Senti Bio Awarded California Institute for Regenerative Medicines (CIRM) Grant for Clinical Development of Logic Gated CAR-NK Cell Therapy
Senti Bio Awarded California Institute for Regenerative Medicines (CIRM) Grant for Clinical Development of Logic Gated CAR-NK Cell Therapy
$8M grant supports ongoing Phase 1 clinical trial of SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia
這筆800萬美元的資助支持SENTI-202治療復發 / 難治性血液惡性腫瘤，包括急性髓細胞白血病的第一階段臨床試驗。
SOUTH SAN FRANCISCO, Calif., July 01, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) ("Senti Bio"), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that the California Institute for Regenerative Medicines ("CIRM") has awarded an $8 million grant to Senti Bio. The CIRM grant will support the ongoing clinical development of SENTI-202, a potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer ("CAR-NK") investigational cell therapy, for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia ("AML"). The Phase 1 clinical trial of SENTI-202 is ongoing, with initial efficacy data anticipated by year-end 2024 and initial durability data following in 2025.
加利福尼亞州南舊金山，2024年7月1日/美通社/--Senti Biosciences, Inc. (Nasdaq: SNTI)（“Senti Bio”）是一家生物技術公司，利用其專有的基因線路平台開發下一代細胞和基因療法，今天宣佈，加州再生醫學研究所（“CIRM”）向Senti Bio授予800萬美元的資金。CIRM補助將支持SENTI-202的持續臨床開發，SENTI-202是一種潛在的一類邏輯門控的現成嵌合抗原受體自然殺傷細胞（“CAR-NK”）研究性細胞療法，用於治療復發/難治性血液腫瘤，包括急性髓細胞白血病（“AML”）。SENTI-202的一期臨床試驗正在進行中，初步有效性數據預計將於2024年底公佈，初步耐受性數據將在2025年公佈。
"On behalf of the Senti Bio team, I'd like to express our sincere gratitude to CIRM for its support of our Phase 1 trial of SENTI-202 and for recognizing SENTI-202's potential to improve the lives of people living with AML," said Timothy Lu, M.D., Ph.D., Chief Executive Officer and Co-Founder of Senti Bio. "We are proud of the clinical development progress to date as the Phase 1 trial continues to enroll and will remain steadfast in our mission to provide potentially lifesaving treatments for people living with cancer."
“我代表Senti Bio團隊，向CIRM表達我們的真誠感激之情，感謝其支持SENTI-202一期臨床試驗，並認識到SENTI-202有潛力改善生活與AML一起生活的人，”Senti Bio首席執行官兼聯合創始人Timothy Lu博士表示。 “作爲一期試驗的臨床開發進展已經到位，因此該試驗繼續招募，並將繼續堅定不移地履行我們的使命，爲癌症患者提供潛在挽救生命的治療。”
The Phase 1 clinical trial of SENTI-202 (NCT06325748) is currently enrolling adult patients with relapsed or refractory ("r/r") CD33 and/or FLT3 expressing hematologic malignancies, including AML, at multiple sites in the United States and Australia. The dose finding trial is evaluating two dose levels, either 1 billion or 1.5 billion SENTI-202 cells, administered in cycles, each comprising of three once-per-week doses, after disease specific lymphodepleting conditioning. Patients may continue to receive multiple cycles of treatment based on safety and efficacy data.
SENTI-202 （NCT06325748）的一期臨床試驗目前正在美國和澳大利亞的多個站點招募成年復發或難治（“r/r”）CD33和/或FLT3表達的血液腫瘤患者，包括AML。劑量篩選試驗評估兩個劑量水平，1億或1.5億個SENTI-202細胞，在經過特定疾病的淋巴減滅條件下，每個週期給予三個每週一次的劑量。根據安全性和有效性數據，患者可以繼續接受多個治療週期。
About SENTI-202
SENTI-202 is a Logic Gated off-the-shelf CAR-NK cell therapy product candidate designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, such as AML and myelodysplastic syndrome ("MDS"), while sparing healthy bone marrow cells. SENTI-202 has three main components. First, the OR GATE, which is an activating CAR that targets CD33 and FLT3. By targeting either or both of these antigens, SENTI-202 could effectively kill both the leukemic blasts and leukemic stem cells that form an important basis for AML disease. Second, the NOT GATE, which is designed to recognize the healthy cells and protect those healthy cells from being killed. Third, the calibrated-release IL-15 technology, which is designed to significantly increase cell persistence, expansion and activity of both the CAR- NK cells and the host immune cells. The NK cells used to construct SENTI-202 are sourced from healthy adult donors, which have been screened based on a set of criteria that reflect manufacturability and product quality, and are then cryopreserved prior to use in manufacturing to minimize variability. Senti Bio is currently enrolling adult patients with r/r CD33 and/or FLT3 expressing heme malignancies in a Phase 1 clinical trial for SENTI-202, which can be a potential first-in-class allogenic treatment for AML/MDS patients.
關於SENTI-202
SENTI-202是一種預備癌細胞現成機冠功能、亞健康骨髓細胞選擇性消耗的CAR-NK細胞治療方案。它旨在選擇性地靶向和消滅表達CD33和/或FLT3的血液惡性腫瘤，如AML和骨髓增生異常綜合症（"MDS"），同時保護健康的骨髓細胞。SENTI-202 包含三個主要組成部分：首先是 OR 門，即聚乙烯醇發動機，可以選擇性地靶向CD33和FLT3。通過靶向一個或兩個抗原，SENTI-202可以有效地殺死白血病克隆和造血幹細胞，爲AML疾病創造一個很重要的基礎。第二個是 NOT 門，可以選擇性地識別健康的細胞並保護這些健康的細胞不被殺死。第三個是校準釋放IL-15技術，旨在顯著增加CAR- NK細胞和宿主免疫細胞的持久性、擴張性和活性。用於構建SENTI-202的NK細胞來自經過篩選的健康成人，根據一組反映可製造性和產品質量的標準進行篩選，然後在使用製造前被冷凍以最小化不確定性。Senti Bio目前正在招募r/r CD33和/或FLT3表達的heme惡性腫瘤的成人患者，進行SENTI-202的第一階段臨床試驗，這可能是AML/MDS患者的首個全異種治療。
Senti Bio has published SENTI-202 preclinical data demonstrating the potential of Logic Gated CAR-NK cell therapy for the treatment of AML.
Senti Bio已經發布了SENTI-202的臨床前數據，證明了邏輯門控CAR-NK細胞療法治療AML的潛力。
About Acute Myeloid Leukemia
Acute myeloid leukemia is a cancer of the blood and bone marrow and is the most common type of acute leukemia in adults. It is estimated there will be 20,800 new cases of AML in the United States in 2024. The five-year survival rate for these patients is approximately 30%. AML is currently treated with chemotherapy, targeted therapies, and/or allogeneic or autologous stem cell transplant. For patients with relapsed or refractory AML, there are few treatment options and median overall survival is typically less than seven months.
關於急性髓細胞白血病
急性髓細胞白血病是血液和骨髓的一種癌症，並且是成年人中最常見的急性白血病。據估計，2024年美國新病例將有20,800例。這些患者的五年生存率約爲30％。目前，急性髓細胞白血病的治療方式包括化療、靶向治療和/或異基因或自體幹細胞移植。對於復發或難治性急性髓細胞白血病患者，治療選擇有限，中位總生存期通常不到七個月。
譯文內容由第三人軟體翻譯。