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- Safety and efficacy data released on the adjustment of ABL503/ragistomig monotherapy dosing interval
- Dosing-interval adjustment improves safety while maintaining strong anti-tumor efficacy
Seoul (South Korea) – December 5, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it will attend the European Society for Medical Oncology Immuno-Oncology Congress (ESMO IO) 2025, which will be held from December 10 to 12, and present a poster on the interim results of a new dosing regimen being evaluated in the ongoing Phase 1 clinical trial of ABL503/ragistomig.
ABL503/ragistomig is a PD-L1/4-1BB bispecific antibody candidate being co-developed by ABL Bio and NovaBridge Biosciences (NASDAQ: NBP). It was designed to overcome the limitations of existing PD-(L)1 therapies, such as resistance and low response rates, and is currently being evaluated in ongoing Phase 1 clinical trials in the United States and South Korea.
ABL503/ragistomig previously presented clinical data on the bi-weekly (Q2W) monotherapy regimen at the American Society of Clinical Oncology (ASCO) annual meeting last year, where one complete response and six partial responses were observed. Based on these data, ABL Bio additionally evaluated a six-week monotherapy dosing regimen of ABL503/ragistomig to further improve the therapeutic index.
ESMO IO is an international academic congress that shares a broad spectrum of scientific knowledge in the field of immuno-oncology, ranging from basic research to clinical development. This year’s meeting will be held in London, UK. At the event, ABL Bio will present Phase 1 clinical data evaluating the safety, efficacy, and pharmacokinetics (PK), pharmacodynamics (PD) of the ABL503/ragistomig monotherapy administered every six weeks (Q6W).
The poster to be presented at ESMO IO is titled ‘Phase 1 Clinical Trial of Ragistomig (ABL503/TJ-L14B: PD-L1 × 4-1BB bispecific antibody) Q6W Dosing Balances Favorable Safety and Sustained Efficacy Through Extended Immunologic Memory and Reinvigoration of CD8+ T Cells’, which will be released on December 10.
Sang Hoon Lee, CEO of ABL Bio said, “Extending the dosing interval of ABL503/ragistomig’s effective dose (3 mg/kg) from every two weeks to every six weeks improved safety while maintaining strong anti-tumor efficacy. The next clinical strategy for ABL503/ragistomig is to expand into combination therapies. ABL503/ragistomig is one of the candidates developed using Grabody-T, a 4-1BB–based bispecific antibody platform. Another Grabody-T–based candidate, ABL111/givastomig, has shown encouraging results in a Phase 1b trial as part of a triple combination with chemotherapy and a PD-1 inhibitor. ABL503/ragistomig is likewise expected to become a strong partner for combination treatment.”
About ABL Bio
ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL103, and ABL202 (CS5001/LCB71), are underway for different indications in various countries, including the United States, China, Australia, and Korea. Currently, ABL Bio and Sanofi are in the process of transferring the clinical trial sponsorship of ABL301 (SAR446159) to Sanofi to conduct following clinical studies. ABL001 (tovecimig) has received Fast Track designation by the U.S. Food and Drug Administration (FDA). In addition, ABL111 (givastomig), co-developed with NovaBridge, has presented encouraging data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy in ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
About NovaBridge
NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. We combine deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need.
The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB), and VIS-101, a second-in-class, potentially best-in-class bifunctional biologic, targeting VEGF-A and ANG2.
Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. The Company is also collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors. Additionally, NovaBridge owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody that targets adenosine-driven immunosuppression in cancer.
VIS-101 targets VEGF-A and ANG-2 to provide more potent and durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). VIS-101 is currently completing a large, randomized, dose-ranging Phase 2 study for wet AMD. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia.