CrystalGenomics' Pancreatic Cancer Treatment 'Ivaltinostat' Rapidly Emerging

[Asia Economy Reporter Oh Ju-yeon] Interest in alternative drugs is rising as the approval for Liabax Injection (Tertomotaide Hydrochloride), which was spotlighted as a treatment for pancreatic cancer, has been revoked.

According to the pharmaceutical industry on the 15th, pancreatic cancer is a difficult intractable cancer with a 5-year survival rate of only 3%, leading to high demand for the development of pancreatic cancer treatments. Recently, Liabax Injection was conditionally approved with the requirement to submit a Phase 3 clinical trial report within 5 years from the clinical trial approval date. However, failing to meet this deadline, it received a cancellation notice from the Ministry of Food and Drug Safety. As a result, CrystalGenomics' pancreatic cancer drug candidate Ivaltinostat is gaining new attention.

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Ivaltinostat is a molecular targeted anticancer agent targeting HDAC (histone deacetylase protein), and is being developed for various indications including pancreatic cancer, liver cancer, COVID-19 treatment, and fibrosis.

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In particular, for the pancreatic cancer indication, it was designated as a development-stage orphan drug in Korea in June 2018, and the Phase 2 clinical trial results were presented at the European Society for Medical Oncology in July. In August 2019, it was also designated as an orphan drug for the same indication in the United States.

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According to Korea Investment & Securities, the Phase 2 clinical trial results of Ivaltinostat showed superior efficacy compared to existing anticancer drugs, raising expectations as a treatment. Researchers Seung-yoon Jung and Hong-guk Jin stated, "It demonstrated superior efficacy even when compared to currently marketed drugs or drug candidates in clinical trials." Based on these results, they plan to apply for conditional approval in the third quarter of this year.

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Benefits are also expected from the recently passed Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act (첨생법) in the National Assembly plenary session last August. This law allows for relaxed review standards under certain conditions when conducting research on regenerative medicine, enabling customized review, priority review, and conditional approval.

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A CrystalGenomics official said, "Ivaltinostat is highly anticipated as a pancreatic cancer treatment as it qualifies under both the Advanced Regenerative Medicine Act implementation and the fast-track promotion bill for innovative pharmaceutical companies."

This content was produced with the assistance of AI translation services.