On October 28, 2022 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported that results for the third quarter ended September 30, 2022, and provided a corporate update (Press release, AC Immune, OCT 28, 2022, View Source [SID1234622584]).
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Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "With the recent positive data for an anti-Abeta antibody, lecanemab, further supporting the amyloid hypothesis in Alzheimer’s disease (AD), we are advancing towards year-end with strong momentum and renewed enthusiasm for the amazing potential of our development programs. The recent data also highlight the importance of intervening early in AD, further underlining the fundamental need for precision medicine in neurodegenerative diseases. This bodes well for our wholly owned vaccine ACI-24.060, which targets the two most toxic forms of Abeta, soluble toxic Abeta oligomers and pyroglu-Abeta. Because ACI-24.060 is a vaccine, it also has the potential to offer safety, efficacy, and logistical advantages compared to monoclonal antibodies. A key Phase 1b readout from ACI-24.060’s translational, biomarker-based trial is planned later this year, and is expected to inform our advancement into Phase 2 cohorts in AD and Down syndrome-related AD."
"Our cutting-edge diagnostic programs also received key external validation last quarter, with our partner Life Molecular Imaging announcing initiation of late-stage clinical development of our Tau PET tracer – triggering a milestone payment. The Michael J. Fox Foundation (MJFF) also recognized our alpha-synuclein (a-syn) tracer with a follow-on grant to develop a-syn PET tracers that could accelerate clinical development. These accomplishments affirm our leadership and commitment to leveraging precision medicine to enable earlier diagnosis, treatment, and ultimately prevention of neurodegenerative disease."
Q3 2022 and Subsequent Highlights
Detailed results from the Phase 2 Alzheimer’s Prevention Initiative (API) study evaluating the anti-Abeta monoclonal antibody crenezumab in autosomal dominant Alzheimer’s disease (ADAD) were presented at the 2022 Alzheimer’s Association International Conference (AAIC) by AC Immune’s partner Genentech, a member of the Roche group, and the Banner Alzheimer’s Institute. Numerical differences favoring crenezumab were observed across both co-primary endpoints, as well as multiple secondary and exploratory endpoints, though none were statistically significant. Demographic and baseline biomarker data indicate a confluence of factors may have led the study to have lower than expected statistical power. All mutation carriers in the study may continue to receive crenezumab while the data are further analyzed.
Provided an update on the Phase 1b/2 ABATE study of the anti-Abeta vaccine ACI-24.060 in patients with prodromal AD and individuals with Down syndrome (DS). Clinical sites in the UK and Spain are now open and recruiting following regulatory clearances in both countries. Interim results are expected around year end 2022 with plans to submit a U.S. Investigational New Drug (IND) application in Q1 2023.
Received clearance for a clinical trial application to initiate an adaptive, biomarker-based Phase 2 study of the anti-a-syn vaccine ACI-7104 in patients with early Parkinson’s disease (PD). Initiation of the trial is expected in Q4 2022.
The Tau PET tracer, PI-2620, is being advanced into late-stage development in AD by our partner, Life Molecular Imaging, following supportive results from an investigator-sponsored Phase 2 AD trial that showed its suitability as a targeted radiopharmaceutical for the detection of Tau deposits and for measuring longitudinal changes in subjects with mild cognitive impairment (MCI) as well as in patients with AD.
Received a MJFF follow-on grant to support the continued development of ACI-12589, AC Immune’s wholly-owned a-syn PET tracer. The new grant brings the total MJFF funding for this program up to USD 3.7 million.
Showcased pipeline of potentially first- and best-in-class therapeutic and diagnostic candidates with 10 presentations at the AAIC.
First-time presentation at AAIC of a biomarker-based, translational clinical trial of AC Immune’s wholly owned anti-Abeta vaccine, ACI-24.060, in patients with AD and individuals with DS.
Hosted a key opinion leader webinar on the potential benefits of vaccines for Alzheimer’s and Parkinson’s diseases. The webinar featured a presentation by Cynthia A. Lemere, Ph.D., of the Ann Romney Center for Neurologic Diseases at Brigham & Women’s Hospital and Harvard Medical School. To view a replay of the webinar, click here.
Achieved and Anticipated 2022 Clinical Milestones
ACI-24.060
anti-Abeta vaccine Dosed first patient in Phase 1b/2 ABATE study of ACI-24.060 in patients with AD and individuals with DS.
Phase 1b safety and immunogenicity data readout in AD and decision to move into DS expected in Q4 2022. Submission of U.S. Investigational New Drug (IND) application planned in Q1 2023.
ACI-35.030
anti-pTau vaccine Reported Phase 1b/2a interim analysis from highest dose group.
Expect the decision to move into late-stage development in Q4 2022.
ACI-7104
anti-a-syn vaccine Initiation of Phase 2 trial in early PD expected in Q4 2022.
Crenezumab
anti-Abeta antibody Reported detailed results from Phase 2 API-ADAD study in autosomal dominant AD.
Additional fluid biomarker data to be presented at CTAD 2022 Conference
Semorinemab
anti-Tau antibody Additional biomarker data from the Phase 2 Lauriet study in mild-to-moderate AD expected at CTAD 2022 Conference.
ACI-12589
a-syn-PET tracer Reported breakthrough results from first-in-human study at AD/PD 2022 conference.
PI-2620
Tau-PET tracer Reported Phase 2 results in AD enabling entry into late-stage development connected to a milestone payment.
Clinical PET study data in orphan indication in Q4 2022.
Analysis of Financial Statements for the Quarter Ended September 30, 2022
Cash Position: The Company had a total cash balance of CHF 140.5 million, composed of CHF 44.5 million in cash and cash equivalents and CHF 96.0 million in short-term financial assets. This compares to a total cash balance of CHF 198.2 million as of December 31, 2021. The Company’s cash balance provides cash for operations into Q3 2024 without consideration of potential incoming milestone payments.
R&D Expenditures: R&D expenses decreased by CHF 0.7 million for the three months ended September 30, 2022, to CHF 14.4 million.
Discovery and preclinical expenses (- CHF 0.8 million): The Company decreased expenditures across a variety of its discovery and preclinical programs.
Clinical expenses (- CHF 0.6 million): The Company’s increased expenditures for the accelerated clinical development programs of ACI-7104 and ACI-24.060 were offset by lower costs in various other clinical programs as they achieved anticipated goals.
Other non-allocated (+ CHF 0.5 million): The Company’s other non-allocated R&D expenditure increased by CHF 0.5 million mostly related to the reallocation of certain IT and facilities costs and IT investments.
G&A Expenditures: For the three months ended September 30, 2022, G&A decreased by CHF 2.1 million to CHF 3.3 million. This decrease is mostly related to the reallocation of certain IT and facilities expenditures made in Q3 2022 that were not reclassified in the prior period and the reversal of certain share-based compensation expenses.
Other Operating Income: The Company recognized CHF 0.3 million in grant income for R&D activities performed under our Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Target ALS grants, an increase of less than CHF 0.1 million compared to the prior period.
IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 13.5 million for the three months ended September 30, 2022, compared with a net loss of CHF 15.9 million for the comparable period in 2021.