Araclon Biotech advances in its innovative vaccine and diagnostic test for Alzheimer's

ABvac40:

• Meets the primary objectives on safety and efficacy of the first part of the phase II clinical study. Also confirms the vaccine's excellent safety and tolerability profile, as well as a strong immune response in patients with amnestic mild cognitive impairment (aMCI) or very mild Alzheimer's disease (vm-AD)
• ABvac40 is based on an active immunization against the amyloid-beta 40 protein to fight early-stage AD

ABtest-MS:

• Two studies confirm the test's ability to identify precisely those subjects with cerebral amyloid load, one of the first signs of early-onset AD
• ABtest-MS, developed entirely in Araclon based on mass spectrometry, is capable of quantifying amyloid-beta 40 and 42 proteins – both associated with the risk of having AD – in plasma samples

ZARAGOZA, Spain, March 15, 2022 /PRNewswire/ -- Araclon Biotech, a Grifols Group company dedicated to the research and development of therapies and diagnostic methods applied to degenerative diseases, will present topline results for the first part of its phase II clinical trial on its active immunotherapy, ABvac40, against Alzheimer's Disease (AD), as well as data on two studies of its assay, ABtest-MS, to identify early-stage AD.

Araclon will present its findings at the 16th International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD™ 2022), held March 15-20 in Barcelona.

Regarding the vaccine ABvac40, the principal data analyzed until now (Part A) are satisfactory in that they support the continuation of the trial's extension phase (Part B). Researchers have confirmed that the vaccine shows an excellent safety and tolerability profile, in addition to demonstrating a high immune response in patients with amnestic mild cognitive impairment (aMCI) or very mild AD.

"We are pleased to communicate these data at the international Conference AD/PD™ 2022, which confirm previous results on the safety and tolerability of ABvac40 in the early stages of Alzheimer's disease," said Jose Terencio, Araclon CEO and Vice President of Innovation at Grifols. "In addition the vaccine demonstrates that it induces a strong immune response characterized by the increase in anti-Aβ40 titers at the same time that Aβ40 levels rise in plasma. We are analyzing the results of the secondary variables (exploratory), related to efficacy, and we hope that ABvac40 shows its potential and lead to an innovative vaccine for patients."

This multicenter, random and double-blind phase II trial included a total of 124 patients with aMCI or very mild AD and were divided evenly between the treated group and the control group.

As far as the primary objective of safety, there were no significant differences between the participants in the group that received ABvac40 and those dosed with the placebo, including incidences of ARIA-H. No ARIA^[1]-E events were reported during Part A of the study. These data confirm those obtained in phase I and presented in July 2016, which showed a good safety profile.

With respect to the other primary objective, efficacy (immunogenicity), the administration of six doses of ABvac40 resulted in a significant increase in the specific antibody levels, greater than those observed in the phase I trial (three doses).

This phase II evaluates as secondary efficacy variables (exploratory) changes in the disease's biomarkers, as well as in cognition and the quality of life resulting from ABvac40. The study's Part B is progressing according to plan.

Studies confirm the predictive potential of ABtest-MS for the early diagnosis of AD in heterogeneous cohorts with different clinical characteristics

In addition, Araclon Biotech continues with its research focused on the development of solutions to detect AD in its early stages. Diverse studies confirm the high predictive ability of its assay ABtest-MS to identify precisely those subjects with cerebral amyloid load, a sign of early-onset AD, which would enable management of the condition in its initial phases.

ABtest-MS, a novel and unique method developed entirely in Araclon and based on the mass spectrometry technique, is capable of accurately quantifying amyloid 40 and 42 proteins – both associated with the risk of having AD – in plasma samples.

The results to be presented at the AD/PD™ 2022 Conference are centered on two recent studies. Data from the trial conducted on the FACEHBI^[2] cohort, obtained after two years of follow up, confirm the potential of the ABtest-MS to predict the cerebral amyloid load, an initial sign of AD, in individuals with subjective memory complaints (SMCs) and the potential that the analysis of these markers have as an indicator of how the condition evolves. The data corresponding to five years of follow up with the cohort are currently being analyzed.

In the second study, the multicenter A4 Study^[3] carried out in 50 centers, the ABtest-MS predicted the cerebral deposit of the amyloid protein (measured by PET) in plasma samples from 731 subjects. It also confirmed the suitability of utilizing a centralized and extensively validated method such as this assay in these broad and heterogenous studies.

These data confirm other results previously obtained on more than 1,000 subjects in different AD stages from various international cohorts (BioFINDER, DPUK) that have been recently featured in scientific publications such as Alzheimer's Research & Therapy, Nature Aging and Alzheimer's & Dementia: The journal of the Alzheimer's Association, confirming the relation between amyloid biomarkers in plasma and AD.

"This test's predictive ability makes it ideal to detect early-stage Alzheimer's and accelerate the recruitment for clinical trials of new treatments, reducing the screening failure rate and associated costs," said Terencio.

ABtest-MS is a differentiating method that doesn't contain antibodies and whose process avoids enzymatic digestion, saving time and expense.

Access to communications and publications:

• Access to ABtest-MS featured in Alzheimer's Research & Therapy here
• Access to ABtest-MS featured in Nature Aging here
• Access to ABtest-MS featured in Alzheimer's & Dementia: The journal of the Alzheimer's Association here

The posters and the scientific presentation will be available beginning March 21 on Araclon Biotech's web

About Araclon Biotech

Araclon Biotech specializes in researching and developing therapies and diagnostic methods for Alzheimer's disease (AD) and other neurodegenerative diseases. The company, in which Grifols holds a stake of almost 76%, focuses on two research areas: the early diagnosis of AD by means of detecting amyloid-beta peptides in the blood, and the treatment of the disease using immunotherapy (vaccines).

About Grifols

Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services that are sold in more than 110 countries.

Pioneers in the plasma industry, Grifols operates a growing network of donation centers worldwide. It transforms collected plasma into essential medicines to treat chronic, rare and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion. In addition, the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.

Grifols, with more than 23,000 employees in 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership.

In 2021, Grifols' economic impact in its core countries of operation was EUR 7.7 billion. The company also generated 141,500 jobs, including indirect and induced.

The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols' non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).

For more information, please visit www.grifols.com

LEGAL DISCLAIMER

The facts and figures contained in this report that do not refer to historical data are "future projections and assumptions". Words and expressions such as "believe", "hope", "anticipate", "predict", "expect", "intend", "should", "will seek to achieve", "it is estimated", "future" and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols Group.

[1] Amyloid Related Imaging Abnormalities (ARIA)

[2] The project Ace Healthy Brain Initiative (FACEHBI) is a study on the early detection of Alzheimer's designed and coordinated by Ace Alzheimer Center Barcelona in 2014. Specifically, an exhaustive medical follow up was conducted on 200 cognitively healthy people with memory loss.

[3] El A4 Study (Anti-Amyloid treatment in Asymptomatic Alzheimer's disease) selected more than 5,000 healthy individuals between 65 and 85 years old that showed signs of having accumulated amyloid protein in the brain, demonstrated through PET images.

SOURCE Araclon Biotech

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