Medicilon Assist - The IND application for the first new drug NB002 of Neologics Bioscience was approved by the FDA for clinical application

Recently, Neologics Bioscience announced that its research and development pipeline NB002 for the treatment of solid tumors has successfully passed the review of the US FDA and agreed to conduct phase I clinical trials (IND number: 165196).

Shanghai Medicilon Inc, as a partner of Neologics Bioscience, provided preclinical research services such as safety evaluation and pharmacokinetics for NB002, and assisted its IND application successfully obtain FDA clinical approval. Novel humanized TIM-3 antibody NB002 is expected to open up a new path for tumor immunotherapy.

NB002 of Neologics Bioscience.webp

NB002, independently developed by Neologics Bioscience, is a monoclonal therapeutic antibody targeting a unique epitope of TIM-3, which has a significant single-drug anti-tumor therapeutic effect. It not only significantly activates the activity of T and NK cells and enhances their anti-tumor ability, but more importantly, NB002 rebuilds the suppressed innate immunity in the tumor environment, restores the ability of DC cells to respond, improves the antigen presentation function of myeloid cells, and holistically relieves the inhibitory effect of TIM-3 from natural immunity to acquired immunity, effectively enhancing tumor immune killing ability. The company is committed to the innovation of Best in Class and First in Class biological immunotherapy, integrating a powerful computer data mining, analysis and phenotypic target verification system to ensure the sustainable development of the pipeline.

About Neologics Bioscience
Founded in 2018, Neologics Bioscience is an innovative biopharmaceutical company, focusing on the preclinical stage of immunomodulatory biologics, and the disease areas include cancer, autoimmunity and inflammation. The company has established Tier-A platform for discovery and functional verification of immune regulatory targets, which can screen and verify multiple new cancer immune targets. At present, one project has obtained FDA clinical approval, and 5 candidate drugs are in the early discovery stage. The company has the strong support of well-known professional VCs such as Oriza Holdings, Co-Win Ventures, Yonghua Capital, and Elikon Venture. It has obtained a pre-A round of financing of more than RMB 100 million, and has established a research and development center in San Diego, USA.

About Medicilon
Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. By the end of 2022, Medicilon has provided new drug R&D services to more than 1,840 clients around the world, and participated in the R&D of 330 new drug projects that have been approved for clinical trials. Medicilon is proud to contribute to human health in the globe.

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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