GI Innovation said that it has licensed out GI-101, a bispecific fusion protein for treating solid tumors, to Simcere, a Chinese pharmaceutical company. GI-101 is a bispecific immunotherapy agent made using the GI-SMART platform, a technology for developing bispecific fusion proteins owned by GI Innovation.
|GI Innovation CEO Nam Su-youn (second from left) and Simcere CSO Pin Wang hold up the licensing agreement at Signiel Seoul on Thursday.|
Through combining the cluster of differentiation 80 (CD80) and interleukin 2 (IL-2) variant, the drug shows the synergy of anti-cancer treatment effect by simultaneously acting on two mechanisms of immune cell proliferation and activation. The company plans to apply for phase 1 and 2a clinical trials simultaneously in the U.S. and Korea next June.
Under the contract, Simcere will acquire exclusive rights for developing and commercializing G1-101 in China, Hong Kong, Macau and Taiwan, while giving an upfront payment of $6 million to GI innovation.
GI innovation is also eligible to receive up to $790 million in the course of developing, commercializing and winning regulatory approval as well as sales milestone payments. If approved, the company can also get tiered royalties of up to a double-digit figure, based on future net sales of the drug.
Initially, the two companies plan to develop combination therapies with immune checkpoint inhibitors in treating cancer that can maximize efficacy and reduce side effects.
Afterward, they are going to expand the indication of the treatment in inducing anti-cancer immune responses in tumors that are resistant to checkpoint inhibitors by converting the "cold tumors," which are cancers that haven't been recognized or provoked a strong response by the immune system, into immunologically-active "hot tumors."
"We believe that GI-101 may address the unmet medical needs due to its checkpoint inhibitor plus cytokine approach, potentially leading to superior efficacy and safety," GI Innovation CEO Nam Su-youn said. "GI-101's IL-2 variant has been optimally engineered to maximize the anticancer effect without compromising safety to a greater extent than other IL-2 therapies." Considering the superior efficacy and safety profiles of the drug, GI-101 has the potential to become an alternative treatment that can overcome the limits seen with first-generation immuno-oncology drugs, Nam added.
Simcere's CSO Pin Wang also said, "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."
Simcere will collaborate with GI so that it may accelerate the development of GI-101 so that cancer patients can benefit from this promising immunotherapeutic drug sooner, Wang added.