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


Govt to Introduce Targeted Subsidies at Utility Stores for Ehsaas Beneficiaries

The government has planned for introducing targeted subsidies at the Utility Stores for the Prime Minister Ehsaas program beneficiaries by linking their Ehsaas Cards/national identity cards with the sale points.

This was revealed by senior officials of the Ministry of Industries and Production and the Utility Stores Corporation (USC) while briefing the Senate Standing Committee. The Committee meeting was held with Syed Faisal Ali Subzwari in the chair here on Thursday, in which the members were given a detailed briefing on the functions and performance of USC. The members expressed strong reservations over the substandard items being sold at the stores.

The Committee was also informed that the government was planning to link the national identity cards/Ehsaas Cards of the beneficiaries with Utility Stores, which would only allow them to purchase items at subsidized rates. The main objective of the initiative is to make the government’s subsidy more targeted.

The Committee stressed the need for the benefits of subsidies to trickle down to the neediest. It recommended franchising.

The Ministry informed the Committee that the government planned to make these stores a targeted subsidy tool.

Reviewing the performance of Utility Stores, the Committee was of the view that stringent measures must be taken to curb pilferage, theft, and other irregularities. It also recommended that the stores must adopt the ERP [enterprise resource planning] system to keep logistics in check.

The Committee was informed that there were around 4,500 stores in the country that cover a minimal percentage of the population. The total sales at the Utility Stores remained at Rs. 114 billion with a net profit of only Rs. 0.7 billion.

USC will focus in 2021-22 on the points of sale implementing a targeted subsidy, the revamped policies and procedures in line with the best practices, automation of supply chain, finance, human resource, administration, a shift from small stores to large ones for provision of better services to customers, and centralization to achieve better control on business decisions and cost.

The Committee was told that 90 stores were running losses as they were providing facilities to the residents of far-flung areas. Over 50 units were operating in erstwhile FATA and PATA. To control the losses, the government plans to cross-subsidize goods. The Committee, on request of the Ministry, agreed to take up the issue after 90 days on completion of the computerization and barcoding exercise, crucial for the progress of the organization.

Senator Falak Naz, Senator Fida Muhammad, Senator Faisal Saleem Rehman, Senator Muhammad Abdul Qadir, Senator Saifullah Sarwar Khan Nyazee, Senator Hidayat Ullah, Senator Imamuddin Shouqeen, and senior officers from the Ministry of Industries and Production attended the meeting.

Source: Pro Pakistani

Govt Considering to Reduce Duties and Sales Tax on Steel Imports

The government is considering removal of duties on iron scrap, reducing the sales tax up to 14 percent as well as the steel import in order to decrease the steel prices in the country which have shot from Rs. 90000 per ton to Rs. 178,000 during the last single year.

This was revealed by senior officials of the Ministry of Industries and Production while briefing the Senate Standing Committee which met with Syed Faisal Ali Subzwari in the chair on Thursday. A reduction of 10 percent in taxes and duties may reduce steel prices by up to Rs. 23,000 per ton.

Dr. Hamid Atiq Sarwar, Additional Secretary, Ministry of Industries and Production, said that the steel sector was not regulated, but after the ‘prices shocks’, the government could intervene to fix them. Steel prices are cheaper in India and Iran than Pakistan due to the availability of raw materials domestically, he added.

The Committee discussed issues pertaining to steel price rise and its impact on circular debt and unemployment. The members were of the view that this would affect the Prime Minister Housing Scheme and other residential projects benefitting the common man. The Committee Chairman directed the Ministry to share details of price reduction possibilities along with its financial impact with the Committee.

The Committee was informed that there were four different types of players (shipbreakers, large steel units, melters, rerollable mills) with different raw materials with volatile international prices and it was not guaranteed that tax interventions would definitely reduce the price.

The Committee was informed that the reasons behind the increase in steel prices include:

i. A worldwide increase in steel raw material prices (scrap) i.e. from $290/- to $540/- per ton in the last year

ii. An increase in ship freight from 430-35/- to $70-80/- per ton

iii. Increased power tariff from Rs. 13 per unit to Rs 20 per unit

iv. 100 percent increase in gas /coal/ RLNG prices in last one year;

v. An overall increase in the cost of doing business due to price escalation due to dollar appreciation

vi. Impact of duties and taxes (which goes into the government’s kitty) of 24 percent, i.e., @ 0 percent customs duty, two percent additional customs duty, five percent regulatory duty and 17 percent general sales tax

Dr. Sarwar said the main reason for the rise in steel prices was the high cost of scrap in the global market, which increased from $250 to $510.

The Committee was informed that the decline in iron ore production due to the closure of Pakistan Steel Mills and the increase of ships’ transportation charges from $35 to $80 also contributed toward an increase in steel prices. It was further informed that a 10 percent reduction in taxes and duties is proposed to reduce steel prices, which was likely to reduce the rate by Rs. 22,000 to Rs. 23,000 per ton. The second option is to import steel products, but this could affect the local industry and lead to unemployment. Shutting down the steel unit will waste extra power and increase circular debt. The Committee called for a comprehensive plan to reduce steel prices.

The Committee was informed that the remaining employees of Pakistan Steel Mills, which has remained closed since 2015, are planned to retire voluntarily. In this regard, Rs. 10 billion will be spent in the current financial year. In the last financial year, 55 percent of the employees were paid Rs. 11 billion under the voluntary retirement scheme. A total of Rs. 24 billion will be spent on payment of arrears. Expression of Interest (EOI) has been invited for rehabilitation of 1,228 acres of the Steel Mill plant with the help of the private sector by investing one billion dollars.

The Additional Secretary said that issues pertaining to liabilities with the National Bank of Pakistan and SSGCL are near resolution, after which they would issue NOC and pave way for moving forward for PSM transactions.

The Additional Secretary said that issues pertaining to liabilities with the National Bank of Pakistan and SSGCL are near resolution, after which they would issue NOC and pave way for moving forward for PSM transactions.

Source: Pro Pakistani

NA Committee Urges Govt to Balance Out Prices of Fertilizers

The National Assembly Standing Committee on Industries and Production, in its 18th meeting on Thursday, expressed grave concerns over the skyrocketing prices of fertilizers and urged the government to take serious note of the issue. The meeting was chaired by Acting Chairman Committee Usama Qadri.

The prices of fertilizers have increased. Especially, the price of DAP [Di-ammonium phosphate] has reached Rs. 6,700 per bag with sugar price hitting Rs. 120 per kg.

The Committee member Rana Mohammad Ishaq Khan said that farmers got DAP at Rs. 6,700 per bag, making it difficult for them to complete wheat sowing. In such a situation, he warned, a wheat crisis is looming over the country. “The DAP prices are being increased at a rate of Rs. 100 per day, which is cruel,” he remarked, adding that sugar was being sold at Rs. 120 per kg in the market with a daily increase of up to Rs. 5 per day. The government should take notice of the situation, he emphasized. He also expressed displeasure over the absence of the Minister and Secretary of the Ministry of Industries and Production in the Committee meetings.

Member of National Assembly (MNA) Amjad Ali Khan, who moved the “The Export Processing Zones Authority (Amendment) Bill, 2019,” apprised the Committee of the salient features of the said Bill. He informed that the rules of both the National Assembly and the Senate provided that the delegated legislation might be examined by the Committees concerned, but practically, no effective parliamentary oversight had been made. In the prevalent legal system, he added, it was also a departure from the principle of separation of powers that laws should be made by the elected representatives of people in the Parliament and not by the executive government.

“In parliamentary democracies, the principle has been largely preserved through an effective system of parliamentary control of executive law-making by making provisions that copies of all subordinate legislation shall be laid before each House of the Parliament within prescribed sitting days thereof, otherwise, they cease to have [an] effect.”

A representative of the Ministry of Law and Justice, also present in the meeting, invited the attention of the Committee toward Article 99 of the Constitution of the Islamic Republic of Pakistan clause (2) and (3) reproduced as under:

“The [Federal Government] shall by rules specify the manner in which orders and other instruments made and executed [in the name of the President] shall be authenticated, and the validity of any order or instrument so authenticated shall not be questioned at any court on the grounds that it was not made or executed by the President.

The federal government shall also make rules for the allocation and transaction of its business”

After a detailed discussion, the Committee decided that the legal opinion from the Ministry of Law and Justice would be obtained on the Bill. And, the Minister and Secretary Law may also be invited to the meeting of the Committee for further deliberation in this regard.

Separately, the Committee deferred the agenda pertaining to Point of Order, moved by MNA Saira Bano, regarding the booking of MG vehicles for its next meeting due to some official engagements of the honorable mover.

The meeting was attended by MNAs Nasir Khan Musa Zai, Muhammad Abdul Ghafar Watto, Syed Mobeen Ahmed, Sahibzada Sibgatullah, Shandana Gulzar Khan, Sajida Begum, Aliya Hamza Malik, Amir Talal Gopang, Ali Gohar Khan, M. Perviaz Malik. and Rana M. Ishaq Khan, besides the senior officers from Ministry of Industries & Production, Ministry of Law & Justice, and MG Automobile Industries.

Source: Pro Pakistani

Gwadar’s Retrocession to Pakistan a Foreign Policy Success Story: IPS Chairman

The successful retrocession of Gwadar to Pakistan, especially in view of its geoeconomic and geostrategic positioning, underscores the commendable vision and efficiency of Pakistan’s foreign policy actors in its early years. However, the continued failure to benefit from the dividends of retrocession and the poor socio-economic condition of the people of Gwadar speaks volumes of the governance crisis the country is still faced with.

This was the crux of a webinar titled, ‘63 Years of Gwadar’s Retrocession to Pakistan: Achievements, Prospects and Challenges,’ which was organized by the Institute of Policy Studies (IPS), Islamabad in collaboration with the National Institute of Maritime Affairs (NIMA) and the Center for Strategic and Contemporary Research (CSCR).

Senator Kauda Babar Baloch, a legislator from Gwadar, appreciated the recent development initiatives under the southern Balochistan package of the federal government, allocating a huge amount of funds for the southern districts of Balochistan, especially for Gwadar’s development. He also lauded the finalization of the power purchase agreement with a Chinese firm for setting up a coal power plant in the emerging port city that suffers a severe power crisis. The finalization of transshipment regulations last year for the first time in the country’s history will help realize the true potential of Gwadar, he said.

Regarding Gwadar’s retrocession to Pakistan on 8th September 1958, Senator Baloch said his elders and the people of Gwadar rejoiced becoming a part of Pakistan and immensely loved their homeland. It was the will of the people of Gwadar, which provided moral justification and support to the governments in the early years of Pakistan to deal with the British and Omani governments effectively, he asserted.

Addressing the webinar as a keynote speaker earlier, Vice Admiral Iftikhar Ahmad Rao (retd) informed that he narrated in detail in his forthcoming book, Gwatar Bay to Sir Creek, a work based on archival research that how Pakistan began negotiations over the transfer of Gwadar from Oman to Pakistan right after its independence in 1947. He said the British government, which played an intermediary role to facilitate negotiations, kept delaying the handover of Gwadar to Pakistan till the ascendance of Feroz Khan Noon as the Prime Minister of Pakistan, who went as far as threatening to take Gwadar by force.

He also revealed that Gwadar Development Plan was already in place even before the retrocession took place in 1958. Despite this, Gwadar has not received the due attention of policymakers in the country over the decades, he said.

Highlighting various development projects underway in the Rs. 600 billion southern Balochistan package, Commodore Jawad Akhtar said that Rs. 23 billion were allocated for roads and infrastructure development in the city. Work on a 300-MW coal power plant was set to begin this year, he said, adding that many development projects were being planned under public-private partnerships. He regretted that the previous governments showed apathy toward the socio-economic development in the districts with the lowest Human Development Index (HDI) scores, including Gwadar. However, he assured the people of Gwadar, many development projects regarding skills development, digital connectivity, food security, electricity generation, and water provision were already launched and were expected to yield long-term benefits for them.

Commodore (retd) Dr. Anjum Sarfraz shed light on the potential of Gwadar as a transshipment hub in the region. He commented that the Gwadar port was built to handle transit trade of China, Afghanistan, and Central Asian Republics (CARs) and serve as a transshipment hub. Nonetheless, the port operation progress of Gwadar has remained surprisingly slow despite the fact that Gwadar port as a transshipment hub has the capacity to outmatch regional ports provided appropriate steps are taken, he added.

Lamenting upon the lack of housing facilities in Gwadar, Zaigham M. Rizvi argued that the housing scheme promised to be built in 2006 is yet to be completed. He emphasized the need for ensuring ease of doing business for local and foreign investors and expediting work on development projects so that the basic facilities like water and electricity were provided at the doorstep in the port city.

Chairman IPS Khalid Rahman termed the retrocession of Gwadar as a foreign policy success story of Pakistan that needs to be highlighted time and again.

He opined that the governance crisis had been continuing in Pakistan since the early years of its foundation and Gwadar was no exception to it. However, the new development projects under the Ministry of Planning, Development and Special Initiatives were expected to address the plight of the local population of Gwadar.

Vice-Chairman IPS Ambassador (retd) Syed Abrar Hussain, Ambassador (retd) Naghmana Alamgir Hashmi, former Pakistan ambassador to China, Dr. Kanwar M. Javed Iqbal senior researcher from NIMA, and Farzana Yaqoob, executive director, Centre for Asian-African Studies (CAAS) also spoke on the occasion.

Source: Pro Pakistani

Need for A More Cautious Approach to Structural Reforms in Pakistan: IMF

The Independent Evaluation Office (IEO) of the International Monetary Fund (IMF) stated that case studies highlight the need for more cautious assumptions on feasibility and growth payouts of structural reforms in Pakistan.

The IEO has released its report “Growth and adjustment in IMF-supported programmes,” which assesses how well IMF-supported programmes have helped sustain economic growth while delivering adjustment needed for external viability. It focuses on IMF financing arrangements over the period 2008–19, under both the General Resources Account (GRA) and the Poverty Reduction and Growth Trust (PRGT).

While the evaluation does not assess the experience during the COVID-19 pandemic, its lessons have become even more relevant as many countries now face strong headwinds to growth as they seek IMF support for achieving durable recoveries.

The report noted that in Jordan, Pakistan, and Tunisia, Fund staff underestimated the complexity of the political transition and the impact of intervening political, security-related, and regional shocks. At the same time, country officials wanted to show hope to sustain political support for challenging reforms. The consequence was a disconnect between optimistic growth projections and actual outcomes.

It further stated that several case studies emphasize that staff had unrealistic expectations regarding the feasibility and growth payoffs of reforms. In Jordan, Pakistan, and Tunisia, case studies highlight the need for more cautious assumptions on feasibility and growth payouts of structural reforms. Fund staff underestimated the complexity of the political transition and the impact of intervening political, security-related, and regional shocks.

The consequence was a disconnect between optimistic growth projections and actual outcomes. This gap also reflected “the need to show hope,” which was also advocated by country officials seeking to sustain political support for challenging reforms.

In Pakistan (2013), the exchange rate was managed heavily as a contribution to inflation control in the 2008 Stand-By Arrangement (SBA) and 2013 Extended Fund Facility (EFF), allowing a gradual appreciation of the real effective exchange rate; the loss of competitiveness was eventually reversed by a sharp market-driven depreciation ahead of the 2019 EFF.

The report noted that in some cases, particularly earlier in the evaluation period (e.g., Grenada 2010, Jamaica 2010, and Pakistan 2008), authorities felt that staff were too inflexible in insisting on front-loading of fiscal adjustment that was hard to sustain.

Specifically, program reviews adapted fiscal targets due to weaker growth outcomes or fiscal overruns in many programs, including Bangladesh, Cameroon, Grenada, Latvia (where Fund staff sought less fiscal consolidation than the authorities), Mongolia, Pakistan (not in the first review but subsequent reviews), Romania, Senegal, and Ukraine.

Program reviews were also combined and/or extended to provide the authorities more time to take corrective policy actions after policy slippages in a range of programs, including Bangladesh, Ghana, Honduras, Jordan, Malawi, Mongolia, Pakistan, Tunisia, and Ukraine. In Pakistan progress was made in power sector reforms in the 2013 EFF after failure in this area in the 2008 SBA, it added.

By contrast, Pakistan (2008 SBA) is a case in which limited political support undermined critical tax reform implementation. Despite massive IMF TA and program extensions to allow more time to unlock the VAT reform, the tax reform failed to be implemented before the program expired in 2011 due to a lack of political support. As the VAT reform remained politically infeasible, another program in 2013 sought revenue mobilization via a combination of several incremental reforms (e.g., scaling back tax exemptions, broadening the tax base, increasing goods and services taxes, and improving tax administration) and achieved a partial success.

Several case studies (e.g., Ghana, Grenada, Jamaica, Jordan, and Pakistan) highlight the challenges of adjusting adequately the volume and pace of structural reforms to the countries’ capacity and circumstances, as well as building political and social consensus. Ambitious reform agendas often stretched the available absorption capacity, resulting in implementation delays.

In this regard, country officials were generally very appreciative of the Fund’s extensive technical assistance support but commented that while helpful, the provision of IMF TA was not a full substitute for domestic implementation capacity.

Pakistan (2008) programs paid little attention to structural issues outside the area of the Fund’s core expertise and took a hands-off approach by relying on other agencies for Structural Conditions (SC) implementation and follow-up.

Source: Pro Pakistani