News

Discoverer of the Klotho Gene and Pioneer in Longevity and Disease Prevention Dr. Makoto Kuro-o Joins Scientific Advisory Board of ADvantage Therapeutics

Dr. Kuro-o to speak at Second Annual Entrepreneurship, Longevity and Biotech Conference Held in Boca Raton, Florida

 

BOCA RATON, FL and Vienna, Austria, February 5, 2024 (GLOBE NEWSWIRE) –ADvantage Therapeutics, a pioneer in developing therapies for neurodegenerative conditions by addressing the biology of aging, today announced the appointment to its Scientific Advisory Board of Professor Makoto Kuro-o, a pioneer in the science of aging and longevity and the first to identify the klotho gene.  In addition, Advantage’s CEO, Jeffrey Madden, will provide updates on the development of ADvantage’s lead compound, AD04™, now in phase 2 clinical trials in Alzheimer’s Disease patients, and on the company’s work on the klotho protein, which aims to reduce the effects of aging.

Kuro-o and Madden will speak at the invite-only Entrepreneurship, Longevity, and Biotech Conference in Boca Raton on February 9 and 10. The conference assembles biotech and longevity scientists and entrepreneurs to share research and exchange ideas for improving the biotech and longevity industries.  Last year, Moderna co-founder Professor Robert Langer gave the keynote address.

“The biology of aging is growing in prominence as scientists discover how damage accumulates throughout the body and how some factors, such as the klotho protein, rejuvenate and protect multiple systems,” said Madden. “ADvantage is working to reduce the burden of aging in Alzheimer’s specifically and other age-related conditions more generally, and Dr. Kuro-o will be a tremendous addition in that effort. His discovery of the klotho gene opened a new field that we will work together to advance.

Makoto Kuro-o, M.D., Ph.D. is a professor at the Center of Molecular Medicine, Jichi Medical University, Japan.  He has more than 30 years of research and clinical experience in endocrinology, endocrine fibroblast growth factors, molecular biology of aging, nephrology, and mineral metabolism. He discovered and named the klotho gene in 1997, and since then has written and published extensively on the topic. His pioneering research has opened new and promising paths toward understanding longevity as well as preventing and treating disease. Dr. Kuro-o received his degrees from the University of Tokyo, Japan.

Other speakers at this year’s conference include Dr. Carmela Abraham, Chief Science Officer, ADvantage Therapeutics, Dr. Rudy Tanzi, Professor of Neurology, Harvard Medical School and Director of the Genetics and Aging Research Unit, MGH, Dr. Leona Krohle CEO and Founder, Bluezone Longevity Sphere, Nathan Cheng, General Partner, Healthspan Capital, Lisa Fabiny-Kiser, CEO, SENS Research Foundation, Agustin Fernandez III, CEO, Rational Vaccines, Iosif Gershteyn, CEO, ImmuVia, Bryan Johnson, Founder and CEO, Blueprint, Jeff Madden, CEO, ADvantage Therapeutics, Fiona Miller, Managing Partner, QuadraScope, Jim O’Neill, Co-founder, the Thiel Fellowship, Former HHS Official, Dr. Achim Schneeberger, Chief Medical Officer, ADvantage Therapeutics, Yuri Deigin, Co-Founder, YouthBio Therapeutics, Petr Sramek, CEO, healthylongevity.clinic, Managing Partner, Longevitytech.fund, Dr. Jean Hebert, Professor, Albert Einstein College of Medicine, Daniel Gropper, Dean, FAU College of Business, Dr. Siri Terjesen, Phil Smith Professor, Associate Dean of Research & External Relations, Executive Director, Madden Center for Value Creation at Florida Atlantic University, Leonardo Ferreira, Professor at Medical University of South Carolina. Jonathan Gootenberg, McGovern Fellow at MIT, Omar Abudayyeh, McGovern Institute Fellow at MIT, Andre Watson, Chairman and CEO, Ligandal, and other biotech visionaries.

Sponsored by the Madden Center for Value Creation at FAU’s College of Business and in collaboration with FAU Health, the conference is being held February 9th and 10th on the FAU campus in Boca Raton, Florida.

 

About AD04™

ADvantage Therapeutics is developing AD04™ as a novel immunotherapy for mild Alzheimer’s Disease. The compound has been used extensively as an adjuvant in human and animal vaccination programs. In a previous trial, AD04™ serving as a control against another compound appeared to demonstrate statistically significant slower decline in cognitive and quality of life clinical measures compared to other treatment groups. AD04™ also showed slower decline in hippocampal volume as a biomarker.

The Company believes that rather than being limited to a specific aspect of AD pathology, such as amyloid beta or tau, AD04™ may address inflammatory mechanisms in the brain, functioning as an immunomodulator, stimulating and/or regulating the immune system to reduce AD pathology.

 

About Alzheimer’s Disease

About fifty million people worldwide suffer from Alzheimer’s Disease, which is the sixth leading cause of death in industrialized countries. In 2019, the World Health Organization estimated the total worldwide cost of dementia at $1.3 trillion and expects this cost to rise to $2 trillion by 2030. The socio-economic burden of Alzheimer’s Disease is enormous. AD devastates the lives of patients and their families. AD victims lose their memory and independence. Alzheimer’s Disease is a high unmet medical need as there are currently no disease-modifying drugs approved worldwide. The availability of a safe, effective, affordable drug would transform the life of an AD patient from accepting a debilitating disease to the retention of personality, independence, and dignity.

 

About ADvantage Therapeutics, Inc.

Headquartered in the Wynwood neighborhood in Miami, ADvantage Therapeutics is developing therapies to treat neurodegenerative conditions with a central focus on Alzheimer’s Disease. The Company’s lead compound AD04™ is a subcutaneous injectable therapy that entered, in November 2023, confirmatory Phase 2b clinical trials in Europe, to evaluate its safety and efficacy in early AD patients. The Company believes that AD04™ may function as an immunomodulator, stimulating and regulating the immune system to reduce AD pathology, rather than limiting therapy to attack the misfolded proteins, beta amyloid and tau. The Company is exploring additional approaches to mitigating neurodegenerative disease, among them increasing the levels of Klotho, a life and health extending protein which will have an overall impact on longevity.

 

About ADvantage Therapeutics GmbH

ADvantage Therapeutics GmbH, founded in 2021, is the Vienna BioCenter-based subsidiary of ADvantage Therapeutics, Inc., where the Company conducts early research and drug development.

 

Safe Harbor-Forward-Looking Statements

This press release may contain forward-looking statements, including statements of potential mode of action, potential clinical effect, potential safety, and ADvantage’s potential clinical development program and pipeline program. ADvantage is in the early stages of developing and testing its AD04™ compound and may not receive future regulatory approvals needed for marketing it as a drug. The described clinical effect of our lead compound AD04™ is primarily based on results of a Phase 2 study designed to evaluate a different compound. The described results need to be confirmed for proof of concept, might not be representative of larger scale clinical trials, and do not guarantee future clinical success. Any preclinical results presented here are interim. The mechanism of action of AD04™, as potentially determined in our future investigations, particularly in future clinical trials with patients with Alzheimer’s Disease, might differ from the one presented.

 

Contacts:

For ADvantage Therapeutics

195 NW 40th Street

Miami, FL 33127

 

Jeffrey Madden CEO

[email protected]

(786) 542-5499

 

David Buchsbaum CFO

[email protected]

(786) 542-5499

 

 

 

 

 

 

 

 

 

 

02-05-2024 – ADVantage Thx – Kuro-o and Corference FINAL 02.05.2024 FINAL

News

ADvantage Therapeutics Has Commenced Enrollment for Its Phase 2b Clinical Trial of AD04™ for Treatment of Alzheimer’s Disease

MIAMI, November 27, 2023 (GLOBE NEWSWIRE) – ADvantage Therapeutics, Inc. (“ADvantage” or “the Company”), a pioneer in developing therapies for neurodegenerative conditions by addressing the biology of aging, today announced the first patient enrolled in the Company’s European Phase 2b clinical trial on its lead candidate, AD04™ for the treatment of mild Alzheimer’s disease (AD).

The Phase 2b randomized, double-blind, placebo-controlled trial aims to confirm proof-of-concept and establish the safety and efficacy of AD04™ in patients with mild AD.  The first patient was enrolled at Institut Neuromed, Korneuburg, Austria. The study is authorized to be conducted in Austria, France, Poland, Bulgaria, and Slovakia, and is expected to expand to Germany and the U.K. in the coming months.

Dr. Andreas Winkler, MSc., principal investigator at Institut Neuromed, commented, “AD represents a significant global problem as the adult population is aging which further challenges  our ability to care for those who suffer from this terrible, progressive disease.  AD04 represents a significant departure from approaches seen to date and one that may change our understanding of how to manage it as well as the disease itself.  We look forward to continuing to participate in the trial to help contribute to its development.”

The primary endpoint of the 12-month study is to be a composite score integrating ADAScog, ADCS-ADL and CDR-sb (at 12 months). Other measured outcomes include hippocampal volume, CDR-sb, the Neuropsychiatric Inventory (NPI), the Alzheimer’s disease Assessment scale – cognition 13-item scale (ADAScog13), the Alzheimer’s Disease Cooperative Study – Activities of Daily Living Standards (ADCS-ADL), and the patient quality of Life-Alzheimer’s disease.

In a previous study, a 2mg dose of AD04™ used in a control arm exhibited a statistically significantly slower decline in cognitive and quality of life measures compared to other arms of that trial. The AD04™ control group also showed slower decline in MRI-measured hippocampal volume as a biomarker of AD progression. Preclinical studies have indicated that AD04 decreased the number of pro-inflammatory microglial cells in the hippocampus of mouse models.Pro-inflammatory microglia are one of the neuropathological events observed in the brains of Alzheimer’s patients.

Achim Schneeberger, M.D., chief medical officer of ADvantage, further commented, “Inclusion of this first patient is representative of many years and many dedicated professionals collaborating toward the common goal of better treating Alzheimer’s disease.  We look forward to continuing our collaboration with the European regulatory agencies and the clinical sites to populate this important trial.”

Recently, the Company received an Innovation Passport for the treatment of AD under the Innovative Licensing and Access Pathway (ILAP) for AD04™ in the United Kingdom. This allows for close collaboration with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and NHS England and NHS Improvement (NHSE&I). In addition, patients are considered key partners, and the patient voice is integrated at every development stage. ILAP incorporates the concepts of innovation and patient need according to the MHRA.

“It is gratifying to achieve this milestone after months of labor by a most dedicated team of professionals.  We intend to create medicines that will help to prolong lives but also improve their quality.  We look forward to providing additional updates on the progress of this potentially landmark trial,” added Jeffrey Madden, ADvantage Therapeutics CEO.

ADvantage Therapeutics is dedicated to advancing the science of neurodegenerative diseases and committed to developing innovative therapies that can make a meaningful difference in the lives of patients. For more information on ADvantage Therapeutics, Inc., please visit www.advantagetherapeutics.com.

 

About AD04™

ADvantage Therapeutics is developing AD04™ as a novel therapy for mild Alzheimer’s Disease. The compound has been used as an adjuvant in human and animal vaccination programs. In a previous trial, AD04™ serving as a control against another compound appeared to demonstrate statistically significantly slower decline over other treatment groups in cognitive and quality life clinical measures. AD04™ also showed slower decline in hippocampal volume as a biomarker.

The Company believes that rather than being limited to a specific aspect of AD pathology, such as amyloid beta or tau, AD04™ may address innate immunological mechanisms in the brain. The Company believes AD04™ may function as an immunomodulator, stimulating and/or regulating the innate immune system to reduce AD pathology.

About Alzheimer’s Disease

About forty-four million people worldwide suffer from Alzheimer’s Disease, and it is the sixth leading cause of death in industrialized countries. According to Alzheimer’s Disease International,  the annual global cost of dementia is now above US$ 1.3 trillion and is expected to rise to US$ 2.8 trillion by 2030. The socio-economic burden of Alzheimer’s Disease is enormous. AD devastates the lives of patients and their families. They lose their memories and independence, and the loss of a loved relation leaves behind guilt, grief, and anger. Alzheimer’s Disease is a high unmet medical need as there are currently no disease-modifying drugs approved worldwide. The availability of a safe, effective, affordable drug would transform the life of an AD patient from accepting a debilitating disease to the retention of personality, independence, and dignity.

About ADvantage Therapeutics

Headquartered in the Wynwood neighborhood in Miami, ADvantage Therapeutics is developing therapies to treat neurodegenerative conditions with a central focus on Alzheimer’s disease. The Company’s lead compound AD04™ is an injectable therapy in the process of entering into a confirmatory Phase 2b clinical trials in Europe to evaluate safety and efficacy of the product in mild Alzheimer’s Disease. The Company believes that AD04™ may function as an immunomodulator, stimulating and regulating the immune system to reduce AD pathology, rather than limiting therapy to AD-modified proteins such as amyloid and tau. The Company is also exploring additional approaches to mitigating neurodegenerative disease, which it believes will eventually have an overall impact on longevity.

About ADvantage Therapeutics GmbH

ADvantage Therapeutics GmbH, founded in 2021, is the Vienna BioCenter-based subsidiary of ADvantage Therapeutics, Inc., where the Company conducts early research and drug development. ADvantage is developing therapies to treat neurodegenerative conditions like Alzheimer’s Disease (AD).

11-27-2023 – ADvantage Therapeutics – 1st Patient in FINALCRA corrected copy[43]Safe Harbor-Forward-Looking Statements

This press release may contain forward-looking statements, including statements of potential mode of action, potential clinical effect, potential safety, and ADvantage’s potential clinical development program and pipeline program. ADvantage is in the early stages of developing and testing its AD04™ compound and may not receive regulatory approval to conduct the contemplated Phase 2b trial. The described clinical effect of our lead compound AD04™ is primarily based on results of a Phase 2 study designed to evaluate a different compound. The described results need to be confirmed for proof of concept, might not be representative of larger scale clinical trials, and do not guarantee future regulatory approval or clinical success. Any preclinical results presented here are interim. The mechanism of action of AD04™ as potentially determined in our future investigations, particularly in future clinical trials with patients with Alzheimer’s Disease, might differ from the one presented.

 

Contacts:

 

For ADvantage Therapeutics

195 NW 40th Street

Miami, FL 33127

 

Jeffrey Madden CEO

[email protected]

(786) 542-5499

 

David Buchsbaum CFO

[email protected]

(786) 542-5499

 

For Media:

Jules Abraham

JQA Partners, Inc.

[email protected]

(917) 885-7378

News

ADvantage Therapeutics taking disruptive approach to mild Alzheimer’s

Closely-held ADvantage Therapeutics is awaiting regulatory approval in Europe to proceed with a Phase 2b confirmatory clinical trial of its lead drug candidate, AD04, for the treatment of mild Alzheimer’s disease (AD).

“We consider AD to be an autoimmune disease,” Jeffrey Madden, CEO of ADvantage, says in an interview with BioTuesdays.

“And, instead of going after the consequences of AD, such as tau-protein and amyloid aggregates, we analyze immunological and neuroinflammatory events in specific parts of the brain. We believe these are causes of brain shrinkage and cognitive decline seen in AD,” he contends.

By targeting neuron inflammation, AD04 has been designed to “prime the peripheral immune system and reduce neuroinflammation in the brain. Early clinical results suggest that this approach, which disrupts conventional thinking, may circumvent the amyloid hypothesis.”

Mr. Madden explains that AD04 is an injectable immunotherapy that has been used as an adjuvant in human and animal vaccination programs for decades and generated a well-established safety record.

AD04 traces its roots to a Phase 2 study in 2014 where it served as a control arm for an unsuccessful vaccine against amyloid-beta peptides in mild AD. But researchers discovered the 2 mg dose AD04 control arm demonstrated a statistically significant slower decline in cognition and quality of life than other arms of the trial.

Importantly, the AD04 control group showed slower decline in MRI-measured hippocampus volume as a biomarker of AD progression. The hippocampus is the part of the brain that harbors memory and orientation functions.

In labs at the Vienna BioCenter, Mr. Madden points out that ADvantage’s scientists have used animal studies to identify the mechanism of action for AD04 that connects to an important interleukin known to modulate the activation of microglia in the brain.

Specifically, AD04 decreased the number of inflammatory microglial cells in the hippocampus of mouse models. An increase of inflammatory microglial cells in the hippocampus is commonly associated with the eventual development of amyloid-lipid plaques in the brain.

“In layman terms, think of this interleukin as a Wi-Fi signal that communicates to the brain to switch from neuroinflammation to neuroprotection to regain homeostasis,” he suggests.

In April 2023, the UK’s Medicines and Healthcare Products Regulatory Agency granted AD04 an Innovation Passport for the treatment of AD under the innovative Licensing and Access Pathway (ILAP), which accelerates patient access and commercialization. AD04 is only the second Alzheimer’s drug candidate to receive this designation.

The Innovation Passport facilitates working with the National Institute for Health and Care Excellence regarding reimbursement during the Phase 2b study and patient access during the Phase 3 trial.

ADvantage has applied for clinical trial authorization at 16 sites in France, Germany, Austria, Bulgaria, Poland, and Slovakia for a randomized, placebo-controlled, double-blind Phase 2b study with 122 participants to further confirm proof of concept and establish the safety and efficacy of AD04 in mild AD patients.

The 12-month study will measure standard clinical parameters plus hippocampal volume as an objective biomarker endpoint. Other measured outcomes include immune response, neuroinflammation and lipid metabolism, in addition to exploratory biomarkers from preclinical studies.

Founded in 2021, ADvantage has privately raised more than $10-million. Looking forward, an additional $10-million will be required to complete its Phase 2b clinical trial and $5-million for preclinical research and corporate purposes not covered by grants. This is expected to fund operations until the interim readout of the Phase 2b study in the second half of 2024, Mr. Madden says.

ADvantage also is in preclinical development to improve the bioavailability of the Klotho protein, which is also known as the longevity gene that may play a role in neurodegeneration in the brain, including AD.

Preventing the normal decline in Klotho during aging may protect against age-related diseases through the mitigation of oxidative stress and inflammation, Mr. Madden points out. While Klotho levels decline with age, higher Klotho levels are associated with higher cognitive reserve and a lower rate of dementia.

“We are enthusiastic about ADvantage’s preclinical research in raising Klotho expression,” he contends. “Our proprietary Klotho mRNA is more than five times as potent as the native Klotho mRNA.”

ADvantage filed a patent for its Klotho discovery in March 2023. In total, the company has 22 patents issued and six pending that protect aluminium oxyhydroxide for use in the treatment and prevention of AD; as the active agent and use at specific minimum doses for the treatment of AD; as well as aluminium salts in a method of treatment of AD.

About 44 million people worldwide suffer from AD, with six million to eight million new cases each year. AD is the sixth leading cause of death in the industrialized world. And according to the World Health Organization, total worldwide costs of dementia are forecast to reach $2-trillion by 2030.

In June 2021, the FDA approved Biogen’s Aduhelm (aducanumab), a monoclonal antibody that targets amyloid beta found in the brains of people with AD to reduce its buildup.

However, many researchers contend that aducanumab did not show a strong signal for cognitive decline in pivotal studies. The FDA’s scientific advisory panel recommended against approving the antibody in an eight-to-one vote, and three panel members resigned after the FDA authorized it anyway.

When compared to historical studies for aducanumab, donanemab, lecanemab and solanezumab using the GST (global statistical test), AD04 shows superior treatment effect sooner, Mr. Madden says.

Relative to monoclonal antibodies, he says AD04 has a low manufacturing cost, simple storage, and can be easily administered subcutaneously. “If safety and efficacy continue to be demonstrated in additional clinical trials, AD04 has the potential to democratize Alzheimer’s treatment and provide patients with affordable access to a better life.”

Editor’s Note: This article does not constitute an offer to sell or the solicitation of an offer to buy any securities of ADvantage, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

• • • • •

To connect with ADvantage Therapeutics or any of the other companies featured on BioTuesdays, send us an email at [email protected].

News

MHRA Grants ADvantage Therapeutics Innovative Licensing and Access Pathway (ILAP) Designation for Novel Lead Product AD04™ for Phase 2b Trial in Alzheimer’s Disease

ILAP Designation accelerates patient access and commercialization

 

MIAMI, APRIL XX, 2023 (GLOBE NEWSWIRE) – ADvantage Therapeutics, Inc. (“ADvantage” or “the Company”), which is developing therapies to treat neurodegenerative conditions with a central focus on Alzheimer’s Disease (AD), today announced that the Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom National Competent Authority, has granted the Company’s lead compound AD04™ an Innovation Passport for the treatment of AD under the Innovative Licensing and Access Pathway (ILAP).

ILAP was established in 2021 to reduce the time to market for innovative medicines in the United Kingdom. According to the Agency, the ILAP combines the MHRA’s globally recognized strengths of independence and high standards of quality, safety, and efficacy, with improved efficiency and flexibility, readying the MHRA for a new era in medicines approvals in the UK. The designation allows for significant input and collaboration with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and NHS England and NHS Improvement (NHSE&I).  In addition, patients are also considered key partners and the patient voice is integrated at every development stage.  The MHRA indicates that ILAP incorporates broad and inclusive concepts of innovation and patient need.

“We are delighted that MHRA has recognized the potential of AD04™ at same time we are launching our confirmatory trial,” said Jeffrey Madden, chief executive officer of ADvantage.  “AD04™ may completely change the approach to the treatment of Alzheimer’s Disease.  The ILAP designation creates an accelerated pathway to approval, commercialization, and patient access, by providing a more open dialogue with all the U.K. agencies, including NICE, which oversees access and integration of novel therapies into the National Health Service (NHS) and NHS Wales. We believe our novel immunotherapy for Alzheimer’s has a low manufacturing cost, simple storage, subcutaneous administration, and believe that forthcoming clinical studies will confirm safety, efficacy and tolerability. If proven and approved, the rapid introduction of AD04™ into the U.K. health system may support accelerated clinical adoption in other worldwide healthcare systems.”

The Phase 2b trial for AD04™ in the ILAP application will be a randomized, placebo-controlled, double-blind study to confirm proof of concept and establish the safety and efficacy of AD04™ in mild AD patients.  The 12-month study will measure hippocampal volume as an objective/biomarker endpoint. Other measured outcomes include the Alzheimer’s Disease Assessment scale – cognition 13-item scale (ADAScog13), the Alzheimer’s Disease Cooperative Study – Activities of Daily Living Standards (ADCS-ADL), the Clinical Dementia Rating – sum of boxes (CDR-sb), the patient Quality of Life-Alzheimer’s Disease and the Neuropsychiatric Inventory (NPI).

A 2mg dose of AD04™ served as a control in a prior study of another compound, where it demonstrated a statistically significantly slower decline in outcomes (cognition, function and quality of life) than other arms of that trial.  In addition, the AD04™ control group showed slower decline in MRI-measured hippocampal volume as a biomarker of AD progression. To date, preclinical studies have shown that AD04™ decreased the number of inflammatory microglial cells in the hippocampus of mouse models. Inflammation and hyperproliferation of microglial cells are pathological immunological events in the brain of Alzheimer’s patients.

Dr. Rudolph Tanzi, who serves as Chair of the Scientific Advisory Board at ADvantage Therapeutics, Inc. stated, “The democratization of Alzheimer’s disease treatments that are safe, effective, and affordable for all are of utmost importance. We hope this AD04™ trial with ILAP designation will bring us one step closer.” he concluded.

 

About ILAP
The Innovative Licensing and Access Pathway (ILAP) aims to provide significant benefits to patients, the National Health Service (NHS) and the life sciences industry by delivering a safe and efficient route for accelerated access to new medicines, as well as encouraging growth of pharmaceutical research and investment in the UK. In addition to (MHRA, NICE, SMC, AWTTC), other partners within the pathway include NHS England and NHS Improvement (NHSEI) and the National Institute for Health Research (NIHR).  The ILAP has for the first time facilitated collaboration between NICE, the AWTTC, and the SMC under a unified umbrella to support activities, provide scientific advice, and engage a variety of stakeholders in the Health Technology Assessment (HTA) evaluation of new technologies.

Product developers within the ILAP are given the ability to jointly consult all partners as required at each stage and discuss potential hurdles in advance for obtaining concurrent advice on navigating the path for successful market access. It requires applicants to meet three key criteria.  The first is that the condition the medicinal product aims to treat is life-threatening or seriously debilitating or there is a significant patient or public health need.

Second, the medicinal product must fulfill one or more specific criteria, which include being an innovative medicine such as an advanced therapy medicinal product (ATMP) or new chemical or biological entity or novel drug device combination, a medicine being developed in a clinically significant new indication for an approved medicine, a medicine for rare disease and/or other special populations such as neonates and children, elderly, and pregnant women, or is a development aligning with the objectives for UK public health priorities such as the Chief Medical Officer, Department of Health and Social Care (DHSC), or Life Sciences Sector Deal (including those in Devolved Administrations, where appropriate).

Third, the medicinal product must have the potential to offer benefits to patients.

 About AD04™
ADvantage Therapeutics is developing AD04™ as a novel immunotherapy for mild Alzheimer’s Disease. The compound has been used as an adjuvant in human and animal vaccination programs. In a previous trial, AD04™ serving as a control against another compound appeared to demonstrate statistically significantly slower decline over other treatment groups in cognitive and quality life clinical measures.  AD04™ also showed slower decline in hippocampal volume as a biomarker.

The Company believes that rather than being limited to a specific aspect of AD pathology, such as amyloid beta or tau, AD04™ may address immunological mechanisms in the brain and at the periphery.  The Company believes AD04™ may act as an immunomodulator, stimulating and/or regulating the immune system to reduce AD pathology.

About Alzheimer’s Disease
About 44 million people worldwide suffer from Alzheimer’s Disease, and it is the sixth leading cause of death in industrialized countries.  In 2019, the World Health Organization estimated the total worldwide cost of dementia at $1.3 trillion and expects this cost to rise to $2 trillion by 2030.  While the FDA provisionally approved an anti-amyloid-beta antibody, Aducanumab, in 2021, widespread coverage has not been granted, nor have European countries approved the product.  The socio-economic burden of Alzheimer’s Disease is enormous. AD devastates the lives of patients and their families. They lose their memories and independence, and the loss of a loved relation leaves behind guilt, grief, and anger. Alzheimer’s Disease is a high unmet medical need as there are currently no disease-modifying drugs approved worldwide. The availability of a safe, effective, affordable drug would transform the life of an AD patient from accepting a debilitating disease to the retention of personality, independence, and dignity.

About ADvantage Therapeutics
Headquartered in the Wynwood neighborhood in Miami, ADvantage Therapeutics is developing therapies to treat neurodegenerative conditions with a central focus on Alzheimer’s disease. The Company’s lead compound AD04™ is an injectable therapy in the process of entering into a confirmatory Phase 2b clinical trials in Europe to evaluate safety and efficacy of the product in early Alzheimer’s Disease.  The Company believes that AD04™ may act as an immunomodulator, stimulating and regulating the immune system to reduce AD pathology, rather than limiting therapy to the aggregation of the proteins present once pathology is present. The Company is also exploring additional approaches to mitigating neurodegenerative disease, which it believes will eventually have an overall impact on longevity.

About ADvantage Therapeutics GmbH
ADvantage Therapeutics GmbH, founded in 2021, is the Vienna BioCenter-based subsidiary of ADvantage Therapeutics, Inc., where the Company conducts early research and drug development. ADvantage is developing therapies to treat neurodegenerative conditions like Alzheimer’s Disease (AD) and is currently preparing for clinical trials in Europe and in the U.S.

Safe Harbor-Forward-Looking Statements
This press release may contain forward-looking statements, including statements of potential mode of action, potential clinical effect, potential safety, and ADvantage’s potential clinical development program and pipeline program. ADvantage is in the early stages of developing and testing its AD04™ compound and may not receive regulatory approval to conduct the contemplated Phase 2b trial.  The described clinical effect of our lead compound AD04™ is primarily based on results of a Phase 2 study designed to test a different compound. The described results need to be reproduced for proof of concept, might not be representative of larger scale clinical trials, and do not guarantee future regulatory approval or clinical success. Any preclinical results presented here are interim. The mechanism of action of AD04™ as potentially determined in our future investigations, particularly in future clinical trials with patients with Alzheimer’s Disease, might differ from the one presented.

 

Contacts:

For ADvantage Therapeutics

195 NW 40th Street

Miami, FL 33127

Jeffrey Madden CEO

[email protected]

(305) 846-9027

David Buchsbaum CFO
[email protected]

(305) 846-9027

 

For Media:
Jules Abraham
JQA Partners, Inc.
[email protected]

(917) 885-7378

News

Renowned Public Health Advisor Jim O’Neill Joins Board of Directors of ADvantage Therapeutics Appointment announced today at inaugural Entrepreneurship, Longevity and Biotech Conference Held in Boca Raton

Renowned Public Health Advisor Jim O’Neill Joins Board of Directors of ADvantage Therapeutics Appointment announced today at inaugural Entrepreneurship, Longevity and Biotech ConferenceHeld in Boca Raton 

BOCA RATON, Fla. and VIENNA, Austria, March 24, 2023 (GLOBENEWSWIRE) — ADvantage Therapeutics, Inc. (“ADvantage” or “theCompany”), which is developing therapies to treat neurodegenerativeconditions with a central focus on Alzheimer’s disease, todayannounced the election of James O’Neill — a recognized leader inhealth, aging, and longevity — to its Board of Directors. ADvantage CEOJeffrey Madden also provided updates on the development of theCompany’s lead compound, AD04™ in Alzheimer’s Disease andintroduced an advancement in the protein klotho designed to benefitlongevity.

“The addition of Jim to our Board of Directors signals the next level ofdevelopment for our company,” said Jeffrey Madden, chief executiveofficer. “As we embark upon our confirmatory Phase 2b study forAD04™ in early Alzheimer’s disease, we are fortunate to have Jim’stalents and experience to guide us during this exciting time.”

“In addition, Jim’s deep expertise in longevity will serve us well as wedevelop our mRNA technology to fight pathologies of aging byadvancing and sustaining the capabilities of klotho, which manyconsider the longevity gene. We are developing platform technology to

create a pipeline of [targets] to tackle the most common diseases ofaging by using the klotho protein. We look forward to Jim’s guidance inthis area,” concluded Mr. Madden.

Mr. O’Neill began his career in public policy and helped lead the U.S.Department of Health and Human Services as the principal associatedeputy secretary. He oversaw policy and regulations for NIH, FDA, andCDC. He helped structure the department’s $700 billion budget,oversaw two sweeping reforms of FDA, and led many other projects,especially in security, intelligence, preparedness, and health diplomacy.

Since leaving government, Mr. O’Neill has advised or invested in morethan sixty science and technology companies. While leading the ThielFoundation, he co-founded the Thiel Fellowship. He also served as amanaging director at Clarium/Thiel Macro, a global macro investmentfund.

As CEO and board member of SENS Research Foundation (SRF), Mr.O’Neill oversaw strategy and operations for a team of scientists whoresearch, develop, and promote comprehensive regenerative medicinesolutions for the diseases of aging. SRF supports research focused on adamage repair paradigm at labs across America and Europe. 

As global health advisor to Rational Vaccines, Jim advances thecompany’s mission to relieve suffering from all diseases resulting from herpes simplex virus 1 and herpes simplex virus 2 infections.

In addition, Mr. O’Neill supported the creation of the Armed ForcesInstitute for Regenerative Medicine, served on the steering committeeof the Biomedical Advanced Research and Development Authority, andserved on the United States delegation to the World HealthAssembly. O’Neill also served on the President’s Management Council, the Task Force on New Americans, and the Suitability and SecurityClearance Performance Accountability Council, as well as frequently representing the Department on the Homeland Security Council, theNational Security Council, the Domestic Policy Council, and the Council for Environmental Quality.

An advocate for global human rights, he has spoken at the OsloFreedom Forum, the Human Rights Foundation’s annual gathering ofdissidents, advocates, journalists, tech entrepreneurs, and artists.

Mr. O’Neill lives in Marin County, California. He holds a B.A from Yale University and an A.M. from the University of Chicago.

“Following tens of billions of dollars the industry devoted to the amyloidhypothesis, ADvantage Therapeutics’ approach to Alzheimer’s diseaseis fresh and extremely promising,” said O’Neill. “AD04 has the potential to radically improve the lives of millions. I am excited to collaborate with ADvantage to help propel it forward.”

Mr. Madden made the announcement at the invite-only Entrepreneurship, Longevity, and Biotech Conference, which assembled biotech and longevity scientists and entrepreneurs in Boca Raton to share research and exchange ideas for improving the biotech and longevity industries. 

Sponsored by the Madden Center for Value Creation at FAU’s College ofBusiness and in collaboration with FAU Health, the conference is being held today on the FAU campus.

The conference features speeches by Moderna co-founder Robert Langer; former HHS Deputy Secretary Eric Hargan; Cambrian Bio CEO James Peyer; Kernel, Blueprint, and Braintree founder Bryan Johnson; and other biotech visionaries.

About AD04™ADvantage Therapeutics is developing AD04™ as a novel immunotherapy for early Alzheimer’s disease. The compound has been used as an adjuvant in human and animal vaccination programs. In aprevious trial, AD04™ serving as a control arm against another compound appeared to demonstrate statistically significantly slower decline over other treatment groups in cognitive and quality life clinical measures. AD04™ also showed slower decline in hippocampal volumeas a biomarker.

The Company believes that rather than being limited to a specific aspect of AD pathology, such as amyloid beta or tau, the use of AD04™may address the immunological mechanisms in the brain and peripheral immune system. The Company believes AD04™ may act asan immunomodulator, stimulating and/or regulating the immunesystem to reduce AD pathology.

About Alzheimer’s disease

About 44 million people worldwide suffer from Alzheimer’s disease, and it is the sixth leading cause of death in industrialized countries. In 2019,the World Health Organization estimated the total worldwide cost of dementia at $1.3 trillion. While the FDA provisionally approved an anti-amyloid beta antibody, aducanumab, in 2021, widespread coverage has not been granted, nor have European countries approved the product. The socio-economic burden of Alzheimer’s disease is enormous. AD devastates the lives of patients and their families. They lose their memories and independence, and the loss of a loved relation leaves behind guilt, grief, and anger. Alzheimer’s disease is a high unmet medical need as there are currently no disease-modifying drugs approved worldwide. The availability of a safe, effective, affordable drug would transform the life of an AD patient from accepting a debilitating disease to the retention of personality, independence, and dignity.

About ADvantage Therapeutics

Headquartered in Miami, ADvantage Therapeutics is developing therapies to treat neurodegenerative conditions with a central focus on Alzheimer’s disease. The Company’s lead compound AD04™ is an injectable therapy in the process of entering into a confirmatory Phase 2b clinical trials in Europe to evaluate safety and efficacy of the product in early Alzheimer’s disease. The Company believes that Alhydrogel may act as an immunomodulator, stimulating and regulating the immune system to reduce AD pathology, rather than limiting therapy to the aggregation of the proteins present once pathology is present. The

Company is also exploring additional approaches to mitigatingneurodegenerative disease, which it believes will eventually have anoverall impact on longevity.

ADvantage Therapeutics GmbH

Founded in 2021 is the Vienna BioCenter-based subsidiary of ADvantage Therapeutics, Inc., where the Company conducts early research and drug development. ADvantage is developing therapies to treat neurodegenerative conditions like Alzheimer’s disease (AD) and is currently preparing for clinical trials inEurope and in the U.S.

Safe Harbor-Forward-Looking Statements

This press release may contain forward-looking statements, including statements of potential mode of action, potential clinical effect, potential safety, and Advantage’s potential clinical development program and pipeline program. ADvantage is in the early stages of developing and testing its AD04™ compound and may not receive regulatory approval to conduct the contemplated Phase 2b trial. The described clinical effect of our lead compound AD04™ is primarily based on results of a Phase 2 study designed to test a different compound. The described results need to be reproduced for proof ofconcept, might not be representative of larger scale clinical trials, anddo not guarantee future regulatory approval or clinical success. Any preclinical results presented here are interim. The mechanism of actionof AD04™ as potentially determined in our future investigations,particularly in future clinical trials with patients with Alzheimer’sdisease, might differ compared to the one presented.

Contacts:

For ADvantage Therapeutics

195 NW 40 thStreetMiami, FL 33127

Jeffrey Madden CEO

[email protected]

(305) 846-9027

David Buchsbaum CFO

[email protected]

(305) 846-9027

For Media:

Jules Abraham

JQA Partners, Inc.

[email protected]

(917) 885-7378

Tags#ADvancedTherapeutics#Alzherimer’sdisease#JimO’Neill#AD04#Klotho#MaddenCenter#RobertLanger#longevity