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- Type B meeting with the FDA completed based on positive Phase 1b data, written meeting minutes received
Seoul (South Korea) – March 17, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its partner NovaBridge Biosciences (NASDAQ: NBP) has confirmed the possibility of an accelerated approval pathway for givastomig (ABL111), a gastric cancer treatment under development, during a meeting with the U.S. Food and Drug Administration (FDA). The meeting was conducted based on positive data from a Phase 1b clinical trial evaluating the combination therapy of givastomig (ABL111) with the PD-1 inhibitor nivolumab and chemotherapy.
NovaBridge held a Type B meeting with the FDA and subsequently received written meeting minutes outlining the potential pathways toward an accelerated approval for givastomig.
In addition, the companies aim to initiate a registrational clinical trial as early as Q4 2026, with the final study design to be determined through further discussions with the FDA.
“Givastomig (ABL111) has demonstrated strong efficacy and safety not only in tumors with high Claudin18.2 expression but also in those with low expression, giving it broader market potential than currently approved Claudin18.2 therapies. Givastomig is expected to generate $3 billion in sales in the first-line gastric cancer market across the United States, European 5 countries, and Japan alone, and $5 billion if its indications are expanded to other Claudin18.2-positive tumors. Through close collaboration with NovaBridge, we will accelerate development and aim to become a leader in the Claudin18.2 therapeutic market” Said Sang Hoon Lee, CEO of ABL Bio.
“We are thrilled to receive the positive feedback from FDA confirming givastomig’s eligibility for an accelerated approval pathway,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. “This important regulatory milestone builds on compelling Phase 1b givastomig results, that showed robust efficacy and favorable overall tolerability, with marked improvement relative to historical benchmarks for the standard of care in cross trial comparisons. Givastomig has the potential to be a first-in-class and best-in-class Claudin 18.2 therapeutic for gastric cancer in combination with immunochemotherapy. We are looking forward to continuing our discussions with FDA and bringing givastomig to patients as quickly as possible.”
Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive (CLDN 18.2+) tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2+ gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of the proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.
Givastomig is being jointly developed through a global partnership with NovaBridge Biosciences, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.
About ABL Bio
ABL Bio is advancing a diverse pipeline of preclinical and clinical-stage programs based on its proprietary bispecific antibody platform, Grabody. Clinical development programs for 10 pipeline assets—including ABL301 (SAR446159), ABL001 (Tovecimig), ABL111 (Givastomig), ABL503 (Ragistomig), ABL105 (Nesfrotamig), ABL104 (YH32364), ABL103, ABL202 (CS5001/LCB71), ABL206 (NEOK001), and ABL209 (NEOK002)—are underway across multiple countries, including the United States, China, Australia, and South Korea.
Following the completion of its Phase 1 clinical trial in the United States, further development of ABL301 (SAR446159) will be led by Sanofi. ABL001 (Tovecimig), currently being evaluated in a Phase 2/3 clinical trial for patients with biliary tract cancer, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). ABL111 (Givastomig), which is being co-developed with NovaBridge, has initiated a Phase 2 clinical trial in combination with nivolumab and chemotherapy, and plans to present additional data from the Phase 1b study at a global conference in the second half of this year.
In addition, multiple preclinical programs—including bispecific ADCs and dual-payload ADCs—are being continuously advanced through research and development.
About NovaBridge
NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. The Company combines 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, Claudin 18.2 X 4-1BB bispecific antibody, and VIS-101, purpose-designed to be a best-in-class dual VEGF-A X ANG-2 inhibitor.