NeoImmuneTech, Genexine's affiliate, received approval from the U.S. Food and Drug Administration last Thursday to conduct the clinical trial for the combination therapy of HyLeukin-7 and vaccine on elderly patients who received anticancer treatment.
The FDA nod is based on the optimal clinical capacity in the clinical trial plan approved last year. Genexine is also planning to conduct clinical research to prevent microbial infections that cause respiratory diseases, such as coronavirus, by increasing lymphocytus T (T-cell) immunity for elders in Korea and China.
HyLeukin-7 is a T-cell amplifier, which applied Interleukin-7, an essential factor for T cell development and proliferation, to Genexine's hyFc, a continuous platform technology.
This study targets to enhance the efficacy of the vaccine by increasing the number of T cells in aged patients who lack T cell numbers. Old patients tend to have a relatively lower T cell, which makes them vulnerable to infection. Even the vaccine administration generally does not induce a sufficient immune response.
About 63 percent of the confirmed new coronavirus patients lacked T cell, according to a Lancet article published on Jan. 24. Infected patients with low T cell required treatment at intensive care units 5.7 times more than regular patients.
Lancet's follow-up report released on Jan. 29 also said that 11 patients among 99 died, and eight of them had a lower number of T cells, indicating that a proportional relationship between T cell deficiency and coronavirus infection.
HyLeukin-7 has proven its restoring ability of T cell deficiency at the Society for Immunotherapy of Cancer's 34th Annual Meeting & Pre-Conference Programs in 2019.
In addition to immune-oncology drugs that strengthen immunity by amplifying T cell, Hyleukin-7 can also be used to prevent highly lethal viral infections, including coronavirus, and enhance the effectiveness of flu and vaccination against various viruses.
Genexine and Pohang University of Science and Technology announced the results of their animal experiments on the Journal of Virology in 2016 that the nasal administration of Hyleukin-7 effectively prevented viral infections with high mortality.