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ABL Bio has spent nearly a decade positioning itself as Korea’s breakout biotech platform. On Monday night, that bet either pays off—or comes crashing down.
At 10 p.m. KST, topline results will drop from the phase 2/3 U.S. trial of ABL001 (also known as CTX-009), a bispecific antibody co-developed with Compass Therapeutics for second-line biliary tract cancer (BTC). It’s the company’s first major readout from a partnered program and, by all accounts, its make-or-break moment.
“This isn’t just another data point,” ABL CEO Lee Sang-hoon told investors Friday morning, speaking at a closed-door session ahead of the company’s ninth annual shareholders’ meeting. “This could define our trajectory. It’s not just about stock price. It’s about trust, cash flow, and proving we can deliver results, not just science.”
Compass Therapeutics, which is running the trial, will release the data. ABL Bio, notably, hasn’t seen it yet.
ABL Bio CEO Lee Sang-hoon speaking Friday at an investor meeting in Pangyo Techno Valley ahead of the company’s annual shareholders’ gathering. (Credit: Korea Biomedical Review)
ABL Bio CEO Lee Sang-hoon speaking Friday at an investor meeting in Pangyo Techno Valley ahead of the company’s annual shareholders’ gathering. (Credit: Korea Biomedical Review)
A strong showing could vault ABL into a rare class of Korean biotechs—those with royalty-bearing revenues from a globally approved drug. Only Yuhan has pulled it off, breaking 2 trillion won ($1.37 billion) in revenue last year, fueled by licensing income from Leclaza (lazertinib), its EGFR lung cancer drug now sold by Johnson & Johnson.
“If this doesn’t go well,” one shareholder said during Friday’s session, “everything you’ve said before risks falling apart in terms of market trust.”
Lee didn’t flinch. He didn’t try to soften it either. “We won’t know anything until the lid comes off,” he said. "But based on the data so far, we believe expectations are justified.”
The company’s early hopes rest on performance signals already indicated in Korea, where ABL001 showed a 62 percent objective response rate (ORR) as a monotherapy in advanced solid tumors, including BCT. Lee said that Compass later revised the BTC-specific ORR to around 50 percent after excluding three rectal cancer patients.
Compass' latest update pegs the ORR for CTX-009 plus paclitaxel at 37.5 percent in 24 patients, with a median progression-free survival of 9.4 months and overall survival at 12.5. Lee insists those numbers could still be significant. "A 33 percent response rate could be meaningful—if the durability and safety data hold," he said.
But if it misses, the fallout could ripple beyond this one drug; it could shake investor confidence and undercut ongoing licensing talks that the company says are underway.
According to Lee, milestone revenue this year is expected to hit 65 billion won, largely from its Compass partnership and licensing deals with I-Mab and CStone Pharmaceuticals.
Lee has also called 2025 an inflection point. Grabody-B, its blood-brain barrier shuttle platform, is back on the table for an exclusive licensing deal after a prior deal fell through over exclusivity terms. The company is aiming now for long-term, royalty-sharing partnerships modeled after deals struck by Alteogen and LigaChem Biosciences.
Returns, he added, could start landing in two to three years.
Meanwhile, its immunotherapy platform, Grabody-T, continues to move through early development. The lead program, ABL111—licensed to I-Mab—targets CLDN18.2 and is being tested in gastric cancer alongside Opdivo (nivolumab) and chemotherapy. Lee claims it can hit low-expression tumors that zolbetuximab, Astellas’ CLDN18.2-targeting drug, misses.
A 17-patient interim update is expected this summer. Full enrollment could stretch into 2026.
Meanwhile, its U.S. subsidiary, now led by former Genentech and Citi executive Mayank Gandhi, who brings what Lee called “clinical fluency and Wall Street grit,” is preparing a portfolio of bispecific ADCs. Gandhi is steering ABL206 and ABL209 toward the clinic, with deal-making targeted for four to five years out. "Traditional ADCs miss the mark," he said. "You inject 100 units and less than 0.1 percent reaches the tumor. Bispecifics change that."
Lee pointed to SystImmune's $800 million upfront ADC deal with BMS as a sign of the market's appetite. But for all the forward-looking talk, everything circles back to ABL001. “We’re hoping for the best,” he said. “But we’re also ready if it goes the other way.”
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Kim Ji-hye jkim404@docdocdoc.co.kr
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