바이오스펙테이터

바이오스펙테이터 Jongwon Jang 기자

Korea’s biotherapeutics company Genexine said on March 21 that it has signed a manufacturing order worth $4.6 million with Korea’s Samsung BioLogics, a full service provider of quality-driven contract process development and cGMP manufacturing to the global biopharmaceutical industry.

The order puts Samsung BioLogics in charge of producing clinical samples for Genexine’s immuno-oncology drug, HyLeukin.

HyLeukin is genetically fused Interleukin-7, which is known to be an essential factor in the proliferation and homeostasis of T cells, and generates long-lasting memory T cells, with Genexine’s hybrid Fc platform. The drug candidate has the potential to be developed to treat cancer, lymphopenia, and other infectious diseases.

Currently, the Phase 1b clinical trial of HyLeukin to target patients with solid tumors is underway in Korea. Genexine will sooner or later begin multicenter trials in the United States and Europe.

Under the recent approval from the U.S. Food and Drug Administration, Genexine also plans to run a Phase 1b/2a trial of HyLeukin in the U.S. this year, through its affiliate NeoImmuneTech in Maryland.

Last year, Genexine signed a USD 548 million worth exclusive regional licensing deal with China’s I-Mab Biopharma to develop and commercialize HyLeukin.

Genexine can secure clinical samples for Phase 2/3 trials of HyLeukin from Samsung BioLogics.

Genexine officials said, "We aim to develop other pipeline products. So, we will further strengthen our partnership with Samsung BioLogics through the production of clinical samples and commercialization."