NKGen Biotech Announces FDA Clearance Of IND Application For SNK01 NK Cell Therapy in Parkinson's Disease
NKGen Biotech Announces FDA Clearance Of IND Application For SNK01 NK Cell Therapy in Parkinson's Disease
NKGen advances its neurodegenerative disease program with FDA IND clearance for its Phase 1/2a SNK01 Clinical Trial in patients with Parkinson's disease.
NKGen推進其神經退行性疾病項目，美國食品藥品管理局批准了其針對帕金森氏病患者的1/2a期 SNK01 臨床試驗。
The Company expects to initiate a Phase 1 clinical trial in PD in 2H 2024.
該公司預計將在2024年下半年啓動PD的1期臨床試驗。
SANTA ANA, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (NASDAQ:NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug ("IND") application for SNK01 NK cell therapy for the treatment of Parkinson's disease ("PD"). SNK01 is an autologous, nongenetically modified NK cell product that has enhanced cytotoxicity and activating receptor expression, potentially addressing a novel approach to tackling Parkinson's disease.
加利福尼亞州聖安娜，2024年4月29日（GLOBE NEWSWIRE）——專注於創新自體、異基因和CAR-NK自然殺手（“NK”）細胞療法開發和商業化的臨床階段生物技術公司 NKGen Biotech, Inc.（納斯達克股票代碼：NKGN）（“NKGen” 或 “公司”）今天宣佈，美國食品藥品監督管理局（“FDA”）已批准該公司用於治療帕金森氏病（“PD”）的 SNK01 NK細胞療法的研究性新藥（“IND”）申請。SNK01 是一種自體、非基因改造的 NK 細胞產物，具有增強細胞毒性並激活受體表達，有可能解決一種治療帕金森氏病的新方法。
The FDA IND clearance enables NKGen to initiate a Phase 1/2a clinical trial evaluating the safety, tolerability, and exploratory efficacy of SNK01 in patients with PD. The trial is designed to enroll up to 30 patients (20 receiving SNK01 and 10 receiving placebo). NKGen expects to begin the trial, with the first patient dosed, in the second half of 2024.
美國食品藥品管理局的IND批准使NKGen能夠啓動一項1/2a期臨床試驗，評估 SNK01 對PD患者的安全性、耐受性和探索性療效。該試驗旨在招收多達 30 名患者（20 名接受 SNK01，10 名接受安慰劑）。NKGen預計將在2024年下半年開始試驗，爲第一位患者服藥。
"The IND clearance marks a significant milestone as we advance our pipeline of NK cell therapy in neurodegenerative diseases," said Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen. "This is our second IND approval for SNK01 within the past several months and underscores our focused dedication towards developing safe and effective treatments that target both protein deposition and neuroinflammation for patients with neurodegenerative diseases such as Alzheimer's and Parkinson's. We are excited to start our first clinical trial in PD as there currently is a high unmet medical need in this indication."
NKGen董事長兼首席執行官Paul Y. Song醫學博士表示：“在我們推進神經退行性疾病NK細胞療法產品線的過程中，IND的批准標誌着一個重要的里程碑。”“這是我們在過去幾個月內第二次獲得 SNK01 的IND批准，這凸顯了我們致力於爲阿爾茨海默氏症和帕金森氏症等神經退行性疾病患者開發針對蛋白質沉積和神經炎症的安全有效的治療方法。我們很高興在PD開始我們的第一項臨床試驗，因爲目前該適應症有大量未得到滿足的醫療需求。”
Dr. Song further commented, "Given the encouraging outcomes regarding the reduction in neuroinflammation observed in our Phase 1 Alzheimer's trials, we are optimistic about the potential benefits that may emerge in our Parkinson's trial. Although these two neurodegenerative diseases differ, both share a neuroinflammatory component, which has led to our hypothesis that SNK01 may be beneficial in both indications. While directly inhibiting neuroinflammation, whether as an independent approach or in conjunction with other interventions, may not address the etiology, it can potentially decrease the production of factors that contribute to neurotoxicity, thereby hopefully leading to clinical improvements."
宋博士進一步評論說：“鑑於我們在1期阿爾茨海默氏症試驗中觀察到的減少神經炎症的令人鼓舞的結果，我們對帕金森氏症試驗可能產生的潛在益處持樂觀態度。儘管這兩種神經退行性疾病不同，但它們都具有神經炎性成分，這使我們假設 SNK01 可能對兩種適應症都有益。儘管直接抑制神經炎症，無論是作爲獨立方法還是與其他干預措施結合使用，都可能無法解決病因，但它有可能減少導致神經毒性的因子的產生，從而有望帶來臨床改善。”