Adagio Therapeutics Reports Reduction in In Vitro Neutralizing Activity of ADG20 Against Omicron SARS-CoV-2 Variant

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, 1AB Monique Allaire, THRUST Strategic Communications
Dan@1abmedia.com monique@thrustsc.com


Cool Scheme to Reduce Food Waste in Nigeria

ColdHubs installation at Relife Outdoor Food Market, Owerri, Imo State, Nigeria. The World Bank estimates that 40 percent of all food produced goes to waste in Nigeria. Credit: ColdHubs.

By Busani Bafana
Bulawayo, Zimbabwe, Dec 14 2021 – Food spoilage forced smallholder farmers out of pocket and out of business – until an entrepreneur came up with a cool idea.

Growing up on a farm in Southern Nigeria, Nnaemeka Ikegwuonu observed how smallholder farmers rushed to sell their produce before sunset to avoid spoiling or selling it at give-away prices. Ikegwuonu came up with a cool idea to save the produce from spoiling: solar-powered cold rooms.

Smallholder farmers in Africa experience high post-harvest food losses owing to poor handling, poor packaging and lack of storage for their produce before it reaches the market.

According to the World Bank, food loss accounts for 40 percent of all food produced in Nigeria.

ColdHubs Ltd is a Nigerian social enterprise that designs, installs, operates and rents walk-in cold rooms known as ‘ColdHubs’. The Cold Hubs can store and preserve fresh fruits, vegetables and other perishable foods, extending their shelf life from two to 21 days.

Describing spoilage as a wicked problem, Ikegwuonu’s ColdHubs concept is helping farmers and retailers preserve their produce for longer, reducing waste and ensuring farmers get better prices for it.

The mission is to reduce food spoilage due to lack of cold food storage at key points along the food supply chain, explains Ikegwuonu, who has won global recognition for his innovations in farming and entrepreneurship. In 2016 he was named a Rolex Award Laureate.

Social entrepreneur and farmer, Nnaemeka Ikegwuonu, posing in front of one of his solar-powered cold rooms. Credit: ColdHubs

In 2003, Ikegwuonu started the Smallholders Foundation. This non-profit developed rural radio services, delivering information to improve agricultural methods and conserve the environment to more than 250 000 daily listeners across the country.

During a radio roadshow in the city of Jos, the capital of Plateau state in central Nigeria, where he was doing a radio programme on cabbage, Ikegwuonu realised many farmers were throwing away their produce because it was spoiling before they could sell it all.

“At that point, it dawned on us that there is no form of cold storage which is an important infrastructure for any outdoor markets for fresh fruits and vegetables. After some research, we built solar-powered cold rooms, and these were well received by farmers,” Ikegwuonu told IPS in an interview.

“Spoilage entraps farmers into poverty cycle because, by the time the food arrives in the outdoor market, the value has reduced, economically and nutritionally.”

Farmers and retailers rent out the walk-in cold rooms for a low fee of $0.25 (100 Naira) per 20kg plastic crate for one day. Each cold room has a capacity of storing three tonnes of food with other storage units that can hold 10 tons and 100 tons of food at a time.

Ikegwuonu said in designing the cold rooms, emphasis was placed on the solar power generation capacity to run the cold rooms every day of the week. The units generate energy from rooftop solar panels during the day. The energy is transferred and stored in batteries that run the cold rooms at night.

Currently, 54 cold rooms are operating in 38 clusters across two states in Nigeria, and Ikegwuonu plans to double the number in 2022.

ColdHubs have created 66 jobs for young women by hiring and training them as hub operators and market attendants. The ColdHubs, located in outdoor markets, serve more than 5 000 smallholder farmers, retailers and wholesalers in Nigeria.

In 2020, the cold rooms stored more than 40 000 tonnes of food which helped reduce food waste and increased farmers’ profits, according to Ikegwuonu.

“Farmers had commended the technology and have increased their income by about 50 percent before we started deploying ColdHubs. Now they are earning about $150 every month from selling the products that used to be spoiled and thrown away or sold at ridiculous rock bottom prices.”

Food waste occurs during industrial processing, distribution, and final consumption of food, research by the Barilla Center for Food and Nutrition shows. In developing countries, food losses occur upstream in the production chain.

According to the Food Sustainability Index (FSI) developed by the Economist Intelligence Unit with the Barilla Center for Food & Nutrition, food loss and waste need urgent action given its environmental and economic impacts. The FSI, which ranks countries on food systems sustainability – is a quantitative and qualitative benchmarking model measuring the sustainability of food systems in the categories of food loss and waste, sustainable agriculture and nutritional challenges.

Nigeria was ranked five with a score of 74.1 for food loss and waste on the FSI 2018 results for middle-income countries.

Spoilage of fruit and vegetables robs farmers of income while contributing to food waste. Credit: Busani Bafana/IPS

“Tackling consumer food waste and post-harvest waste (the loss of fresh produce and crops before they reach consumer markets) will involve everything from changing consumption patterns to investing in infrastructure and deploying new digital technologies,”  the Barilla Center for Food & Nutrition report noted, emphasising that ending hunger and meeting rising food demand will not be possible without tackling high level of food loss and waste.

Fruits and vegetables have the largest losses across developing countries, accounting for 42 percent of the developing country loss and waste globally, a report by the Rockefeller Foundation found, noting that growth in the commercial sale and use of loss averting technologies among smallholder farmers and value chain actors was an opportunity to reduce spoilage.

An estimated 93 million smallholder farmers and food supply chain actors are affected by food loss in Nigeria.

The United Nations’ Food and Agriculture Organisation (FAO) has urged for accelerated global action to reduce food loss and waste, with less than nine years to the deadline for achieving Sustainable Development Goals (SDGs).  Seven years ago, global leaders agreed to the 17 SDGs, and Goal 12 specifically commits to halve by per capita global food waste at the retail and consumer levels by 2030.

Reducing food loss and waste contributes to the realisation of broader improvements to agri-food systems towards achieving food security, food safety, improving food quality and delivering on nutritional outcomes,” the FAO highlighted in marking the 2021 International Day of Awareness of Food Loss and Waste. The UN specialised agency has urged investment and prioritisation of new technology and innovations that directly address post-harvest food loss.

Investments to encourage African youth turning away from agriculture to reconsider opportunities in the sector is key given the need to generate jobs and repair food systems particularly impacted by the current COVID-19 pandemic, says Heifer International, which has promoted young, creative professionals deploying technology innovations to transform agriculture in Africa.

“Young entrepreneurs across Africa understand the struggles of their parent’s generation and have seen how this has discouraged the people around them from pursuing careers in the agriculture sector,” commented Adesuwa Ifedi, senior vice president of Africa Programmes at Heifer International.

With support from Heifer and the AYuTe Africa Challenge, Ikegwuonu predicts to expand from 50 to 5000 ColdHubs across West Africa in the next five years.

“Too many African farmers do not get the income they deserve because they have no way of keeping their produce fresh. We are revolutionising storage with our Cold Hubs and ensuring that farmers get value for their produce by avoiding spoilage,” said Ikegwuonu.

 


!function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?’http’:’https’;if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+’://platform.twitter.com/widgets.js’;fjs.parentNode.insertBefore(js,fjs);}}(document, ‘script’, ‘twitter-wjs’);  

Greed-Driven Pandemic Still Killing Millions

By Jomo Kwame Sundaram and Nazihah Noor
KUALA LUMPUR, Malaysia, Dec 14 2021 - Failure to vaccinate most in poor countries sustains the COVID-19 pandemic. Rich country greed and patent monopolies block developing countries from [...] Read more »