The mortality rate for patients with acute liver failure reaches 70%. With no effective treatment other than liver transplantation, medical professionals and patients' families have been left to watch helplessly. However, Shift Bio, armed with exosome-based precision drug delivery technology, is offering a glimmer of hope in this desperate situation. We met with CEO Nam Ki-hoon, who is challenging the previously intractable with this innovative technology that has raised the efficiency of existing drug delivery systems to unprecedented levels.
Nam Ki-hoon, CEO of Shift Bio, graduated from Korea University College of Medicine, completed a doctoral program at the KU-KIST Convergence Graduate School, and worked as a researcher at Harvard Medical School's Dana-Farber Cancer Center. I was curious why he chose entrepreneurship over a stable career in medicine.
"I'll never forget the patient who suffered from side effects during my clinical training. Seeing how the drug attacked not only the diseased cells but also normal cells, I began to ask myself, 'Can't we deliver the drug exactly where it's needed?' While treating one patient is meaningful, I realized that a single, innovative new drug could fundamentally change the lives of countless patients."
The Secret to Exosome 'Guided Missiles': 140-Fold Improved Precision
Shift Bio's core technology is exosome-based drug delivery systems. While existing LNP-based delivery systems achieve a mere 0.5% efficiency, these systems boast an astonishing 70% efficiency. This is made possible by a unique scaffold technology called "NSM (Natural Nanoparticle Sorting Motif)."
"By screening numerous amino acid sequence combinations, we discovered a sequence that can efficiently load drugs and targeting factors. We've evolved exosomes from simple nanoparticles into precise 'guided missile'-like drug delivery vehicles."
CEO Nam Ki-hoon emphasized that the company has completed a full-cycle platform encompassing "design, verification, and mass production." "NNP Design AI," developed in collaboration with global company Dassault Systèmes, simulates new drug candidates in virtual reality, reducing the risk of failure. Furthermore, the "NNP Manufacturing Platform," developed with Rooster Bio in the US, serves as the foundation for mass-producing high-quality exosomes. These achievements were published in the international journal Nature Communications, acknowledging their scientific excellence.
The disease ShiftBio selected for its first pipeline is acute liver failure. It is a fatal disease with a mortality rate exceeding 70%, and there is no cure other than liver transplantation.
“We believed that the innovation potential of our technology could best be demonstrated in areas where there is a critical unmet medical need.”
The candidate drug, SBI-102, reaches damaged livers and reprograms immune cells. This reprograms cells that previously caused inflammation to clear away dead cells and promote new tissue regeneration. In preclinical studies, it significantly reduced liver cell death and increased survival rates, and no toxicity was observed even at high doses exceeding 100 times the therapeutic dose.
Based on this data, the US FDA designated SBI-102 as an orphan drug. The company aims to enter Phase 1 clinical trials within the next year, and its potential for use in various inflammatory diseases, including liver failure, renal failure, and pulmonary fibrosis, has been confirmed.
CEO Nam Ki-hoon explains that the collaboration with Dassault Systèmes began with a “bold question.”
"The question was whether exosome delivery systems could be simulated in virtual reality. This is a world-first attempt, applying Dassault Systèmes' expertise in reducing real-world uncertainty through digital twin technology in aerospace and automotive fields to the development of drug delivery systems."
The result is "NNP Design AI." This allows for the design and validation of drug delivery systems in virtual reality, prior to actual experiments. Furthermore, the project is expanding into a "virtual human" project that predicts drug distribution and toxicity within the body.
Smart Money 30 Billion and Global Partnership Strategy
Shift Bio has secured approximately 30 billion won to date. Being selected as a "First Penguin" by the Korea Credit Guarantee Fund was a symbolic recognition of its technological innovation.
"More important than the size of the investment is the direction. By securing strategic investors who share our vision and necessary research funding, we've secured smart money perfectly suited to our growth."
The exosome mass production process was implemented at GMP standards in partnership with Rooster Bio. An IPO remains a strategic option for when large-scale funding is needed. The key is not simply to sell the technology, but to form strategic partnerships with global big pharma companies to maximize its value.
Shift Bio is pursuing a global, simultaneous clinical trial, simultaneously conducted in multiple countries, including Australia and Korea, in addition to the US FDA. The US, which accounts for more than half of the global market, is its top priority, and Asian markets, including Japan and China, are also being closely reviewed.
He defines exosomes as a core platform for the "drug delivery system (DDS)" market, not the "therapeutic market." He emphasized that he intends to position himself as a "game changer" in this market, which is projected to reach hundreds of trillions of won by 2030, armed with three innovations: reprogramming immune cells in the body, precision targeting of autoimmune diseases, and blood-brain barrier penetration technology.
"The answer lies in the name ShiftBio. We want to create a fundamental paradigm shift in the global pharmaceutical and biotechnology industry."
CEO Nam Ki-hoon envisions a company that will stand as a global leader in programmable pharmaceuticals in 10 years. He envisions a future where ShiftBio's technology will be embedded as the engine behind both its own pipeline and the blockbuster new drugs of global big pharmas.
"My ultimate goal is to eliminate the incurable. One day, I dream of meeting a patient whose life has been transformed by a drug we've developed."
A doctor who once felt helpless watching patients suffer from side effects has become an entrepreneur tackling previously intractable conditions with exosome technology. From dramatically improved drug delivery efficiency to FDA orphan drug designation and strategic partnerships with global companies, CEO Nam Ki-hoon's steps are reaching patients.
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