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Genexine inks licensing pact with I-Mab Biopharma to develop & commercialize immuno-oncology drug, HyLeukin in Greater China territories

Seoul, Korea
Thursday, December 28, 2017, 11:00 Hrs  [IST]

Genexine, a clinical stage biotechnology company developing innovative biologics, announced the signing of a licensing agreement with I-Mab to develop and commercialize a proprietary long-acting immuno-oncology drug ‘HyLeukin’ in the Greater China territories.

HyLeukin is an immuno-oncology agent comprised of an optimally engineered Interleukin-7 (IL-7) molecule based on Genexine’s proprietary long-acting protein 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. Clinical results showed that IL-7 has strong synergistic effects with other immuno-oncology drugs such as checkpoint inhibitors. NeoImmuneTech (NIT), a US spin-off company of Genexine established three years ago, is actively pursuing clinical development of HyLeukin in US.

Under the terms of the agreement, I-Mab will provide an upfront payment in exchange for an exclusive license for development and commercialization rights of HyLeukin in the greater China in the field of oncology. In addition, there is potential for various milestone payments and tiered, single-digit royalty payments to Genexine, contingent on regulatory approvals and accumulated net sales. Further financial details are not disclosed.

“China provides good opportunities to demonstrate efficacy of new immuno-oncology drug in cancer patients, and I-MAB is the best partner to carry out these clinical trials at the global level. We believe this licensing partnership with I-Mab represents an important step in executing Genexine’s immuno-oncology development and will become a criterion of value determination in future global licensing deals”, said Dr. Young Chul Sung, the founder and CTO of Genexine.

“We are very excited to have brought our partnership with Genexine to a new level. This is a highlight of many on-going projects we have been collaborating with”, said Dr. Jingwu Zang, founder and CEO of I-Mab Biopharma.

I-Mab plans to develop this clinical stage asset in China for cancer patients whose immune cells and functions are severely compromised. “We hope to develop this investigational medicine of the first-in-class potential in parallel with its global development. So, if proven safe and efficacious, patients in China can benefit from such a treatment in line with or even ahead of a global timeline”, commented by Dr. Jingwu Zang.

Phase I trial of HyLeukin is ongoing in Korea, and Genexine plans to initiate Phase Ib trial in patients with solid tumors in Korea early next year. NIT is preparing for various US clinical trials including Glioblastoma in 2018.  

HyLeukin is an immuno-oncology agent designed to reconstitute and enhance anti-tumoral T cell immunity. It is an optimally engineered Interleukin-7 (IL-7) molecule fused with Genexine’s proprietary long-acting protein platform technology, hybrid Fc (hyFc). HyLeukin is under co-development with NeoImmuneTech (NIT), a US-based spin-off company of Genexine. Genexine recently completed a Phase I trial in Korea. The results showed that HyLeukin was safe and well tolerated in healthy volunteers. Genexine plans to treat patients with solid tumors in Korea, and NIT is preparing various US clinical trials including Glioblastoma in 2018. IL-7 is known to be a critical factor for T cells, which acts on increasing both the number functionality of T cells. Furthermore, according to clinical results revealed in the literature, IL-7 is expected to have strong synergistic effects with other immuno-oncology drugs such as checkpoint inhibitors.  

I-Mab is a dynamic and fast-growing global player committed to developing innovative biologics in the areas of immuno-oncology and immuno-inflammation through internal R&D capabilities and global partnerships.

 

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