Genexine and NeoImmuneTech have received approval from the U.S. Food and Drug Administration to conduct the clinical trials of combination treatment between HyLeukin-7, an immunotherapeutic drug candidate, and standard therapies, for newly diagnosed high-grade glioma patients.

HyLeukin-7 is a new drug pipeline that combined optimized interleukin-7 (IL-7) with Hybrid Fc(hyFc), an original technology owned by Genexine. The drug recently received approval from the FDA for brain cancer patients. The clinical trial led by Johns Hopkins Hospital administers a single dose of HyLeukin-7 alone and aims to evaluate the safety and mechanism of action, Genexine said.

However, the new clinical trial will go one step further and monitor lymphocyte recovery and inhibition of cancer recurrence by using the drug in combination with the standard treatment.

“Through this clinical trial, Genexine and NeoImmuneTech expect to improve clinical efficacy by proliferating T cell numbers in patients with brain cancer whose prognosis is poor with conventional therapies,” NeoImmuneTech’s Chief Medical Officer NgocDiep Le said.

“Previous studies have shown that patients with brain cancer who received standard therapy develop a serious side effect of reducing immune cells, which in turn lead to the decrease in survival rate,” he said. “Therefore, the clinical trial will assess whether HyLeukin-7 restores immune cells and increases the survival rate of patients.”

The two companies plan to recruit 46 brain cancer patients for the clinical trial, while Jian Campian from the Washington University School of Medicine will cooperate in the research.