GI Innovation·A/Z, a study on immuno-cancer drugs combined

GI-101+Imfinzi+Chemistry maximizes clinical efficacy

The appearance of GI Innovation clinical team members challenging large-scale global clinical trials.

 

(Photo provided = GI Innovation)

GI Innovation (CEO Hong Joon-ho) announced on the 17th that it has signed a clinical supply contract with AstraZeneca in the UK to develop a combination therapy with GI-101, an immuno-cancer drug, and Impinzi (Durvalumab).

 

With this contract, GI Innovation will conduct clinical trials with AstraZeneca to evaluate the combination of immuno-cancer drugs GI-101, Impinzi, and chemotherapy.

 

This clinical trial targets patients with small cell lung cancer, gastric/gastroesophageal junction cancer, biliary tract cancer and triple-negative breast cancer in the United States, Australia, and Korea.

 

GI Innovation will be provided with Infinzi necessary for this clinical trial from AstraZeneca, and it will gain the driving force to conduct successful clinical trials by jointly designing clinical trial designs based on AstraZeneca's expertise in developing immuno-cancer drugs.

 

The clinical trials of both companies aim to treat patients with combination therapy with GI-101, an immuno-cancer drug, in addition to the current standard treatment, chemotherapy, in metastatic and advanced cancers.

 

Despite the use of immuno-cancer drugs in clinical settings, small cell lung cancer, gastric/gastroesophageal junction cancer, biliary tract cancer, and triple negative breast cancer did not show sufficient efficacy alone.

 

To compensate for this problem, a combination of chemotherapy and immuno-cancer drugs has recently been attempted, and some carcinomas have shown encouraging therapeutic effects.

 

A typical example is that a combination of chemotherapy and Imfinzi in small cell lung cancer has been approved as a primary treatment.

 

GI Innovation is a strategy to maximize the treatment effect through the combination of GI-101, chemotherapy, and Imfinzi.

 

The IL-2 site of GI-101 not only directly proliferates and activates apoptotic T cells and natural killer cells in the tumor microenvironment, but also effectively inhibits CTLA-4, an immune gateway expressed in immune cells through CD80.

 

Through CD80-CD28 interaction, it is also possible to activate the immune response of cell killing T cells.

 

Finally, it also has a mechanism to relieve immunosuppression by regulatory T cells that express CTLA-4, an immune gateway, in large quantities.

 

Another immune gateway, PD-L1, can be expected to have excellent anticancer immunity when used in combination with Imfinzi, which activates immune cells.

 

GI Innovation's clinical trial was designed as an adaptive and basket trial to confirm the anticancer activity of four solid cancers in one clinical trial and to register more patients in solid cancers that are effective depending on the results of interim analysis.

 

The clinical trial will be conducted at about 20 medical institutions in Korea, the United States, and Australia.

 

Yoon Nari, head of GI Innovation's clinical division, said, "GI-101 is a bispecific fusion protein that has a complex immune regulation function that proliferates and activates cell-killing T cells and natural killer cells only with monotherapy.

 

The combination of GI-101, Imfinzi, and chemical anticancer drugs is designed to fully utilize the inherent mechanisms of the drug to recover the degraded immune response in cancer patients, respectively.

 

Through this clinical trial, we will do our best to secure meaningful clinical differentiation data.