SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16
OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of February, 2019
Commission File Number: 001-37891
AC IMMUNE SA
(Exact name of registrant as specified in its charter)
EPFL Innovation Park
1015 Lausanne, Switzerland
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
|Form 20-F||Form 40-F|
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
INCORPORATION BY REFERENCE
This report on Form 6-K and exhibit 99.1 hereto shall be deemed to be incorporated by reference into the registration statement on Form F-3 (Registration Number: 333-224694), the registration statement on Form F-3 (Registration Number: 333-227016) and the registration statement on Form S-8 (Registration Number: 333-216539) of AC Immune SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|AC IMMUNE SA|
|By:||/s/ Andrea Pfeifer|
|Title:||Chief Executive Officer|
|By:||/s/ Joerg Hornstein|
|Title:||Chief Financial Officer|
|Date:||February 20, 2019|
|99.1||Press Release dated February 20, 2019|
AC Immune Announces Anti-Tau Monoclonal Antibody Entering Second Phase 2 Trial in Moderate Alzheimer’s Disease
Study complements ongoing trial in the prodromal to mild population
Lausanne, Switzerland, February 20, 2019 – 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, is recruiting patients for a second Phase 2 trial for an anti-Tau monoclonal antibody, known as MTAU9937A, RO7105705, in moderate Alzheimer’s disease (AD). The same antibody, RG6100 (MTAU9937A, RO7105705), also is being studied by Genentech in a separate Phase 2 trial to evaluate its efficacy and safety in patients with prodromal-to-mild Alzheimer's disease. This anti-Tau monoclonal antibody was discovered and humanized as part of AC Immune’s collaboration with Genentech.
Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We are highly encouraged that Genentech is broadening its clinical evaluation of our anti-Tau antibody. Interest in targeting Tau was also recently demonstrated by our newest partnership with Eli Lilly, announced in early January, to develop our small molecule Tau MorphomerTM to treat Alzheimer’s. These projects illustrate AC Immune’s scientific leadership in the field and are an important part of our broad portfolio of three product candidates in Phase 2 clinical testing, complementary diagnostics in clinical development, a robust early-stage pipeline and an increasingly visible focus on early projects targeting neuro-orphan and neuro-inflammation indications.”
The trial, posted here, is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of MTAU9937A, RO7105705 in an estimated 260 patients with moderate AD dementia. The study consists of a screening period, a double-blind treatment period, an optional open-label extension (OLE) period, and a safety follow-up period. The primary endpoints are change from baseline to Week 49 in cognitive function as measured by the Alzheimer's Disease Assessment Scale, Cognitive Subscale, 11-item version (ADAS-Cog11) and change from baseline to Week 49 in functional capacities as measured by the Alzheimer's Disease Cooperative Study-Daily Living Inventory (ADCS-ADL).
This anti-Tau monoclonal antibody is part of the strategic collaboration with Genentech entered into in 2012 for the research, development and commercialization of monoclonal humanized antibodies against Tau protein. RO7105705 is a humanized anti-Tau monoclonal antibody with a high specificity for pathological Tau, designed to intercept the cell-to-cell spread of pathological Tau in the extracellular space of the brain.
Tau pathology spreads with a characteristic spatiotemporal pattern throughout the brain, coinciding with both clinical symptoms and disease progression in AD. Slowing the propagation of tau pathology may therefore slow disease progression and reduce cognitive decline, and anti-tau therapies have shown promise in slowing the progression of tau pathology in animal models of tauopathy.
AC Immune has several product candidates addressing the Tau approach, including: ACI-35, an anti-pTau vaccine partnered with Janssen Pharmaceuticals, currently in a Phase 1b/2a trial, a small molecule Tau MorphomerTM, partnered with Eli Lilly and Company, that is scheduled to enter Phase 1 in 2019; and a Tau imaging agent, partnered with Life Molecular Imaging (formerly Piramal Imaging), currently in Phase 2 clinical testing.
About AC Immune SA
AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for Neurodegenerative Diseases. The Company designs, discovers and develops therapeutic as well as diagnostic products intended to prevent and modify diseases caused by misfolding proteins. AC Immune's two proprietary technology platforms create antibodies, small molecules and vaccines designed to address a broad spectrum of neurodegenerative indications, such as Alzheimer's disease (AD). The Company's pipeline features nine therapeutic and three diagnostic product candidates, with five currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Lilly, Biogen, Janssen Pharmaceuticals, Nestlé Institute of Health Sciences, Life Molecular Imaging (formerly Piramal Imaging) and Essex Bio-Technology.
For further information, please contact:
AC Immune Investor Relations
Phone: +1 970 987 2654
Phone: +1 617 792 3937
European Investors & Media
Phone: +41 79 367 6254
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. 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.