"Merck, which is developing Ingenia's macular degeneration treatment candidate, plans to launch it as a blockbuster new drug in 2030, and we will use that as a springboard to leap into global bio corporations."
Han Sang-yeol, CEO of Ingenia Therapeutics, said at an initial public offering (IPO) press briefing on the 14th at the Conrad Hotel in Yeouido, Seoul, "'IGT-427,' a macular degeneration treatment candidate that was licensed out at the preclinical stage in 2022 in a deal worth 1 trillion won, is now in global phase 3 trials led by MSD, and we expect it to grow into a blockbuster new drug with annual sales of more than $5 billion (about 7 trillion won)."
Founded in 2018 in Boston, Ingenia Therapeutics is a bio corporations that develops new drugs based on antibody technology that protects and restores microvasculature. The company is preparing for a KOSDAQ special technology listing, and its expected corporate value is up to 780 billion won. Earlier, in last year's technology evaluation, both institutions gave it an A grade.
Ingenia's core pipeline is the macular degeneration and other ophthalmic disease treatment candidate 'IGT-427.' In 2022, the company licensed out IGT-427 at the preclinical stage to Eyebiotech, a U.S. ophthalmology biotech, in a deal worth about 1 trillion won. MSD, which later acquired Eyebiotech, is now conducting global phase 3 trials.
IGT-427 is a macular degeneration treatment candidate that works by suppressing vascular leakage and restoring the function of damaged blood vessels. Two large-scale global phase 3 trials are underway in patients with wet age-related macular degeneration (wAMD), with about 2,000 total participants. There are more than 140 trial sites.
Han said, "MSD is aiming to complete IGT-427 trials in 2028, obtain U.S. Food and Drug Administration (FDA) approval in 2029, and launch in 2030," adding, "We expect it to become a blockbuster new drug with annual sales of more than $5 billion."
MSD also plans to start a global phase 3 trial in the third quarter of this year for the diabetic macular edema (DME) indication.
Ingenia's competitive edge is an antibody technology that directly activates the "Tie2 receptor," which is involved in vascular stabilization. Han, who graduated from the Department of Biological Sciences at Seoul National University and earned a doctorate in molecular biology, secured the original technology while conducting microvasculature research at the Institute for Basic Science (IBS). Noting that vascular dysfunction is a key cause of various diseases, Han founded Ingenia in Boston in 2018.
In healthy blood vessels, the Ang1 protein binds to Tie2 to keep vessels stable and suppress inflammatory responses. In contrast, in cancer or inflammatory diseases, Ang2 protein increases, reducing Tie2 activation and damaging blood vessels, leading to leakage of blood and body fluids.
Ingenia is developing treatments by creating antibodies that directly activate Tie2 instead of Ang1 to restore damaged blood vessels. Its core platform, "TIE-body," activates Tie2 by binding to a different site than existing therapies.
The company said the technology can maintain efficacy even in disease environments with elevated Ang2 and can overcome the limitations of existing drugs whose effects wane at high doses.
After IGT-427, Ingenia is expanding applicable diseases through follow-up pipelines. 'IGT-303' is being developed as a treatment for chronic kidney disease (CKD), particularly diabetic kidney disease. The company began a phase 2a trial last month in Korea, Australia, and New Zealand, and plans to release topline results early next year.
Han said, "In preclinical primate studies, we confirmed a 58% reduction in proteinuria," adding, "Based on the phase 2a results early next year, we plan to move into full-fledged licensing discussions."
The glaucoma treatment candidate 'IGT-302,' being co-researched with MSD, is also expanding its applicable diseases to anticancer drugs, neurodegenerative diseases, and pulmonary arterial hypertension based on Tie2 activation technology.
Ingenia is broadening its scope beyond ophthalmic diseases to various intractable diseases based on its vascular stabilization platform.
The anticancer candidate 'IGT-532' is preparing to enter phase 1 next year, and the dementia treatment is being developed as a combination therapy leveraging Tie2 activation. The pulmonary arterial hypertension candidate 'IGT-627' is being developed using mechanisms of vascular stabilization and antifibrosis, in joint research with the cardiovascular center at Harvard Medical School.
Ingenia is also strengthening its research and development (R&D) capabilities by recruiting experts with global new drug development experience.
Vice President Yoo Jin-sam (CDO) worked for more than 10 years at Eli Lilly and Company in the United States, serving as senior director in clinical research and overseeing early drug development programs, immunogenicity risk assessment, antibody engineering, and biomarker strategy.
It also formed a scientific advisory board with figures including Eric Pfenning, CEO of mid-sized local bio corporations Mosaic Biosciences, and Tariq Gayur, former distinguished research fellow at global drugmaker AbbVie. Pfenning participated in developing the macular degeneration therapy Eylea at Regeneron in the United States.
Since its founding in 2018, the company has raised a total of 38.6 billion won in investment. As of June, cumulative licensing-related revenue, including equity value and milestone revenue secured through the technology transfer agreement with Eyebiotech, totaled 68.2 billion won.
Starting this year, results are also expected to improve as milestones from the licensing agreement are fully reflected. Ingenia projects a turnaround to profit this year with $32.1 million (about 46.2 billion won) in revenue and $9.74 million (about 14 billion won) in operating profit. In 2028, it aims for 370 billion won in revenue and 266 billion won in operating profit.
Ingenia bases its headquarters and most of its research organization in the Boston bio cluster. On why it is pursuing an IPO in Korea rather than the United States, Han said, "We want to set a precedent for a Korean bio corporations founded in the United States to list on the Korean market and advance into the global market," adding, "After the listing, we will lay the groundwork to conduct late-stage clinical trials and our own drug development in parallel."