UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of December 2016
__________
Commission File Number: 001-37891
AC IMMUNE SA
(Exact name of registrant as specified in its charter)
EPFL Innovation Park
Building B
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 | X |
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):
| Yes | No | X |
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):
| Yes | No | X |
Item 7.01 Regulation FD Disclosure.
AC Immune SA (“AC Immune”) has updated its investor presentation with recent data presented by its partner Genentech, a member of the Roche group, at the 9th Clinical Trials on Alzheimer’s Disease Conference (CTAD) in San Diego. The updated investor presentation and informational poster that summarizes the data are attached hereto as Exhibit 99.1 and 99.2, respectively. From time to time, AC Immune will use this updated presentation and the informational poster in conversations with investors, analysts and others.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
| 99.1 | AC Immune SA Investor Presentation |
| 99.2 | Informational Poster |
SIGNATURE
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 | ||||
| Name: | Andrea Pfeifer | ||||
| Title: | Chief Executive Officer | ||||
| By: | /s/ Martin Velasco | ||||
| Name: | Martin Velasco | ||||
| Title: | Chairman | ||||
Date: December 15, 2016
EXHIBIT INDEX
| Exhibit Number | Description |
| 99.1 | AC Immune SA Investor Presentation |
| 99.2 | Informational Poster |
Exhibit 99.1
Crenezumab Phase I Study © 2016 AC Immune. Not to be used or reproduced without permission.
© 2016 AC Immune. Not to be used or reproduced without permission. 2 Crenezumab Background Crenezumab (RO5490245) is a humanized anti - amyloid β monoclonal IgG4 antibody ▪ Binds multiple forms of amyloïdes β ( monomers , oligomers , fibrils , plaques) with high affinity for oligomers ▪ IgG4 hypothesized to reduce risk of amyloid - related imaging abnormalities (ARIA) enabling higher doses ▪ Clinical studies conducted in sporadic and autosomal dominant Alzheimer’s disease .
© 2016 AC Immune. Not to be used or reproduced without permission. 3 Crenezumab Phase Ib S tudy GN29632 Phase Ib GN29632 ▪ Crenezumab 30, 45, 60 and 120 mg/kg IV Q4 weeks vs placebo Study population ▪ MMSE 18 - 28 ▪ 50 - 90 years ▪ Probable mild to moderate AD by NINCDS - ADRDA criteria ▪ CDR global score 0.5 to 1 ▪ [ 18F] - florbetapir PET scan positive for cerebral amyloid ▪ 50 % of the patients enrolled in each dose level are ApoE4 positive Phase Ib Dosing Study Population Phase Ib study GN29632 serves to inform the safety and tolerability of crenezumab delivered at higher doses Phase Ib Design a Cross - over to crenezumab for patients on placebo b Randomization ratio 5:1 crenezumab:placebo IV= intravenous ; MRI= magnetic resonance imaging MRI scans Placebo dosing b
© 2016 AC Immune. Not to be used or reproduced without permission. 4 Crenezumab Phase Ib S tudy GN29632 Phase Ib GN29632 ▪ Crenezumab 30, 45, 60 and 120 mg/kg IV Q4 weeks vs placebo Study population ▪ MMSE 18 - 28 ▪ 50 - 90 years ▪ Probable mild to moderate AD by NINCDS - ADRDA criteria ▪ CDR global score 0.5 to 1 ▪ [ 18F] - florbetapir PET scan positive for cerebral amyloid ▪ 50 % of the patients enrolled in each dose level are ApoE4 positive Phase Ib Dosing Study Population Phase Ib study GN29632 serves to inform the safety and tolerability of crenezumab delivered at higher doses Phase Ib Design a Cross - over to crenezumab for patients on placebo b Randomization ratio 5:1 crenezumab:placebo IV= intravenous ; MRI= magnetic resonance imaging MRI scans Placebo dosing b
© 2016 AC Immune. Not to be used or reproduced without permission. 5 Crenezumab Phase Ib S tudy A ssessments ▪ Safety • Brain MRI (central read ) • Nature, frequency , severity of adverse events (Aes) and serious AEs • Examinations : Physical and neurologic , vital signs • Laboratory tests ( blood and urine) • ECG assessments ▪ PK: Serum crenezumab concentration ( peak and through ) obtained on dosing days ▪ Exploratory : • Imaging and plasma biomarkers • Clinical scales (ADAS - Cog13, ADCS - ADL, CDR - SB) ADAS - Cog = Alzheimer’s disease assessment scale - cognitive; ADCS - ADL= Alzheimer's disease cooperative study - activities of daily living; AE=adverse event ; CDR - SB= clinical dementia ration - sum of boxes; ECG= electrocardiogram ; MMSE=Mini - Mental State Examination ; MRI= magnetic resonance imaging ; PK= pharmacokinetics .
© 2016 AC Immune. Not to be used or reproduced without permission. 6 Crenezumab Characteristics ▪ Age, mean (range) ▪ Male, n (%) ▪ ApoE status, n (%) E2/E3 E3/E3 E3/E4 E4/E4 ▪ Baseline MMSE, mean (range) ▪ Medium duration of exposure Cohort 1 (n=26) 73.5 (54 - 82) 14 (54%) 1 (2%) 5 (19%) 17 (65%) 3 (12%) 22.4 (18 - 28) 52.1 weeks (4 - 64) Phase Ib S afety R esults: Patient baseline characteristics and treatment exposure Cohort 2 (n=26) ApoE = apolipoprotein E; MMSE=Mini - Mental State Examination . 72.7 (51 - 87) 15 (58%) 0 5 (19%) 18 (69%) 3 (12%) 22.7 (18 - 29) 32.1 weeks (12 - 40)
© 2016 AC Immune. Not to be used or reproduced without permission. 7 Crenezumab Adverse event (AE) summary, n (%) ▪ Total number of patients with at least one AE ▪ AE related to study treatment (as assessed by investigator) ▪ AE Grade ≥ 3 (severe, life - threatening or resulting in death) 1 ▪ Serious AE 2 ▪ Adverse events of special interest 3 ▪ Treatment withdrawal due to AE 4 • No dose - limiting toxicities • No deaths Cohort 1 (n=26) 21 (81%) 7 (27%) 1 (4%) 1 (4%) 4 (15%) 1 (4%) Phase Ib S afety Results : Cohort I (30 & 45 mg/kg) Common and Selected AEs, n (%) ▪ Headache ▪ Cerebral microhemorrhage ▪ Anxiety ▪ Fatigue ▪ Muscle spams ▪ Infusion - related reactions 6 Cohort 1 (n=26) 4 (15%) 4 (15%) 5 (19%) 0 3 (12%) 3 (12) 1. Common Terminology Criteria for Adverse Events (CTCAE) v4.0 2 . Serious AEs Cohort 1: Malignant melanoma (1 patient) 3 . AESI: Cohort I: Cerebral microhemorrhage (3 patients); Cerebrallar microhemorrhage (1 patient) 4. Discontinuations due to adverse event . Cohort 1: Malignant melanoma diagnosis 5. Includes one subject with reported term of cerebrelar microhemorrhage 6. Per protocol, infusion - related reactions defined as adverse events occurring during or within 24 hours after study drug administration and judged to be related to study drug.
© 2016 AC Immune. Not to be used or reproduced without permission. 8 Crenezumab Adverse event (AE) summary, n (%) ▪ Total number of patients with at least one AE ▪ AE related to study treatment (as assessed by investigator) ▪ AE Grade ≥ 3 (severe, life - threatening or resulting in death) ▪ Serious AE 2 ▪ Adverse events of special interest 3 ▪ Treatment withdrawal due to AE 4 • No dose - limiting toxicities • No deaths Cohort 2 (n=26) 20 (77%) 4 (15%) 1 1 (4%) 2 (8%) 2 (8%) 2 (8%) Phase Ib S afety Results : Cohort II (60 mg/kg) Common and Selected AEs, n (%) ▪ Headache ▪ Cerebral microhemorrhage ▪ Anxiety ▪ Fatigue ▪ Muscle spams ▪ Infusion - related reactions 5 Cohort 2 (n=26) 2 (8%) 2 (8%) 1 (4%) 4 (15%) 0 2 (12%) 1 . Common Terminology Criteria for Adverse Events (CTCAE) v4.0 2. Serious AEs Cohort 2: Accidental overdose, pneumonia and subdural hematoma (1 patient), atypical chest pain (1 patient) 3. AESI: Cohort 2: Cerebral microhemorrhage (2 patients), pneumonia (1 patient) 4. Discontinuation due to adverse event : Cohort 2: Confusional state, atrial fibrilation ( both non serious events ) 5. Per protocol, infusion - related reactions defined as adverse events occurring during or within 24 hours after study drug administration and judged to be related to study drug.
© 2016 AC Immune. Not to be used or reproduced without permission. 9 Crenezumab Phase Ib Serum Pharmacokinetics ▪ Serum PK of crenezumab exhibits biphasic disposition with a long half - life (approx. 25 days) - Consistent with other LgG antibodies that exhibit linear kinetics 2 ▪ Steady - state concentrations are achieved within 13 weeks, with modest accumulation ▪ Exposure increase proportional to dose ▪ The observed serum concentration at 60 mg/kgIVQ4W, agrees with projected exposure based on historical data - i.e. four - fold higher than following the 15 mg/kg dose 1. Deng R. et al. Mabs 2011; 31: 61 - 66 2. Projection was based on a two - compartment linear population PK model developed on PK data from the Phase I (ABE4427g and ABE4662g) and Phas e II studies (ABE4869g and ABE4955g ).
© 2016 AC Immune. Not to be used or reproduced without permission. 10 Crenezumab Phase Ib S tudy C onclusions: A nalysis of Cohort I and II ▪ Safety of crenezumab for doses of 30, 45 and 60 mg/kg • Majority of Aes were low - grade and non - serious • No dose - limiting toxicities • No investigator - assessed drug - related serious adverse events • ARIA - No events of ARIA - E - Few patients (6 of 52) had ARIA - H; all were asymtomatic , and did not result in treatment disontinuation ▪ Crenezumab serum PK for doses of 30, 45, and 60 mg/kg • Dose - proportional up to 60 mg/kg IV Q4 weeks , and consistent with historical data - Serum concentrations are four - fold higher than following the 15 mg/kg dose ▪ Safety , tolerability , and PK profiles of crenezumab • Supportive of continued development at doses higher than 15 mg/kg IV Q4 weeks • 60 mg/kg dose implemented in the ongoing Phase III program
Exhibit 99.2
Crenezumab exposure-response across AD endpoints supports a higher dose for Phase 3
Dan Polhamus PhD1, James Rogers PhD2, Robert Paul MD2, Smita Kshirsagar PhD2, Srikumar Sahasranaman PhD2, Jin Y Jin PhD2, Angelica L Quartino PhD2
(1) Metrum Research Group, Tariffville, CT. USA
(2) Genentech, Inc., San Francisco, CA. USA
