GI makes bid with its new anticancer drug as combo therapy

In combination with an NK cell therapy

GI Cell submits IND application for a clinical trial evaluating the use of its drug in combination with an NK cell therapy

Secured positive results as monotherapy in GI-102…will also identify the potential for its combined use

Korean pharmaceutical bio venture company GI Innovation is working to identify the commercialization potential of its immuno-oncology drug in combination with an NK cell therapy.

 

GI Innovation, which succeeded in licensing out its allergy drug candidate last year, plans to show results in the field of anticancer drugs this year.

 

According to the pharmaceutical and bio-industry sources on the 15th, GI Innovation recently submitted an IND to the Ministry of Food and Drug Safety for a Phase Ib/IIa clinical trial of GI-101A, an immuno-oncology drug candidate, in combination with NK cell therapy from its affiliate, GI Cell.

 

GI-101A is the first anticancer drug candidate being developed by GI Innovation.

 

The clinical trial will evaluate the efficacy and safety of the combination in patients with recurrent or refractory solid tumors.

 

GI-101A has a mechanism of action that acts on CD80 and interleukin (IL)-2.

 

IL-2 is involved in immune cell proliferation and activation, and CD80 blocks CTLA4, a receptor that inhibits immune cells that attack cancer cells.

 

GI-101A is a new drug candidate that has improved stability and half-life by increasing the sialic acid content in the company’s existing GI-101 production process.

 

Currently, GI Innovation is conducting Phase I/II clinical trials of GI-101A in combination with the immuno-oncology drug Keytruda in Korea and the United States.

 

In addition to Keytruda, GI Innovation plans to increase the possibility of exporting GI-101A’s technology by demonstrating its use in combination with NK cell therapies.

 

GI Cell’s NK cell therapy, T.O.P.

 

NK, can be mass cultured and has maximized tumor targeting ability and cancer cell killing efficiency.

 

T.O.P.

 

NK has shown encouraging results in a Phase I monotherapy clinical trial in patients with relapsed/refractory solid and hematologic cancers, achieving complete response (CR).

 

GI-101·GI-102 development status.

 

Source: GI Innovation

Larger strides made for NK cell therapies…seeks combined use with GI-102 GI Innovation plans to check the potential of combining T.O.P NK with GI-102 as well.

 

The GI-102 pipeline was engineered to further reduce alpha receptor binding compared to GI-101A.

 

Higher alpha receptor binding is known to increase regulatory T cells and reduce the anticancer effect.

 

GI-102 is being developed as both intravenous (IV) and subcutaneous (SC) formulations.

 

GI-102 has also shown promise in a monotherapy trial.

 

Recently, the company's Phase I/IIa data showed an objective response rate (ORR) of 43% when GI-102 was administered to patients with melanoma.

 

In addition, lymphocyte proliferation was favorably affected by GI-102 treatment, and no serious drug toxicity was observed.

 

GII Innovation expects the drug to be more effective when combined with an NK cell therapy.

 

In non-clinical studies, the company confirmed that GI-102’s use in combination with T.O.P.

 

NK maintained persistence in the body for 1 month and showed increased anti-cancer efficacy compared to T.O.P.

 

NK alone.

 

In addition, GI Innovation is also planning to conduct a clinical trial of GI-102 in combination with CAR-T therapy in diffuse large B-cell lymphoma (DLBCL).

 

The company aims to obtain conditional approval for GI-102 while confirming the possibility of exporting its technology.

 

The clinical results of the combination therapy are also being closely watched as GI Innovation has set a goal to export its immuno-oncology candidate within this year.