ALZ-101 / Alzinova - LARVOL DELTA

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

"Alzinova establishes scaled-up manufacturing process for ALZ-101 ahead of Phase 2 https://t.co/FB0kQkBhAC" (@CisionNews)

"Alzinova etablerar uppskalad tillverkningsprocess för ALZ-101 inför fas-2 https://t.co/605DMlHubk" (@CisionNews)

Alzinova announces positive safety review and continuation of its Phase 1b study in Alzheimer’s disease (PRNewswire) - “Alzinova AB (publ)…today announces that the Data and Safety Monitoring Board (DSMB) completed a planned assessment of the ongoing ALZ-101 Phase 1b clinical study and recommended continuation of the study. The DSMB consists of independent group of experts who review data during the study, with particular attention to safety….As specified in the ALZ-101 study protocol, the DSMB (sic) meets periodically to examine the safety data accumulated during progress of the study.”

DSMB • Alzheimer's Disease • CNS Disorders

A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Alzinova AB

New P1 trial • Alzheimer's Disease • CNS Disorders

Alzinova improves manufacturing process of ALZ-101 to meet phase 2 requirements (PRNewswire) - “Alzinova AB…announces that the manufacturing process for its oligomer-specific vaccine, ALZ-101, has been further improved to facilitate large-scale production….Alzinova's drug substance manufacturing partner, Bachem…has optimised the manufacturing process of the active ingredient in ALZ-101 – a vaccine in clinical development for the treatment of Alzheimer's disease. Process optimisations have resulted in a more efficient and scalable manufacturing process enabling supply of ALZ-101 in the amounts required for phase 2 clinical trials.”

Commercial • Alzheimer's Disease • CNS Disorders

"Alzinova improves manufacturing process of ALZ-101 to meet phase 2 requirements https://t.co/S43oMMbF7g" (@CisionNews)

"Alzinova förbättrar tillverkningsprocess för ALZ-101 för att uppfylla fas-2-krav https://t.co/7bmYplnuAT" (@CisionNews)

First patient recruited into Alzinova’s phase 1b clinical study with the oligomer-specific ALZ-101 vaccine against Alzheimer’s disease (PRNewswire) - “Alzinova AB…today announces that the first patient has been recruited into its phase 1b clinical study with ALZ-101 in Finland…In total, 26 patients will be included in the study. The study participants will receive four doses of either ALZ-101 or placebo. The study investigates two different dose strengths of ALZ-101 during a treatment period of 20 weeks. Topline data for the study is anticipated in the second half of 2023.”

Clinical protocol • P1 data • Trial status • Alzheimer's Disease • CNS Disorders

Alzinova receives approval to start the first clinical study with the oligomer-specific ALZ-101 vaccine in patients with Alzheimer's disease (PRNewswire) - “Alzinova AB…announced today that the company has received approval from the regulatory authorities in Finland to initiate the first clinical study with the vaccine candidate, ALZ-101. The Phase 1b clinical study with ALZ-101 in Alzheimer's patients will evaluate the vaccine candidate's tolerability and safety. It will also study the immunological response to the vaccine after multiple doses, as well as a number of biomarkers that are associated with Alzheimer's disease.”

New P1 trial • Alzheimer's Disease • CNS Disorders

Alzinova presents preclinical data on Alzheimer disease candidates at the AAIC conference (PRNewswire) - “Alzinova…today presenting data on the monoclonal antibody, ALZ-201, at the Alzheimer's Association International Conference (AAIC) held in Denver, USA and online. The preclinical data support the continued development of Alzinova's lead candidate, ALZ-101, which is further in development and is expected to enter the clinical phase with a Phase 1b study in Alzheimer's patients during the third quarter of 2021…These data indicate that it has very high selectivity for the toxic form of the Aβ peptide and a binding profile that differs from other known antibodies in the field. The selectivity may be a critical attribute for achieving a true specific therapeutic effect with favorable tolerability in patients with Alzheimer's disease.”

New P1 trial • Preclinical • Alzheimer's Disease • CNS Disorders

"Statusuppdatering avseende ansökan om att starta den kliniska studien med ALZ-101 https://t.co/40cEXwtZYE" (@CisionNews)