It has been confirmed that Genexine began recruiting patients for phase 1b clinical trials of’GX-I7′, which is being developed as a treatment for a novel coronavirus infection (Corona 19) in January. Genexine’s development of therapeutic agents following the Corona 19 vaccine in Korea is also drawing attention in the future.
On the 18th, an official from Genexine explained, “Since last month, we have started recruiting domestic patients for the development of COVID-19 treatment.”
As a result, Genexine, which received approval for the GX-I7 Phase 1b for Corona 19 treatment from the Ministry of Food and Drug Safety in August last year, finally began recruiting patients in January, after six months. GX-I7 is a long-acting interleukin-7 (IL-7) component of immune anticancer drug candidate, and Genexine plans to develop it as a COVID-19 treatment through drug re-creation.
As clinical patient recruitment began in earnest, new information about GX-I7 Phase 1 was also registered on the National Institute of Health (NIH) clinical trial information site’clinicaltrials.gov’ on the 29th of last month. .
Genexine plans to explore the safety and preliminary effects of GX-I7 in patients with mild corona19 through Phase 1b in Korea. The number of recruited patients is 40 adults over the age of 19, and the clinical trial is conducted at Seoul Boramae Hospital.
The clinical trial of GX-I7 for the development of COVID-19 treatment has taken its first step abroad.
In the United States, Neo-Imuntech, an affiliate, is conducting phase 1 treatments for two GX-I7 COVID-19 treatments and is currently recruiting patients.
In addition, Genexine was approved by the Indonesian Food and Drug Administration (BPOM) at the end of last year for GX-I7 phase 2 treatment. At the time, Genexine announced that it plans to determine the safety and statistically significant treatment efficacy for a total of 210 asymptomatic carriers and mild corona19 patients in the elderly 50 years or older.
According to Genexine, the second phase of Indonesia has been recruiting patients and starting medication at the same time.
On the 18th, Genexine announced that GX-I7 will be transferring technology to’KG Bio’. Prior to this, Genexine signed a contract with KG Bio last year to conduct a joint clinical trial for GX-I7 Indonesia.
KG Bio, which has taken the lead in Indonesian clinical trials with this technology transfer, plans to apply for emergency use approval if the clinical results of GX-I7 prove the efficacy of COVID-19 treatment.
Meanwhile, in accordance with the GX-I7 technology transfer agreement between Genexine and KG Bio, KG Bio is targeting Asian countries excluding Korea, China, Japan, and the United States and regions such as the Middle East, Australia, New Zealand, India, and Africa. You will have the copyright of
In the US, Neo-Imuntech is conducting clinical trials for co-administration with immune checkpoint inhibitors under the product name’NT-I7′. In China, I-MAB biopharma, which previously received GX-I7 technology transfer from Genexin, is undergoing phase 2 of malignant glioblastoma (GBM) under the product name’TJ-107′. All rights reserved in Korea and Japan are maintained by Genexine.