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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

阿爾茨海默神經公司提交免疫療法(ALZN002)I/IIA期試驗的IND申請用於治療阿爾茨海默氏型輕至中度痴呆症
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.

致力於開發治療阿爾茨海默病(“阿爾茨海默病”)、雙相情感障礙、嚴重抑鬱障礙(“MDD”)和創傷後應激障礙(“PTSD”)的新型產品的早期臨牀生物製藥公司阿爾茨海默病(納斯達克:ALZN)(以下稱“阿爾茨海默病”)今天宣佈,該公司向美國食品和藥物管理局(FDA)提交了其候選免疫療法產品ALZN002的研究用新藥(IND)申請。該候選產品旨在治療阿爾茨海默病類型的輕度至中度痴呆症。ALZN002是一種專利的“主動”免疫治療產品,這意味着它是由每個患者的免疫系統產生的。它由自體樹突狀細胞(DC)組成,DC是從每個患者身上提取的激活的白細胞,因此它們可以在體外進行工程,以攻擊與阿爾茨海默氏症相關的澱粉樣β蛋白。這些DC含有一種新型的澱粉樣β蛋白(E22W),旨在增強患者免疫系統對抗阿爾茨海默氏症的能力;目標是出於安全目的培養對治療的耐受性,同時刺激免疫系統減少大腦的β-澱粉樣蛋白負擔,從而減少阿爾茨海默氏症的症狀和體徵。與使用國外血液產品(如單抗)的被動免疫治療方法相比,ALZN002的主動免疫有望在清除澱粉樣蛋白方面提供更強大和更持久的效果。這可能會提供一種更安全的方法,因為它依賴於自體免疫成分,使用每個患者自己的白細胞,而不是外來細胞和/或血液產品。

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