Daily Archives: September 10, 2021

CBP Modifies Top Glove Finding: First Finding Modified in 27 Years

Forced Labor: The international law firm Benjamin L. England & Associates, LLC announces the successful modification of a Customs and Border Protection Finding that imposed a U.S. import ban on Top Glove Corporation Bhd’s disposable gloves manufactured in Malaysia due to forced labor concerns.

Benjamin L. England & Associates, LLC

BALTIMORE, Sept. 10, 2021 (GLOBE NEWSWIRE) — The international law firm Benjamin L. England & Associates, LLC is very proud and pleased to announce obtaining the successful modification of a Customs and Border Protection (CBP) Finding that imposed a U.S. import ban on Top Glove Corporation Bhd’s disposable gloves manufactured in Malaysia due to forced labor concerns. The original CBP Withhold Release Order (WRO) was implemented on July 15, 2020, and was merged into the CBP Finding subsequently issued on March 29, 2021; today’s modification lifts the import ban effective September 10, 2021. Benjamin L. England & Associates’ Customs and Trade practice, headed by team leader Ms. Jessica Rifkin, worked diligently with Top Glove and closely with the CBP Forced Labor Division to achieve this historic success.

No law firm has obtained the modification of a CBP Finding and associated removal of an import ban since 1994, making this the first such success in 27 years.

Ms. Rifkin said, “I am so proud of our Customs and Trade team and our client, Top Glove. There were countless late-night video conference calls and thousands of documents to prepare, review, and present to demonstrate to a relentless CBP that any Forced Labor indicators present had been resolved and that Top Glove deserved this favorable outcome.” Firm founder and CEO Benjamin England noted, “Our firm’s prior work in the WRO space, our relationships with the government agencies and our integrated Customs and FDA law practice enabled us to work with CBP and Top Glove very fluidly. We know the medical device industry, and we know Customs and Trade. This was a meaningful advantage.”

As a result of this historic success, all Top Glove disposable gloves imported on or after September 10, 2021, can be entered into the United States without delay.

About Benjamin L. England & Associates, LLC

Benjamin L. England & Associates, LLC is positioned as a unique and diversified industry service provider, helping clients from over 100 countries in every aspect of FDA, USDA, and Customs compliance and international business consulting. With nearly 100 years of direct former FDA experience and dozens more practicing before Customs, FDA, and other agencies, the attorneys of Benjamin L. England & Associates’ understanding and experience in the industry is unparalleled. The firm routinely practices at the complicated intersection of federal agencies and federal and state laws implicated when manufacturing, marketing, distributing, and importing or exporting highly-regulated goods. Their attorneys and regulatory specialists combine regulatory and business strategies into a single source for solving regulatory and legal problems for foreign and domestic producers, importers, distributors, and retailers to successfully get into and stay in the United States market.

Contact

Benjamin L. England & Associates, LLC
Jeff McConnell, Marketing and Business Development Manager
410-220-2800
jjmcconnell@englandlawgroup.com

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CBP Modifies Top Glove Finding: First Finding Modified in 27 Years

Forced Labor: The international law firm Benjamin L. England & Associates, LLC announces the successful modification of a Customs and Border Protection Finding that imposed a U.S. import ban on Top Glove Corporation Bhd’s disposable gloves manufactured in Malaysia due to forced labor concerns.

Benjamin L. England & Associates, LLC

BALTIMORE, Sept. 10, 2021 (GLOBE NEWSWIRE) — The international law firm Benjamin L. England & Associates, LLC is very proud and pleased to announce obtaining the successful modification of a Customs and Border Protection (CBP) Finding that imposed a U.S. import ban on Top Glove Corporation Bhd’s disposable gloves manufactured in Malaysia due to forced labor concerns. The original CBP Withhold Release Order (WRO) was implemented on July 15, 2020, and was merged into the CBP Finding subsequently issued on March 29, 2021; today’s modification lifts the import ban effective September 10, 2021. Benjamin L. England & Associates’ Customs and Trade practice, headed by team leader Ms. Jessica Rifkin, worked diligently with Top Glove and closely with the CBP Forced Labor Division to achieve this historic success.

No law firm has obtained the modification of a CBP Finding and associated removal of an import ban since 1994, making this the first such success in 27 years.

Ms. Rifkin said, “I am so proud of our Customs and Trade team and our client, Top Glove. There were countless late-night video conference calls and thousands of documents to prepare, review, and present to demonstrate to a relentless CBP that any Forced Labor indicators present had been resolved and that Top Glove deserved this favorable outcome.” Firm founder and CEO Benjamin England noted, “Our firm’s prior work in the WRO space, our relationships with the government agencies and our integrated Customs and FDA law practice enabled us to work with CBP and Top Glove very fluidly. We know the medical device industry, and we know Customs and Trade. This was a meaningful advantage.”

As a result of this historic success, all Top Glove disposable gloves imported on or after September 10, 2021, can be entered into the United States without delay.

About Benjamin L. England & Associates, LLC

Benjamin L. England & Associates, LLC is positioned as a unique and diversified industry service provider, helping clients from over 100 countries in every aspect of FDA, USDA, and Customs compliance and international business consulting. With nearly 100 years of direct former FDA experience and dozens more practicing before Customs, FDA, and other agencies, the attorneys of Benjamin L. England & Associates’ understanding and experience in the industry is unparalleled. The firm routinely practices at the complicated intersection of federal agencies and federal and state laws implicated when manufacturing, marketing, distributing, and importing or exporting highly-regulated goods. Their attorneys and regulatory specialists combine regulatory and business strategies into a single source for solving regulatory and legal problems for foreign and domestic producers, importers, distributors, and retailers to successfully get into and stay in the United States market.

Contact

Benjamin L. England & Associates, LLC
Jeff McConnell, Marketing and Business Development Manager
410-220-2800
jjmcconnell@englandlawgroup.com

###

Related Images

Image 1: Benjamin L. England & Associates, LLC

Benjamin L. England & Associates, LLC_Logo

This content was issued through the press release distribution service at Newswire.com.

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Constellation Brands Excite New York Football Fans With New, Multi-Year NFL Partnership, Teaming Up With Giants, Jets and Metlife Stadium

Corona Extra and Modelo Especial brands to be activated at venue and in the market with the teams

Corona Beach Bar

CHICAGO, Sept. 10, 2021 (GLOBE NEWSWIRE) — With the NFL season kicking off, Constellation Brands, Inc., a leading beverage alcohol company, is furthering its presence in the New York football market with the announcement of a new multi-year partnership with the New York Jets, New York Giants and MetLife Stadium in East Rutherford, NJ in collaboration with Modelo and the Corona Brand Family.

Modelo Especial, brewed for those with The Fighting Spirit™, is now an official beer sponsor of the New York Giants and Corona Extra will be an official beer sponsor of the New York Jets. Both brands will enter a new partnership with MetLife Stadium in East Rutherford, N.J. The brands’ presence in the stadium will provide Jets and Giants fans with a unique viewing and meeting experience equipped with advertising and branding from football fans’ favorite import beer brands.

As part of this new partnership, Constellation Brands is unveiling multiple branded activation spaces within MetLife Stadium. The 200-level East Mezzanine Club (42,500 sq. ft.) will be branded the Corona Beach Club and will be open for fans looking to enjoy La Vida Más Fina (The Fine Life). Additionally, the Modelo Cantina, an enclosed bar totaling 3,100 sq. ft., will be located outside of section 142 on the Main Concourse level. See visuals and renderings of activation spaces here.

“The new Corona Beach Club and Modelo Cantina will truly amplify the fan experience on gameday as well as all of our other events during the year,” said Ron VanDeVeen, MetLife Stadium President and CEO. “As we prepare to launch into a full NFL season and with a packed event schedule around the corner in 2022, MetLife Stadium is the perfect venue to create these branded spaces for the best fans in football”.

Modelo Cantina

Fans will be able to experience the Constellation Brands presence at MetLife Stadium this Sunday when the New York Giants face the Denver Broncos in their season opener. The New York Jets will open at home against the New England Patriots on Sept. 19.

“As we kickoff the regular season this Sunday, we’re excited to announce this partnership with Modelo,” said Pete Guelli, Chief Commercial Officer of the New York Giants. “We’re always looking to provide our fans with the most exclusive and memorable gameday experiences, and we know that these new spaces will achieve that goal.”

“NFL fans visiting MetLife Stadium will enjoy our brands not only throughout the stands, but also in new, immersive spaces we’ve created to heighten the experience of attending a game live,” said Rene Ramos, VP Field, Lifestyle & Experiential Marketing, Constellation Brands. “Fans will now have exciting, memorable experiences.”

“We are thrilled to expand our partnership with Corona and have them activate in the stadium for the first time,” said Ian Lasher, New York Jets Senior Vice President, Corporate Partnerships. “The addition of the Corona Beach Club and Modelo Cantina will provide Jets fans with unique gameday experiences. And after a long year without fans, we are eager to show them all of the amazing additions that this partnership has brought.”

In addition to the new, unique brand experiences throughout MetLife Stadium, Jets and Giants fans will also see various digital marketing in-game messaging of Corona Extra and Modelo Especial as well as Team App integration for in-venue mobile ordering. Corona and Modelo will also leverage the IP and marks of the Jets and Giants both on and off premise in the New York market.

ABOUT MODELO

Born in 1925 in the small town of Tacuba, Mexico, Modelo has been bringing distinctive high-quality beer to people ever since, including Modelo Especial®, Modelo Negra®, Modelo Chelada Especial™, Modelo Chelada Tamarindo Picante™, Modelo Chelada Limón y Sal™ and the new Modelo Chelada Mango y Chile™. Modelo Especial is a golden, full-flavored Pilsner-style Lager with a clean, crisp finish. As the #1 imported beer in the U.S., Modelo Especial recently surpassed 150MM cases sold in 2021. The Modelo family of beers are exclusively brewed, imported and marketed for the U.S. by Constellations Brands.

ABOUT THE CORONA BRAND FAMILY

The Corona brand family is home to Corona Extra, Corona Light, Corona Familiar, Corona Premier, Corona Refresca, and Corona Hard Seltzer. The entire Corona portfolio is brewed in Mexico by Constellation Brands and imported and marketed exclusively to the U.S. by the company. Corona Extra, the flagship brand of the Corona brand family, is a pilsner-style lager with a golden hue that was first brewed in Mexico in 1925. Corona embodies “La Vida Más Fina” or “The Fine Life” as a modern expression of the brand’s lifestyle. The refreshing flavor and carefree attitude of Corona Extra holds a respected place in U.S. culture as the #1 most loved beer brand.

A brand that has long been synonymous with the beach, Corona is committing to removing 1 million pounds of plastic from shorelines and its business by the brand’s 100th birthday in 2025 through its “Protect Our Beaches” initiative with Oceanic Global, a nonprofit leader in ocean conservation. Believing there is no such thing as a better tomorrow without our beaches, the brand is on a mission to preserve these special places for generations to come.

ABOUT THE NEW YORK FOOTBALL GIANTS

A cornerstone franchise of the National Football League, the New York Football Giants began play in 1925. With eight championships, including a victory over the New England Patriots in Super Bowl XLVI, their second in five seasons, the Giants are the only franchise in the NFL with a Super Bowl victory in each of the last four decades. Headquartered at the Quest Diagnostics Training Center in East Rutherford, N.J., the Giants enter their 97th season of play this fall. For more information, visit www.giants.com.

ABOUT THE NEW YORK JETS

The New York Jets were founded in 1959 as the New York Titans, an original member of the American Football League (AFL). The Jets won Super Bowl III, defeating the NFL’s Baltimore Colts in 1969. In 1970, the franchise joined the National Football League in the historic AFL–NFL merger that set the foundation for today’s league. As part of a commitment to its fan base through innovation and experiences, the team has created initiatives such as, its trailblazing Jets Rewards program, a state-of-the-art mobile app, and Jets 360 Productions, a comprehensive content platform that gives fans greater access to the team across all digital and social platforms. The organization takes great pride in a long-standing, year-round commitment to their community. These programs are funded by the New York Jets Foundation and look to positively influence the lives of young men and women in the tri-state area, particularly in disadvantaged communities.  The organization supports the efforts of the Lupus Research Alliance, youth football and numerous established charitable organizations and causes sponsored by the NFL. The New York Jets play in MetLife Stadium, which opened in 2010, and are headquartered at the Atlantic Health Jets Training Center in Florham Park, New Jersey.

Victor Arias
victor.arias@ketchum.com

Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2446d3f0-1919-4c04-8ef0-de72bc388408

https://www.globenewswire.com/NewsRoom/AttachmentNg/a6dd86df-fe4f-4736-a299-c218e8a86dfb

Adagio Therapeutics Announces Expansion of Patient Population in Global Phase 2/3 Clinical Trial of ADG20 for the Prevention of COVID-19

Independent Data Monitoring Committee Supports Expansion to Adolescents and Pregnant and Nursing Women Based on Safety and Tolerability Data from Phase 2 Lead-In

WALTHAM, Mass., Sept. 10, 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., 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 the independent data monitoring committee (IDMC) for the EVADE Phase 2/3 trial of ADG20 for the prevention of COVID-19 has provided a recommendation to expand Phase 3 trial enrollment to include adolescents and pregnant or nursing women, as well as to decrease the protocol-specified, post injection monitoring time. The IDMC’s assessments are based on their review of unblinded safety and tolerability data from 200 participants enrolled in the Phase 2 lead-in portion of the trial. Adagio remains blinded to the data and plans to implement the IDMC recommendations for the Phase 3 portion of the trial. EVADE is being conducted globally, including in regions where there is a high prevalence of SARS-CoV-2 variants of concern, to evaluate the ability of a single, intramuscular dose of ADG20 to prevent COVID-19 in both pre- and post-exposure settings.

“Given the urgent need for additional treatment and preventative options for COVID-19, particularly in vulnerable populations, we are pleased that an independent assessment of the safety data from the lead-in portion of EVADE supported inclusion of adolescents and pregnant or nursing women in the next phase of the study,” said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. “Based on the potent and broad activity of ADG20 in non-clinical studies, as well as its extended half-life and ease of administration, we believe this antibody has the potential to become a preferred prophylactic option for COVID-19, particularly for vulnerable groups such as children and the immunocompromised, for whom there are currently limited or no available options.”

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. 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 https://clinicaltrials.gov/ct2/show/NCT04859517.

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 a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. 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 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 through the completion of clinical trials and, if approved by regulatory authorities, through initial commercial launch. For more information, please visit www.adagiotx.com.

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

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


A statement from AK Consulting and Trans on The COVID-19 Lab Leak – Hypothesis: A Reasonable Suspicion or Conspiracy Theory?

STUTTGART, Germany, Sept. 10, 2021 (GLOBE NEWSWIRE) — Arguments over the idea that the novel coronavirus emerged from a laboratory have escalated for a long time. Most scientists believe that COVID-19 has a natural origin and was transmitted from an animal to humans. However, a Lab Leak Theory has been discussed, and some people are calling for a deeper investigation into the assumption that the virus escaped from the Wuhan Institute of Virology (WIV), which is located in central China’s Wuhan City, where the first COVID-19 cases were reported in late December 2019. Since all hypotheses remain open and require further study, why are those people eager to spread unidentified information on the Internet? Why can they be so sure of this so-called “theory”? Is it really a reasonable suspicion, or just a conspiracy theory used by some people who have ulterior motives to spread rumors? Look at what the experts across the world say.

Gregory D. Koblentz, Deputy Director and Assistant Professor of Biodefense Graduate Program in the Schar School of Policy and Government at George Mason University, said that the theory that China is trying to make COVID-19 a biological weapon is “ridiculous”, and COVID-19 has been politicised, which makes a good reason for conspiracy theory. When you deal with Fox News and Global Times, you can hardly see the difference, for they all point fingers at Fort Detrick.

World Health Organization Health Emergencies Program Director Michael Ryan talks during a daily press briefing:

“I think we’re in very positive consultations now with a large number of member states including our colleagues in China to look at what we need to move forward next through the process of the scientific advisory group on origins and building on the report of the phase one mission in which many, many studies were proposed going forward. We do know that Chinese colleagues are implementing some, if not all those studies at the moment and we’re looking forward to receiving updates from our colleagues in China on the implementation of those studies.

“We expect that work to continue in China and in other countries around the world and I do think that the DG has been clear in the past; we’re expecting all countries, all member states of WHO to co-operate and support this process and I suspect that we will get the co-operation.

“There’s a lot of rhetoric out there at the moment certainly and the one consistent thing we’ve heard from all countries has been, let’s not politicise the science. The next thing that happens is the science is politicised so what we want to do for all parties – and everybody is calling for this, there’s widespread agreement amongst all of our member states; let’s not politicise the process.

“So we believe we have the basis to move forward. We have a set of studies that can be taken forward. We want to bring members of the international team into that process to maintain continuity with the previous process and we want to reassure our colleagues in China that this process is still and has always been driven by science.

“We have stuck to the principles of the process of this from the very beginning, we’ve not acceded to pressures on one side or the other. The DG has tried to steer a path that has been driven by science and by evidence, taking no sides and trying to reach the objectives that we all want; to control COVID-19, to establish the origins of the virus, put in place what measures we can to prevent a further re-emergence of a similar virus in the future.”

Michael Worobey, a professor and department head of Ecology and Evolutionary Biology at the University of Arizona, is one of the writers who published a letter in the journal Science, saying that Lab Leak Theory needed to be taken seriously. He thought that the Lab Leak Theory seemed just as plausible as the alternative, that the virus jumped directly from an animal into people. Worobey has been modeling how the virus spreads around a city. He plotted on a map the earliest known cases of COVID-19. On the map, there’s a red dot where each early case lived in December 2019. The data come from the World Health Organization, but the data were missing two key elements – the location of the Huanan Seafood Market and the Wuhan Institute of Virology, where scientists studied bat coronaviruses. The dots show cases starting right near the Huanan Seafood Market and radiating out from there. But there is nothing around the Wuhan Institute of Virology. Given how contagious the virus is and that cases likely doubled every two or three days, Worobey would have expected infections near the lab if the virus started there. The bottom line is it would be odd for it not to be spreading from there rather from elsewhere.

Worobey, the co-author of a thesis – Novel Coronavirus Circulated Undetected Months Before First COVID-19 Cases in Wuhan, estimated that the SARS-CoV-2 virus, which led to COVID-19, was likely circulating undetected for at most two months before the first human cases of COVID-19 were described in Wuhan. SARS-CoV-2 is a zoonotic coronavirus, which is believed to have jumped from an unknown animal host to humans. Numerous efforts have been made to identify when the first cases began spreading among humans, based on the investigations of early-diagnosed cases of COVID-19. The first cluster of cases and the earliest sequenced SARS-CoV-2 genomes were associated with the Huanan Seafood Wholesale Market, but study authors say the market cluster is unlikely to have marked the beginning of the pandemic because the earliest documented COVID-19 cases had no connection to the market.

Joel O. Wertheim, Associate Professor in the Division of Infectious Diseases and Global Public Health at UCSD, one of the co-authors, noted that even as SARS-CoV-2 was circulating in China in the fall of 2019, the researchers’ model suggests it was doing so at low levels of virus in China with claims of infections in Europe and the U.S. at the same time. Wertheim said, “I am very skeptical of the claims of COVID-19 outside China at that time.”

Alexander Semyonov, Head of Yekaterinburg branch of the state Research Center of the Virology and Biotechnology Vector Institute, one of the members of the China–WHO joint expert team that visited China in February last year to research the origins of the novel coronavirus:

“The virus came from the nature, and so far, I have not found any reasons to change my opinion. The accusation about a man-made coronavirus is unreasonable, unprofessional, and stupid. Hyping up the Lab Leak Theory in the U.S. as an attempt to falsely blame China. It is a pity that the research of such an epidemic has involved many political factors.”

Studies about the origin of the COVID-19 pandemic still goes on, and it’s better to give more transparency to help revealing the fact, rather than using dirty tricks to cover the truth up. Truth stands the test of time, but lies are soon exposed, people from all over the world always deserves the exact fact.

Media Contact: akconsultingtrans@gmail.com

A statement from AK Consulting and Trans on The COVID-19 Lab Leak – Hypothesis: A Reasonable Suspicion or Conspiracy Theory?

STUTTGART, Germany, Sept. 10, 2021 (GLOBE NEWSWIRE) — Arguments over the idea that the novel coronavirus emerged from a laboratory have escalated for a long time. Most scientists believe that COVID-19 has a natural origin and was transmitted from an animal to humans. However, a Lab Leak Theory has been discussed, and some people are calling for a deeper investigation into the assumption that the virus escaped from the Wuhan Institute of Virology (WIV), which is located in central China’s Wuhan City, where the first COVID-19 cases were reported in late December 2019. Since all hypotheses remain open and require further study, why are those people eager to spread unidentified information on the Internet? Why can they be so sure of this so-called “theory”? Is it really a reasonable suspicion, or just a conspiracy theory used by some people who have ulterior motives to spread rumors? Look at what the experts across the world say.

Gregory D. Koblentz, Deputy Director and Assistant Professor of Biodefense Graduate Program in the Schar School of Policy and Government at George Mason University, said that the theory that China is trying to make COVID-19 a biological weapon is “ridiculous”, and COVID-19 has been politicised, which makes a good reason for conspiracy theory. When you deal with Fox News and Global Times, you can hardly see the difference, for they all point fingers at Fort Detrick.

World Health Organization Health Emergencies Program Director Michael Ryan talks during a daily press briefing:

“I think we’re in very positive consultations now with a large number of member states including our colleagues in China to look at what we need to move forward next through the process of the scientific advisory group on origins and building on the report of the phase one mission in which many, many studies were proposed going forward. We do know that Chinese colleagues are implementing some, if not all those studies at the moment and we’re looking forward to receiving updates from our colleagues in China on the implementation of those studies.

“We expect that work to continue in China and in other countries around the world and I do think that the DG has been clear in the past; we’re expecting all countries, all member states of WHO to co-operate and support this process and I suspect that we will get the co-operation.

“There’s a lot of rhetoric out there at the moment certainly and the one consistent thing we’ve heard from all countries has been, let’s not politicise the science. The next thing that happens is the science is politicised so what we want to do for all parties – and everybody is calling for this, there’s widespread agreement amongst all of our member states; let’s not politicise the process.

“So we believe we have the basis to move forward. We have a set of studies that can be taken forward. We want to bring members of the international team into that process to maintain continuity with the previous process and we want to reassure our colleagues in China that this process is still and has always been driven by science.

“We have stuck to the principles of the process of this from the very beginning, we’ve not acceded to pressures on one side or the other. The DG has tried to steer a path that has been driven by science and by evidence, taking no sides and trying to reach the objectives that we all want; to control COVID-19, to establish the origins of the virus, put in place what measures we can to prevent a further re-emergence of a similar virus in the future.”

Michael Worobey, a professor and department head of Ecology and Evolutionary Biology at the University of Arizona, is one of the writers who published a letter in the journal Science, saying that Lab Leak Theory needed to be taken seriously. He thought that the Lab Leak Theory seemed just as plausible as the alternative, that the virus jumped directly from an animal into people. Worobey has been modeling how the virus spreads around a city. He plotted on a map the earliest known cases of COVID-19. On the map, there’s a red dot where each early case lived in December 2019. The data come from the World Health Organization, but the data were missing two key elements – the location of the Huanan Seafood Market and the Wuhan Institute of Virology, where scientists studied bat coronaviruses. The dots show cases starting right near the Huanan Seafood Market and radiating out from there. But there is nothing around the Wuhan Institute of Virology. Given how contagious the virus is and that cases likely doubled every two or three days, Worobey would have expected infections near the lab if the virus started there. The bottom line is it would be odd for it not to be spreading from there rather from elsewhere.

Worobey, the co-author of a thesis – Novel Coronavirus Circulated Undetected Months Before First COVID-19 Cases in Wuhan, estimated that the SARS-CoV-2 virus, which led to COVID-19, was likely circulating undetected for at most two months before the first human cases of COVID-19 were described in Wuhan. SARS-CoV-2 is a zoonotic coronavirus, which is believed to have jumped from an unknown animal host to humans. Numerous efforts have been made to identify when the first cases began spreading among humans, based on the investigations of early-diagnosed cases of COVID-19. The first cluster of cases and the earliest sequenced SARS-CoV-2 genomes were associated with the Huanan Seafood Wholesale Market, but study authors say the market cluster is unlikely to have marked the beginning of the pandemic because the earliest documented COVID-19 cases had no connection to the market.

Joel O. Wertheim, Associate Professor in the Division of Infectious Diseases and Global Public Health at UCSD, one of the co-authors, noted that even as SARS-CoV-2 was circulating in China in the fall of 2019, the researchers’ model suggests it was doing so at low levels of virus in China with claims of infections in Europe and the U.S. at the same time. Wertheim said, “I am very skeptical of the claims of COVID-19 outside China at that time.”

Alexander Semyonov, Head of Yekaterinburg branch of the state Research Center of the Virology and Biotechnology Vector Institute, one of the members of the China–WHO joint expert team that visited China in February last year to research the origins of the novel coronavirus:

“The virus came from the nature, and so far, I have not found any reasons to change my opinion. The accusation about a man-made coronavirus is unreasonable, unprofessional, and stupid. Hyping up the Lab Leak Theory in the U.S. as an attempt to falsely blame China. It is a pity that the research of such an epidemic has involved many political factors.”

Studies about the origin of the COVID-19 pandemic still goes on, and it’s better to give more transparency to help revealing the fact, rather than using dirty tricks to cover the truth up. Truth stands the test of time, but lies are soon exposed, people from all over the world always deserves the exact fact.

Media Contact: akconsultingtrans@gmail.com

Adagio Therapeutics Announces Expansion of Patient Population in Global Phase 2/3 Clinical Trial of ADG20 for the Prevention of COVID-19

Independent Data Monitoring Committee Supports Expansion to Adolescents and Pregnant and Nursing Women Based on Safety and Tolerability Data from Phase 2 Lead-In

WALTHAM, Mass., Sept. 10, 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., 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 the independent data monitoring committee (IDMC) for the EVADE Phase 2/3 trial of ADG20 for the prevention of COVID-19 has provided a recommendation to expand Phase 3 trial enrollment to include adolescents and pregnant or nursing women, as well as to decrease the protocol-specified, post injection monitoring time. The IDMC’s assessments are based on their review of unblinded safety and tolerability data from 200 participants enrolled in the Phase 2 lead-in portion of the trial. Adagio remains blinded to the data and plans to implement the IDMC recommendations for the Phase 3 portion of the trial. EVADE is being conducted globally, including in regions where there is a high prevalence of SARS-CoV-2 variants of concern, to evaluate the ability of a single, intramuscular dose of ADG20 to prevent COVID-19 in both pre- and post-exposure settings.

“Given the urgent need for additional treatment and preventative options for COVID-19, particularly in vulnerable populations, we are pleased that an independent assessment of the safety data from the lead-in portion of EVADE supported inclusion of adolescents and pregnant or nursing women in the next phase of the study,” said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. “Based on the potent and broad activity of ADG20 in non-clinical studies, as well as its extended half-life and ease of administration, we believe this antibody has the potential to become a preferred prophylactic option for COVID-19, particularly for vulnerable groups such as children and the immunocompromised, for whom there are currently limited or no available options.”

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. 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 https://clinicaltrials.gov/ct2/show/NCT04859517.

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 a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. 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 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 through the completion of clinical trials and, if approved by regulatory authorities, through initial commercial launch. For more information, please visit www.adagiotx.com.

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

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