Genexine, NeoImmuneTech have started administering its combination treatment of HyLeukin-7 and MSD’s Keytruda for phase 1b and 2 clinical trials on triple-negative breast cancer (TNBC) patients.

HyLeukin-7 is a T cell amplifier that stabilizes Interleukin-7, an essential growth factor for the development and proliferation of T cells in the body, and dramatically increases the half-life and efficacy of the body by applying hyFc technology, an original technology of Genexine.

Triple-negative breast cancer, unlike other cancers, has cancer stem cells that proliferate making it challenging to treat by targeted cancer chemotherapy. Currently, standard chemotherapy is the only treatment for the disease. Triple-negative breast cancer patients account for about 15 to 20 percent of all breast cancer patients with a higher share among younger women.

The disease often has a poor prognosis as it has a high recurrence rate. Compared with other types of breast cancer, the survival period after recurrence is shorter raising the need for a more effective treatment.

The companies plan to conduct the trial at 10 local medical institutions, including Samsung Medical Center.

Genexine had presented a poster session regarding HyLeukin-7’s new antitumor mechanism during the American Association for Cancer Research (AACR) held in Atlanta this year.

The presentation noted that the administration of HyLeukin-7 in the anticancer animal model significantly increased Killer T cells, while the same Killer T cells had sufficient anticancer effects and shifted toward the cancer cells.

Besides, Killer T cells showed a high response rate in cancer tissues when administrated with GX-I7, whereas regulatory T cells and myeloid-derived suppressor cells (MDSC), which inhibit the anti-cancer activates showed a low response rate.

“The combination of Keytruda and Hyleukin-7 is of great significance as it will try to improve the efficacy of existing standard therapies cure rate for patients with relatively poor or metastatic TNBC,” said Professor Woo Jung-won, head of clinical development for Genexine. “Hyleukin-7 improves T cell depletion symptoms and increases the number of Killer T cells in tumors with anti-cancer activity, which is common in TNBC patients.”

Therefore, the company expects that it will provide an improved result for patients who do not respond to conventional immunotherapy, Woo added.