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Roche stoppt 2 klinische Alzheimer-Studien, bei denen AC Immune der Partner war
http://cws.huginonline.com/A/171580/PR/201901/2232813_5.html
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Wertpapier: AC Immune |
Semorinemab Phase 2 Studie floppt in Alzheimer
- konnte Placebo nicht schlagen beim primären Endpunkt
- zwei wichtige sekundäre Endpunkte (ADAS-Cog13und ADCS-ADL) wurden ebenfalls verfehlt
https://ir.acimmune.com/news-releases/...esults-tauriel-phase-2-trial
https://seekingalpha.com/news/...s-alzheimers-study-shares-plummet-48
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Wertpapier: AC Immune |
Alzheimer-Impfstoff in Phase1b/2a Studie
https://www.fuw.ch/article/...erzielt-erfolg-bei-alzheimer-impfstoff/
https://ir.acimmune.com/news-releases/...e-generates-potent-anti-ptau
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Wertpapier: AC Immune |
Kritikpunkte an der Studie
- winzige Alzheimer Studie, nur 32 Patienten in zwei Dosisgruppen
- Datenfreigabe "unzureichend"
"Obwohl AC Immune sagte, dass sie bei 100% der Patienten die Antikörperspiegel auf "potenziell therapeutische Spiegel" erhöhten, definierten sie nicht, was sie für den potenziellen therapeutischen Spiegel hielten - ob dies ein Anstieg um 5% oder ein Anstieg um 90% war. Und sie sagten nicht, wie hoch der durchschnittliche oder mittlere Anstieg in der Studie war, obwohl sie sagten, dass er höher war als ihre Referenzdaten für Patienten, die infundierte Antikörper erhielten."
https://endpts.com/...heimers-vaccine-data-just-dont-ask-to-see-them/
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schon veröffentlicht..
aber super interessant
https://www.wiwo.de/unternehmen/industrie/...uch-stehen/27767998.html
für die neurodegenerativer Erkrankungen
wie Alzheimer und Parkinson
sehr vielversprechend...
einfach mal den Brüdern Strüngemann
etwas auf der Spur bleiben...
MIG ist auch investiert...
ACI-12589
Unterschied multiple Systematrophie (MSA) von anderen
a-Synucleinopathien und gesunden Probanden
A-syn-PET-Tracer können entwickelt werden, um a-Synuclein-Pathologien zu diagnostizieren, darunter Parkinson-Krankheit, Lewy-Körper-Demenz, MSA
und andere
AC Immune veranstaltet am 29. März ein a-syn Key Opinion Leader-Webinar
LAUSANNE, Schweiz, 16. März 2022 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ: ACIU),
ein biopharmazeutisches Unternehmen im klinischen Stadium, das Pionierarbeit in der Präzisionsmedizin für neurodegenerative Erkrankungen leistet, gab heute die ersten nicht-invasiven Bilder von pathologischem Alpha-Synuclein ( a-syn) im menschlichen Gehirn und präsentierte positive klinische Proof-of-Concept-Daten für einen a-syn-Tracer für die Positronen-Emissions-Tomographie (PET) als bildgebendes Mittel zur Identifizierung von MSA-Patienten.
Die klinische Studie mit dem hundertprozentigen experimentellen a-syn-PET-Tracer von AC Immune wurde vom Team von Oskar Hansson MD, PhD, an der Universität Lund und dem Universitätskrankenhaus Skåne mit Unterstützung eines Stipendiums der Michael J. Fox Foundation for Parkinson's Research durchgeführt (MJFF).
Die bahnbrechenden Bilder von a-syn im Gehirn von Probanden wurden heute zum ersten Mal auf der Plenarsitzung der AD/PDTM-Konferenz in Barcelona, Spanien, von Oskar Hansson, MD, PhD, präsentiert.
Dr. Oskar Hansson, Oberarzt für Neurologie am Universitätsklinikum Skåne und Professor für Neurologie an der Universität Lund, Schweden, sagte: „Dies ist das erste Mal, dass ein PET-Tracer a-syn-Aggregate im Gehirn von Patienten zuverlässig nachgewiesen hat. Die Gehirnscans der ACI-12589-Patienten zeigen die Signalspezifität für a-syn bei MSA-Patienten im Vergleich zu gesunden Probanden und Patienten mit anderen a-Synucleinopathien. Die Ergebnisse stellen einen großen klinischen Fortschritt in dem Bestreben dar, ein diagnostisches Instrument für Patienten bereitzustellen, die an MSA und möglicherweise anderen a-Synucleinopathien leiden.
Dies könnte letztendlich eine frühere und zuverlässigere Differenzierung dieser schwer zu diagnostizierenden neurodegenerativen Erkrankung ermöglichen.“
Prof. Andrea Pfeifer, CEO von AC Immune SA, kommentierte: „Diese erste klinische Validierung eines a-syn-PET-Tracers ist ein transformativer Schritt zur Verwirklichung unserer Vision, Präzisionsmedikamente zur Behandlung neurodegenerativer Erkrankungen zu entwickeln. Ermöglicht wurde dies durch die enge Zusammenarbeit zwischen AC Immune, dem Skåne University Hospital, der Universität Lund und dem MJFF.
Wir freuen uns auf die Fortsetzung der Zusammenarbeit zur Ausweitung dieser Ergebnisse bei MSA und anderen a-syn-Indikationen wie der Parkinson-Krankheit.“
Jamie Eberling, Ph.D., Senior Vice President of Research am MJFF, sagte: „Wir sind von den wissenschaftlichen Möglichkeiten, die diese Ergebnisse bieten, begeistert. Selektive bildgebende Tracer können bei der Weiterentwicklung neuer Therapien für Synucleinopathien wie der Parkinson-Krankheit einen enormen Unterschied machen.
AC Immune Reports First Live Images of Alpha-Synuclein in Human Brain with New PET Tracer for Neurodegenerative Disease at AD/PDTM Conference
ACI-12589 distinguished multiple system atrophy (MSA) from other a-synucleinopathies and healthy volunteers
A-syn PET tracers may be developed to diagnose a-synuclein pathologies, including Parkinson’s disease, Lewy Body Dementia, MSA and others
AC Immune to host a-syn Key Opinion Leader webinar on March 29th
LAUSANNE, Switzerland, March 16, 2022 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced the first non-invasive images of pathological alpha-synuclein (a-syn) in human brain and presented positive clinical proof-of-concept data for an a-syn positron emission tomography (PET) tracer as an imaging agent to identify MSA patients. The clinical trial of AC Immune’s wholly owned experimental a-syn PET tracer was conducted by the team of Oskar Hansson MD, PhD, at Lund University and Skåne University Hospital, with the support of a grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF).
The groundbreaking images of a-syn in the human subjects’ brains were presented for the first time today at the AD/PDTM Conference plenary session in Barcelona, Spain, by Oskar Hansson MD, PhD.
Dr. Oskar Hansson, Senior Consultant in Neurology at Skåne University Hospital and Professor of Neurology at Lund University, Sweden, said: “This is the first time that a PET tracer has reliably detected a-syn aggregates in patients’ brains. The ACI-12589 patient brain scans indicate the signal specificity for a-syn in MSA patients versus healthy volunteers and patients with other a-synucleinopathies. The results represent great clinical progress in the quest to provide a diagnostic tool for patients suffering from MSA and potentially other a-synucleinopathies. This could ultimately enable earlier and more reliable differentiation for this difficult-to-diagnose neurodegenerative disease.”
Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “This first clinical validation for an a-syn PET tracer is a transformative step towards achieving our vision for developing precision medicines to treat neurodegenerative diseases. It was made possible by the close collaboration between AC Immune, Skåne University Hospital, Lund University, and the MJFF. We look forward to continuing the collaboration to expand on these results in MSA and in other a-syn indications, such as Parkinson’s disease.”
Jamie Eberling, Ph.D., Senior Vice President of Research at MJFF, said: “We are energized by the scientific possibilities presented by these findings. Selective imaging tracers can make an enormous difference in advancement of new therapies for synucleinopathies such as Parkinson's disease. Our Foundation has long supported the development of these critical but elusive tools, and we are proud to see progress toward their widespread application. As they have for Alzheimer’s disease, PET tracers for a primary pathological protein would be pivotal in transforming the future of Parkinson’s research and care.”
The data will be presented in more detail on Friday in two presentations at the peer-reviewed scientific conference1,2. Derived from AC Immune’s Morphomer® technology platform, ACI-12589 showed target engagement in vivo in alpha-synucleinopathies with a pharmacokinetic and safety profile suitable for further development as a human brain PET imaging agent. The trial showed that non-invasive PET brain imaging with ACI-12589 successfully differentiated MSA from other types of a-synucleinopathies, like Parkinson’s disease (PD) and Lewy Body Dementia (LBD), as well as from healthy volunteers.
Specifically, the ACI-12589 PET tracer data showed enhanced contrast and a-syn target specificity in participants with MSA. Tracer retention was highest in areas affected by MSA disease processes, particularly cerebellar white matter.
a-syn Key Opinion Leader webinar on March 29th
In addition to the scientific presentations during AD/PDTM, AC Immune has organized a KOL webinar on March 29th at 10:00am ET / 4:00pm CET, where Dr. Hansson and AC Immune’s management will discuss ACI-12589 findings as well as the importance of biomarkers and precision medicine in neurodegenerative diseases. Additionally, members of the AC Immune management team will provide an overview of the Company’s clinical stage a-syn targeted therapeutic and diagnostic candidates.
To register for the webinar, please click here. The materials from the presentation and a replay of the webinar will be available on the Events Page of AC Immune’s website following its conclusion.
References
1Capotosti F.; Discovery of [18F] ACI-12589, a novel and promising PET-tracer for alpha-synuclein; Oral presentation; ADPD 2022 International Conference; Barcelona, Spain; March 18, 2022
2Smith R.; Initial scans using [18F] ACI-12589, a novel PET-tracer for alpha-synuclein; Oral presentation; ADPD 2022 International Conference; Barcelona, Spain; March 18, 2022
About Multiple System Atrophy (MSA)
MSA is a rare, degenerative neurological disorder affecting the body’s involuntary (autonomic) functions, including blood pressure, breathing, bladder function and motor control. MSA causes deterioration and shrinkage (atrophy) of portions of the brain (cerebellum, basal ganglia and brainstem) that regulate internal body functions, digestion and motor control. Under a microscope, the damaged brain tissue of people with MSA shows nerve cells (neurons) that contain an abnormally high amount of pathological a-syn protein. MSA is difficult to diagnose and is often confused with PD (about 1 in 40 PD patients has MSA), and, currently, many MSA patients never receive a proper diagnosis. While there is overlap, therapeutic treatment strategies are different in MSA and PD; so, achieving a correct diagnosis is very important.
About AC Immune SA
AC Immune SA is clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features ten therapeutic and three diagnostic candidates, six of which are currently in clinical trials. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and Janssen Pharmaceuticals, Inc., resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.
SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP and RU. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, and NO.
For further information, please contact:
Media Relations
Saoyuth Nidh
AC Immune
Phone: +41 21 345 91 34
Email: saoyuth.nidh@acimmune.com
Investor Relations
Gary Waanders, Ph.D., MBA
AC Immune
Phone: +41 21 345 91 91
Email: gary.waanders@acimmune.com
U.S. Media
Shani Lewis
LaVoieHealthScience
Phone: +1 609 516 5761
Email: slewis@lavoiehealthscience.com
U.S. Investors
Corey Davis, Ph.D.
LifeSci Advisors
Phone: +1 212 915 2577
Email: cdavis@lifesciadvisors.com
Forward looking statements
This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/...ac90-44b1-83f3-ad7e65204765
data readouts presented last week at the AD/PD 2022 conference.
The first-in-human study of our alpha-synuclein diagnostic, ACI-12589,
showed it has strong potential to become the first reliable and accurate
PET tracer for alpha-synucleinopathies (e.g. multiple system atrophy, MSA).”
“Pairing cutting-edge diagnostics with highly targeted and selective therapeutic agents, such as our vaccines targeting alpha-synuclein, phosphorylated-Tau, and Abeta, which are all advancing into later-stage development this year, we aim to shift the therapeutic paradigm of neurodegenerative diseases towards earlier, more accurate diagnosis, treatment, and prevention
https://ir.acimmune.com/static-files/...6-f3a6-4711-b4d8-08b12d079c0a
für die Alpha-Synuclein-Diagnostik zeigt Durchbruchspotenzial
für neurodegenerative Erkrankungen
...das 2. Halbjahr 2022 wird spannend !