Vaccinex to Report Promising New Efficacy Data for SIGNAL-AD Phase 1b/2 trial of Pepinemab at Clinical Trials on Alzheimer’s Disease (CTAD) Conference on October 31, 2024
Vaccinex (NASDAQ: VCNX) announced upcoming presentation of new efficacy and safety data from its SIGNAL-AD phase 1b/2 trial of pepinemab for Alzheimer's disease at the CTAD Conference in Madrid on October 31, 2024. The study focuses on pepinemab's ability to block SEMA4D, a molecule highly upregulated in damaged neurons during AD progression. The treatment aims to prevent harmful astrocyte activation that may accelerate disease progression. Key outcomes include impacts on cognitive decline and disease progression biomarkers. Notably, pepinemab shows potential benefits for brain vascular integrity, addressing a common concern with current AD treatments that can cause microhemorrhages.
Vaccinex (NASDAQ: VCNX) ha annunciato la prossima presentazione di nuovi dati di efficacia e sicurezza provenienti dal suo trial SIGNAL-AD di fase 1b/2 sul pepinemab per il trattamento dell'Alzheimer, che si terrà alla Conferenza CTAD a Madrid il 31 ottobre 2024. Lo studio si concentra sulla capacità del pepinemab di bloccare la SEMA4D, una molecola altamente regolata in modo anomalo nei neuroni danneggiati durante la progressione dell’AD. Il trattamento mira a prevenire l'attivazione dannosa degli astrociti che potrebbe accelerare la progressione della malattia. I risultati chiave includono impatti sul declino cognitivo e sui biomarcatori della progressione della malattia. È notevole che il pepinemab mostra potenziali benefici per l'integrità vascolare cerebrale, affrontando una preoccupazione comune con i trattamenti attuali per l'AD che possono causare microemorragie.
Vaccinex (NASDAQ: VCNX) anunció la próxima presentación de nuevos datos de eficacia y seguridad de su ensayo SIGNAL-AD de fase 1b/2 sobre pepinemab para la enfermedad de Alzheimer en la Conferencia CTAD en Madrid el 31 de octubre de 2024. El estudio se centra en la capacidad del pepinemab para bloquear la SEMA4D, una molécula altamente regulada en exceso en neuronas dañadas durante la progresión de la EA. El tratamiento tiene como objetivo prevenir la activación perjudicial de los astrocitos que puede acelerar la progresión de la enfermedad. Los resultados clave incluyen impactos en el deterioro cognitivo y biomarcadores de progresión de la enfermedad. Es notable que el pepinemab muestra beneficios potenciales para la integridad vascular cerebral, abordando una preocupación común con los tratamientos actuales para la EA que pueden causar microhemorragias.
백시넥스 (NASDAQ: VCNX)는 2024년 10월 31일 마드리드에서 열리는 CTAD 컨퍼런스에서 알츠하이머병을 위한 페피네맵의 SIGNAL-AD 1b/2 임상 시험의 새로운 효능 및 안전성 데이터를 발표할 예정이라고 발표했습니다. 이 연구는 알츠하이머 진행 과정에서 손상된 신경세포에서 과도하게 조절된 분자인 SEMA4D를 차단하는 페피네맵의 능력에 집중하고 있습니다. 이 치료는 질병 진행을 가속화할 수 있는 해로운 별아교세포의 활성화를 예방하는 것을 목표로 합니다. 주요 결과에는 인지 저하 및 질병 진행 바이오마커에 대한 영향이 포함됩니다. 특히, 페피네맵은 미세출혈을 유발할 수 있는 현재 알츠하이머 치료제에서 흔히 발생하는 우려를 해결하여 뇌 혈관의 무결성에 대한 잠재적인 이점을 보여줍니다.
Vaccinex (NASDAQ: VCNX) a annoncé la prochaine présentation de nouvelles données d'efficacité et de sécurité issues de son essai SIGNAL-AD de phase 1b/2 sur le pepinemab pour la maladie d'Alzheimer lors de la Conférence CTAD à Madrid le 31 octobre 2024. L'étude se concentre sur la capacité du pepinemab à bloquer la SEMA4D, une molécule fortement régulée lors de l'endommagement des neurones pendant la progression de la MA. Le traitement vise à prévenir l'activation nuisible des astrocytes qui pourrait accélérer la progression de la maladie. Les résultats clés incluent des impacts sur le déclin cognitif et les biomarqueurs de progression de la maladie. Il est à noter que le pepinemab montre des avantages potentiels pour l'intégrité vasculaire cérébrale, ce qui répond à une préoccupation courante concernant les traitements actuels de la MA qui peuvent provoquer des micro-hémorragies.
Vaccinex (NASDAQ: VCNX) gab bekannt, dass sie am 31. Oktober 2024 auf der CTAD-Konferenz in Madrid neue Daten zur Wirksamkeit und Sicherheit aus ihrer SIGNAL-AD Phase 1b/2 Studie zu Pepinemab bei Alzheimer präsentieren werden. Die Studie konzentriert sich auf die Fähigkeit von Pepinemab, SEMA4D zu blockieren, ein Molekül, das bei der Schädigung von Neuronen während des Fortschreitens von AD stark hochreguliert ist. Die Behandlung hat das Ziel, schädliche Astrozytenaktivierungen zu verhindern, die den Krankheitsverlauf beschleunigen könnten. Zu den Schlüssel-Ergebnissen gehören Auswirkungen auf kognitive Beeinträchtigungen und Biomarker der Krankheitsprogression. Bemerkenswert ist, dass Pepinemab mögliche Vorteile für die Gefäßintegrität des Gehirns zeigt und ein häufiges Problem bei aktuellen AD-Behandlungen anspricht, die Mikroblutungen verursachen können.
- Treatment shows potential to preserve brain vascular integrity, addressing a key safety concern in AD treatments
- Study received funding support from Alzheimer's Association and Alzheimer's Drug Discovery Foundation
- Efficacy data not yet disclosed
- Still in early clinical trial phases (1b/2)
Insights
The upcoming presentation of SIGNAL-AD Phase 1b/2 trial data represents a routine conference announcement without actual results being disclosed. While the article provides background on pepinemab's mechanism of action in targeting SEMA4D and its potential role in Alzheimer's disease, it does not contain any new efficacy or safety data. The presentation is scheduled for October 31, 2024, making this a forward-looking announcement rather than impactful news that would affect immediate investment decisions.
In addition to cognitive benefit, pepinemab is believed to preserve vascular integrity in brain, a key consideration to avoid toxicity in Alzheimer’s disease
ROCHESTER, N.Y., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease (AD) and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced that it will present promising new efficacy and safety data for its randomized, double-blind, phase 1b/2 SIGNAL-AD study of pepinemab treatment for Alzheimer’s disease at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference in Madrid, on October 31, 2024. Elizabeth Evans, PhD, Chief Operating Officer and Senior VP Discovery and Translational Medicine, will present results of the study in a podium presentation.
Presentation title: Results of SIGNAL-AD, a randomized, phase 1b/2 trial to evaluate safety and efficacy of pepinemab, anti-SEMA4D antibody believed to block reactive astrogliosis, in patients with Mild Cognitive Impairment (MCI) and Mild Dementia due to AD
Presenter: Elizabeth Evans, PhD
Date: Thursday October 31, 2024, 2:55 PM Central European Time, 9:55 AM EDT.
Venue: Madrid Marriott Auditorium Hotel and Conference Center
What can we expect to learn from results of this study?
- Vaccinex scientists discovered and published that Semaphorin 4D (SEMA4D), a molecule that binds to high affinity plexin-B1 receptors expressed on astrocytes in the brain, is highly upregulated on stressed or damaged neurons during progression of Alzheimer’s Disease (AD)
- Astrocytes, which are key brain cells that support the health and function of neurons, undergo extensive changes in morphology and gene expression when SEMA4D binds to their receptors. They switch from normal supportive functions to neurotoxic inflammatory activity that is believed to aggravate and accelerate progression of AD.
- The Company’s hypothesis, which is being tested in the SIGNAL-AD study, is that treating with pepinemab antibody that binds SEMA4D can block signaling through astrocyte receptors and slow or prevent the damaging consequences of astrocyte activation.
- The Company has previously reported that antibody blockade of SEMA4D appears to protect healthy astrocyte functions and to slow disease progression in patients with Huntington’s disease.
- Key outcomes of the SIGNAL-AD study include the impact of pepinemab treatment on cognitive decline as well as biomarkers of disease progression.
- Deposition of Aβ amyloid in the brain is currently the earliest recognized event in the pathologic cascade leading to AD. Aggregates of Aβ are believed to trigger a series of subsequent events, including astrocyte reactivity and formation of toxic tau tangles in neurons, which are believed to be key drivers of neurodegeneration. Levels of soluble biomarkers, such as astrocyte protein glial fibrillary acidic protein and phosphorylated tau peptide (p-tau 217), are, therefore, key biomarkers of disease progression, and it is important to characterize expression of these biomarkers in relation to treatment effects.
- Some currently approved drugs have been reported to compromise the integrity of brain vasculature leading to inflammation and microhemorrhages. Vaccinex will report evidence from new preclinical models suggesting beneficial effects of pepinemab treatment on brain vasculature.
The SIGNAL-AD study was funded in part by a grant from the Alzheimer’s Association as well as by investments from the Alzheimer’s Drug Discovery Foundation (ADDF).
About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can otherwise bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton in cells and lead to loss of homeostatic functions of astrocytes and other glial cells in the brain and of dendritic cells in immune tissue. Pepinemab appears to have been well-tolerated with a favorable safety profile in multiple clinical trials in different neurological and cancer indications.
About Vaccinex Inc.
Vaccinex, Inc. is pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases and cancer through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes triggers damaging inflammation in chronic diseases of the brain and prevents infiltration and activation of immune cells in tumors. Pepinemab is being studied as a monotherapy in the Phase 1b/2 SIGNAL-AD study in Alzheimer’s Disease, and the Company has previously published promising Phase 2 data in Huntington’s disease. Pepinemab could be an important contributor to combination therapy in AD. In oncology, pepinemab is being evaluated in combination with KEYTRUDA® in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer (HNSCC) and in combination with BAVENCIO® in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma (PDAC). The oncology clinical program also includes several investigator-sponsored studies in solid tumors including breast cancer and melanoma.
Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA. BAVENCIO®/avelumab is provided by Merck KGaA, Darmstadt, Germany, previously as part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about expectations and objectives with respect to the results and timing of the SIGNAL-AD clinical trial; expectations with respect to compliance with Nasdaq listing standards; our plans, expectations and objectives with respect to the results and timing of the SIGNAL-AD and KEYNOTE-B84 clinical trials; the use and potential benefits of pepinemab in R/M HNSCC, lung cancer, metastatic pancreatic adenocarcinoma (PDAC) and other indications; the potential for benefits as compared to single agent KEYTRUDA® or BAVENCIO®; expectations with respect to the collaboration of Merck,; and other statements identified by words such as “anticipate,” “believe,” “plans,” “schedule,” “being,” “will,” “appears,” “expect,” “ongoing,” “potential,” “promising,” “suggest”, and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical studies and clinical trials, that interim and preliminary data may not be predictive of final results and does not ensure success in later clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the possible delisting of our common stock from Nasdaq if the Company is unable to regain and sustain compliance with the Nasdaq listing standards, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, the Company assumes no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Securities and Exchange Commission and the other risks and uncertainties described in the Company’s annual year-end Form 10-K and subsequent filings with the SEC.
Investor Contact
Elizabeth Evans, PhD
Chief Operating Officer, Vaccinex, Inc.
(585) 271-2700
eevans@vaccinex.com
FAQ
What are the key endpoints of Vaccinex's SIGNAL-AD trial for pepinemab (VCNX)?
How does pepinemab work in treating Alzheimer's Disease according to Vaccinex (VCNX)?
When will Vaccinex (VCNX) present the SIGNAL-AD trial results?
