Seasun Biomaterials (CEO Park Hee-kyung) is spurring the development of a molecular diagnostic system that can determine the suitability of anticancer drugs regardless of cancer type.

Tumor-agnostic drug refers to an anticancer drug that is comprehensively recognized for indications for all types of cancer that are effective when a specific oncogene, gene mutation, or gene fusion occurs regardless of the site of cancer occurrence.

Merck (MSD)'s 'Keytruda' (ingredient name: Pembrolizumab) is the world's first anticancer drug for any type of cancer. In May 2017, it was approved as a solid cancer anticancer drug that can be prescribed based on a biomarker (MSI-H or dMMR) regardless of cancer type.

Since then, 'Vitrakvi' (component name: Larotrectinib, currently owned by Bayer) developed by Lilly affiliate Loxo Oncology has been used in all solid cancers with NTRK gene fusion (neurotrophic receptor tyrosine kinase gene fusion). It was approved by the U.S. Food and Drug Administration (FDA) in November 2018 as an anticancer drug.

Roche's 'Rozlytrek' (ingredient name: entrectinib) was also approved as an anticancer drug with the same mechanism as Vitrakbi in August 2019.

NTRK fusion, in which the NTRK gene is mixed with other adjacent genes, is found in more than 91% of childhood fibrogranulomas, 2-12% of thyroid cancers, and 10% of high-grade gliomas in children. In addition, it occurs in less than 3% of sarcoma, colon cancer, glioblastoma, head and neck cancer, and lung cancer.

The next version that appeared is the RET gene fusion-related anticancer drug. The world's first RET (rearranged during transfection) gene mutation or gene fusion target oral anticancer drug 'Retevmo' (Retevmo ingredient selpercatinib) developed by Loxo Oncology acquired FDA approval in May 2020. At the time, it was approved for three indications: non-small cell lung cancer, medullary thyroid cancer, and advanced or metastatic RET fusion benign thyroid cancer. We are moving towards an anticancer drug regardless of cancer type.

Gavreto (ingredient: pralsetinib) from Roche and Blueprint Medicines received FDA approval in September 2020 for the treatment of metastatic RET fusion-positive non-small cell lung cancer.

RET (rearranged during transfection) is a member of the glial cell-derived neurotrophic factor (GDNF) as one of the proto-oncogenes expressing the tyrosine kinase receptor. Letevmo and Gabreto selectively inhibit RET mutations by blocking kinases. In the case of Gabreto, it also has the ability to inhibit non-small cell lung cancer with 1-2% RET fusion.

In addition, Amgen's 'Lumakras' (Lumakras ingredient name sotorasib) obtained FDA approval for KRAS G12C mutant non-small cell lung cancer in May 2021, and it has the potential to become an anticancer drug for any type of cancer. In addition, GlaxoSmithKline's PD-1 inhibitor latecomer 'Gemperli' (Jemperli ingredient name: dostarlimab) was approved in August 2021 as a treatment for all solid tumors with replication error repair defects (dMMR) regardless of carcinoma. received.

In a situation where interest in anticancer drugs for any type of cancer is growing, Seasun Bio is primarily developing a new type of gene fusion analysis panel that can select patients suitable for the NTRK gene fusion inhibitors 'Vitrak B' and 'Rosley Trek'. is under development Second, it plans to develop an analysis panel targeting the RET gene fusion inhibitors 'Retevmo' and 'Gabretto'.

An official from Seasun Bio said, "NTRK and RET gene fusion-related tumor-independent anticancer drugs are currently using next-generation sequencing (NGS), real-time polymerase chain reaction (Real-Time PCR), immunohistochemistry (IHC), and fluorescence in situ hybridization (FISH). Attempts are being made to determine the suitability of anticancer drugs through diagnosis such as, but there is still no diagnostic product with strong competitiveness in accuracy and convenience, so it is urgent to develop a diagnostic method that saves time and money and improves accuracy. We are developing a gene fusion diagnostic method that compromises our strengths.”

Gene fusion is a mutation in which different genes are combined due to an error during cell division, and when a highly expressed gene is combined with a disease-related gene, pathological carcinogens are expressed and cancer can be caused.

Gene expression imbalance refers to a situation in which the expression ratio of each region of the transcript (RNA) does not exist in the same ratio due to gene mutation (gene fusion, exon skipping, etc.), and the difference in the ratio By analyzing the gene fusion, it can be determined whether or not the gene is fused.

An official from Seasun Bio said, "NGS is expensive and long analysis time, PCR is useless unless an efficient biomarker is secured, and IHC and FISH are limited in that the judgment is arbitrary and the sensitivity and specificity are low." "Gene expression imbalance Research to develop a panel that efficiently and accurately analyzes
Park Hee-kyung, CEO of Seasun Bio, said, "It is a very important point to select the optimal anticancer drug for the patient based on epigenetic analysis and biomarker (gene mutation or fusion)-specific phenomena in patient-tailored precision medicine." "'Patio Gene Fusion Detection Kit (tentative name)’ is the goal to develop and commercialize within this year, and by 2025, it will be possible to create a market of more than $27 million.”

Seasun Bio developed the 'U-TOP MSI diagnostic kit' in August 2017 to select patients suitable for Keytruda prescription, and is expecting sales of $1.4 million this year. This kit is currently being used usefully in clinical settings to select patients with colorectal cancer, gastric cancer, endometrial cancer, pancreatic cancer, and malignant melanoma with high expression microsatellite instability (MSI-H).

In December last year, 'Epi-TOP mMGMT Detection Kit', an MGMT gene methylation diagnostic product for predicting the prognosis of temozolomide anticancer drug used to treat glioblastoma, a malignant brain tumor, obtained domestic approval. Patients with methylation of the MGMT gene due to epigenetic mutations are selected as suitable prescription targets due to the good anticancer effect of temozolomide.

In addition, the 'Epi-TOP MPP Assay Panel' is being developed for various anticancer drugs based on various epigenetic biomarkers to predict the prognosis of whether the effect will be effective in 7 types of cancer. MPP is an abbreviation for Multidrug Prognosis & Prediction, and its goal is to become the 'finalizer' of personalized anticancer drug treatment.