HONG KONG – Seoul, South Korea-based GI Innovation Inc. has licensed to Nanjing, Jiangsu-based Simcere Pharmaceutical Co. Ltd. rights to its immunotherapy drug candidate, G1-101, a bispecific CD80/interleukin2 (IL-2) variant fusion protein.

Under the agreement, Simcere will have rights to the clinical development, regulatory approval and commercialization of the drug in mainland China, Hong Kong, Macau and Taiwan. GI Innovation will receive an up-front payment of $6 million from Simcere, and will be eligible to receive up to $790 million in the course of clinical development, government approval, commercialization and sales. Separately, the Korean company can also receive royalties of an up-to-two-digit figure rate based on Simcere’s net sales of the drug in the regions.   

“Considering the potential momentum of licensing-out in Europe or the U.S., the deal will hugely raise GI Innovation’s corporate value,” VC investment team manager Hojong Kim, at Dayli Partners Inc., one of the investment firms that joined GI Innovation’s series B funding, told BioWorld Asia. 

By combining CD80 and an IL-2 variant, GI-101 creates cancer treatment effects including immune checkpoint inhibitors and immune cell proliferation and activation. It works by increasing immune cell cytotoxic T lymphocytes and natural killer cells. The Korean company will conduct GI-101’s phase I/IIa trial in the U.S. and Korea in June next year.  

The preclinical trial results, presented in September at the European Society for Medical Oncology meeting in Barcelona, Spain, showed GI-101 to have high affinity to both CTLA4 and PD-1, along with preferential binding to IL-2 receptor β. The drug also resulted in improved restoration of immune functions compared to a CD80-Fc in in vitro settings using human peripheral blood mononuclear cells co-cultured with PD-L1hi tumor cells. In CT26 tumor-bearing mice, GI-101 was superior at inhibiting tumor growth when compared to a combination of aPD-1/aCLTA4 in association with a profound increase in cytotoxic T cells and natural killer cells, without causing an increase in regulatory T cells in the tumor microenvironment.  

“We believe that GI-101 may address unmet medical needs through combination therapy as well as monotherapy,” said GI Innovation CEO Suyoun Nam. “Given that GI-101's IL-2 variant has been more optimized to creating anticancer effect than any other existing IL-2 therapies, we expect that its clinical efficacy of the combination therapy will be increased.  

“GI-101’s development strategy is combination therapies with immune checkpoint inhibitors in cancer indications for which first-generation checkpoint inhibitors are approved, which is aimed at maximizing efficacy and reducing side effects,” Nam noted. “The second strategy is to induce anticancer immune responses in those tumors that are resistant to checkpoint inhibitors by converting the ‘cold tumors’ into immunologically active ‘hot tumors,’” she added.    

According to GI Innovation, it has increased GI-101’s production yield through a contract development manufacturing organization deal with Samsung Biologics Co. Ltd., and the productivity assisted creating the deal with the Chinese company.  

“Development of next-generation cancer immunotherapy drugs is urgent so that more patients can gain durable benefits from immunotherapies,” Simcere’s chief strategic officer, Pin Wang, told BioWorld Asia.

“GI Innovation is led by a strong scientific and management team and has established an efficient technology platform for discovering biological molecules for immunotherapeutic applications, whereas Simcere is very experienced in drug development and commercialization,” Wang added.  

Founded in 2017, GI Innovation is focused on immuno-oncology and inflammation/immunological diseases. It uses its GI-SMART platform technology to accelerate biologics R&D through the efficient optimization of multitargeting fusion protein therapeutics. The company’s CEO, Nam, formerly worked for Korean pharmaceutical giant Yuhan Co. Ltd., and led the R&D on lazertinib, a third-generation oral EGFR tyrosine kinase inhibitor for non-small-cell lung cancer that was out-licensed to Janssen Pharmaceutica NV in November 2018.

Simcere specializes in R&D and the manufacture of therapies for various diseases in the areas of oncology, the central nervous system, rheumatology, infection and the cardiovascular system. The company’s portfolio comprises more than 50 products, most of which are listed in the National Medical Insurance and National Essential Drugs Catalogue of China. As an R&D-driven company, it operates five branches focusing on drug development in the U.S., U.K., mainland China and Hong Kong.

Founded in 1995, the company is the first Chinese biological and chemical pharmaceutical company to be listed on the New York Stock Exchange. Its national key laboratory for translational medicine and innovative drugs has been approved by the Ministry of Science and Technology of China.

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