ADvantage Therapeutics Developing Therapies to Treat Neurodegenerative Conditions with Focus on Alzheimer’s Disease
Company Awaits Regulatory Clearance to Conduct Confirmatory Phase 2b Trial for Lead Product Candidate AD04™...
ADvantage Therapeutics is developing therapies to treat neurodegenerative conditions with a major focus on Alzheimer’s Disease (AD). We are currently preparing for clinical trials in Europe and in the US. Furthermore, ADvantage is developing potentially paradigm-changing therapies to treat AD in its labs at the Vienna BioCenter.
The most fruitful basis of the discovery of a new
drug is to start with an old drug.
~ Sir James W. Black,
1988 Nobel Prize in Medicine
We will sustain a knowledge-building culture, rooted in win-win relationships, that combines leading-edge scientific skill, unencumbered by conventional assumptions, with a passion for bringing paradigm-changing medical treatments to patients worldwide.
Jeffrey Madden
My fuel is my conviction in our science.
Frank Mattner
Since we have found by serendipity the first disease-modifying compound for Alzheimer’s, we will make Alzheimer’s patients to benefit at last!
Walter Schmidt
Late onset Alzheimer’s disease runs in my family history which, is the driving force behind creating the greatest medication we may need ourselves later in life.
Sylvie Trembleau
Developing a novel Alzheimer’s drug with disease modifying potential together with global investigators and employing state-of-the-art clinical tools is in and of itself inspiring.
Achim Schneeberger
The pursuit of new therapeutics for such a pernicious disease as Alzheimer’s requires disruptive approaches based on data which modify progression at an early stage.
David Buchsbaum
Over the last 20 years, Alzheimer’s research concentrated on therapies to produce antibodies against different amyloid-beta peptide species, which were shown to accumulate in the brains of Alzheimer’s patients. However, clinical trial efficacy proved elusive.
Meanwhile, the research team led by Drs. Frank Mattner, Walter Schmidt and Achim Schneeberger developed a (mimotope-based) vaccine, AD02, against amyloid-beta peptides (with a free N-terminus).
In 2014, the team orchestrated a double-blinded, randomized clinical phase 2 trial with AD02 in 332 Alzheimer’s patients. In this trial, Alhydrogel® (now called AD04™) served as a control group.
Unexpectedly, the patients from the control group significantly benefited from the AD04™ application while the AD02 vaccinated groups did not. The shrinkage of the Hippocampus, where memory and orientation are located, was positively impacted by AD04™ treatment coupled with slowdown of cognitive decline.
After several years of negotiation, Frank and Walter bought the patent rights for AD04™. They joined Agustin Fernandez and Jeffrey Madden and founded ADvantage Therapeutics Inc. in order to provide Alzheimer’s patients a transformative, life-enhancing treatment.
*1 The Hippocampus is the part of the brain that harbors memory and orientation functions.
Our product candidate, AD04™, is a known immuno-stimulant: this compound has been widely used as an adjuvant in human and animal vaccination programs and has a well-established safety record. However, injection of this compound as single ingredient for the treatment of AD is a proprietary approach.
What results have you seen that support the clinical development of AD04™?
Our data obtained in patients with early AD indicated that AD04™, applied repeatedly to the subcutis of the upper arm induced a statistically significant slower decline over the combined 4 other groups on clinical outcomes (e.g. cognition and quality of life) and MRI hippocampal volume as biomarker. Importantly, reduced loss of the hippocampal volume correlated with significantly less decline in cognitive measures, e.g., adapted Alzheimer’s Disease Assessment Scale-cognitive (aADAS-cog), but not in functional endpoints supporting AD04™ as a therapeutic entity (see “Summary of Phase 2”).
AD04™ tested in the respective clinical trial arm (n=51 patients) was safe and well tolerated. There was neither evidence for autoimmunity nor for hematological abnormalities or hepato-/nephrotoxicity.
MORE ABOUT OUR SCIENCE Our PipelineThe world desperately needs disease-modifying therapies for AD: we combine immunology and neuroscience to create first-in-class therapeutics.
MORE ABOUT OUR PIPELINECompany Awaits Regulatory Clearance to Conduct Confirmatory Phase 2b Trial for Lead Product Candidate AD04™...
Our work suggests that our lead therapeutic (AD04™) regulates the immune system to provide patients with a unique positive effect on the course of Alzheimer’s Disease pathology. Our vision is to provide patients with a disease-modifying therapeutic for early Alzheimer’s Disease, thereby making the world a distinctly better place.
All decisions are made with the best interest of the patient. Period.
Root-cause explanations — with experimental evidence — drive our work and may overturn widely held assumptions. Knowledge building is in our DNA.
Integrity is key. We seek win-win relationships with stakeholders inside and outside the organization. We are only as good as our word.
Entrepreneurs at heart, we thrive taking on significant challenges and breaking new ground. In the words of Marie Curie, “I was taught that the way of progress was neither swift nor easy.”
Vaccines using Alhydrogel® (e.g. AD02) contain in addition an antigen, which plays a central role in guiding the immune response. Thus, AD04™ as single ingredient stimulates necessarily the immune system in a different way.
AD04™ tested in preclinical studies improved cognition, mirroring the results of the clinical trial. Nevertheless, the mode of action of AD04™ on Alzheimer’s brain is not fully understood. Our hypothesis is that AD04™ regulates the immune system in a way that reduces AD pathology. To test this assumption, we are conducting additional preclinical studies in parallel to clinical development. We aim to demonstrate how AD04™ regulates cellular/molecular processes associated to neuroinflammation and neurodegeneration. For that purpose, we use state-of-the-art multi-omics, biochemistry, and immunohistology techniques.
Concomitantly to defining the mode of action of AD04™, the preclinical studies aim to identify pharmacodynamic biomarkers easily accessible (e.g. in the blood) that will then be tested in the clinical trial. Such biomolecules, so-called surrogate markers of clinical outcome, are important in clinical trials to measure more accurately pathway and/or target engagement (enabling dose selection), and to obtain faster data of the therapeutic impact of the tested compound (enabling decisions on the next phase of development).
We have observed that AD04™, an immuno-modulator, is effective in the clinic having an effect in the brain, particularly on the hippocampus, a part associated to memory; with this understanding, we have built a pipeline of discovery-stage compounds (see Table).
Our strategy focuses on deep learning from AD04™-triggered biological pathways to..
…harness specific circuits of the immune system to inhibit AD
…create therapeutics tackling specific biomolecules having specific function(s) along these pathways, e.g novel immuno-modulator of a neuro-inflammatory axis in the hippocampus
Thus, AD10 to AD13 are discovery-stage drugs that will be selected for their impact on relevant pharmacodynamic biomarkers identified in the AD04™ preclinical program (see § “How are the preclinical studies of AD04™ informing the clinical development?”).
Lipids and lipid circuits play a crucial role in the pathogenesis of AD, reflecting the fact that the brain is an organ with high lipid content. We investigate compounds potentially able to restore lipid homeostasis in the brain.
Using an appropriate panel of pharmacodynamics biomarkers that will be identified in the AD04™ preclinical program, we plan to setup an investigational blood-based diagnostic assay for AD.
We design optimized mRNAs encoding relevant proteins as investigational therapeutics (e.g. AD09) for treating AD.
Typically, our program starts with 5 to 10 mRNA candidates encoding the protein of interest designed by our platform (level A). These are screened for efficacy and compared to the native sequence in relevant in vitro assays (level B). The next step is the in vivo validation of the results obtained in vitro (level C). Further analysis steps might be necessary depending of the protein.
Key features of our mRNA platform:
David Buchsbaum is the Chief Financial Officer at ADvantage Therapeutics. He is also currently Managing Director at a boutique Investment Bank specializing in healthcare and biotechnology. After starting at Claire’s Stores, a NYSE fashion accessories retailer, he spent most of his career as a senior equity analyst where he covered consumer discretionary companies most notably at Wells Fargo. More recently Mr. Buchsbaum helped manage the Holtzman Opportunity Fund, a shareholder activist hedge fund and private equity holdings for Jewelcor. He has a J.D. in Law from the University of Miami and a B.S. in business from the University of Richmond.
Dr. Walter Schmidt studied biology at the university of Göttingen, Germany. He got his PhD in 1990 at the Max-Plank-Institute of Experimental Medicine with Fritz Eckstein and was awarded the Otto-Hahn Medal for his thesis. From 1991 till 1997 he started as Postdoc and later became staff scientist at Boehringer’s “think tank” Institute of Molecular Pathology in Vienna, Austria. Walter co-founded Intercell (now Valneva) in 1991, the first Austrian biotech company that went public serving as CTO in the beginning and Founding Vice President for Business Development afterwards. Later in 2003, he co-founded together with Dr. Frank Mattner, AFFIRIS and served as CEO until he moved on to co-found ACCANIS in 2015 again together with Dr. Mattner. 2021 he became a co-founder of ADvantage Inc. and since then he is member of the Board of Directors and Director of the mRNA department.
Dr. Trembleau is an immunologist with 25+ years’ experience in industry and academic institutions. She obtained her PhD degree in immunology in 1997 with High Honors, as well as receiving the European Doctorate Label (“Doctor Europaeus”). She carried out her PhD work at Roche (Milan, Italy) in collaboration with the University of Strasbourg (France) under the supervision of top-ranked Italian scientist Dr. Luciano Adorini and world-renowned immunologist Prof. Diane Mathis. Her entire career, she has been working on therapeutic approaches to inhibit pathological immune reactions and restore tissue homeostasis. Briefly, she initially investigated peptide-based immunotherapies with the aim of selectively blocking the presentation of pathogenic antigens to T lymphocytes. (Sandoz, now Novartis, Basel, Switzerland). Afterwards, she performed pioneer work demonstrating the therapeutic effect of interleukin (IL)-12 antagonists and their action on the Th1/Th2 cell balance in type 1 diabetes (Roche, Milan, Italy). Then, she worked on immunological mechanisms regulating autoimmune arthritis (Medical University of Vienna, Austria). Dr Trembleau co-authored 30 peer-reviewed articles and book chapters on these topics. She became interested in Alzheimer’s disease as the scientific community realized that the pathogenesis of this disease involves immunological mechanisms both in the brain and in the periphery. She now serves as Chief Technology Officer at ADvantage Therapeutics and is eager to demonstrate the mode of action of the lead compound AD04.
Dr. Achim Schneeberger has over 20 years’ experience in biomedical research and development focusing on immunotherapeutic approaches in cancer and chronic diseases. Following the study of Medicine at the Universities of Tübingen, Germany and Bordeaux, France, he started his career at the Department of Dermatology, Medical University of Vienna, Austria. At the time, he studied melanoma vaccines and was instrumental in translating the most promising candidates into the arena of clinical testing. This work and its results led to several prizes including the thesis award of the Medical University of Tübingen and the Egner Dermatooncology Prize of the German Dermatological Research Society. In 2005, Dr. Schneeberger joined the Laboratory of Prof. Yokoyama at Washington University, Saint Louis, to study the interactions between NK cells and cancer. Upon returning to Europe, he joined AFFiRiS to build and lead their clinical department. As CMO, he was responsible for the clinical development of the company’s vaccine candidates. Under his lead, AFFiRiS initiated clinical programs in the indications of Alzheimer’s, Parkinson’s, MSA and atherosclerosis covering a total of 18 clinical trials. He was instrumental for AFFiRiS being awarded with significant grants from the Michael J. Fox Foundation and the European Union (FP7 programs SYMPATH and MultiSYN).
Dr. Frank Mattner is Co-founder and Chief Science Officer at ADvantage Therapeutics with 25+ years’ experience as an immunologist and entrepreneur that includes Hoffmann-La Roche (Basel, Switzerland and Milan, Italy), InterCell AG, AFFiRiS AG, and Accanis Biotech GmbH (Vienna, Austria). Frank co-founded AFFiRiS (2003) where he served as Chief Science Officer, and Accanis (2015), where he served as Chief Operating Officer. Frank graduated (as graduate scholarship holder of the State of Rhineland-Palatinate) from the University of Mainz, Germany. Dr. Mattner is the co-author of more than 500 patents.
Jeffrey Madden is a Co-founder and Chief Executive Officer at ADvantage Therapeutics. His career spans more than 20 years in the institutional investment management industry including Partner and Portfolio Manager at IronBridge Capital Management and Senior Vice President and Portfolio Manager at RMB Capital. He also worked at Accenture in the Management Consulting Practice. Jeffrey is an active board member and lead investor of Rational Vaccines, which is developing therapeutic and prophylactic live attenuated vaccines for HSV-1 and HSV-2. He also serves on the boards of Leading India’s Future Today, which offers educational programs attuned to sound economic thinking, and the Bartley J. Madden Foundation, which creates employment opportunities for those most in need. Jeffrey graduated from the University of Iowa with Business Honors and Distinction.
Dr. Lemere is a Scientist in the Ann Romney Center for Neurologic Diseases at Brigham & Women's Hospital and Associate Professor of Neurology at Harvard Medical School in Boston, MA USA. Her research focuses on understanding and using the immune system therapeutically to prevent and treat Alzheimer's disease. Dr. Lemere earned a bachelor’s degree in psychology and education from Mount Holyoke College and a master’s in neurobiology from SUNY Albany. Her current research involves: 1. nonclinical studies of antibody treatments targeting a pathogenic form of amyloid-beta protein found in plaques in Alzheimer’s disease brain; 2. the role of the innate immune system’s complement signaling in aging and Alzheimer’s disease; and 3. the effects of deep space galactic cosmic radiation on brain aging and the risk of Alzheimer’s disease in studies in mouse models and human neural cells in preparation for NASA’s first manned mission to Mars. Her lab is funded by NIH and NASA. Dr. Lemere serves as an advisor to the Alzheimer’s Association, the BrightFocus Foundation and Cure Alzheimer’s Fund. In addition, she serves as a consultant for several companies.
Dr. Tanzi is the Vice-Chair of Neurology, Director of the Genetics and Aging Research Unit, Co-Director of the Henry and Allison McCance Center for Brain Health, and Co-Director of the MassGeneral Institute for Neurodegenerative Disease at Massachusetts General Hospital. He also serves as the Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard Medical School. Dr. Tanzi received his B.S. (microbiology) and B.A. (history) at the University of Rochester in 1980 and his Ph.D. (neurobiology) at Harvard Medical School in 1990.
Dr. Tanzi was a key member of the teams that discovered the first Alzheimer’s disease (AD) gene, the amyloid precursor protein (APP) gene, and the two other early-onset familial AD genes, presenilin 1 and presenilin 2. As leader of the Cure Alzheimer’s Fund Alzheimer’s Genome Project, Dr. Tanzi identified several other AD genes, including CD33, the first AD gene shown to regulate neuroinflammation in AD. He also discovered the Wilson’s disease gene and several other neurological disease genes.
Dr. Tanzi’s team was the first to use human stem cells to create three-dimensional mini human brain organoids of AD, dubbed “Alzheimer’s-in-a-Dish”. This model was the first to recapitulate all three key AD pathological hallmarks. He and his team have successfully used these organoids to screen for approved drugs and natural products that can stop AD brain pathology. Dr. Tanzi has developed several novel therapies for AD including gamma secretase modulators targeting amyloid pathology (Phase 1 planned 2021) and AMX0035, which was already successful in a clinical trial of ALS and now under priority review for approval at the FDA. Dr. Tanzi also discovered that beta-amyloid plays a functional role in the brain as an anti-microbial peptide, supporting a potential role for infection in the etiology of AD.
Dr. Tanzi serves as Chair of the Cure Alzheimer’s Fund Research Leadership Group and on numerous scientific advisory and editorial boards, He has published over 600 research papers and is one of the top 50 most cited neuroscientists in the world. He has received the highest awards in his field, including the Metropolitan Life Foundation Award, Potamkin Prize, Ronald Reagan Award, Oneness in Humanity Award, Silver Innovator Award, the Smithsonian American Ingenuity Award, the Brain Research Foundation Award, and the Kary Mullis Award for Medical Research. He has also been named to TIME magazine’s list of TIME100 Most Influential People in the World. Dr. Tanzi is also a New York Times bestselling author, who has co-authored the books Decoding Darkness, and bestsellers, Super Brain, Super Genes, and The Healing Self.
Dr. Gauthier is a member of Departments of Neurology and Neurosurgery, Psychiatry and Medicine of McGill University. Director of Alzheimer Disease and Related Disorders Research Unit at the McGill Center for Studies in Aging, and Research Chair in the Canadian Institutes for Health Research program for health research. Many prizes and distinctions such as 2009 “Irma M. Parhad Award for Excellence”, 2012 “prix Hubert Reeves”, 2014 “Queen Elisabeth II Diamond Jubilee Medal” and member of the “Order of Canada”.
Prof. Dr. med. Oliver Peters, Full Professor at Charité Universitätsmedizin Berlin, is currently chief of the branch Geriatric Neuropsychiatry at the Department of Psychiatry and Psychotherapy, Charité - Campus Benjamin Franklin. He is head of the Memory Clinic and Dementia Prevention Center at Experimental Clinical Research Center (ECRC), Charité - Campus Berlin Buch. He is principal investigator at the German Center for Neurodegenerative Diseases (DZNE) and board member of the German Dementia Competence Network (KND e.V.). He is interested in the establishment of, and has extensively worked on, new biomarkers for early diagnosis of chronic neurodegenerative diseases. He has participated as Principal Investigator in numerous observational and interventional clinical trials.
Professor of Neurology, Sorbonne University, Paris; Director of the Behavioural Neurology Department and of the Dementia Research Center at Salpêtrière Hospital, Paris; Director of a Research Unit Inserm at Paris Brain Institute. Past-President of the French Society of Neurology. Coordinator of the Center of Excellence in Neurodegeneration (CoEN) of Paris. Member of the ‘Académie Nationale de Médecine’. Many prizes and distinctions such as “Chevalier de la Legion d’Honneur”. Member of the European Alzheimer Disease Consortium (EADC) and of the European Academy of Neurology (EAN). Principal or co-investigator of a number of research programs focusing on Alzheimer’s disease and Parkinson disease. Chairman of the International Working Group (IWG) on the new criteria for Alzheimer’s disease.
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