• Genexine to receive an upfront payment and entitled to tiered, single-digit royalties on net sales of HyLeukin plus milestone payments from I-Mab Biopharma (I-Mab). 

• I-Mab receives exclusive development and commercialization rights to HyLeukin in China, China Taiwan, Hong Kong and Macao 

Genexine, a clinical stage biotechnology company developing innovative biologics, today announced the signing of a licensing agreement with I-Mab Biopharma (I-Mab) to develop and  

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 chairman 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.

◆ About HyLeukin

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. 

◆ About Genexine  

Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on immuno-oncology and orphan disease. Genexine has robust pipelines in clinical and pre-clinical stages based on long-acting Fc fusion technology and therapeutic DNA technology. In the clinical stage, Genexine has GX-H9 (long-acting human growth hormone, hGH-hyFc) for both adult and pediatric growth hormone deficiencies, currently in multinational phase II trials. GX-188E, therapeutic DNA vaccine for HPV-associated diseases, is in Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia II/III. Founded in 1999, Genexine has over 140 employees, and half of them are scientists with MSc, or Ph.D. Genexine is located in Pangyo Techno Valley near Seoul, Korea with a branch office in New York. ir@genexine.com

◆ About I-Mab

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. I-Mab’s pipeline is driven by the company’s development strategy to address unmet needs in China and to bring innovative assets to the world. Following the recent Series B financing of $150 million and rapid growth in internal R&D capabilities, I-Mab is now well positioned to advance its China portfolio of multiple Phase 2 and Phase 3 innovative clinical assets and its global portfolio of first-in-class and best-in-class assets in China and/or US in 2018. I-Mab’s long-term commitment is to deliver transformational medicines to patients globally with a focus on unmet needs in China. More information: http://www.i-mabbiopharma.com/en/