Clinical Trials

Date: 2017-12-29

Type of information: Clinical trial authorisation

phase: 1b

Announcement: clinical trial authorization

Company: Genexine (Republic of Korea)

Product: HyLeukin®

Action mechanism:

  • protein/immunotherapy product. HyLeukin is an immuno-oncology agent comprised of an optimally engineered Interleukin-7 (IL-7) molecule based on Genexine’s proprietary long-acting hyFc platform technology, focusing on cancer, infectious diseases and lymphopenia. IL-7 is known to be the critical factor of the immune system to increase the number and functionality of tumor-killing T cells. Although National Cancer Institute (NCI) of US has already noted the importance of IL-7 as an immuno-oncology agent, IL-7 showed high unmet needs of short half-life and instability which lower therapeutic efficacy.However, HyLeukin significantly enhanced its half-life by fusing IL-7 to hyFc technology, and improved the stability and manufacturing yield. HyLeukin is considered unique because it is known as the only suitable IL-7 for clinical and commercial use.
  • HyLeukin is being co-developed with NeoImmuneTech, a spin-off company of Genexine located on Maryland, USA.

Disease: advanced solid tumors

Therapeutic area: Cancer - Oncology

Country: Republic of Korea

Trial details:

Latest news:

  • • On December 29, 2017, Genexine announced that HyLeukin® received Phase 1b IND approval from Ministry of Food and Drug Safety (MFDS) in Korea for patients with solid tumors. HyLeukin has completed Phase I clinical study in healthy volunteers this December, and now is available to enter Phase 1b trial.

Is general: Yes