Medicilon Assists ABM Therapeutics to Obtain US FDA Orphan Drug Qualification for ABM-1310 for the Treatment of Patients with Brain Glioblastoma Carrying BRAF V600 Mutation

Shanghai, China/San Diego,USA - August 2, 2023, ABM Therapeutics announced that its self-developed small molecule BRAF inhibitor ABM-1310 has obtained orphan drug qualification from the US FDA for the treatment of BRAF V600 mutant brain glioblastoma (GBM).

In the research and development of ABM-1310, the chemical FTE (Full-time equivalent) team of Shanghai Medicilon Inc provided drug discovery services in a flexible cooperation mode. It has laid a solid foundation for ABM Therapeutics' ABM-1310 to obtain the US FDA Orphan Drug Qualification.

Medicilon Chemical FTE Team
Facilitate Rapid Discovery of Innovative Drugs

The chemical FTE team of Medicilon can serve clients in different stages of drug development, including the generation and optimization of hit compounds, the identification and optimization of lead compounds, synthesis amplification chemical process research and other services. This collaboration model is based on client and project needs, and can flexibly adjust R&D personnel allocation, experimental plans and project priorities. In addition, the FTE team can not only synthesize according to the synthetic circuit designed by the client, but also reasonably design the synthetic circuit according to the client's idea. Currently, the Medicilon FTE team has successfully empowered many pharmaceutical companies and scientific research institutions around the world to develop drugs in a compliant, safe and efficient manner.

About ABM Therapeutics

ABM Therapeutics is a clinical stage new drug research and development company. The company focuses on the R&D of small molecule drugs that can break through the blood-brain barrier. Its small-molecule targeted inhibitors under development can break through the blood-brain barrier, significantly improve the efficiency of drugs entering the brain, and are expected to solve the problem of brain metastasis of tumors. ABM Therapeutics has developed steadily since its establishment, and has established R&D operation centers in the United States and China. Through independent research and development, the company has built a rich R&D pipeline for brain-injecting drugs, and has become a brain-penetrating kinase drug R&D platform (BPKddTM) for anti-cancer drugs and small-molecule drugs for brain-injecting drugs.

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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