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    Home > Biochemistry News > Biotechnology News > CD3 Double Anti-Entry Solid Tumors: An International Multicenter Clinical Trial of Cardoso Double Anti-Gastric Cancer will begin.

    CD3 Double Anti-Entry Solid Tumors: An International Multicenter Clinical Trial of Cardoso Double Anti-Gastric Cancer will begin.

    • Last Update: 2020-07-29
    • Source: Internet
    • Author: User
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    The mechanism of action of T cell engaged bispecific antibodies T cell engager dual anti-drugs is the mechanism of the formation of immune synapses by simultaneously binding T cell surface antigens (e.gCD3) and tumor cell surface antigens (e.gCD19), thus directly activating, proliferating T cells, and thus releasing cytotoxins or cytokines to kill tumor cellsGenerally speaking, the activation process of this T-cell is simple and straightforward, and does not require specific T lymphocyte cloning through the presentation of tumor cell antigens, so it is not limited by MHC or HLA, and the clinical conversion rate is highTo date, two drugs have been approved for market worldwide: Removab (Catumaxomab, CD3xEpCAM) and Blincyto (Blinatumomab, CD3xCD19); In the post-PD-1 era, the new pattern of cancer immunodrugs plays an increasingly important roleCatumaxomab: The vaccine-effective T cell engager bispecific antibody Cartoso is an asymmetrical bispecific antibody with a classic IgG structure, combined with EpCAM on tumor cell surface and CD3 on the surface of T cellIn addition to the functional function of the t cell engager Fab end with a broad spectrum, another notable feature of Cardoso is the selective combination of its Fc endFcɣRIIa which produces a potential vaccine effect (vaccinal effects), which is very similar to the latest literature findingsIn addition, the combination of Fc-FcɣR can strengthen the second total stimulus signal, such as CD86/CD28, and thus further activate The T cellsThe latest literature-related studies have also proved the synergy effectofs of CD3 double resistance and total stimulation of CD28 double resistanceIn 2009, cardoso bi-antimony was approved by THE EMA for treatment of malignant ascites, and became the first T cell engager bispecific antibody to be listed, based on excellent critical clinical dataKey Clinical Trial Results Effectiveness In critical clinical trials of malignant ascites, a total of 258 patients with malignant ascites were enrolled in 75 clinical centres in Europe, including ovarian cancer (n-129), stomach cancer (n-66), breast cancer (n-13), pancreatic cancer (n-9), colon cancer (n-8), endometrial cancer (n-6) multi-type cancer patientsThe results showed that the median apoletation-free water piercing survival (Puncture free, PFS) in the Catuso dual-resistance test group was significantly longer than that of the control group (46 days vs 11 days, HR was 0.254, p-lt;0.0001), reached the clinical primary endpoint, and the clinical effect was very significantnoteworthy, although this critical clinical design did not end with total survival (OS), the median OS in the gastric cancer subgroup (n-66) also showed a statistically significant improvement in the sense (71 days vs 44 days, p-0.0313, HR 0.469)Safety The most common cardoso-associated adverse reactions are cytokine release-related symptoms (fever, nausea and vomiting) and abdominal painThese adverse reactions are mainly caused by the mechanism of cardoso immune activation, mostly for mild symptoms and reversibleThere were no cardoso-related deaths during the trialImmunogenicity Due to the rat-derived nature of cardoso bi-anti- can cause the human body to produce anti-rat antibodies (HAMA) Retrospective analysis of critical clinical practice showed that PATIENTs with HAMA-positive were more beneficial than THOSE who had HAMA-negative: HAMA-positive patients had a puncture-free survival of 64 days, while hama-negative patients had a puncture-free survival of 27 days (HR.330, p-lt;0.0001) Data have been shown that the presence of anti-drug antibodies has no adverse effect on patient sbenefits and safety the recurrence of peritoneal metastasis is one of the leading causes of death from advanced stomach cancer, and the higher the degree of peritoneal metastasis, the shorter the survival period Based on the clinical performance of Cartoso's double resistance, Guangzhou Lingteng Biopharmaceutical Co., Ltd is about to conduct an international multicenter clinical trial of peritoneal metastatic gastric cancer in China, Taiwan and Korea, which is not suitable for systemic chemotherapy The main researchers of this project will be Professor Shen Lin, Vice President of The Oncology Hospital of Peking University and Vice Chairman of the Gastric Cancer Committee of the China Anticancer Association It is worth noting that Cardoso is likely to become the first CD3 double anti-drug for solid tumors to enter the third phase of clinical phase In addition, according to Ling Teng Pharmaceutical's official website, The re-listing application for the original indicationofia of Catoso is also in progress Refs Peter Ruf, Horst Lindhofer, Induction of a long-lasting anti-tumorimby by a trifunctional bispecific antibody Blood , 2001, 98: 2526-2534 David J DiLillo, Jeffrey V Ravetch, Differential Fc-Dell engagement drives an anti-tumor vaccinal Cell, 2015, 161: 1035-1045 Seimetz D, Lindhofer H, Bokemeyer C Development and the approval of the triffobody catumaxomab (anti-EpCAM x anti-CD3) as a targeted cancer cancer cancer Cancer Treatment Rev 2010, 36:458-67 Dimitris Skokos, et al A class of co-merrillIC CD28-bi antity it the stoo itthetantith antithyth activity y CD3-bithty antibodies Sci TransL Med, 12, eaaw7888, 2020 Markus M Heiss, et al The trifunctional antibody catumaxomab for the treatment of the malignant ascites due to epithelial cancer: results of aprospective randomized phase II/III trial Int J Cancer, 2010, 127: 2209-2221.
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