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“Time Saved” Calculations to Improve Decision-Making in Progressive Disease Studies

Disease modifying therapies (DMTs) are a focus of research for Alzheimer’s disease (AD). DMTs are expected to change the trajectory of disease progression and slow rates of clinical decline (1-3). DMTs may be most beneficial when treatment is begun early in disease to maintain higher levels of function longer and for patients to derive the most total benefit from treatment.

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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

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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