"ABL Bio's biggest hope is "ABL111." We placed it most prominently in the newly prepared investor relations (IR) materials."
ABL Bio is pushing to break the record for the largest out-licensing (L/O) deal in Korea's biotech history with its pipeline ABL111 at the forefront. With a goal to enter global phase 3 trials by the end of this year, the company aims to launch a mega blockbuster new drug within five years.
Chief Executive Lee Sang-hoon of ABL Bio on the 24th (local time) met with Korean reporters at the "BIO USA" venue in San Diego, California, to unveil this blueprint.
Lee said, "The practical work to start phase 3 in December this year is already progressing smoothly," and projected, "If we successfully reach the commercialization stage, the pipeline's value will reach about $2.5 billion (about 4 trillion won)."
◇ "ABL111," granted FDA fast track, to disclose 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 cancer-cell recognition and immune activation.
Data disclosed so far confirm an advantage over existing therapies in terms of efficacy and market expandability.
The monotherapy "Viloie (ingredient name zolbetuximab)" from Japan's Astellas Pharma, the standard first-line treatment for metastatic gastric cancer, posted an objective response rate (ORR) of 40.3% in combination trials with chemotherapy.
By contrast, ABL111 showed an ORR of 83% in data from the effective dose cohort of a phase 1b trial presented at last year's European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI). Given the small scale of the early study, verifying reproducibility in a large phase 3 remains a task, but numerically it more than doubles the existing standard of care.
The target patient range is also broad. While Viloie is limited to CLDN18.2 high-expression patients (expression in at least 75% of tumor cells), ABL111 is designed to encompass even low-expression patients with expression of 1% or higher. In the roughly $12 billion global first-line gastric cancer treatment market, this means it can widen potential patient coverage compared with rival 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 dataset at major conferences in the second half, reaffirming its value to the market.
◇ Mitigating late-stage clinical risk through co-development; aiming for out-licensing after entering phase 3
Practical preparations to enter phase 3 within the year are taking shape. Lee said, "We are currently discussing the budget with our partner, Novabridge, for phase 3 preparations," adding, "We plan to finalize a contract with a contract research organization (CRO) by this summer and begin manufacturing the investigational medicinal product (clinical supply) for phase 3."
Financial risk in the late clinical stages, which require large funding, has been eased through a co-development structure. Lee explained, "We have a contract structure to split clinical expense 50-50 with Novabridge, reducing the financial burden associated with entering phase 3."
ABL Bio plans to pursue out-licensing negotiations targeting the point at which the pipeline's value is elevated after entering phase 3. The company said multiple global big pharma firms are showing interest in ABL111's clinical data and continuing meetings.
The first gate to gauge global big pharma's willingness and the sincerity of a deal is expected to be the size of the nonrefundable upfront cash payment. The current record in Korea's biotech sector for the largest upfront on a single asset is roughly 130 billion won, received by LigaChem Biosciences from global pharmaceutical company Janssen.
Lee said, "If we surpass the existing upfront record, it could set a new milestone in Korea's late-stage clinical and out-licensing landscape."
◇ Next year, U.S. subsidiary to pursue series B; BBB platform expands into siRNA
Leveraging its U.S. Antibody-Drug Conjugate (ADC) subsidiary as another growth engine, the company is moving to accelerate global clinical development. Through NeokBio, an ADC clinical development specialist incorporated last year, ABL Bio completed first-patient dosing in U.S. phase 1 trials for its bispecific ADC pipelines "ABL206" and "ABL209."
NeokBio plans to attract a U.S. venture capital (VC) firm as a lead investor in a series B round next year, independently carry the programs through phase 2, and then pursue a Nasdaq listing or global mergers and acquisitions (M&A). Lee explained, "We structured the entity as an independent U.S. unit to resolve simultaneous listing restrictions for parent-subsidiary companies in Korea's capital market and to diversify financial risk from large-scale global trials."
The blood-brain barrier (BBB) penetration platform "Grabody-B," chosen by Eli Lilly and Company, is making a full-fledged push into central nervous system (CNS) therapeutics. After signing a technology transfer agreement with Eli Lilly and Company last year and attracting a $15 million strategic equity investment, ABL Bio is now conducting joint research with Lilly.
The core of this research is developing a modified, upgraded version of the platform optimized for delivering small interfering RNA (siRNA). Lee said, "We are aligning direction through regular joint research meetings with Lilly's scientists, so development is moving quickly," adding, "By the end of this year, we expect to enter animal studies."