License In from RNA Targeted Anticancer Drug Developer Neonaro
Co-development of Diagnostic Kit Utilizing Multiple Biomarkers
KPS Holds Global Distribution Rights
[Asia Economy Reporter Jang Hyowon] KPS announced on the 9th that it has signed a license-in agreement with Neona, a developer of RNA (ribonucleic acid) targeted anticancer drugs, for liver cancer diagnostic biomarker technology. The two companies plan to collaboratively develop an early liver cancer diagnosis kit and enter the global diagnostic market, starting with approval from the Ministry of Food and Drug Safety.
KPS stated that it has secured global rights from Neona for the early liver cancer diagnosis business using multiple liver cancer-specific biomarkers, including 'HMMR (hyaluronan-mediated motility receptor)', 'NXPH4 (neurexophilin 4)', 'PITX1 (paired-like homeodomain 1)', 'THBS4 (thrombospondin 4)', and 'UBE2T (ubiquitin-conjugating enzyme E2T)'.
According to Neona, a researcher-led clinical trial was conducted using two or three markers as multi-indicators on 86 healthy individuals and 132 liver cancer patients. The results showed sensitivity (patient detection rate) and specificity (normal detection rate) close to 99%. This significantly outperforms the existing single marker for liver cancer diagnosis, serum alpha-fetoprotein (AFP), which has sensitivity and specificity of about 66% and 82%, respectively. The new concept of multiple markers greatly improved both sensitivity and specificity simultaneously.
Neona, established in August last year by Professor Nam Seokwoo of the Catholic University College of Medicine, is developing an RNA-targeted anticancer pipeline. The company was selected as a TIPS (Tech Incubator Program for Startup) by the Ministry of SMEs and Startups in May this year and gained attention by publishing research results on RNA immuno-oncology drugs that reduced liver cancer size in mouse models in the liver cancer specialized journal Hepatology.
KPS and Neona will first jointly cooperate to develop the diagnostic kit for approval by the Ministry of Food and Drug Safety and will proceed with clinical trials. A Neona official stated, "The current liver cancer biomarker (AFP) has low sensitivity and specificity, resulting in low accuracy in early diagnosis. Reliable early diagnosis is urgently needed for high-risk liver cancer patients, and by utilizing Neona's multiple markers, it is expected that all liver cancer patients can be diagnosed early, enabling liver cancer treatment."
Following the breast cancer new drug (Neorings tablets), KPS’s bio business division, which is building an anticancer pipeline, is also showing swift progress in the diagnostic market. Since it has entered the diagnostic market alongside anticancer drug development, the strategy is to secure various biomarkers to expand its business.
Last month, KPS announced that it partnered with Kyung Hee University College of Pharmacy to enter the development of a circulating tumor cells (CTC)-based liquid biopsy diagnostic platform. Since then, it has been actively securing various biomarkers that will determine the success of the precision diagnosis business.
KPS CEO Kim Hayong emphasized, "The early cancer diagnosis market is a field with limitless potential for business expansion, comparable to a new drug, and it is becoming an essential element for precision medical services such as companion diagnostics in future anticancer drug development. The global rights secured for these biomarkers will serve as a milestone for the full-scale establishment of the anticancer pipeline."
Meanwhile, liver cancer, known as the "worst cancer," was the second leading cause of cancer death among men in South Korea last year, following lung cancer (based on 2017 data). According to Statistics Korea and the National Health Insurance Service, the number of new patients in 2018 alone reached 15,736, and approximately 290,000 patients underwent liver cancer surveillance tests, including for hepatitis B, hepatitis C, and liver cirrhosis. Hepatitis B and C account for 80% of liver cancer causes.
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