Stages in Drug Development

Voronoi is developing novel kinase inhibitors and TPDs (Target protein degraders) in the following stages, with the aim to treat intractable and rare diseases.
Drug development process consists of discovery and development stages.

Discovery

The discovery stage is further divided into Hit-Lead-Candidate stages. When a compound is found to be efficacious on a particular protein, it is called a “hit”. When structural similarities between hits are identified to create a series of compounds, they are called “leads”. When a large amount of the selected series of compounds are synthesized and verified for years through enzyme/cell/animal tests, and the compound is ready for pre-clinical tests, it is called a “candidate.”

During the discovery process, Voronoi rapidly identifies leads based on molecular modeling, X-ray crystallography and AI, utilizing its in silico system. The best and the brightest young minds in Korea are doing research on medicinal chemistry as a team. They are also doing joint research with Dr. Nathanael Gray, professor of biological chemistry and molecular pharmacology at Harvard Medical School and professor of cancer biology at Dana-Farber Cancer Institute.

Development

The development stage is further divided into pre-clinical and clinical development stages. After validating safety and efficacy on animals, clinical development begins on humans. Clinical trials consist of phase 1, verifying safety, phase 2, efficacy, and phase 3, where safety and efficacy are tested on an increased number of applicants. Application for approval as a drug is only possible when positive results are proven through clinical trials.

Voronoi is conducting pre-clinical and clinical development with the top-notch partners in Korea and abroad, in all areas including API production, formulation development, toxicity study for approval and clinical investigation.

Meet the experts

Nathanael Gray, PhD

​Nathanael Gray is the Nancy-Lurie Marks Professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School and the Dana Farber Cancer Institute.

Research

As competition for new drug development intensifies, demand for new targets based on innovative research rises day by day. Voronoi partners with the best research institutes at home and abroad, to stay away from wasteful competition and maximize the value of its pipeline. We have established research partnership with Korea Brain Research Institute, National Cancer Center, and DFCI, etc.

Kinase inhibitor

Kinase inhibitor is a well-known therapy that targets the signal transduction pathway of cells. As depicted above, it binds with the target protein and inhibits its activity.

Targeted therapy represents the therapy market, accounting for 70 to 80 % of all therapies in 2017. It started with Glivec (Ingredient name: Imatinib), a blockbuster therapy approved in 2001. Glivec’s sales continued to increase, and was over KRW 2 trillion in 2017. Voronoi has the capability to quickly develop candidates with high selectivity and pharmacological value, by tapping into its proprietary focused library and full-panel kinase profiling database.

TPD(Target Protein Degraders)

TPD (Target Protein Degraders) is a drug development technology that induces the protein degrading enzymes (Proteasom depicted above), widely prevalent in cells, to degrade pathological protein.

In general, kinase inhibitors treat diseases by suppressing the activity of target protein that has increased abnormally within cells. Antibody therapies, a more recent technology, cannot penetrate cell membranes. So they work on pathological protein (e.g. amyloid beta) from outside the cells or receptors exposed extracellularly. This means, if pathological protein is accumulated abnormally in the cells, there is no way to remove it at the moment. TPD is expected to overcome this limitation of the existing therapies and tackle the cause of disease inside the cells that could not be targeted before.

This implies that TPD technology can tackle tau tangles and alpha-synuclein aggregates, known causes of dementia or Parkinson’s disease. Also, TPD can remove more a variety of targets more effectively, while maintaining the benefits of kinase inhibitors, namely low production cost, oral administration and intracellular protein targeting. Voronoi’s technology development is led by experts who have experienced this field at the best institutes in the world.

2019-07-30T16:19:49+00:00
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