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NKGen Biotech Presents New Positive SNK01 Biomarker Data at the 2024 Alzheimer's Association International Conference

NKGen Biotech Presents New Positive SNK01 Biomarker Data at the 2024 Alzheimer's Association International Conference

NKGen生物技術在2024年阿爾茨海默病國際會議上展示了新的SNK01生物標誌物積極數據。
GlobeNewswire ·  07/30 08:05

SNK01, a cryopreserved autologous non-genetically modified NK cell product, is able to effectively reduce α-synuclein (α-syn) protein levels in the cerebral spinal fluid (CSF) of Alzheimer's patients; an important finding since increased α-syn has been correlated with worse cognitive performance and is not a target for any currently approved Alzheimer's treatments

冷凍保存的自體非基因改造Nk細胞產品SNK01可有效降低阿爾茨海默病患者腦脊液中α-突觸核蛋白(α-syn)的水平;這是一項重要的發現,因爲α-syn增加與較差的認知表現有關,目前已批准的阿爾茨海默病治療尚未針對它。

SNK01 treatment appears to stabilize or improve cognitive function and reduce α-synuclein levels in CSF in addition to improving previously reported amyloid, tau, and neuroinflammatory markers (GFAP, NfL, YKL-40) in the majority of patients

SNK01治療似乎能夠穩定或改善認知功能,並降低腦脊液中的α-突觸核蛋白水平,除了能改善已報道的澱粉樣蛋白、tau和神經炎性標誌物(GFAP,NfL,YKL-40)之外,大多數患者還有改善。

SANTA ANA, Calif., July 30, 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 the presentation of a poster entitled, "Subjects treated with expanded non-genetically modified autologous Natural Killer cells (SNK01) show improved changes in CSF α-synuclein and in cognitive function." SNK01 is a first-in-kind, autologous non-genetically modified NK cell product with significantly increased cytotoxicity and over 90% activating receptor expression that can be consistently produced from any donor. Clinical trial data on the effect of SNK01 α-synuclein and cognitive assessments in patients with Alzheimer's Disease ("AD") was presented at the 2024 Alzheimer's Association International Conference ("AAIC") held in Philadelphia, PA on July 30, 2024.

加州聖安娜,2024年7月30日(環球新聞社)- NKGen生物技術公司(納斯達克:NKGN)(「NKGen」或「公司」)是一家專注於開發和商業化創新的自體、異體和CAR-Nk自然殺傷細胞(「NK」)治療產品的臨床生物技術公司,今天宣佈展示了題爲「受到擴展的非基因修飾自體自然殺傷細胞(SNK01)治療的受試者表現出腦脊液α-突觸核蛋白和認知功能改善」的海報。SNK01是一種首創的非基因修飾自體NK細胞產品,具有顯著增強的細胞毒性和超過90%的激活受體表達,可以從任何供體中始終產生。針對SNK01 α-突觸核蛋白治療效果和對阿爾茨海默病(「AD」)患者認知評估的臨床試驗數據已於2024年7月30日在費城舉辦的2024年阿爾茨海默病協會國際會議(「AAIC」)上進行了發佈。

Elevated levels of α-syn in the CSF have been linked to cognitive impairment in AD patients and correlate with worse cognitive performance (Twohig and Nielson, 2019). NKGen's in vitro data demonstrated that SNK01 had, similarly to microglial (HMC3) cells, the ability to internalize and degrade α-syn aggregates which further supports the rationale for its use for α-synucleinopathies. Following an initial Phase I biomarker analysis that showed SNK01 could improve CSF levels of amyloid, tau, and neuroinflammation (GFAP, YKL-40, NfL), a secondary analysis was performed looking at the effect of SNK01 specifically on α-syn protein levels in CSF. Despite 70% of patients in this trial being treated with relatively low doses of SNK01, 60% had a reduction in their CSF levels of α-synuclein. In addition, 90% of patients (median MMSE score of 14 at baseline) showed stable or improved cognitive function at 11 weeks using the ADCOMS score.

腦脊液中α-突觸核蛋白升高與AD患者認知功能受損相關,並與更糟糕的認知表現相關(Twohig和Nielson,2019)。NKGen的體外數據表明,與微膠質細胞(HMC3)細胞類似,SNK01具有內化和降解α-突觸核蛋白聚集體的能力,進一步支持其在α-突觸核蛋白病中的使用理由。在初步的I期生物標誌物分析顯示SNK01能改善腦脊液中澱粉樣蛋白、tau蛋白和神經炎症(GFAP、YKL-40、NfL)水平後,進行了第二次分析,專門研究了SNK01對腦脊液中α-突觸核蛋白水平的影響。儘管在此試驗中70%的患者接受的SNK01劑量相對較低,但有60%的患者腦脊液中α-突觸核蛋白水平有減少。此外,90%的患者(基線中等MMSE評分爲14)在11周使用ADCOMS評分顯示穩定或改善的認知功能。

"The additional data from our Phase I Alzheimer's trial shows that SNK01 has the ability to reduce CSF α-synuclein levels in Alzheimer's patients, which is important because studies have shown that high levels of α-syn are correlated with disease progression and worsened cognitive function in AD," said Dr. Paul Y. Song, MD, Chairman and CEO of NKGen. "To our knowledge, there is no treatment for Alzheimer's disease on the market that currently targets this protein as well as amyloid and tau while also reducing neuroinflammation like SNK01 does. We are excited that this additional data appears to show that treatment with SNK01 can also target, and reduce, α-syn while improving cognitive function in Alzheimer's patients. We are working diligently to expand our investigation of SNK01 in a larger Phase II trial with higher doses and a longer treatment duration. We are also looking to expand the use of SNK01 for other synucleinopathy-related neurodegenerative diseases."

我們阿爾茨海默病I期臨床試驗的附加數據顯示,SNK01有能力降低阿爾茨海默病患者的腦脊液中的α-突觸核蛋白水平,這很重要,因爲研究表明高水平的α-突觸核蛋白與疾病進展和AD的認知功能惡化相關。"NKGen的董事兼首席執行官Paul Y. Song博士表示,"據我們所知,目前市場上沒有針對這個蛋白以及澱粉樣蛋白和tau蛋白,並降低神經炎症的治療方法。我們對這些附加數據似乎顯示SNK01也可以針對並降低α-突觸核蛋白,同時改善阿爾茨海默病患者的認知功能感到興奮。我們正在努力將SNK01擴展到更大劑量和更長治療時間的二期試驗,並希望將SNK01的用途擴展到其他與突觸核蛋白病相關的神經退行性疾病。"

Data Highlights from the Poster Presentation:

海報展示的數據亮點:

  • Our in vitro studies have shown that SNK01 is able to effectively internalize and degrade α-synuclein aggregates.
  • Despite 70% of subjects being treated at relatively low doses of SNK01:
    • 90% of all evaluable subjects had either stable or improved (±0.1) composite ADCOMS scores at week 11 (one-week after the final dose).
    • 60% of subjects (6/10) had a decrease in CSF α-syn compared to baseline values.
    • At Week 11, the decreases in α-syn corresponded to stable/decrease in ADCOMS in 5/6 subjects and where data was available, the α-syn levels continued below baseline through Week 22. One additional subject had a decrease in CSF α-syn compared to baseline values at Week 22.
  • No treatment related adverse events were observed. SNK01 is well-tolerated by AD subjects with no dose-limiting toxicities observed at all doses tested.
  • SNK01 appears to stabilize or improve cognitive function in the majority of subjects, despite 70% of subjects being treated at relatively low doses.
  • SNK01 appears to reduce α-synuclein levels in CSF.
  • We hypothesize that SNK01 is safe, can cross the blood brain barrier (BBB) and can impact both cognition and protein aggregates in Alzheimer's patients.
  • This data warrants further investigation in a larger Phase Il trial with higher doses and a longer treatment duration.
  • 我們的體外研究表明,SNK01能夠有效內化和降解α-突觸核蛋白聚集物。
  • 儘管70%的受試者接受了相對較低劑量的SNK01:
    • 所有可評估受試者中,90%在第11周(最後一劑藥物一週後)的複合ADCOMS評分要麼穩定要麼有所改善(±0.1)。
    • 10個受試者中有60%(6/10)的受試者的腦脊液α-突觸減少與基線值相比
    • 在第11周,α-突觸的減少與5/6個受試者的ADCOMS的穩定/減少相對應,在數據可用的情況下,α-突觸水平在第22周繼續低於基線。額外的一個受試者在第22周α-突觸的減少與基線值相比
  • 未觀察到與治療相關的不良事件。SNK01在所有測試劑量下,AD患者耐受性良好,沒有觀察到劑量限制毒性
  • 儘管有70%的受試者接受相對較低劑量的治療,但SNK01似乎能夠穩定或改善大多數受試者的認知功能
  • SNK01似乎能夠降低腦脊液中的α-突觸水平
  • 我們假設SNK01是安全的,可以穿越血腦屏障(BBB),並且可以影響阿爾茨海默病患者的認知和蛋白質聚集
  • 這些數據需要在更大規模的第二階段試驗中進行進一步研究,使用更高劑量和更長的治療週期

A copy of the poster is available on the Scientific Publications page of the Company's website at . Previously disclosed Phase I data on the positive effects of SNK01 on amyloid, tau, and neuroinflammation biomarkers in Alzheimer's patients, which may not be included in this poster presentation, can also be found on the Scientific Publications webpage.

公司網站的科學出版物頁面上有海報的副本 此前披露的SNK01對阿爾茨海默病患者的澱粉樣蛋白、tau蛋白和神經炎症生物標誌物的積極影響的I期數據,可能不包括在本海報展示中,也可以在科學出版物網頁上找到。

About SNK01

關於SNK01

SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer cell, immunotherapeutic drug candidate. NKGen Biotech, Inc. is developing SNK01 for the treatment of neurodegenerative disorders and a broad range of cancers.

SNK01是一種新型的基於細胞的、患者特異性的體外擴增自體天然殺傷細胞免疫治療藥物候選。NKGen生物技術公司正在開發SNK01,用於治療神經退行性疾病和廣泛的癌症。

About NKGen Biotech

NKGen 是一家專注於開發和商業化創新的自體、異體和 CAR-Nk NK 細胞治療法的臨床階段生物技術公司。NKGen 總部位於美國加利福尼亞州聖安娜。有關更多信息,請訪問

NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK NK cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit .

本新聞稿中的聲明可能包含 "前瞻性聲明",其屬於 1934 年修正版證券交易法第 27A 條和第 21E 條的範疇。前瞻性聲明可通過使用諸如 "預計"、"相信"、"可能"、"繼續"、"期望"、"估計"、"可能"、"計劃"、"展望"、"未來" 和 "項目" 等類似的表達方式來識別,這預示或表明未來事件或趨勢或不是歷史事實的陳述。由於此類陳述面臨風險和不確定性,其中許多風險和不確定性是公司無法控制的,實際結果可能與這樣的前瞻性聲明所表達的相差甚遠。此類聲明包括但不限於公司計劃和預期 SNK01 的開發計劃和時間,包括預計完成並公佈其正在進行中的臨床研究的更多結果的時間;以及公司開發其產品候選人和其產品候選人潛在好處的預期時間。有助於不確定性前瞻性聲明的風險包括:公司執行其計劃和策略的能力;執行臨床研究相關的風險;對臨床研究的初步和中期結果不一定能夠預測出最終結果,以及所有的臨床結果可能在階段性地改變,因爲受試者招募繼續,數據得到更全面的審查,並且隨着更多的患者數據變得可用;可能延遲開始、招募和完成臨床研究以及從中報告數據的風險;研究如不按計劃完成的風險;摘要將不會按計劃發佈,包括時機、格式或可訪問性的延遲;以及 NKGen 獲得額外資金完成其產品開發的能力。這些和其他風險和不確定性在"風險因素"和公司的其他文件和報告中描述得更全面,可通過訪問美國證券交易委員會網站www.sec.gov和公司網站「投資者—財務和報告」的子標題下免費獲取。投資者在作出投資決策時應考慮這些風險,不應依賴前瞻性聲明。本新聞稿中包含的所有前瞻性聲明僅於其發表之日發表。公司無義務更新這些聲明以反映發生或存在於其發表之日之後的事件或情況,除非法律規定要求這樣做。.

Forward-Looking Statements

前瞻性聲明

Statements contained in this press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate", "believe", "could", "continue", "expect", "estimate", "may", "plan", "outlook", "future" and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Company's control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company's plans and expected timing for developing SNK01, including the expected timing of completing and announcing further results from its ongoing clinical studies; and the Company's expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the Company's ability to execute its plans and strategies; risks related to performing clinical studies; the risk that initial and interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; the risk that the abstract will not be published as planned including delays in timing, format, or accessibility; and NKGen's ability to raise additional funding to complete the development of its product candidates. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in the Company's filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission's website at www.sec.gov and on the Company's website under the subheading "Investors—Financial and Filings". Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

內部聯繫人:

Internal Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com

Denise Chua,MBA,CLS,Mt(ASCP)
949-396-6830
投資者關係和公司通訊副總裁
949-396-6830
dchua@nkgenbiotech.com

External Contacts:
Chris Calabrese
Managing Director
LifeSci Advisors, LLC
ccalabrese@lifesciadvisors.com

外部聯繫人:
Chris Calabrese
董事總經理
LifeSci Advisors,LLC
ccalabrese@lifesciadvisors.com

Kevin Gardner
Managing Director
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com

Kevin Gardner
董事總經理
LifeSci Advisors,LLC
kgardner@lifesciadvisors.com


声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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