Genexine said Tuesday that it has received approval to go ahead with the phase 1 and 2a clinical trials for HyLeukin -- an immunotherapeutic drug candidate co-developed with NeoImmunetech -- from the U.S. Food and Drug Administration (FDA)
HyLeukin is a new drug pipeline that combined optimized interleukin-7 (IL-7) with hyFc, an original technology owned by Genexine. The company plans to use the drug candidate in treating various diseases, including cancer, infectious diseases, and lymphopenia.
The clinical trial will assess the safety and efficacy of HyLeukin in about 50 to 70 patients with brain cancer by investigating the increase of immune cells, the survival rate and therapeutic responses when administered with the drug.
Brain cancer is a malignant tumor that infests the glial cell, which is abundant in brain tissues. Despite standard treatment methods such as surgery and chemotherapy, the average survival time after treatment is about 12 months.
The standard procedure of removing the cancer cells from the brain can rapidly shrink immune cells, especially T-cells, fighting cancer. Recent studies have reported that reduced T-cells can significantly shorten the survival rate of patients.
“This is the first Genexine product to receive clinical trial approval in the U.S.,” a company official said. “The approval is an important milestone in the global clinical development of HyLeukin will fund we aim to further expand clinical development with various carcinomas in the future.”
The company will also accelerate its goals to make HyLeukin into a global product by carrying out joint studies with other immunostimulants.
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