AC Immune Progress Update on Phase 2 Active Immunotherapy Clinical Pipeline for Alzheimer's and Parkinson diseases

AC Immune Progress Update on Phase 2 Active Immunotherapy Clinical Pipeline for Alzheimer's and Parkinson diseases

• ABATE Phase 1b/2 AD trial of ACI-24.060 completed enrollment of cohorts 1 and 2 and is expected to complete cohort 3 in January; 6-month and 12-month amyloid PET data expected in H1 & H2 2024, respectively
• ReTain Phase 2b clinical trial of ACI-35.030 in preclinical AD being launched now by partner

• VacSYn Phase 2 PD trial of ACI-7104.056 completed enrollment of cohort 1 and commenced cohort 2; safety and immunogenicity update expected in H2 2024
• Cash for operations extends into 2026 with USD50 million equity financing and ACI-35.030-related milestones

Lausanne, Switzerland, January 3, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today provided an update on positive progress in its active immunotherapy programs, with three Phase 2 trials progressing to key clinical milestones in 2024.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “AC Immune has continued steady clinical development progress throughout 2023, and we end the year in a very strong position. We now have three active immunotherapies from our precision medicine pipeline in Phase 2 clinical testing, with key milestones for ACI-24.060 in 2024. We are moving ever closer to delivering therapeutics that use the immune system to slow the onset and ultimately prevent neurodegenerative diseases, much like vaccines for infectious disease. To succeed, we must pursue earlier diagnoses and begin using active immunotherapies before permanent damage occurs to neurons.”

“Our financial position was reinforced in December by our successful USD50 million equity offering, which was supported by some of the world’s preeminent specialist investors, as well as a CHF15 million milestone payment. This was the first of two payments from our partner relating to the Phase 2b ReTain trial of ACI-35.030 in preclinical AD patients. With the second milestone payment expected in 2025, we have sufficient financing to support operations into 2026.”

ACI-24.060: AC Immune’s wholly-owned anti-amyloid beta (Abeta) active immunotherapy (vaccine)-candidate. The ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial of ACI-24.060 for treatment of Alzheimer’s disease (AD) continues fully blinded, with cohorts 1 and 2 enrolled and cohort 3 enrollment to be completed in January. Following data safety monitoring board (DSMB) review, no safety concerns have been raised to date, consistent with previous results. Immunogenicity of the vaccine is very encouraging with clear evidence of anti-Abeta antibody responses against toxic Abeta species observed in the blinded data. The six-month Abeta positron emission tomography (PET) imaging results are expected in H1 2024, and the 12-month Abeta PET data are expected in H2 2024.