Novomics

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Precision
Medicine

Precision Medicine

Precision medicine could provide the personalized healthcare services based on the analysis of individual variability in genome, medical records, environmental factors, lifestyle, etc.

Source: Ministry of Health and Welfare(2016)

Precision medicine has emerged with technology advancements in genome sequencing and biomedical data analysis and contributed to clinical trials for precision medicine with consideration of the individual patient's medical condition.
Apple, Google, and IBM are also expanding their business with importance of data collection, management and analysis in healthcare.
The active investing in precision medicine can address timely and cost-effective medical solutions, such as increased health care spending, the cost of drug development, etc. In addition, with advancement in next-generation sequencing and computational analysis tools, it allows cost reduction in personal genomic analysis. Also, human population-based omics profiling analysis became possible with technological advances such as genetic engineering, IoT (Internet of Thing), big-data analysis, etc.

Clinical Validation History

The recent advances in precision medicine have rapidly increased knowledge and understanding of tumor molecular biology and made fast and cost-effective personal genomic analysis possible. Certainly, the development and expanding use of targeted therapy to counter specific biomarker is actively studied and lead the way to the development of treatments based on a patient’s cancer genome analysis.
The clinical trials tend to shift toward a rapid and effective way with investigation of the drug response in identified patients group compared to traditional clinical trials which consume a long time and high-cost to recruit patients and evaluate the drug efficacy.

Category Basket or
Bucket trials
Umbrella
trials
Exceptional
responder trials
Histology
/ drug
Variety of cancer types

Single drug targeting a single mutation
Single cancer or variety of cancer types

Multiple drugs targeting multiple mutations
Any cancer type and drug where a patient had an unusually robust clinical benefit
Advan
tages
Access to study drug for rare cancers with a given mutation Evaluate targeting a given mutation in a variety of cancers

Takes advantage of specific screening strategies for certain Cancers

May demonstrate clinical activity in patients carrying specific mutations which can inform future trials

May facilitate FDA approval of biomarker-drug combinations
Evaluates variety of mutations and drugs in the context of one trial

Provides access to study drug for rare cancers with a variety of mutations

May provide hints of clinical activity in patients carrying specific mutations which can inform future trials

Screens large numbers of patients for multiple targets, reducing the screen failure rate

May facilitate FDA approval of biomarker-drug combinations
Likelihood of finding a molecular characteristic that could account for the response

Informs patient selection for future trials
Disadvan
tages
Evaluates only one drug / mutation pair at a time Unable to draw definitive conclusions for a given drug / mutation pair in trials enrolling patients with a variety of cancers

Large patient numbers, resource intense
Molecular characteristics linked to clinical activity must be tested subsequently in a larger number of patients before drawing definitive conclusions

Need access to broad array of testing platforms to evaluate potential characteristics that may account for the response

Personalized Treatment, Novomics

Novomics has 8 pipelines to develop molecular diagnostics including nProfiler® 1 Stomach Cancer Assay, which was approved in Nov 2017. We are now working on discovery of various cancer related genes and accumulation of big clinical data generated by highly sensitive measurement platform. We create the basis of cancer diagnostic deep learning platform based on comprehensive information of profiling pathological spatial data and genome sequencing data with next-generation sequencing (NGS) system.
Novomics established a clinical research collaboration with the Beijing Cancer Hospital for an introduction of diagnostic services. The Beijing Cancer Hospital is one of the famous large hospitals with a reputation in the field of gastric cancer in China and has completed numerous research projects. We have conducted a retrospective validation research of nProfiler® 1 with archived gastric cancer stage II-III samples at the Beijing Cancer Hospital. Through this research, we would initiate a prospective research and entry into the Chinese market.
In pursuit of precision medicine realization, Novomics focuses on making strategic partnerships with global pharmaceutical companies. A pharma-diagnostic partnership would accelerate the drug development which are expensive and time consuming, by reducing in failure rate. Through a partnership with big pharma, we are aiming at further expanding our business to the companion diagnostics market for precision medicine development based on our algorithm with genomic information.
We can practically apply our clinical data analysis skills and robust and reliable data accumulated from continuous researches (⒜ Cell-line data ⒝ data on response to chemotherapies using Patient-derived xenograft (PDX) model ⒞ data from Discovery clinical trial • Confirmatory clinical trial • Investigator Initiated Trial (IIT) ⒟ Artificial Intelligence (AI)-based big data ⒠ data on cancer biology based response to metabolite using auto-screening platform) to new drug discovery.