CHA Biotech Confirms Safety of Early Ovarian Failure Cell Therapy in Phase 1 Clinical Trial

[Financial News] CHA Biotech announced on the 29th that it has confirmed the topline data of the domestic Phase 1 clinical trial of the early ovarian failure treatment 'CordSTEM (CBT210-POI)', which uses umbilical cord-derived stem cells as the main ingredient, confirming tolerability and safety.
This clinical trial was conducted on six patients aged 25 to 40 with early ovarian failure, after receiving Phase 1 clinical trial plan (IND) approval from the Ministry of Food and Drug Safety in November 2022. After a single intravenous injection of 'CordSTEM', safety and potential therapeutic effects were observed.
All six participants in the clinical trial experienced mild (Grade 1) drug-related adverse reactions, but no special problems occurred, and they recovered.
A serious adverse reaction occurred in one person, but it was evaluated as 'suspected to be related' to the drug as a Grade 1 (Mild) 'infusion-related reaction', and it was ultimately reported as recovered/resolved.
As a result of confirming ovarian function recovery evaluation indicators up to 24 weeks after administration to the participants, a decrease in follicle-stimulating hormone (FSH) levels, an increase in estradiol (E2) levels, and an increase in uterine lining thickness were observed in some participants.
In addition to the improvement in hormone levels, there were cases where clinical improvement effects were observed. One participant resumed menstruation at 18 weeks after administration after being in a long-term amenorrhea state following an early ovarian failure diagnosis. In another participant, a mature follicle that had not been observed before was confirmed at 24 weeks after administration, confirming the potential of CordSTEM as a treatment for early ovarian failure.
CHA Biotech plans to receive the final clinical trial report (CSR) in the third quarter of this year based on these results.
Early ovarian failure is a condition experienced by about 1% of women of childbearing age before the age of 40, making it difficult to conceive due to ovarian function loss. As the age of first marriage and childbirth increases, the decline in ovarian function is emerging as a major cause of infertility in women, but there is no fundamental treatment.
Early ovarian failure is mainly managed with estrogen-based hormone therapy. Some studies have reported that long-term hormone therapy may increase the risk of breast cancer, cardiovascular disease, and stroke. Therefore, the need for research and development of safer and more effective alternative treatments is being raised.
Nam Soo-yeon, head of CHA Biotech R&D, said, “CordSTEM is an innovative treatment selected as a target for the government's 'Regenerative Medicine Technology Development Project' in 2021. We plan to change to the globally established cell line CHAMS-201 cell therapy and conduct clinical development in Korea and overseas, including Japan, to establish the optimal dosing frequency and route,” adding, “It is expected to contribute not only to the unmet medical needs of early ovarian failure patients but also to solving social issues such as low birth rates and aging due to infertility by maintaining ovarian hormone function in the long term.” 



vrdw88@fnnews.com Kang Jung-mo Reporter