Month: September 2021

WM’s ICLM and TUV Unitary Global Payments Systems provide a fully operational and benign model for a functioning Cashless Society worldwide

NEW YORK and ST PETER PORT, Guernsey, Sept. 29, 2021 (GLOBE NEWSWIRE) — To create its Global Clearing System – a digital version of John Maynard Keynes’s proposed “International Clearing Union” – Global Telephony Provider Webtel.mobi (“WM”) also created a Global Unitary Payment System – with two Global Payment Facilities – the ICLM Payments and the TUV Digital Currency Payments (also known as “TUV Payments”).

Both Payment Systems have all the characteristics of Cash Payments and Digital Payments combined, are globally applicable, globally available, require no specialized equipment to function, have multicurrency wallets, enable multicurrency payments with FX Conversions in-wallet, and are equally available to Banked and Unbanked persons.

One of these Payment Systems – the ICLM Payments – is ultra-low cost to use, and the other – TUV Payments – is completely free to use.

These Payment Systems not only facilitate a “Cashless Society”, but have also already introduced a fully operational global Cashless Society system in a benign way. It is benign because this version of a Cashless Society preserves individuals’ privacy, freedom, and choice.

WM’s Payment Systems do not require a Central Bank issued Digital Currency or CBDC to function because WM’s TUV Digital Currency itself is already the equivalent of a Global CBDC.

WM’s Payment Systems – like all its other facilities – are not new. They were functional and operational in 2009, but WM spent nine years testing and perfecting them – and subjecting its system to multiple third-party Due Diligences worldwide – to ensure compliance and robustness before rebuilding its Platform 2 to provide these Facilities in an unrestricted manner internationally.

Access to WM’s services is only available to WM Members because it is a Closed-Loop Members-Only service. However, it is free and instant to join WM as a Member.

WM has one of the safest systems internationally in Security and Anti Money Laundering. WM’s Payment Systems synchronize, into one product, the characteristics of Cash and Digital Money with the ease of use of Cash and the safety of Digital Money. They also have the security of a closed, monitored system and transactions – ensuring robust security and Anti-Money Laundering capacities.

To load WM accounts, Members can transfer funds (”Stored Credit”) into their accounts using any means, and also purchase TUV Digital Currency from WM Agents (“VSMPs”) for cash. The system provides a Unitary and level playing field – and entry into a 21^st Century Digital Economy for all people – whether Banked or Unbanked. It renders even the concepts of “Banked” or “Unbanked” redundant – because the only differentiator is the method used to load funds (“Stored Credit”) onto WM Accounts.

All funds (“Stored Credit”) of WM Members is held in regulated Bank Accounts, so the WM System has permanent 100% liquidity, and all Payment and Settlement Transactions are carried out simultaneously in 1/100^th of a second.

WM’s ICLM Payments and TUV Payments are fully operational, and available to all WM Members on its platform. Examples of some of WM’s ICLM and TUV Payments Systems’ characteristics in comparison to other Payment Systems in the Offline Payments role are as follow:

OFFLINE PAYMENTS CHARACTERISTIC	CARD PAYMENTS	MOBILE PAYMENTS	CASH PAYMENTS	ICLM PAYMENTS	TUV PAYMENTS
Payments made Instantly	Yes	Yes	Yes	Yes	Yes
Functions 24/7/365	Yes	Yes	Yes	Yes	Yes
Funds Secure in Digital Wallets	Yes	Yes	No	Yes	Yes
Functions without a Physical or Digital Card	No	No	Yes	Yes	Yes
Has Combined Usability of Cash and Digital	No	No	No	Yes	Yes
Has Identical Usability to Cash	No	No	Yes	Yes	Yes
Pure Peer 2 Peer Transactions (PP2P)	No	No	Yes	Yes	Yes
Impossible to Carry Out Fraudulent Transactions	No	No	Yes	Yes	Yes
Impossible for Merchants to Incur Chargebacks	No	No	Yes	Yes	Yes
Instant No-Retention Settlement to Merchants	No	No	Yes	Yes	Yes
Payment Process without Intermediaries	No	No	Yes	Yes	Yes
Payment Process without Intermediary Fees	No	No	Yes	Yes	Yes
Receive Payments without Terminals/Equipment	No	No	Yes	Yes	Yes
Functions Alone Without Any Other Entities	No	No	Yes	Yes	Yes
Functions in all Countries and Territories	No	No	Yes	Yes	Yes
Merchant and Payer can Split Payment Fees	No	No	Yes	Yes	Yes
Self-Contained Unitary Global System	No	No	No	Yes	Yes
Uniform Global Security and Standards	No	No	No	Yes	Yes
Total Access from Any Smart Phone	No	No	No	Yes	Yes
Total Access from Any Pre-Smart Mobile Phone	No	No	No	Yes	Yes
Impossible for a 3rd Party to use if Stolen	No	No	No	Yes	Yes
Impossible for a 3rd Party to use if Lost	No	No	No	Yes	Yes
Impossible to Clone or Counterfeit	No	No	No	Yes	Yes
Clients can Pay in Multiple Currencies Globally	No	No	No	Yes	Yes
Clients Control FX Conversions	No	No	No	Yes	Yes
Merchants can Accept Multicurrency Payments	No	No	No	Yes	Yes
Merchants Control FX Conversions	No	No	No	Yes	Yes
Totally Free to Make and Receive Payments	No	No	Yes	0.25% to 1%	Yes

Once people have joined WM as Members and loaded Stored Credit onto their accounts, they can start using the ICLM Payments of TUV Payments Systems immediately – to make or receive payments. The only requirement is a Smart Phone – or a Pre-Smart Phone (which still comprise 50% of Mobile Phones in use) – and the ITAN Number and Registered Mobile Number of the WM Member they want to pay. That is all.

ITAN Numbers (“Inter-TEL.mobi Account Numbers”) are the unique Account Numbers issued to all WM Members when they join, and the Registered Mobile Number is the member’s Mobile Phone Number.

For Merchants to notify clients they accept ICLM and TUV Payments of WM’s unique Global Account Numbering system, they simply need to display this sign, and indicate they accept payment in only one currency, only some currencies or in all currencies.

As all WM Members can execute in-wallet Currency Conversions or Currency Swaps within WM, it makes no difference whether only one currency or all currencies are accepted. This is because all Members can convert before paying or after receiving payments. Examples of the Merchant notifications for accepting ICLM and TUV Payments are as follow:

	We Accept ICLM and TUV Payments						We Accept ICLM and TUV Payments
	Our ITAN:	WM1234567891234567891234					Our ITAN:	WM9876543219876543219876
	Our Mobile:	+XX 1234 567 890					Our Mobile:	+XX 9876 543 210
	Payment Currencies Accepted:		All Currencies				Payment Currencies Accepted:		USD only
	Instant Confirmation by Text:		Yes				Instant Confirmation by Text:		Yes

Resources:

Media Contact:
Nick Lambert: wm@thoburns.com

Video on WM’s Regulatory Compliance:
https://youtu.be/u522lVsGIJI

Video on The Capacities of the WM System:
https://youtu.be/XYBrCikUhn8

Research Reports on the Capacities of the WM System:
https://tinyurl.com/TUVresearch

WM’s urls:
https://webtel.mobi/pc (Tablets / Laptops / Desktops)
https://webtel.mobi (Smart Phones)
https://webtel.mobi/wap (Pre-Smart Mobile Phones)

ADG20 Continues to be Well Tolerated in Healthy Volunteers with Prolonged Half-Life and Serum Virus Neutralization Activity Observed out to Six Months in Ongoing Phase 1 Study

Data from Quantitative Systems Pharmacology/Whole-Body Physiologically Based Pharmacokinetic Modeling Support Evaluation of 300 mg Intramuscular Dose of ADG20 Given as a Single Intramuscular Injection in Ongoing Phase 2/3 Studies

Data to be Presented During IDWeek 2021 and 19^th Annual Discovery on Target Conference

WALTHAM, Mass., Sept. 29, 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 announced new data from the company’s COVID-19 antibody program. Updated, six-month data from its ongoing Phase 1 study of ADG20 in healthy participants and data validating the selection of the 300 mg intramuscular (IM) dose given as a single injection that is being evaluated in the company’s ongoing global Phase 2/3 treatment (STAMP) and prevention (EVADE) clinical trials will be presented during four poster sessions at the Infectious Disease Society of America’s IDWeek 2021, being held from Sept. 29 – Oct. 3, 2021. In addition, Adagio’s chief scientific officer, Laura Walker, Ph.D., will present a subset of the ADG20 Phase 1 data as well as background on the identification and optimization of this differentiated antibody clinical candidate in an oral presentation at the 19^th Annual Discovery on Target Conference on Sept. 30, 2021.

“The continued strength of the safety and pharmacokinetic data from our Phase 1 study is encouraging and further underscores the potential impact an antibody like ADG20 – which was designed to be potent, broadly neutralizing and delivered as a single IM injection – could have on people with or at risk of COVID-19,” said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. “These Phase 1 data combined with our dose selection strategy, which relied on our innovative modeling approach, have allowed us to initiate and advance our pivotal trials of ADG20 in the treatment and prevention of COVID-19. We anticipate these data will support an Emergency Use Authorization (EUA) application in the first quarter of 2022, which could enable us to bring an important treatment option to patients.”

Phase 1 Trial Update
Adagio is evaluating ADG20 in a Phase 1 randomized, double-blind, placebo-controlled single ascending-dose study to assess safety and tolerability, pharmacokinetics (PK), immunogenicity, and serum virus neutralizing activity of ADG20 ex vivo against SARS-CoV-2. Data from a six-month evaluation timepoint confirmed the extended half-life of ADG20, which approached 100 days based on data from the 300 mg IM dose that was given as a single injection. In addition, 50% serum virus neutralization titers at six months after a 300 mg IM dose of ADG20 were similar to observed peak titers with the mRNA-1273 vaccine and exceeded those achieved with the AZD1222 vaccine series. Importantly, ADG20 was well tolerated with no study drug-related adverse events (AEs), serious AEs, or injection-site or hypersensitivity reactions reported through a minimum of three months follow-up across all cohorts. Participants will continue to be followed through 12 months to assess safety and tolerability, PK, immunogenicity and serum virus neutralizing activity.

Phase 1 Poster Information: (633) Preliminary Results from a Phase 1 Single Ascending-Dose Study Assessing Safety, Serum Viral Neutralizing Antibody Titers (sVNA), and Pharmacokinetic (PK) Profile of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)

Dose Selection Strategy
To support dose selection for Adagio’s global Phase 2/3 STAMP and EVADE clinical trials, the company modified an existing quantitative systems pharmacology whole-body physiologically-based pharmacokinetic (QSP/PBPK) model to better characterize the PK of extended half-life monoclonal antibodies in serum and key sites of viral replication in the respiratory tract. Adagio’s model adequately a priori predicted the observed ADG20 serum PK in non-human primates (NHPs) and humans. The model was further optimized based on data from Adagio’s Phase 1 clinical trial and then applied for dose selection for STAMP and EVADE.

For the STAMP treatment trial, data compiled to date suggest that the 300 mg IM regimen has a projected ability to rapidly achieve and maintain target concentrations at key tissue sites of viral replication, including the ability to attain near complete (> 90%) and durable (> 28-day) SARS-CoV-2 receptor occupancy across a range of baseline viral loads. Further, for the EVADE prevention trial, data compiled to date suggest the 300 mg IM regimen has a projected ability to rapidly exceed target serum concentrations in the majority of simulated patients and to maintain potentially effective concentrations for up to 12 months.

Dose Selection Poster Information

• (1086) A Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model that a priori Predicts Intramuscular (IM) Pharmacokinetics of ADG20: an Extended Half-life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)
• (1089) Use of a Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Prevention of Coronavirus Disease (COVID-19)
• (1088) A Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment of Coronavirus Disease (COVID-19)

The STAMP and EVADE clinical trials are currently ongoing and enrolling patients globally. For more information, please visit clincialtrials.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 administered by a single intramuscular injection, 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 (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. 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 to support the completion of clinical trials and initial commercial launch. 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 our planned EUA application, initiation 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; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our manufacturing capabilities and strategy; and our ability to successfully commercialize our product candidates. 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, those risks described under the heading “Risk Factors” in Adagio’s prospectus filed with the Securities and Exchange Commission (“SEC”) on August 6, 2021 and in Adagio’s future reports to be filed with the SEC, including Adagio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. 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:
Dan Budwick, 1AB
Dan@1abmedia.com

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