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Alzamend Neuro Submits IND Application For Phase I/IIA Trial For An Immunotherapy (ALZN002) To Treat Mild To Moderate Dementia Of The Alzheimer's Type

Alzamend Neuro Submits IND Application For Phase I/IIA Trial For An Immunotherapy (ALZN002) To Treat Mild To Moderate Dementia Of The Alzheimer's Type

阿尔茨海默神经公司提交免疫疗法(ALZN002)I/IIA期试验的IND申请用于治疗阿尔茨海默氏型轻至中度痴呆症
Benzinga Real-time News ·  2022/09/29 08:02

Alzamend Neuro, Inc. (NASDAQ:ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease ("Alzheimer's"), bipolar disorder, major depressive disorder ("MDD") and post-traumatic stress disorder ("PTSD"), today announced that it submitted an investigational new drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for its immunotherapy product candidate ALZN002. The product candidate is designed to treat mild to moderate dementia of the Alzheimer's type. ALZN002 is a proprietary "active" immunotherapy product, which means it is produced by each patient's immune system. It consists of autologous dendritic cells ("DCs") that are activated white blood cells taken from each individual patient so that they can be engineered outside of the body to attack Alzheimer's-related amyloid-beta proteins. These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed to bolster the ability of the patient's immune system to combat Alzheimer's; the goal being to foster tolerance to treatment for safety purposes while stimulating the immune system to reduce the brain's beta-amyloid protein burden, resulting in reduced Alzheimer's signs and symptoms. Compared to passive immunization treatment approaches that use foreign blood products (such as monoclonal antibodies), active immunization with ALZN002 is anticipated to offer a more robust and long-lasting effect on the clearance of amyloid. This could provide a safer approach due to its reliance on autologous immune components, using each individual patient's own white blood cells rather than foreign cells and/or blood products.

致力于开发治疗阿尔茨海默病(“阿尔茨海默病”)、双相情感障碍、严重抑郁障碍(“MDD”)和创伤后应激障碍(“PTSD”)的新型产品的早期临床生物制药公司阿尔茨海默病(纳斯达克:ALZN)(以下称“阿尔茨海默病”)今天宣布,该公司向美国食品和药物管理局(FDA)提交了其候选免疫疗法产品ALZN002的研究用新药(IND)申请。该候选产品旨在治疗阿尔茨海默病类型的轻度至中度痴呆症。ALZN002是一种专利的“主动”免疫治疗产品,这意味着它是由每个患者的免疫系统产生的。它由自体树突状细胞(DC)组成,DC是从每个患者身上提取的激活的白细胞,因此它们可以在体外进行工程,以攻击与阿尔茨海默氏症相关的淀粉样β蛋白。这些DC含有一种新型的淀粉样β蛋白(E22W),旨在增强患者免疫系统对抗阿尔茨海默氏症的能力;目标是出于安全目的培养对治疗的耐受性,同时刺激免疫系统减少大脑的β-淀粉样蛋白负担,从而减少阿尔茨海默氏症的症状和体征。与使用国外血液产品(如单抗)的被动免疫治疗方法相比,ALZN002的主动免疫有望在清除淀粉样蛋白方面提供更强大和更持久的效果。这可能会提供一种更安全的方法,因为它依赖于自体免疫成分,使用每个患者自己的白细胞,而不是外来细胞和/或血液产品。

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