ABL Bio's top hopeful is "ABL111." We placed it front and center even in the newly prepared investor relations (IR) materials.
ABL Bio is taking on the development of a blockbuster new drug of unprecedented scale in Korea's biotech history, led by the pipeline ABL111. Starting with entry into global phase 3 at the end of this year, the company aims to pursue a range of development strategies, including a technology out-licensing deal with a global big pharma.
On the 24th (local time), Chief Executive Lee Sang-hoon of ABL Bio met with Korean reporters at the Bio USA venue in San Diego, California, and unveiled this blueprint.
Lee said, "Operational work to initiate a phase 3 trial in December this year is already going smoothly," and projected, "If it successfully reaches the commercialization stage, the pipeline's value could reach about $2.5 billion (about 4 trillion won)."
◇ ABL111, granted FDA fast track, to release full data in the second half
ABL111 is a bispecific antibody immuno-oncology therapy being co-developed by ABL Bio and U.S.-based Novabridge Biosciences. It simultaneously targets "claudin 18.2 (CLDN18.2)," a protein overexpressed in cancers such as gastric and pancreatic cancer, and the immune T-cell activating receptor "4-1BB," employing a mechanism that organically induces tumor recognition and immune activation.
Data released so far show an advantage over existing therapies in terms of efficacy and market expandability.
The standard first-line therapy for metastatic gastric cancer, the monoclonal antibody "Vyloy (ingredient name zolbetuximab)" by Japan's Astellas Pharma, recorded an objective response rate (ORR) of 40.3% in a chemo-combination trial.
By contrast, ABL111 showed an ORR of 83% in the phase 1b effective-dose cohort data presented at last year's European Society for Medical Oncology Gastrointestinal Cancers (ESMO GI) meeting. Given the small early-stage nature of the trial, reproducing the result in a large phase 3 remains a task, but numerically it exceeds the existing standard therapy by more than twofold.
The target patient population is also broad. While Vyloy limits dosing to CLDN18.2 high-expressing patients (expression in at least 75% of tumor cells), ABL111 was designed to include even low-expressing patients with expression of 1% or higher. In the approximately $12 billion global first-line gastric cancer therapy market, this means it could broaden potential patient coverage versus competing drugs.
On the back of this potential, ABL111 won U.S. Food and Drug Administration (FDA) fast-track designation in June this year. ABL Bio plans to present the full phase 1b data at major conferences in the second half to revalidate its value in the market.
◇ Mitigating late-stage clinical risk through co-development; aiming for out-licensing after entering phase 3
Operational steps to enter phase 3 within the year are also taking shape. Lee said, "We are currently negotiating the budget for phase 3 preparations with our partner Novabridge," and added, "We will proceed sequentially with the contract for a contract research organization (CRO) and the production of phase 3 clinical drug material (samples)."
They have mitigated the financial risk of late-stage trials, which require large funding, through a co-development structure. Lee explained, "We have a contract structure to split clinical expenses 50-50 with Novabridge, reducing the financial burden associated with entering phase 3."
ABL Bio plans to review multiple development strategies, including technology out-licensing, targeting the point when the pipeline's value is elevated after entering phase 3.
The first checkpoint to gauge the willingness of global big pharma to sign and the sincerity of a deal is expected to be the size of the nonrefundable upfront cash payment. The current record for the largest upfront payment in Korea's biotech industry for a single asset is about 130 billion won, received by LigaChem Biosciences from global pharmaceutical company Janssen.
Lee said, "If we surpass the existing upfront record, it could become a new milestone in Korea's late-stage clinical and technology out-licensing landscape."
◇ U.S. subsidiary to pursue a series B next year; BBB platform expands into siRNA
Leveraging its U.S. Antibody-Drug Conjugate (ADC) subsidiary, another growth engine, the company is pursuing a strategy to accelerate global clinical development. Through Neok Bio, an ADC clinical development entity established last year, ABL Bio completed first-patient dosing in U.S. phase 1 trials for its bispecific ADC pipelines "ABL206" and "ABL209."
Neok Bio plans to attract U.S. venture capital (VC) as a major investor in a series B funding round next year, independently carry out development through phase 2, and then seek a Nasdaq listing or a global merger and acquisition (M&A). Lee explained, "We structured the entity as an independent U.S. operation to resolve the issue of simultaneous listings of parent and subsidiary in the domestic capital market and to distribute the financial risk associated with large-scale global trials."
The blood-brain barrier (BBB)–penetrating platform "Grabody-B," selected by Eli Lilly and Company, is making a full-fledged move into the central nervous system (CNS) therapeutic space. After signing a technology transfer agreement with Eli Lilly and Company last year and securing a $15 million strategic equity investment, ABL Bio is now conducting joint research with Lilly.
The core of this research is to develop a refined, modified version of the existing platform optimized for delivering small interfering RNA (siRNA). Lee said, "We are aligning direction through regular joint research meetings with Lilly's team, so development is progressing quickly," adding, "We expect to enter animal studies by the end of this year."