AC Immune (NASDAQ:ACIU)

AC Immune N 

Valor: 32902310 / Symbol: ACIU
  • 10.61 USD
  • -3.37% -0.37
  • 18.11.2017 02:10:00
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AC Immune (NASDAQ:ACIU)

AC IMMUNE DISCOVERS NEXT-GENERATION ANTIBODIES FOCUSED ON NEURODEGENERATIVE DISEASES

  • Pipeline expansion with new antibodies against alpha-synuclein and TDP-43
  • Proprietary scientific approach rapidly delivers high-quality assets
  • Execution of clear strategy around three pillars 
    • Alzheimer's disease
    • Other significant neurodegenerative and neuro-orphan indications
    • Diagnostics

 

Lausanne, Switzerland, August 22, 2017 - AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced it has discovered new antibodies against two targets in the pathogenesis of neurodegenerative diseases. Alpha-synuclein is an established target for Parkinson's disease and other Lewy body diseases, while TDP-43 is a recently identified target of growing interest for neuro-orphan indications such as Frontotemporal Lobar Degeneration. More interestingly, both targets also play an important role in other significant neurodegenerative indications such as Alzheimer's disease, beyond the established hallmarks of Abeta and Tau. These next-generation antibodies were discovered using the company's proprietary SupraAntigen(TM) platform, which has already generated four products in clinical development, including crenezumab partnered with Genentech/Roche in Phase 3 for Alzheimer's.

 

Prof. Andrea Pfeifer, CEO of AC Immune said: "We are very pleased to move these next-generation antibodies into our discovery pipeline. They have significant potential for addressing the underlying pathology of a range of unmet indications, and reinforce our belief that precision medicine is critical to delivering effective treatments in Alzheimer's disease and other neurodegenerative diseases. We are executing a clear strategy around three pillars:  Alzheimer's disease, other significant neurodegenerative diseases and neuro-orphan indications, and diagnostics. Our unique combination of scientific knowledge and assets continues to expand our high-value pipeline of candidates for both in-house development and partnerships."

 

Andreas Muhs, Ph.D., Chief Scientific Officer of AC Immune, added: "Many neurodegenerative diseases share their mode-of-action and targets, which provides opportunities for synergistic development of product candidates. Our common scientific approach to proteinopathies complemented with proprietary diagnostics, consistently and rapidly delivers new high-quality treatments for precision medicine in neurodegenerative diseases. These two latest antibody programs have unique binding properties to only the pathological forms of alpha-synuclein and TDP-43, and we are encouraged by the observations of expert groups on their potential attributes as novel therapeutics."

 

Powerful combination of therapeutics and diagnostics

The Company believes it will generate additional value by leveraging its deep understanding and experience in Alzheimer's disease into other significant and neuro-orphan indications. Our unique immunotherapy approach addresses and treats the underlying misfolding of proteinopathies that causes neurodegenerative diseases, rather than simply treating the symptoms. Moreover, the company pairs early detection diagnostics with therapeutic candidates to ensure better clinical trials, superior patient care and reduced costs in development.

 

The two antibody discovery programs announced today use the Company's SupraAntigen(TM) platform. They complement the R&D collaboration with Biogen (announced April 2016) comprised of two radiopharmaceutical diagnostic programs to develop PET-ligands for both alpha-synuclein and TDP-43, using AC Immune's proprietary Morphomer(TM) chemistry technology platform, designed to interact with the basic process of protein misfolding.

 

These latest antibody discovery programs reflect the growing body of evidence about the benefits of targeting pathological elements (Brettscheider et al, Nature Reviews 2015) and the different modelling techniques used to generate specific binding properties of compounds. AC Immune is collaborating with various expert groups to elucidate the exact mode of action of the two next-generation antibodies.

 

About alpha-synuclein

Alpha-synuclein is a protein expressed principally in the central nervous system, but is also produced in other tissues. The pathological form of this protein is a major component of Lewy bodies, clumps of aggregated protein that are a cardinal neuropathological feature of Parkinson's disease, dementia with Lewy bodies and multiple system atrophy. The recently identified mechanism of spreading of the alpha-synuclein pathology in neurodegenerative diseases make alpha-synuclein a target for this antibody program.

 

About TDP-43

TDP-43 (TAR DNA binding protein 43) is a new target in the area of neurodegenerative diseases. Misfolded, aggregated TDP-43 is found in diseases as Frontotemporal Lobar Degeneration (FTLD-TDP), chronic traumatic encephalopathy and Huntington's disease. There is growing body of evidence that the pathological TDP-43 protein plays an important role in multiple neurodegenerative diseases, including Alzheimer's and Parkinson's disease. The link of clinical features associated with Alzheimer's (Josephs et al, Acta Neuropathol., 2014) and the mechanism of spreading of the pathology make TDP-43 a target for this antibody program.

Valor: 
32902310 - AC Immune
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Auch wenn der Aktienkurs

Auch wenn der Aktienkurs aktuell depremierend ist, bin ich für die Zukunft (in den nächsten 3-4 Jahren) sehr zuversichtlich. 

2 hochinteressante Beiträge:

https://seekingalpha.com/article/4006234-ac-immune-ipo-potential-proceed-caution 

http://www.watson.ch/Wissen/Interview/376998317-Alzheimer-Forscherin--%C2%ABDas-Problem-ist--dass-man-nicht-ins-Hirn-schauen-kann%C2%BB

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Sorry ich meine dieser

Sorry ich meine dieser Artikel von seeking alpha (aktualisiert nach der Failure von Eli Lilly)

https://seekingalpha.com/article/4087044-ac-immune-compelling-speculative-investment 

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Alzheimer's focused AC Immune has multiple shots on goal

14 August 2017

Jefferies targets a punchy $25 for the shares, well over three times' the current price of at $7.30 (ndlr. 9$ today)

Alzheimer's focused biotech AC Immune Ltd (NASDAQ:ACIU) is undervalued in the light of its multiple shots on goal for treating the brain disease, says US broker Jefferies, which rates shares a 'buy'.

Jefferies targets a punchy $25 for the shares, well over three times' the current price of at $7.30 - up 2.53% on the day.

Its candidate Crenezumab underpins the broker's valuatrion of the group, which is partnered with Genentech in a Phase III trial with data expected in the second half of 2020. The broker estimates US$4.4bn world wide peak sales for the drug by 2028 estimates for $16 a share net present value (NPV).

Analyst Peter Welford notes that ACIU has three other Phase Ib-IIa products for a pipeline providing a multitude of catalysts by 2018.

He reckons the biotech's below $300mln enterprise value (EV) substantially undervalues the group.

Last week the group confirmed that all key pipeline programmes were on-track, he adds.

"We still expect a further update on anti-Abeta vaccine ACI-24 by YE, with the 4th dose cohort ongoing in Phase I/IIa."

Welford adds: "We forecast cash to be adequate for burn well into 2019E, by which time a significant number of catalysts could crystallise value."

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Die nächsten Wochen könnten

Die nächsten Wochen könnten spannend werden: 

Ergebnisse ACI-24 - anti-Abeta vaccine for AD in Phase 1/2a
The Phase 1/2a clinical study to evaluate safety, tolerability, immunogenicity and biomarker endpoints in patients with mild to moderate AD is ongoing in Europe. An interim analysis of the first three doses (cohort 1-3) revealed positive safety and tolerability. The study was not powered to examine efficacy but a trend towards reduction in the accumulation of brain amyloid measured by PET imaging was observed in cohort 3. A similar pattern of reduction of clinical decline assessed by the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) was observed in cohort 3 compared to placebo at week 52 although this did not reach statistical significance. After further analysis of the results including the ongoing cohort 4, a decision for the design of a potential next clinical trial will be made.

Ergebnisse ACI-35 - anti-Tau vaccine for AD partnered with Janssen Pharmaceuticals
A Phase 1b clinical study to evaluate the safety, tolerability and immunogenicity of ACI-35 in patients with mild to moderate AD is ongoing in Finland and the United Kingdom. The study includes five cohorts with escalating doses and different dosing schedules. To date, safety and tolerability is considered satisfactory as assessed by the Data Safety Monitoring Board. An interim analysis showed a dose-dependent and target-specific antibody response to pTau. Further results, which we expect to have completed in the second half of fiscal 2017, will be the basis for the program's future development. Janssen is expected to assume responsibility for the clinical development of Phase 2 and beyond, as well as the regulatory approval, manufacturing and commercialization of ACI-35.

Ergebnisse Anti-tau Antibody RO 7105705 partnered with Genentech
In July 2016, Genentech/Roche Group began enrolling for a first Phase 1 study of 71 volunteers comprising both healthy controls and people with mild to moderate Alzheimer's disease. Conducted in Tennessee, this trial compares the antibody to placebo on safety, tolerability, pharmacokinetics, and preliminary activity outcomes. The trial design combines single dose, dose-escalation, and multiple dosing. The study is expected to run until May 2017.

 

Positive Ergebnisse würden die Pipeline von AC Immune deutlich stärken. 

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CTAD 2017

Congress CTAD 2017 (10TH CLINICAL TRIALS ON ALZHEIMER'S DISEASE) wird vom 1. bis 4. November stattfinden.

Es ist gut möglich, dass Janssen, Genentech und AC Immune während dieser Veranstaltung kommunizieren. 

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welche Daten erwartest du?

die Timeline ist gegeben - oder?

2018 zu ACI 24

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robincould hat am 17.10.2017

robincould hat am 17.10.2017 23:15 geschrieben:

die Timeline ist gegeben - oder?

2018 zu ACI 24

2018: News zu ACI 24 in Down Syndrome, nicht AD.

Near term value drivers

  • ACI-24 in AD: Phase 2 expected to commence in 2017
  • ACI-35: Next phase of clinical development based on Phase 1b data expected to commence in 2017
  • Anti-Tau antibody: Phase 1 data expected in 2017, Phase 2 expected to commence in 2017

Mehr Infos: http://phx.corporate-ir.net/External.File?t=1&item=VHlwZT0yfFBhcmVudElEP...

Congress CTAD: im Programm steht mindestens Anti-Tau Antibody (Genentech) 

 

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Anti-tau Antibody RO 7105705

Anti-tau Antibody RO 7105705 moved to phase 2

AC Immune hat das noch nicht angekündigt, aber es ist sichtbar in der Oktober-Präsentation von Roche: https://www.roche.com/dam/jcr:bf6a0b14-e682-4af8-b4e1-7cc59c2e23fc/en/ir... (Seite 51) Man in love

Mehr Infos am CTAD-Kongress in 2 Wochen (Phase 1 Data).

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spannende Aktie

ich spiele das Thema mit Probiodrug - nicht ganz so erfolgreich, aber ich bleibe dabei

mein Biotechportfolio ist bereits voll - wünsche dir viel Erfolg

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Morgen startet CTAD. Keine

Morgen startet CTAD. Keine News zu ACI-35 und ACI-24 aber:

  • Targeting Tau with RO7105705 (Anti-Tau Antibody): Phase 1 results and design of a Phase 2 study in prodromal-to-mild Alzheimer's disease. Am 2. November (Oral presentation)
  • Characterization of the selective in vivo and in vitro properties of crenezumab: insights into crenezumab's unique mechanism of action. Am 2. November (Oral presentation)
  • Clinical trial design of CREAD studies: randomized, double-blind, placebo-controlled, parallel-group Phase 3 studies to evaluate the efficacy and safety of crenezumab in patients with prodromal to mild Alzheimer's disease.  Am 1. und 2. November (Poster)
  • Crenezumab pharmacokinetic-pharmacodynamic analysis to describe the increase in total plasma amyloid beta following treatment in patients with mild to moderate Alzheimer's disease. Am 3. und 4. November (Poster)
  • Clinical evaluation of 18F-PI-2620 (Tau-Pet imaging agent), a next generation Tau-PET agent in subjects with Alzheimer's disease and progressive supranuclear palsy. Am 2. November (Oral presentation)

 

AC Immune wird sich zudem an zwei investor conferences vorstellen: 

  • Credit Suisse Healthcare Conference, Scottsdale, AZ - November 7, 2017
  • Jefferies London Healthcare Conference, London, UK - November 16, 2017

Mit Webcast auf www.acimmune.com/en/investors/

Ich würde mich auf News zu ACI-35 und ACI-24 vor Ende Jahr freuen. Mit Anti-Tau Antibody sind sie aus meiner Sicht die potentiellen «Kurstreiber» der Stunde.

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AC Immune SA to Receive

AC Immune SA to Receive Milestone Payment for Anti-Tau Antibody Moving into Phase 2 Trial for Alzheimer's Disease

 

                           

  • AC Immune to receive third milestone payment of CHF 14 million under collaboration agreement with Genentech

  • Phase 2 to evaluate effects of anti-Tau antibody in people with prodromal-to-mild Alzheimer's disease

  • Phase 1 data to be presented today at CTAD conference, Boston, USA

 

Lausanne, Switzerland, November 2, 2017 - AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that Genentech, a member of the Roche Group, has dosed the first patient in a Phase 2 clinical trial for Alzheimer's disease (AD) with an anti-Tau monoclonal antibody known as RO7105705. This investigational medicine was discovered and humanized as part of the company's collaboration with Genentech. Upon the dosing of the first patient in the Phase 2 clinical trial, AC Immune becomes eligible to receive a milestone payment of CHF 14 million, which is expected to be paid in the fourth quarter of 2017. This will be the third milestone payment under the 2012 strategic collaboration and licensing agreement with Genentech for anti-Tau antibodies for the treatment of AD and other neurodegenerative diseases. AC Immune also has a licensing agreement for the anti-Abeta antibody crenezumab, which is in Phase 3 clinical studies being conducted by Genentech.

 

Prof. Andrea Pfeifer, CEO of AC Immune, commented: "We are delighted that our collaboration partner Genentech is taking this anti-Tau antibody into Phase 2. Tau pathology is widely recognized to be closely associated with cognitive decline and neurodegeneration in Alzheimer's disease and other tauopathies." She continued "Our unique understanding of the pathology of misfolding proteins is exemplified by the depth of our pipeline and the range of our collaborations."

 

About the Phase 2 clinical trial

The Phase 2 clinical trial is conducted by Genentech and will enroll 360 patients to assess the safety, tolerability and efficacy of the anti-Tau monoclonal antibody RO7105705 in people with prodromal-to-mild AD. Participants will receive one of three active doses or placebo for 72 weeks, followed by a 96-week optional open label extension. Primary endpoints include safety measures and the composite functional and cognitive endpoint CDR (Clinical Dementia Rating scale) sum-of-boxes score. Change from baseline in Tau pathological burden is an important exploratory endpoint.

 

Phase 1 results to be presented at CTAD conference Boston

The start of the Phase 2 clinical trial follows the completion of a Phase 1 clinical trial that involved 75 subjects and evaluated the safety, tolerability, pharmacokinetics and preliminary activity of RO7105705 in people with mild-to-moderate AD and in healthy volunteers. Preliminary data relating to the single and multiple dose cohorts were presented at the International Conference on Alzheimer's & Parkinson's Disease (AD/PD) in March 2017 (Kerchner et al, Genentech) and the Alzheimer's Association International Conference (AAIC) in July 2017 (Kerchner et al, Genentech). The full analysis of the Phase 1 will be presented by Dr. Kerchner at the Clinical Trials on Alzheimer's Disease (CTAD) conference today, November 2, 2017 (3:00pm EST | 8:00pm CET) in Boston, USA. RO7105705 was administered at single doses of up to 16,800 mg in healthy volunteers and multiple doses of 8,400 mg in healthy volunteers and patients with AD. No dose-limiting toxicities were observed. RO7105705 exhibited a dose proportional pharmacokinetic profile, indicated CNS exposure and showed a median half-life of more than 32 days. Plasma total Tau concentration increased with increasing drug doses and was greater in participants with AD than in healthy volunteers, suggesting a pharmacodynamic signal.

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Live webcast

Heute, 19:55

Presentation by Prof. Andrea Pfeifer, CEO, AC Immune
Credit Suisse Healthcare Conference, Scottsdale, AZ

Link zum Livestream: https://cc.talkpoint.com/cred001/110717a_as/?entity=22_CMNO3UN

 

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https://cc.talkpoint.com

Bestätigt! Kommt noch dieses Jahr:

  • 2017: ACI-24 in AD Phase 1/2a (safety-only data)
  • 2017: ACI-35 in AD Phase 1b results