Sangsangin Securities, "CrystalGenomics, Ivaltinostat Value Increase... Stock Price Upward Momentum Expected"

[Asia Economy Reporter Oh Ju-yeon] SangSangIn Securities analyzed on the 14th that CrystalGenomics is expected to have a stock price rise momentum until the end of the year, as the value of its new drug pipeline is increasing due to the possibility of Ivaltinostart being designated for expedited review as a pancreatic cancer treatment in late November, the presentation of clinical phase 1 data for the blood cancer treatment CG-806 at the American Society of Hematology (ASH) in December, and the ongoing phase 2 clinical trial of a COVID-19 treatment in the US by the end of the year.

Researcher Ha Tae-gi reported that for pancreatic cancer, "In July 2020, data from phase 1/2 was presented at the European Society for Medical Oncology Gastrointestinal Cancers Symposium (ESMO GI), showing that the survival rate of patients who completed a 6-week (approximately 6 months) regimen was 12.5 months, an improvement over the standard treatment of 8.5 months. In August, Ivaltinostart was designated as an orphan drug for liver cancer by the US Food and Drug Administration (FDA), which led to an upward trend in the stock price."

Researcher Ha highlighted the key new drug development schedule for CrystalGenomics in the fourth quarter of this year, stating, "Based on phase 2 clinical data for pancreatic cancer, an application for expedited review was submitted at the end of September. If designated, the conditional approval review period will be shortened." He added, "Following approval by the Ministry of Food and Drug Safety (MFDS), product approval could be granted domestically around April 2021. There are plans to conduct phase 2 clinical trials in the US by the first half of 2021. The global target market is estimated at 2.5 trillion KRW, and the domestic market at around 50 billion KRW."

Attention was also drawn to the interim results of the phase 1 clinical trial of the blood cancer treatment CG-806 (FLT3/BTK multi-inhibitor). CG-806 has been licensed out to the US biotech company Aptose. The interim phase 1 results are scheduled to be presented at the ASH in the first week of December 2020.

Furthermore, utilizing Ivaltinostart, which is being advanced for US clinical trials as a COVID-19 treatment, efforts are underway to obtain approval for and administer phase 2 clinical trials in the US within this year, with related patent applications also under consideration.

Researcher Ha explained, "Unlike drug repurposing, the development is based on proprietary new drug candidates, which differentiates it from other domestic pharmaceutical companies." Additionally, he forecasted that in early November, the subsidiary Makaon (100% owned) will complete investment attraction worth 28 billion KRW for a fibrosis treatment, and that phase 2 clinical trials combining Ivaltinostart with anti-PD-1 antibodies for liver cancer are expected to proceed in the US during 2021.

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