CrystalGenomics to Begin Phase 2 Clinical Trial Dosing for Pancreatic Cancer in the US in May

Sangsangin Securities Report

[Asia Economy Reporter Hyungsoo Park] Researcher Ha Taegi of Sangsangin Securities analyzed CrystalGenomics, stating, "The announcement of the interim results of the US Phase 2 clinical trial for pancreatic cancer combination therapy is the biggest turning point for the increase in corporate value."

He added, "In May, the Phase 2 combination clinical trial for pancreatic cancer will begin dosing, and in the second half of this year, the application and approval status of the Investigational New Drug (IND) for the US clinical trial plan for combination prescription for liver cancer will act as short-term stock momentum."

Researcher Ha introduced, "Dosing will start in the US from May targeting pancreatic cancer patients," and "the total clinical trial period is 34 months, with total clinical costs amounting to $15 million." He also explained, "They plan to pursue technology export based on the Phase 2 clinical trial results," and "early data from Phase 2 is likely to be presented at the American Society of Clinical Oncology (ASCO) around June next year."

He emphasized, "In the third quarter of this year, they plan to apply for and obtain approval for a bridging (for approval purposes) clinical trial plan (IND) for Camrelizumab for lung cancer (NSCLC) from the Korean Ministry of Food and Drug Safety," and "sales are expected to begin in the second half of the year following the export of the new drug Aselex to Russia."

Researcher Ha analyzed, "Currently, they hold about 110 billion KRW in cash assets," and "there is no debt, and even considering the annual ordinary R&D cost of 5 billion KRW plus additional US clinical costs, the financial situation still has room for flexibility."

Ivaltinostat is an HDAC (histone deacetylase) inhibitor with a mechanism that suppresses cancer cell proliferation. Compared to competing drugs, it targets a greater variety of HDAC enzymes and has excellent selective inhibitory ability. It is a core pipeline that has received orphan drug designation from the US FDA for pancreatic cancer, liver cancer, and acute myeloid leukemia.

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