ALZ-101 / Alzinova - LARVOL DELTA

Alzinova initiates operational start-up of global Phase 2 study with ALZ-101 (Nasdaq) - "Alzinova AB...announces that the Company, together with contract research organization Worldwide Clinical Trials ('Worldwide'), has initiated the operational start-up phase of the Phase 2 study of the vaccine candidate ALZ-101 for the treatment of Alzheimer’s disease. Alzinova and Worldwide have completed the study kick-off and are now working on preparations including regulatory and ethics submissions, as well as the allocation of clinical trial sites, with the aim of enrolling the first participants around the turn of the year 2026/2027. Approximately 120 participants are planned to be enrolled....The study is designed to evaluate the efficacy of the vaccine candidate in a larger patient population and generate additional clinical data to support the continued development of ALZ-101."

New P2 trial • Alzheimer's Disease

Safety, tolerability and immunogenicity of vaccine ALZ-101 in patients with early Alzheimer's disease: randomised, controlled trial. (PubMed, Alzheimers Res Ther) - P1 | "In this small Phase 1 study in early AD, ALZ‑101 was not associated with clear safety signals and elicited strong, durable Aβ‑specific antibody responses. Exploratory biomarker and ADCOMS findings are compatible with a possible disease‑modifying effect, but formal evidence of clinical efficacy is lacking, and all non‑primary analyses should be interpreted with caution. These results support further evaluation of ALZ‑101 in larger, adequately powered trials. Registered at clinicaltrials.gov: NCT05328115, 14 April 2022."

First-in-human • Journal • Alzheimer's Disease • CNS Disorders • Dementia • APOE • Aβ42

Alzinova expands its portfolio – initiates diagnostic collaboration with Amsterdam UMC [Google translation] (BioStock) - "In collaboration with the highly regarded Amsterdam University Medical Center (UMC), Alzinova will further develop a blood-based test to measure these specific antibodies. The project, which is covered by the company's existing budget, is expected to run for three to four months, with initial results anticipated during the third quarter of 2026...The new collaboration operates independently of the ongoing clinical development of ALZ-101, while operational planning for phase II proceeds according to plan...Alongside short-term revenue opportunities, the long-term vision is to establish the test as a companion diagnostic for ALZ-101."

Companion diagnostic • Licensing / partnership • Alzheimer's Disease

Alzinova appoints leading Alzheimer's authority ahead of next clinical phase [Google translation] (BioStock) - "Alzinova is accelerating preparations for the upcoming phase II study with the vaccine candidate ALZ-101 as Dr Marwan Sabbagh, one of the world's leading experts in Alzheimer's disease, steps into the role of Global Principal Investigator. The partnership brings an international Key Opinion Leader with extensive registrational trial experience to the heart of the project’s continued development."

New P2 trial • Alzheimer's Disease

Alzinova advanced partner discussions at the J.P. Morgan Healthcare Conference in San Francisco (Alzinova Press Release) - "During the week, Alzinova’s management actively advanced ongoing discussions with potential partners and investors, with a clear focus on the continued development of the vaccine candidate ALZ-101....During the meetings, Alzinova highlighted its positive Phase 1b data, the regulatory positioning of ALZ-101, including FDA Fast Track designation, and the preparatory work underway to support the next stage of clinical development."

Clinical • Trial status • Alzheimer's Disease

Results from a Phase 1b trial on anti-A? oligomer vaccine ALZ-101 in early Alzheimer's disease (CTAD 2025) - No abstract available

P1 data • Alzheimer's Disease • CNS Disorders

Alzinova announced that two abstracts on the vaccine candidate ALZ-101 have been accepted for presentation at the Clinical Trials on Alzheimer’s Disease (CTAD) 2025, to be held December 1–4 in San Diego, USA. (Alzinova Press Release)

Clinical data • Alzheimer's Disease

Alzinova Receives FDA (IND) Approval for Phase II Study of ALZ-101 in Alzheimer’s Disease (TradingView)

IND • Alzheimer's Disease

Alzinova submits applications for clinical trial initiation (IND) and Fast Track status to the FDA (TradingView) - "To enable the start of the planned Phase II study with ALZ-101, which is expected to commence in the second half of 2025, Alzinova has now submitted an IND application to the FDA...Alzinova therefore estimates that notifications in both cases can be expected during the third and fourth quarters of 2025."

Fast track • IND • Alzheimer's Disease

Alzinova aims for scientific publication as Phase II progresses (Nasdaq) - "Alzinova AB...announces that the company is focusing on preparing the well-received results from its Phase 1b study for scientific publication, while simultaneously intensifying partnership discussions and the regulatory and operational preparations ahead of the Phase II study with ALZ-101. The study is expected to commence in the second half of 2025....The company has chosen to focus on preparing the results for publication in a peer-reviewed scientific journal, an approach that enhances credibility and ensures broad international reach. Instead of presenting the data at AAIC, this strategic step is now being prioritized with the aim of submitting the manuscript during the third quarter of 2025."

New P2 trial • P1 data • Alzheimer's Disease

Alzinova's ALZ-101 normalizes protective antibody levels in Alzheimer's patients (BioStock) - P1 | N=33 | NCT05328115 | Sponsor: Alzinova AB | "Alzinova announces promising new clinical results for its vaccine candidate ALZ-101 in the treatment of Alzheimer's disease. A Phase I study has shown that the candidate increases the levels of protective antibodies in patients to levels comparable to healthy older individuals...Now, Alzinova has been able to present results that can take this development track further. The findings are based on the Phase I study ALZ-C-001, in which the company used its proprietary Aβ42CC technology to accurately measure immune responses to toxic amyloid-β oligomers – the structures thought to contribute to the neurodegenerative process in Alzheimer’s disease. The results show that healthy older people have higher levels of naturally occurring antibodies against these harmful proteins than both younger adults and Alzheimer’s patients."

P1 data • Alzheimer's Disease

A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: Alzinova AB | Recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Aβ42

Developing Topics. (PubMed, Alzheimers Dement) - P1 | "The results suggest that ALZ-101 vaccination is safe and generates an Aβ oligomer-specific humoral immune response that has an impact on several biomarkers associated with disease progression. Taken together, these findings support further development of ALZ-101 as a potential novel disease-modifying treatment for patients with AD."

Biomarker • Clinical • Journal • CNS Disorders • Inflammation • Aβ42 • CHI3L1 • p-tau181

First study participant completed treatment in Alzinova's phase Ib study [Google translation] (BioStock) - "By the fact that the first study participant in the company's phase Ib study with the vaccine candidate ALZ-101 has now completed his last treatment session, Alzinova is taking another step in the development of the next generation of Alzheimer's treatment. All study participants are expected to have completed the study in early 2025, after which a planned phase II study looms."

Trial status • Alzheimer's Disease • CNS Disorders

Phase 1b trial on the safety, tolerability and immunogenicity of anti-amyloid vaccine ALZ-101 in subjects with MCI or mild AD (AAIC 2024) - P1 | "The results suggest that ALZ-101 vaccination is safe and generates an A β oligomer-specific humoral immune response that has an impact on several biomarkers associated with disease progression. Taken together, these findings support further development of ALZ-101 as a potential novel disease-modifying treatment for patients with AD."

Clinical • P1 data • CNS Disorders • Inflammation • Aβ42 • CHI3L1 • p-tau181

A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Alzinova AB | Active, not recruiting ➔ Recruiting | Trial primary completion date: Dec 2023 ➔ Jan 2025

Enrollment open • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Aβ42

A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1 | N=27 | Active, not recruiting | Sponsor: Alzinova AB | Trial completion date: Jul 2023 ➔ Dec 2024 | Trial primary completion date: Jul 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Alzinova submits request for Pre-IND meeting with FDA and applies for EMA Scientific Advice (Market Screener) - "Alzinova...today announces that a request for a Pre-IND meeting with the US Food and Drug Administration (FDA) has been submitted and an application for EMA Scientific Advice from the European Medicines Agency (EMA). The purpose of these regulatory interactions is to prepare for the company's Phase 2 study with the ALZ-101 vaccine candidate being developed for the treatment of Alzheimer's disease. 'The communication with the FDA and EMA is important in the planning of the phase 2 study for our vaccine candidate ALZ-101. It is important to understand the authorities' requirements early on and to receive their guidance when planning and conducting our phase 2 study. We look forward to working with the FDA and EMA to develop ALZ-101 into a new effective and safe treatment for all those suffering from Alzheimer's disease.'"

European regulatory • FDA event • Alzheimer's Disease • CNS Disorders

Alzinova: New positive interim data from ongoing phase 1b study with vaccine candidate ALZ-101 – Initiates extension of the study (Market Screener) - P1 | N=26 | NCT05328115 | Sponsor: Alzinova AB | "Alzinova AB...announces today that a second planned interim analysis has been conducted of the ongoing clinical phase 1b study with the vaccine candidate ALZ-101 against Alzheimer’s disease. The analysis shows positive data with continued good safety and tolerability as well as a clear immunological response, that is, that specific antibodies have been formed. Based on this positive second interim analysis, the Company has decided to conduct an extension of the study. Analysis of 26 patients administered with ALZ-101 or placebo showed that those treated with ALZ-101 responded to treatment with antibody levels increasing with the number of doses given. The analysis also shows continued good safety and tolerability."

P1 data • Alzheimer's Disease • CNS Disorders

Interest from potential partners and positive response to ALZ-101 at the AD/PD (Market Screener) - "Alzinova AB...presented data from studies with the Company's vaccine candidate ALZ-101 at the international Alzheimer conference AD/PD™ held in Gothenburg, March 28 - April 1 2023. The scientific poster shows that the vaccine candidate has a long-term effect and that antibodies are found in the brain in the expected amount. The results attracted great interest at the conference and several important contacts were established. Alzinova's Chief Scientific Officer Anders Sandberg presented a scientific poster at the conference summarizing preclinical data for the Company's vaccine candidate ALZ-101 (phase 1b study ongoing)."

Clinical data • Preclinical • Alzheimer's Disease • CNS Disorders

Alzinova presents at several conferences and investor meetings in the spring of 2023 (Market Screener) - “Alzinova AB…will present the Company at both Swedish and international investor meetings and conferences during the spring of 2023. In March, the Alzheimer's conference AD/PD™ will take place in Gothenburg, bringing together international industry players and researchers from academia. In June, the Biotech International Convention, (‘US Bio’) will take place, which is an important American business conference for partner meetings. During the event, the Company will present its ALZ-101 vaccine candidate and ALZ-201 antibody to potential partners. During the spring, Alzinova will also present the Company to investors at various capital market events.”

Clinical • Alzheimer's Disease • CNS Disorders

PRE-CLINICAL AND INTERIM CLINICAL PHASE 1 ANTIBODY TITRE ANALYSIS OF ANTI-AMYLOID BETA OLIGOMER VACCINE ALZ-101 (ADPD 2023) - P1 | "Aims: The first immune therapy candidate targeting amyloid beta (Abeta) to treat Alzheimer's dise ase (AD), the vaccine AN1792, appeared to provide plaque removal without clinical improvement (Holmes et al., 2008). Four late -stage clinical trials on monoclonal antibodies have recently provided similar aducanumab, lecanemab, gantenerumab, and donanemab; all reducing plaque load, but with questionable safety and very modest clinical efficacy... The current evidence supports the continued clinical development of ALZ -101 as a specific, long -acting, and safe immunotherapy for targeting toxic Abeta oligomers in AD."

P1 data • Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Aβ42

A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1 | N=26 | Active, not recruiting | Sponsor: Alzinova AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders

ALZ-201, A MONOCLONAL ANTIBODY THERAPY FOR SPECIFIC NEUTRALISATION OF TOXIC AMYLOID-Β IN ALZHEIMER’S DISEASE. (CTAD 2022) - P1 | "These assemblies are effectively targeted by monoclonal antibodies (mAb) exhibiting selectivity for aggregated forms of Aβ (aducanumab, lecanemab, and gantenerumab) or specificity for pyroglutamated forms (donanemab). Our studies confirm the binding specificity of the unique mAb ALZ-201, which recognises a conformational epitope on the stabilised oligomer antigen in vaccine ALZ-101 and a subset of synthetic Aβ42 oligomers. We previously demonstrated that ALZ-201 specifically binds to a toxic species in post-mortem AD brain extracts to cause a positive physiological and protective impact on the integrity and morphology of mouse neurons. Biosimilars of aducanumab, lecanemab, and gantenerumab, on the other hand, were here shown to exhibit no conformational preference for Aβ, indicating that their weak binding to non-aggregated forms stem almost exclusively from fast binding off-rates."

Alzheimer's Disease • CNS Disorders

Alzinova announces new positive safety review of its Phase 1b study in Alzheimer's disease (PRNewswire) - “Alzinova…announces today that a second external safety review has been carried out of the Company's clinical phase 1b study - with a positive assessment to continue the study as planned. Behind the review is an independent expert group, Data and Safety Monitoring Board (‘DSMB’), which continuously reviews the study. Based on the patients included in the study, the DSMB recommends continuing the study as planned without adjustments. The Company has previously communicated DSMB's first review in April 2022, which also gave the green light to continue the study….Enrolment in the study is ongoing and topline data for the study is anticipated in the second half of 2023.”

DSMB • P1 data • Alzheimer's Disease • CNS Disorders