"2026 will be a year when ABL Bio's technology licensing and clinical trial results are both crucial."
On the 14th (local time) in San Francisco, at the JP Morgan Healthcare Conference, Chief Executive Lee Sang-hoon of ABL Bio, who met with ChosunBiz, said, "Beyond technology licensing, we will strengthen our in-house new drug development capabilities and reinvent ourselves as corporations that hold multiple asset at the phase 2 stage," laying out his New Year's ambitions.
Lee assessed that the global pharma-biotech industry has reached an inflection point. Big Pharma, which has found it increasingly difficult to seek innovation only within the United States, is in earnest turning its gaze to "East," and opportunities are opening for Korean biotech corporations.
ABL Bio has its "Grabody" technology that helps drugs cross the blood-brain barrier (BBB) well. Buoyed by a series of major technology licensing deals last year, it joined the KOSDAQ market cap "10 trillion won club."
The company signed a technology transfer agreement worth up to 2.063 billion pounds (about 4 trillion won) with GSK plc last year, followed by a technology transfer and joint research deal worth up to $2.602 billion (about 3.8 trillion won) with Eli Lilly and Company.
Lee said, "On the ground this time, I felt that the meeting of the West and the East has become truly important," adding, "Recently, global Big Pharma has brought in a large number of technologies from Chinese biotech corporations, and I sensed that the next opportunity after China lies in 'Korea.'"
◇ "We will advance to phase 2" What is the strategy behind establishing a U.S. subsidiary
During the event, the corporations whose presentation Lee closely followed was Denmark-based biotech Genmab. The company licensed out a bispecific antibody to Johnson & Johnson (J&J), a major U.S. pharmaceutical company, succeeded in commercialization, and set up a structure to receive royalties. But it worried about not having its own pipeline and chose a strategy to acquire and grow Netherlands-based biotech Merus.
Lee said, "Genmab was not a company that had many pipelines from the start," adding, "It began with technology, did technology transfer, reinvested that revenue into clinical development, and now it has become 'a company that knows clinical and commercial,' not a 'technology company.'"
It established a virtuous cycle of "license-out → royalties → building its own pipeline → commercialization." Lee said, "Seeing Genmab gave us confidence that the direction we are heading is not wrong."
ABL Bio's official launch of its U.S. subsidiary Neok Bio in November last year was also a strategy based on this assessment. Neok Bio is a wholly owned subsidiary established to oversee global clinical development of bispecific antibody ADCs (antibody-drug conjugates). Officially launched in November last year, it is leading development of key Antibody-Drug Conjugate (ADC) pipelines such as ABL206 and ABL209.
Lee said, "ABL Bio carried out a 140 billion won rights offering, which brought overhang concerns and share price pressure, but money was essential to expand clinical programs." Lee added, "Technology transfer brings in money, but its limits are clear. So we set up another company in the United States to directly drive programs through phase 2 and chose a strategy to aim for a bigger exit, such as M&A or selling development candidates."
Lee explained, "Because the company holds equity in Neok Bio, revenue from a Neok Bio exit ultimately returns to ABL Bio," adding, "It is similar to the Yuhan Corp. model." Lee said, "Clinical development is the flower of biotech," and emphasized, "Korean corporations need to create multiple asset that have advanced to phase 2."
◇ "BBB shuttles are essential for Big Pharma… ABL001 making steady clinical progress"
Lee said, "BBB shuttle (carrier) technology has already become a must-have for global Big Pharma." The BBB is a protective barrier that prevents external substances from entering the brain, and the technology to cross it is key to developing central nervous system (CNS) therapies.
In fact, Novartis, Roche, Genentech, AbbVie, J&J, Sanofi, GSK, and Eli Lilly and Company have all consecutively signed introduction deals with corporations that possess BBB shuttle technology, including ABL Bio.
Lee also emphasized the potential to combine with siRNA (short interfering RNA, RNA fragments that block specific genes from producing proteins inside cells). ABL Bio developed technology to deliver siRNA to the brain and neurons by using the delivery pathway of the insulin-like growth factor 1 receptor (IGF-1R), which is also expressed in the brain and nerve cells.
Lee said, "If left alone, siRNA goes to the liver. To go to muscle or neurons, a shuttle is essential," adding, "We modified the shuttle structure of IGF-1R to enable far better siRNA delivery, and in animal studies it's a new modality (drug delivery method) where knockdown occurred in neurons." This means the siRNA worked inside nerve cells and showed a reduction in protein production by the target gene.
During the event, Lee also attended the presentation by Compass Therapeutics, ABL Bio's global partner.
Lee said, "In this presentation, Compass Therapeutics clearly imprinted that its core pipeline is the VEGF/PD-1 bispecific antibody 'ABL001,' which is being developed as a second-line therapy for cholangiocarcinoma," adding, "While the clinical data are the same as before, the company stressed that it will disclose top-line data for overall survival (OS) and progression-free survival (PFS) at the end of March this year."
Lee said, "Originally, Compass tried to release the key data at the end of last year, but even at the 80% cutoff point, patients are surviving, so the blind is being maintained." This means the clinical trial is continuing because efficacy such as survival rate is good. Lee added, "In the United States, Compass said it will commercialize on its own, and last week it appointed a chief commercial officer (CCO)."
Lee said, "If ABL001's clinical results show the possibility of success, ABL Bio can step up to the next level."