Genexine and KG Bio agree to sign License agreement for Genexine’s novel immuno-oncology drug GX-I7

• Maximum $1.2 billion deal signed including $30 million upfront payment, followed by registration and commercialization milestones.

• Currently in phase 2 clinical trial in Indonesia as treatment for COVID-19, and will be developed further with different cancer indications. 

• KG bio is showing potential to transform into SE Asia’s biggest biotech company.

[2021/02/18] Genexine(KOSDAQ 095700) has signed a licensing agreement with KG Bio, which is a subsidiary company of PT Kalbe Farma, one of the largest pharmaceutical companies in Southeast Asia, for the development and commercialization of GX-I7 (Efineptakin alpha), the long-acting interleukin-7 fused to Genexine’s hyFc technology platform.

The agreement includes an upfront payment of 27 million dollars for the development and commercialization rights within the territory of the Middle East, Oceania, India, Africa, and all Asian regions, except for Japan and Korea, regardless of indications. Considering the milestone payments for upcoming clinical development, BLA, or commercialization, the total deal scale two companies agreed upon is 1.1 billion dollars with no obligation of returning the upfront and milestone payment. In addition, there is also royalty payment of 10% based on the sales revenue generated within the territory.

Over the years, Genexine has closed  a number of deals strategically with global partners based on territories and/or indications in order to increase the value of each pipelines. In case of GX-I7, Genexine has licensed-out to NeoImmuneTech for EU and US territory regardless of indications and to I-MAB Biopharma(NASDAQ: IMAB) for cancer indications.

KG Bio, a subsidiary company of PT Kalbe Farma, one of the top pharmaceutical companies in Southeast Asia is now transforming into thetop biotech company in Asia based on its recent merge with the leading companies in clinical research CRO and manufacturing CMOservices, enabling the full development of pipelines from R&D, to clinical trials, and finally to the mass production of the pharmaceutical product.

In 2016, KG Bio licensed-in Genexine’s long-acting erythropoietin GX-E4(Efepoetin alfa) to correct anemia, and is currently conducting phase 3 clinical trial in Austrailia, Taiwan, and ASEAN countries. Later in 2019, the company also signed a licensing-in agreement with Henlius (HK 2696), a subsidiary company of Fosun Pharma, at 692 million dollars, adding an immune checkpoint inhibitor HLX10 into the portfolio and expanding the market to the immuno-oncology field.

Through the licensing agreement with Genexine for GX-I7, an innovative immuno-oncology drug with unique abilities to correct lymphopenia, KG Bio has a high potential to grow further as Southeast Asia’s top biotech company. As a potential COVID-19 treatment, GX-I7 is currently under phase 2 clinical trial in Indonesia with specific aim to apply for the emergency use approval following the phase 2 trial. Additionally, combination clinical trials of GX-I7 with anti-PD1 HLX10 will be conducted, increasing and expanding the pipeline value and simultaneously providing the innovative therapeutic drugs to 655 million Southeast Asian population via Kalbe farma’s international sales and marketing network in which they will expand to India, Oceania, and the Middle East to get the recognition from the global market as leading innovative immune oncology pipeline.

Dr. Sung, CEO of Genexine said “the licensing deal with KG Bio has proved the high value of GX-I7 once again.” He continued, “Genexine will continue for active collaboration with global partners in order for the global recognition of GX-I7 as innovative immune-oncology drug.”

GX-I7 is in clinical development in different countries targeting multiple cancer indications in mono and combination therapies. Especially, according to the Genexine’s interim result of combination clinical trial with Merck’s Keytruda targeting mTNBC patients showed 5 folds higher ORR when comparing to the Keytruda Mono result, the company is also planning for combination with Roche’s Avastin. I-mab who owns GX-I7’s license to develop in Chinese market is conducting clinical trials in China for GBM and solid tumor patients. On the other hands, in US, NeoImmuneTech is working together with global pharmaceutical companies for collaboration and combination studies with global blockbuster immuno-oncology drugs such as Roche’s Tecentriq, Merck’s Keytruda, BMS’s Opdivo, and Novartis’ Kymriah.