Appealing Data of CARsgen Therapeutics' CAR-T (CT041) in Advanced Gastric Cancer Presented at ESMO
Appealing Data of CARsgen Therapeutics' CAR-T (CT041) in Advanced Gastric Cancer Presented at ESMO
SHANGHAI, Sept. 19, 2021 /PRNewswire/ -- On September 19, 2021, CARsgen Therapeutics (stock code: 2171.HK) disclosed the latest progress of the investigator-initiated trial (IIT) of Claudin18.2 (CLDN18.2) CAR-T (CT041) for the treatment of digestive system tumors. Results of this trial have been orally presented at the European Society of Medical Oncology Congress 2021 (ESMO 2021). The presenter was Dr. Changsong Qi from Beijing Cancer Hospital.
上海，9月2021年19號/美通社/--2021年9月19日，卡斯根治療公司(股票代碼：2171.HK)披露了克勞丁18.2(CLDN18.2)CAR-T(CT041)用於治療消化系統腫瘤的研究者發起試驗(IIT)的最新進展。這項試驗的結果已在2021年歐洲醫學腫瘤學學會大會(ESMO 2021)上口頭公佈。推薦人是來自北京腫瘤醫院的常鬆奇醫生。
CT041, developed by CARsgen Therapeutics, is currently the only CLDN18.2-targeted CAR-T cell therapy that has obtained IND clearance and is under clinical trials in both China and the United States. CT041 was granted an "Orphan Drug" designation by the FDA in 2020 for the treatment of gastric cancer/gastroesophageal junction (GC/GEJ) cancer and was granted the "Orphan Medicinal Product" designation by the EMA for the treatment of gastric cancer in 2021.
CT041由CARsgen治療公司開發，是目前唯一獲得IND批准並正在中國和美國進行臨牀試驗的CLDN18.2靶向CAR-T細胞療法。CT041於2020年被FDA授予用於治療胃癌/胃食管交界處(GC/GEJ)癌症的“孤兒藥物”稱號，並於2021年被EMA授予用於治療胃癌的“孤兒藥品”稱號。
Appealing Data of CLDN18.2 CAR-T in Advanced Gastric Cancer Revealed at ESMO
蘋果ESMO會議公佈CLDN18.2 CAR-T在進展期胃癌中的Aling數據
This trial is a multicenter open-label investigator-initiated clinical trial in China for patients with CLDN18.2+ (≥+, ≥10%) digestive system tumors. This clinical trial consists of a dose escalation stage and a dose expansion stage. The primary objective of this trial is to assess the safety and tolerability of CT041 and the secondary objective is to assess the efficacy and pharmacokinetics.
這項試驗是中國一項針對CLDN18.2+(≥+，≥10%)消化系統腫瘤患者的多中心開放標籤研究人員發起的臨牀試驗。本臨牀試驗分為劑量遞增階段和劑量擴大階段。本試驗的主要目的是評估CT041的安全性和耐受性，次要目標是評估其療效和藥代動力學。
As of April 8, 2021, 37 patients received CT041 infusion and completed at least 12 weeks of evaluation, including 28 cases of gastric/ gastroesophageal junction cancer (GC/GEJ), 5 cases of pancreatic cancer (PC) and 4 cases of other types of digestive system tumors. The cell dose levels were 2.5×108, 3.75×108 and 5.0×108 CAR-T cells respectively. Approximately 84% of patients had received at least 2 prior lines of therapies and the median number of metastatic organs was 3. For the 28 patients with GC/GEJ, 67.9% of the subjects had peritoneal metastases. 42.9% and 35.7% of the subjects had been exposed to anti-PD-(L)1 antibody and polykinase inhibitors respectively.
截至2021年4月8日，37名患者接受了CT041輸注，並完成了至少12周的評估，包括28例胃/胃食管交界癌(GC/GEJ)，5例胰腺癌(PC)和4例其他類型的消化系統腫瘤。細胞劑量水平為2.5×108, 3.75×108和5.0×108CAR-T細胞。約84%的患者至少接受過2次治療，轉移器官的中位數為3個。在28例GC/GEJ患者中，67.9%的患者有腹膜轉移。42.9%的受試者曾接觸過抗PD-(L)1抗體，35.7%的受試者曾接觸過多聚激酶抑制劑。
In terms of safety profile, CT041 was generally well-tolerated. No treatment-related death or immune cell therapy-associated neurotoxicity syndrome (ICANS) were reported. Approximately 95% of patients experienced CRS, all being grade 1 or 2.
就安全性而言，CT041總體耐受性良好。沒有與治療相關的死亡或免疫細胞治療相關的神經毒性綜合徵(ICANS)的報道。大約95%的患者經歷了CRS，均為1級或2級。
For the 36 patients with target tumor lesions (GC/GEJ, PC and other types of digestive system tumors), 31 subjects had different degrees of shrinkage of target lesions with an ORR of 48.6% and a disease control rate (DCR) of 73.0%.
36例靶腫瘤(GC/GEJ、PC等消化系統腫瘤)患者中，31例有不同程度的靶病變縮小，ORR為48.6%，疾病控制率(DCR)為73.0%。
18 GC/GEJ patients who failed at least 2 prior lines of therapy (including 8 (44% of) patients ever exposed to an anti-PD-(L)1 antibody) at the dose of 2.5×108 (recommended phase 2 dose (RP2D)) CAR-T cells achieved an ORR of 61.1%, DCR of 83.3%, median PFS of 5.6m, median DOR of 6.4m, median OS of 9.5m with a median follow up of 7.6m.
18名GC/GEJ患者(包括8名(44%)曾接受過2.5×10次抗PD-(L)1抗體治療的患者)之前至少兩次治療失敗8(推薦2期劑量(RP2D))CAR-T細胞的ORR為61.1%，DCR為83.3%，中位PFS為5.6M，中位DOR為6.4m，中位數操作系統為950萬，隨訪中位數為7.6m.
For the 28 GC/GEJ patients, subgroup analysis revealed that ORR could be maintained at 50% and above in patients with different baseline characteristics.
對28例GC/GEJ患者進行亞組分析，發現不同基線特徵的患者ORR可維持在50%以上。
Historical data shows that for the GC/GEJ patients who failed at least 2 prior lines of therapy, the efficacy rate of chemotherapy is about 4% to 8%, and the efficacy rate of anti-PD-1 antibody is about 11%. Therefore, compared with other treatments for GC/GEJ patients who failed at least two prior lines of therapies, CT041 has a significant improvement of ORR. Since many patients in this phase of the trial had received anti-PD-(L)1 antibody treatment, the efficacy data disclosed indicate that CT041 may become a new treatment for advanced GC/GEJ patients.
歷史資料顯示，至少2次以上治療失敗的GC/GEJ患者，化療有效率約為4%~8%，抗PD-1抗體有效率約為11%。因此，與至少兩種先前治療失敗的GC/GEJ患者的其他治療方法相比，CT041在ORR方面有顯著改善。由於這一階段試驗中的許多患者都接受了抗PD-(L)1抗體治療，因此公佈的療效數據表明，CT041可能成為晚期GC/GEJ患者的一種新療法。
Further data of this clinical trial is planned to be disclosed in academic journals or conferences.
這項臨牀試驗的進一步數據計劃在學術期刊或會議上公佈。
In 2020, there were 480,000 new cases of gastric cancer in China, accounting for 43.9% of the total incidence globally. Moreover, there is a rising trend in the incidence of gastric cancer among young people. Major treatments for advanced gastric cancer are chemotherapy and HER2-targeted therapy, but the percentage of HER2 positive patients in gastric cancer is only 7-20%. Despite several products such as PD-1 monoclonal antibodies that have been approved for advanced gastric cancer in recent years, there are still significant needs for innovative therapies.
2020年，我國胃癌新發病例48萬例，佔全球總髮病率的43.9%。此外，年輕人的胃癌發病率有上升的趨勢。進展期胃癌的主要治療方法是化療和HER2靶向治療，但HER2陽性患者在胃癌中所佔比例僅為7-20%。儘管近年來PD-1單克隆抗體等幾種產品已被批准用於晚期胃癌，但對創新療法的需求仍然很大。
Professor Lin Shen of Beijing Cancer Hospital commented that, "Gastric cancer is of high incidence globally and particularly in Asia. Gastric cancer incidence in China is approximately 50% of the overall global incidence. Research and treatment options for gastric cancer are still quite limited and there are strong needs for more innovative therapies to change the treatment paradigm. Data presented at ESMO showed significant efficacy and excellent tolerability of CT041 and we hope that it could benefit more cancer patients."
北京腫瘤醫院的林申教授評價説，胃癌在全球範圍內發病率很高，尤其是在亞洲。年胃癌發病率中國約佔全球總髮病率的50%。胃癌的研究和治療選擇仍然相當有限，迫切需要更多的創新療法來改變治療模式。在ESMO上公佈的數據顯示，CT041具有顯著的療效和極好的耐受性，我們希望它能使更多的癌症患者受益。"
Dr. Zonghai Li, Co-founder, CEO, CSO, Chairman of the Board of CARsgen Therapeutics, commented that, "I would like to express the sincere gratitude to Dr. Changsong Qi for presenting the latest clinical trial data of CT041 in ESMO 2021 and to all the other investigators and researchers involved in the development of this CLDN18.2 CAR-T, which offers new hope for the gastric cancer patients. With the mission of 'making cancer curable', we will continue our endeavours in developing more innovative technology and products for cancer patients worldwide."
CARsgen治療公司董事會主席、CSO聯合創始人兼首席執行官李宗海博士評論説, "我謹向李博士表示誠摯的謝意。.我非常感謝長鬆奇先生在ESMO 2021年上展示了CT041的最新臨牀試驗數據，並向所有參與CLDN18.2 CAR-T開發的其他研究人員和研究人員表示感謝，這為胃癌患者帶來了新的希望。本着“讓癌症變得可治癒”的使命，我們將繼續努力為世界各地的癌症患者開發更多創新的技術和產品。"
CARsgen Therapeutics has applied to China NMPA for the initiation of the pivotal phase II trial of CT041 in China. In US and Europe, CT041 has obtained the Orphan Drug Designation from the FDA and the EMA. The pivotal phase II clinical trial in the United States is anticipated to initiate in 2022.
卡斯根治療公司已向中國NMPA提出申請，啟動CT041在中國的關鍵二期試驗。在美國和歐洲，CT041已獲得美國食品及藥物管理局(FDA)和美國食品藥品監督管理局(EMA)的孤兒藥物稱號。美國關鍵的第二階段臨牀試驗預計將於2022年啟動。
CARsgen Therapeutics currently has 11 product candidates, all of which were fully developed in house with global rights, covering conventional 2nd-generation, next-generation, and allogeneic CAR-T cell therapies, indicating a comprehensive and visionary portfolio development. CARsgen Therapeutics has obtained 7 IND approvals for CAR-T therapies in China, the United States and Canada, ranking the first among all CAR-T companies in China.
卡斯根治療公司目前有11種候選產品，所有這些產品都是在擁有全球權利的內部完全開發的，涵蓋了常規的2種發送-新一代、下一代和同種異體CAR-T細胞療法，表明了全面和富有遠見的產品組合開發。CARSGEN治療公司已經在中國獲得了7項CAR-T療法的IND批准，美國和加拿大，在所有CAR-T公司中排名第一中國.
(Source: https://www.carsgen.com/en/pipeline)
(來源：https://www.carsgen.com/en/pipeline)
According to the data from Nature Biotechnology, by the end of 2019, ranked by the total number of CAR-T patents, CARsgen Therapeutics was the only Asian company among the top 20 institutes or companies globally.
根據來自自然生物技術截至2019年底，按CAR-T專利總數排名，CARsgen Treeutics是全球排名前20的機構或公司中唯一家亞洲公司。
In addition to existing product pipeline, CARsgen Therapeutics strives to continue advancing technologies centered on 4 strategic pilliars against the major challenges of the industry: 1) increasing efficacy against solid tumors 2) enhancing safety profile 3) expanding patient accessibility and 4) improving target availability. Powered by these proprietary technologies, such as CycloCAR and THANK-uCAR, CARsgen Therapeutics plans to develop more innovative product candidates for the cancer patients worldwide.
除了現有的產品線外，CARsgen治療公司還致力於繼續推進以4個戰略試點為核心的技術，以應對該行業的主要挑戰：1)提高對實體腫瘤的療效；2)增強安全性；3)擴大患者的可及性；4)提高靶標可用性。在CycloCAR和Thank-Ucar等專利技術的支持下，CARsgen治療公司計劃為世界各地的癌症患者開發更多創新的候選產品。
About CT041
關於CT041
CT041, developed by CARsgen Therapeutics, showed acceptable safety profile and promising antitumor activities in patients with refractory CLDN18.2 + cancer of digestive system. CARsgen Therapeutics is the first in the world to successfully identify, validate, and report CLDN18.2 and GPC3 as rational targets for CAR-T cell therapies. In addition to the investigator-initiated trials in China, we have initiated a Phase Ib/II clinical trial for advanced (unresectable or metastatic) GC/GEJ and PC in China and a Phase Ib clinical trial for advanced (unresectable or metastatic) gastric or pancreatic adenocarcinoma in the United States.
CARsgen Treeutics公司開發的CT041在難治性CLDN18.2+消化系統癌症患者中表現出可接受的安全性和良好的抗癌活性。卡斯根治療公司是世界上第一家成功識別、驗證和報告CLDN18.2和GPC3作為CAR-T細胞治療的合理靶點的公司。除了在中國的研究人員發起的試驗外，我們還啟動了晚期(不能切除或轉移)GC/GEJ和PC的Ib/II期臨牀試驗。中國以及在美國進行的晚期(無法切除或轉移性)胃腺癌或胰腺癌的Ib期臨牀試驗。
CT041 is the only CLDN18.2 targeted CAR-T cell product that has obtained IND approval globally. CT041 was granted an "Orphan Drug" designation by the FDA in 2020 for the treatment of gastric cancer or gastroesophageal junction (GC/GEJ) cancer and was granted the "Orphan Medicinal Product" designation by the EMA for the treatment of gastric cancer in 2021.
CT041是全球唯一獲得IND批准的CLDN18.2靶向CAR-T細胞產品。CT041於2020年被FDA授予用於治療胃癌或胃食管交界處(GC/GEJ)癌的“孤兒藥物”稱號，並於2021年被EMA授予用於治療胃癌的“孤兒藥品”稱號。
About CARsgen Therapeutics
關於卡斯根治療公司
CARsgen Therapeutics (stock code: 2171.HK) is a biopharmaceutical company with operations in China and the U.S. focused on innovative CAR-T cell therapies for the treatment of hematological malignancies and solid tumors. We have built an integrated cell therapy platform with in-house capabilities that span from target discovery, lead antibody development, clinical trials to commercial-scale manufacturing. We have internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR-T cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors and reducing treatment costs. Our vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.
卡斯根治療公司(股票代碼：2171.HK)是一家生物製藥公司，業務遍及中國和美國，專注於治療血液惡性腫瘤和實體腫瘤的創新CAR-T細胞療法。我們已經建立了一個集成的細胞治療平台，具有從靶標發現、領先抗體開發、臨牀試驗到商業規模生產的內部能力。我們在內部開發了具有全球權利的新技術和產品線，以應對CAR-T細胞療法的主要挑戰，如改善安全性、提高治療實體腫瘤的療效和降低治療成本。我們的願景是成為一家全球生物製藥領先者，為世界各地的癌症患者帶來創新和差異化的細胞療法，並使癌症成為可治癒的。
SOURCE CARsgen Therapeutics
來源：CARSGEN治療公司
譯文內容由第三人軟體翻譯。