GI Innovation released passing of early clinical research of GI-101 in SITC, U.S.A

-SITC 2021, re-hosted face to face  meeting for the first time in 2 years due to COVID-19…topic for overcoming tolerance of Immuno-oncology
-International researchers pay attention to immuno-oncology GI-101’s material excellence that had the mechanism of overcoming tolerance

GI Innovation revealed KEYNOTE-B59’s clinical research process of GI-101(CD80/IL-2 variant bispecific fusion protein) in SITC opened this year. This clinical trial is being conducted jointly with MSD.  

SITC is the largest conference in the field of immunotherapy research held every year in the U.S., and this conference shares a novel new drug and clinical result and, etc., to gather the specialists in the immuno-oncology field all over the world, global pharmaceutical and FDA anti-cancer judges. This year face to face meetings had resumed for the first time in two years due to covid-19, many specialists from around the world participated face-to-face and online.  
 
In this conference, GI Innovation revealed a new immuno-oncology GI-101’s clinical 1/2 phase progress that is ongoing to target 375 cold tumor patients in domestic and the U.S. Currently, GI Innovation has finished dosing the enrolled patients in Cohort 2 smoothly without dose-limiting toxicities (DLTs) in the GI-101 monotherapy dose increase section.
In addition, GI Innovation discussed the global KOL(Key opinion leader) including main cancer hospital researchers of the U.S. such as Washington University in St. Louis; WASU, Mayo clinic, and etc., about the development strategy of GI-101 and the next generation pipeline through face to face meeting.

Nari Yun VP, Head of Clinical Division, said, “We are very pleased to share the current clinical state of GI-101 to cancer researchers from all over the world. In this conference, overcoming tolerance of immuno-oncology is focused on new emerging unmet needs in the middle of PD-1/PD-L1 antibody as the standard treatment for most solid cancer. Through this conference, GI-101 confirmed that it has high expectations as the next immuno-oncology with a possible mechanism of immuno-oncology overcoming tolerance.”

Han-Liim Moon CEO of Medirama, clinical advisory committee member of GI Innovation said. “Abroad researchers and scientists who have attended in SITC showed interests and were surprised by the excellence of mechanism and material of GI-101 and expressed high expectations on the participation and collaboration. Through this, we expect that GI-101’s value will be higher with accelerated R&D and deriving conclusions from various translation research in GI-101’s clinical research. Also, this conference was a highlight such as CD80-CD28 mechanism, NK cell therapy, bone marrow-derived immune cell and GI-101 is centered among the various immune checkpoint therapies.”

Meanwhile, unlike the conventional phase I clinical trial that only checks drug safety, GI-101 clinical trial of cancer immunotherapy of GI Innovation is designed into three methods.

The methods are seamless (processing mono and combined therapy simultaneously), basket (evaluating multiple cancerous species) and adaptive (Expansion of cancerous species that respond positively to drugs). 

In addition, this clinical trial consists of 4 parts ?GI-101 monotherapy ? Combined therapy with Keytruda® of MSD (including 7 cancer types combined therapy) ?Lenvima® (a multiple kinase inhibitor including VEGFR) with combined therapy ?Combined radiotherapy. The MSD Keytruda® and the combined therapy include free Keytruda® support to around 200 patients from MSD.