GC Cell's CAR-NK Offers 'New Hope' to Patients with Peripheral T-Cell Lymphoma

[Financial News] A new treatment opportunity has opened for patients with peripheral T-cell lymphoma who have few viable options after existing treatments. GCC2005, a CD5 CAR-NK cell therapy being developed by GC Cell, has received approval from the Ministry of Food and Drug Safety for treatment use.
GC Cell, represented by Kim Jae-wang and Won Seong-yong, announced on the 18th that its investigational therapy GCC2005 (CD5 CAR-NK) had received approval for treatment use from the Ministry of Food and Drug Safety.
The approval followed an application by Seoul National University Hospital for patients with peripheral T-cell lymphoma who have limited treatment options after existing therapies. Accordingly, Seoul National University Hospital plans to administer GCC2005, an investigational drug, to the patient for treatment purposes.
The treatment-use approval system allows investigational drugs that have not yet received approval from the Ministry of Food and Drug Safety to be used exceptionally for severely ill or terminally ill patients whose lives are at risk or who have no alternative treatment options.
GCC2005 is an allogeneic CD5-targeted CAR-NK cell therapy candidate that GC Cell is developing as a first-in-class innovative drug. It is one of the company's key pipelines. The company has completed patient dosing in its domestic Phase 1a trial and is preparing to begin Phase 1b.
Professor Byun Ja-min of the Department of Hematology and Oncology at Seoul National University Hospital, who is leading this treatment, is a researcher directly involved in Korea's Phase 1 clinical trial of GCC2005. He has expertise and clinical experience in GCC2005's mechanism of action and the treatment of T-cell and NK-cell lymphomas.
Professor Byun Ja-min said, "Patients with refractory T-cell lymphoma who have failed standard anticancer treatment have extremely limited treatment options," adding, "I hope this treatment-use approval will provide patients with a meaningful treatment opportunity."
A GC Cell official said, "We consider it meaningful that we can provide GCC2005 to patients whose condition is too urgent to wait for participation in Phase 1b and whose treatment alternatives are limited," adding, "We will work closely with the research team at Seoul National University Hospital to support the smooth delivery of treatment and will continue pursuing GCC2005's clinical development and global development strategy."
 
[email protected] Reporter Jung Myung-jin