Reporter Seongmin Kim, Bio Spectator
GI-101 domestic, US KEYNOTE-B59 clinical IND application completed…”expected to proceed with clinical trial this April”
GI Innovation announced on the 8th that it has obtained’A’ grades in all three technical evaluations for listing on the KOSDAQ.
In the case of a technical special listing, two specialized evaluation institutions must obtain an A grade and a BBB grade or higher.Gi Innovation obtained a grade that meets the qualification requirements for a technical special listing by obtaining’A’ from all three specialized evaluation institutions.
GI Innovation, which is pursuing a special listing for growth potential, plans to submit a request for preliminary examination on the KOSDAQ to the Korea Exchange and begin the IPO process. GI Innovation explained that it plans to enter the KOSDAQ through a special listing for growth potential in the first half of this year.
In the event of a special listing for growth potential, the organizer is responsible for the share price after the IPO and is obligated to take a put-back option (repurchase right). In the event of a sluggish share price after listing, the listing organizer is responsible for repurchasing shares at 90% of the offering price.
Myung-ho Jang, CEO of GI Innovation, said, “Through this technological evaluation, we have been recognized for the high technology and growth potential of GI Innovation.” We will spur research and development.”
GI Innovation’s main pipeline is GI-101, an immuno-cancer drug, and GI-301, an allergy treatment, produced using its own platform, GI-SMART technology. GI-101 was up to $796 million (900 billion won) including a down payment of 6 million dollars to Simceer in China in 2019, and GI-301 was up to 1 trillion including a down payment of 20 billion won to Yuhan Corporation in 2020. Each technology transfer was achieved at 400 billion won.
GI Innovation completed a clinical trial plan (IND) submission to the Korean Food and Drug Administration and the US Food and Drug Administration (FDA) in January for a phase 1/2, global clinical trial for GI-101. The company predicts that clinical trials will be conducted around April. For clinical development of GI-101 co-administration, Gia-Innovation has signed an agreement from Merck (MSD) of the United States for the free provision of the immune anticancer drug Keytruda® for clinical trials.
This clinical trial is conducted on a total of 400 patients across 12 solid cancers, and it was designed as a seamless, basket trial Phase 1/2 clinical trial to confirm anticancer activity in various carcinomas.
In this clinical trial, △Single administration of GI-101 △Co-administration with MSD Keytruda® (including cohort of 7 carcinomas) △Co-administration with Lenvima®, a multiple kinase inhibitor including VEGFR △Radiation It consists of four parts: therapy and co-administration. They explained that they will receive free support for about 200 patients from MSD for the cohort of cohort administration with Kitruda.
Nam Soo-yeon, CEO of GI Innovation, said, “The development strategy of immune anticancer drugs has recently evolved. “There have been reports of positive initial clinical results for interleukin-2-based treatments and CTLA-4 inhibitors, such as immune checkpoint inhibitors, angiogenesis inhibitors, and radiation therapy.”