Medicilon Helps iMBioRay's CAR-raNK Cell Therapy Approved Clinical Trial

Recently, IBR854 Cell Injection of iMBioRay (Hangzhou) Biomedical Co., Ltd. (iMBioRay) obtained the permission of the NMPA for clinical trials. IBR854 Injection is a universal off-the-shelf CAR-raNK cell product derived from allogeneic peripheral blood. The indication is the treatment of patients with unresectable locally advanced or metastatic solid tumors who currently have no or cannot tolerate standard treatment. It is the first non-gene-modified CAR-raNK cell therapy for solid tumors in China, and the world's first FIC (First in class) products.

Shanghai Medicilon Inc. (Medicilon), as a partner of IBR854 Cell Injection, provides efficient, high-quality and comprehensive preclinical research services (including pharmacokinetic studies and safety evaluation) in compliance with GLP regulations. The IBR854 Cell Injection is successfully approved at the end.

Medicilon cell immunotherapy drug service platform
Enabling the sustainable development of global cellular immunotherapy

Cellular immunotherapy is currently known as the most promising treatment for cancer. In recent years, China's cell therapy industry is booming, and the advent of innovative drugs represented by CAR-T cell therapy has endowed immune cell therapy with more potential.

Medicilon, as a one-stop biopharmaceutical preclinical comprehensive R&D service CRO in China, has always been at the forefront of advanced technology, and has built a one-stop research platform for the preclinical R&D of cellular immunotherapy drugs. Using a wealth of animal models and a variety of advanced analytical techniques, Medicilon could provide pharmacodynamic research, drug safety evaluation, and pharmacokinetic research for a variety of immunotherapeutic drugs including CAR-T, TCR-T, and CAR-NK, bioanalysis and other R&D services. Medicilon has completed several preclinical development projects of immunotherapy programs for clients worldwide.

The clinical approval of IBR854 injection means that China's NK cell therapy industry has taken a further step forward, which strongly proves the advantages and innovation capabilities of iMBioRay’s CAR-raNK cell technology platform, as well as the R&D service strength of Medicilon’s cell immunotherapy drug platform. Both parties accumulated valuable experience to develop more cellular immunotherapy drugs in the future.

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What is preclinical testing?

In the process of preclinical testing of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a preclinical research phase followed, before which, as described above, the potential toxicity of the compou

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Inventory of the three major in vitro pharmacokinetic research methods

The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

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Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

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