AIR CONDITIONING Immune Receives FDA Fast Track Designation for Anti-Amyloid-beta Active Immunotherapy, ACI-24.060, to Treat Alzheimer’s Disease

AIR CONDITIONING Immune Receives FDA Fast Track Designation for Anti-Amyloid-beta Active Immunotherapy, ACI-24.060, to Treat Alzheimer’s Disease

• Ongoing Phase 1b/2 ABATE research study registering well and broadening to websites in U.S.A. with Investigational New Drug (IND) clearance for ACI-24.060

  

• Dosed initially specific with Down syndrome (DS) in the DS friend of ABATE

• Interim safety and immunogenicity information in Alzheimer’s illness (ADVERTISEMENT) and DS associates anticipated in H2 2023

• Initial animal information on amyloid plaque decrease in advertisement anticipated H1 2024

Lausanne, Switzerland, June 27, 2023 – AIR CONDITIONING Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical business pioneering accuracy medication for neurodegenerative illness, today revealed that it has actually received Fast Track classification from the U.S. Food and Drug Administration (FDA) for its wholly-owned anti-amyloid beta (Abeta) active immunotherapy (vaccine)-prospect, ACI-24.060, for treatment of Alzheimer’s illness. This follows FDA clearance of the Investigational New Drug (IND) application allowing growth to the U.S.A. of the continuous Phase 1b/2 ABATE research study of ACI-24.060 in clients with advertisement and people with DS. Furthermore, the very first person with DS has actually been dosed in ABATE.

Dr. Andrea Pfeifer, CEO of AIR CONDITIONING Immune SA, commented:  “We are delighted to see the quality and importance of our ACI-24.060 program reflected in the granting of Fast Track designation, which offers opportunities for expedited development and regulatory review. This regulatory progress underscores the attraction of an active immunotherapy targeting toxic species of Abeta. By inducing a polyclonal response including antibodies against both oligomeric Abeta and pyroglutamate-Abeta, ACI-24.060 targets the same toxic species as disease modifying anti-Abeta monoclonal antibodies that slowed AD progression in Phase 3 clinical trials. As ACI-24.060, created using our SupraAntigen^® platform, specifically targets the most toxic forms of Abeta, we believe it may offer best-in-class efficacy with all the potential advantages in safety, administration and distribution that can be expected from a vaccine. We look forward to showing in H1 2024 the effect of ACI-24.060 on amyloid plaque reduction, a surrogate marker for disease modification.”

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ACI-24.060’s Fast Track classification and IND clearance, along with the growth of ABATE to consist of people with DS were supported by positive preliminary interim safety and immunogenicity information from ABATE’s very first, low dosage advertisement friend. Dosing in a 2nd, greater dosage advertisement friend started previously this year.

Dr. Johannes Streffer, CMO of AIR CONDITIONING Immune SA, commented: “ABATE’s expansion into the USA will allow us to accelerate the trial’s advancement and build upon the strong momentum we’ve generated in Europe. With today’s announcement, we remain firmly on track to report additional interim safety and immunogenicity data later this year, and for the crucial interim readout of Abeta-PET imaging data in AD in the first half of next year. By benchmarking the amount of Abeta plaque reduction achieved with ACI-24.060 against those achieved with FDA-approved monoclonal antibodies, we believe we can generate early evidence of our vaccine’s therapeutic potential to support its expeditious advancement towards pivotal programs in AD and DS-related AD.”

Dr. Michael Rafii, Medical Director of the Alzheimer’s Therapeutic Research Institute, Professor of Neurology at the Keck School of Medicine, and the Principal Investigator of the trial commented: “Despite representing the world’s largest population that is genetically at high risk for AD, individuals with DS are vastly underserved and underrepresented in clinical trials. I applaud AC Immune for seeking to address the urgent needs of this population and believe ACI-24.060 holds great promise as a novel therapy that can lower Abeta plaques to delay, or perhaps even prevent, the onset of clinical dementia symptoms in AD and DS-related AD. Moreover, I believe the potential safety, efficacy, and logistical advantages of a vaccine over monoclonal antibodies strongly support the development of therapeutics such as ACI-24.060 as the next generation of anti-Abeta therapies.”

About the Phase 1b/2 ABATE Study (ClinicalTrials.gov Identifier: NCT05462106)
The ABATE research study is a Phase 1b/2, multicenter, adaptive, double-blind, randomized, placebo-controlled research study to evaluate the safety, tolerability, immunogenicity, and pharmacodynamic results of ACI-24.060 in topics with prodromal Alzheimer’s illness and in grownups with Down syndrome. All individuals in the trial need to have brain Abeta pathology validated by a positron emission tomography (FAMILY PET) scan. Recent scientific research studies and FDA approvals have actually verified Abeta as an illness customizing healing target in advertisement and are encouraging of Abeta animal imaging as a surrogate marker of effectiveness. The trial starts with a dosage escalation stage in advertisement clients, throughout which numerous doses/dosing routines might be examined, and likewise consists of people with DS.

About ADVERTISEMENT in Down syndrome
Individuals with Down syndrome (DS) have a 3rd copy of all or part of chromosome 21, which includes the gene that codes for amyloid-precursor protein (APP). Overproduction of APP is thought to trigger the build-up of Abeta plaques. Virtually all people with DS will establish Abeta plaques and advertisement¹, with DS-related advertisement sharing a comparable pathophysiology and biomarkers with other kinds of hereditary advertisement. Given the more foreseeable beginning and development of signs in DS-related advertisement, AIR CONDITIONING Immune thinks ABATE’s outcomes will use essential insights into the capability of ACI-24.060 active immunotherapy to regulate neurodegeneration at its earliest phases and use this population a much required healing choice.

About ACI-24.060
ACI-24.060, originated from air conditioner Immune’s SupraAntigen® platform, has actually been displayed in preclinical research studies to cause a strong polyclonal antibody reaction that develops and is preserved versus both oligomeric and pyroglutamate-Abeta types, essential pathological kinds of Abeta thought to drive Abeta plaque development and illness development. ACI-24.060 is created to boost the development of broad-spectrum protective antibodies with the very same safety and tolerability formerly showed in the ACI-24 program in Phase 1 and 2 trials. This investigational prospect has the possible to effectively hinder plaque development and boost plaque clearance, and therefore might minimize or avoid illness development.

Reference

1. Lott, Ira T., and Elizabeth Head. “Dementia in Down syndrome: distinct insights for Alzheimer illness research study.” Nature Reviews Neurology 15.3 (2019): 135-147.

About AIR CONDITIONING Immune SA
AIR CONDITIONING Immune SA is a clinical-stage biopharmaceutical business that intends to end up being an international leader in accuracy medication for neurodegenerative illness, consisting of Alzheimer’s illness, Parkinson’s illness, and NeuroOrphan indicators driven by misfolded proteins. The Company’s 2 medically verified innovation platforms, SupraAntigen^® and Morphomer^®, fuel its broad and varied pipeline of very first- and best-in-class properties, which presently includes 10 healing and 3 diagnostic prospects, 5 of which are presently in Phase 2 scientific trials and among which remains in Phase 3. AIR CONDITIONING Immune has a strong performance history of protecting tactical collaborations with leading worldwide pharmaceutical business consisting of Genentech, a member of the Roche Group, Eli Lilly and Company, and others, leading to significant non-dilutive financing to advance its exclusive programs and >$3 billion in possible turning point payments.

SupraAntigen^® is a signed up hallmark of AIR CONDITIONING Immune SA in the list below areas: AU, EU, CH, GB, JP, RU, SG and U.S.A.. Morphomer^® is a signed up hallmark of AIR CONDITIONING Immune SA in CN, CH, GB, JP, KR, NO and RU.

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