against the original SARS-CoV-2 strain as well as all known variants of concern. ADG20 has the potential to impact viral replication and subsequent disease through multiple mechanisms of action, including direct blocking of viral entry into the host cell (neutralization) and elimination of infected host cells through Fc-mediated innate immune effector activity. ADG20 is formulated at high concentrations, enabling intramuscular administration, and was engineered to have a long half-life, with a goal of providing both rapid and durable protection. Adagio is advancing ADG20 through multiple clinical trials on a global basis.

About Adagio Therapeutics

Adagio is developing best-in-class antibodies that can broadly neutralize SARS-CoV-2, SARS-CoV and additional pre-emergent coronaviruses. The company’s portfolio of antibodies has been optimized using Adimab’s industry-leading antibody engineering capabilities and are designed to provide patients and clinicians with an unsurpassed 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 through the completion of clinical trials and, if approved by regulatory authorities, through initial commercial launch. For more information, please visit www.adagiotx.com.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media:
Dan Budwick, 1AB
Dan@1abmedia.com

Investors:
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Luminary Launches New Subscription Channel on Apple Podcasts15.6.2021 22:27:00 EEST | Press release

Luminary, a subscription podcast network, today launched a new channel on Apple Podcasts, making all Luminary Original podcasts available globally to Apple Podcasts listeners in more than 170 countries. “We’re thrilled to collaborate with Apple, the house that built podcasting, to bring our original content to millions of listeners across the world,” said Simon Sutton, Luminary CEO. “When we founded Luminary, we believed that supporting premium subscription podcast content was important to listeners and creators alike. Distributing our content on Apple Podcasts is a critical step in fulfilling our vision,” said Matt Sacks, Luminary Co-founder and Executive Chairman. The Luminary channel includes more than 30 Luminary Original podcasts including Under the Skin with Russell Brand, Snap Judgment Presents: Spooked, The C-Word with Lena Dunham, and Leon Neyfakh’s Fiasco. The Luminary channel also includes access to The Midnight Miracle, a new show from creators Talib Kweli, yasiin bey, and

Pony.ai Becomes First Company to Test Driverless Vehicles on Public Roads in Both the U.S. and China15.6.2021 22:00:00 EEST | Press release

Silicon Valley-based Pony.ai, a leading autonomous driving company, today announced that it has begun regular and daily fully driverless testing on public roads in Fremont and Milpitas, CA. Along with the recent launch of fully driverless testing in Guangzhou, China, the company has become the first to get fully driverless automated vehicles on public roads in three cities across the world's two most dynamic mobility markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210615005458/en/ The successful kick-off is authorized by the previously announced driverless permit received from the California Department of Motor Vehicles for a fleet of six driverless vehicles, facilitating the total operational coverage over 100 square kilometers. Countless stealth technology iterations and numerous driverless readiness evaluations executed by a top-notch team have reinforced this significant milestone. As U.S. cities reopen in phases

Proteintech Group Celebrates 20-Year Anniversary15.6.2021 18:09:00 EEST | Press release

Proteintech Group, a leading manufacturer of antibodies and related products, is celebrating the 20th anniversary of its founding. To celebrate the achievements and challenges of the past years, Proteintech will host special events throughout the year with its customers, collaborators, and employees while still looking forward to future opportunities. “Over the years we have witnessed countless discoveries and we couldn’t be prouder of everything our customers have achieved. We want to thank all of our customer for their tireless efforts and sacrifices to advance scientific discovery,” Dr. Jason Li, CEO Proteintech Group was founded in early 2001 by a small group of scientists including its current CEO, Dr. Jason Li. The founders set out with a vision to produce an antibody for every single protein coded in the human genome. Comprehensive coverage of all human gene products is a massive undertaking, but critical because it is difficult for researchers to predict which targets may be re

Norsk Titanium Expands into the Industrial Application Market in Collaboration with Hittech Group15.6.2021 18:00:00 EEST | Press release

Norsk Titanium AS (Norsk Titanium; Euronext: NTI), a global leader in additive manufacturing of aerospace-grade titanium components, announced an expansion of its customer base into the industrial application market sector in collaboration with the Hittech Group, based in Den Haag, Netherlands. The production of the first industrial component in this development supports a Hittech end customer in the growing semiconductor equipment market. Norsk expects significant near-term investment by manufacturers in the semiconductor market as they seek to modernize their supply chains. This effort represents Norsk’s first step to support these modernization efforts with a faster, more cost efficient and environmentally friendly approach. Using Norsk’s revolutionary Rapid Plasma Deposition™ (RPD™) process, Norsk engineers have designed a titanium alloy preform that will reduce Hittech’s raw material needs by over 45 percent as compared to legacy wrought product used to fabricate the end component

i2c Becomes First Company to be a Visa Fintech Fast Track Member in Four Regions15.6.2021 17:15:00 EEST | Press release

i2c, a leading provider of digital payment and banking technology, today announced the extension of its membership in Visa’s Fintech Fast Track program to the Asia-Pacific region (AP), making it the first company to become an enablement partner in all four regions of the acclaimed program. As an enablement partner, i2c helps lay the foundation for fintechs to build and expand their products locally, regionally or globally over its single stack, modular platform. Designed to accelerate the process of integrating with Visa, the Fintech Fast Track program brings together services and expertise to support fintech companies in their efforts to launch payments solutions. Partners leverage the payment network’s reach, capabilities, and security to realize faster onboarding times, and allow fintechs to scale more quickly. “We are excited to be able to simplify the process of launching a card program in 10 more countries, as an extension of our commitment to being a truly global partner for our

Viking Malt: Foundation Stone Laid: Construction of the New Production Plant in Lahti, Finland, is Progressing as Planned15.6.2021 17:04:00 EEST | Press release

Viking Malt has laid the foundation stone for its new production plant in Lahti. The plan is that the new malting house will start its operations in 2023. It is about 90 million euro project in size and the production capacity will be ca. 85 000 tons per year. Owner Pär-Gustaf Relander and CEO Kasper Madsen hosted the ceremony at the construction site on Pippo-Kujala industrial area. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210615005825/en/ The time capsule and the representants from Construction Consultant Afry, Viking Malt and the Mayor of Lahti, Pekka Timonen. Photo by Viking Malt. The company is already over 130 years old and the key to success has always been to focus on high quality and to be open to innovation and new technology. The new plant is a continuation of this tradition. Building a new plant gives a unique opportunity to utilize the newest technology to both increase efficiency and to become more enviro

New Data Shows $30 Billion Streaming Advertising Disconnect Among Publishers, Brands and Consumers15.6.2021 17:00:00 EEST | Press release

Conviva, the intelligence cloud for streaming media, released its inaugural State of Streaming Advertising report today, revealing big gaps in how publishers, buyers and consumers perceive streaming ads, and what this means for the future of the multibillion dollar streaming ad industry. For example, while 69% of sellers believe ad quality on streaming is as good as on linear television, just over half of buyers feel similarly (55%) and only about a third of consumers agree (35%). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210615005329/en/ Conviva's State of Streaming Advertising 2021 (Graphic: Business Wire) “With streaming, there is an opportunity to provide high-quality creative to consumers, but we need to evaluate how and when we reach them,” said Scott McDonald, President & CEO, Advertising Research Foundation (ARF). “It’s time to move on from 1:1 targeting, with growing concerns over privacy and the challenge of s

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom