I-Mab Biopharma Signs Licensing Agreement for HyLeukin With Genexine
SHANGHAI, December 25, 2017
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 Mainland 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 commercialize a proprietary long-acting immuno-oncology drug ‘HyLeukin’ in Greater China.
HyLeukin is an immuno-oncology agent comprised of an optimally engineered Interleukin-7 (IL-7) molecule based on Genexine’s proprietary long-acting platform technology. Genexine will establish a joint development committee with I-Mab to pursue global commercialization and new drug development of multi-target antibody-based candidates in immuno-oncology areas. 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 greater China in the field of oncology. In addition, there is potential for various milestone payments and tiered, low single digit royalty payments to Genexine, contingent on regulatory approvals, and accumulated net sales. Further financial details are not disclosed. “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 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 Jingwu Zang.
HyLeukin is an immuno-oncology agent designed to reconstitute and enhance anti-tumoral Tcell immunity. It consists of an optimally engineered Interleukin-7 (IL-7) molecule biologically fused with the Genexine’s proprietary long-acting platform technology, hybrid Fc (hyFc). HyLeukin is under co-development with Neo Immune Tech (NIT), a US-based spin-off company of Genexine. Genexine recently completed Phase I trial in Korea and based on the current results, HyLeukin demonstrated it was safe and well tolerated in healthy volunteers. Genexine plans to target 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 cell which does not only increase the number of T cells but also enhances T cell functionality. 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 check point 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. 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 2and 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.
Genexine, Inc., 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 hasGX-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 and plans to enter into a Phase 1b/2 trial in cervical cancer in combination with KEYTRUDA, an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, NJ, USA. Founded in 1999, Genexine has over 150 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.