- Pivotal Phase III clinical trial expected to commence as early as the fourth quarter of 2026
- Detailed Phase Ib data to be presented at a major international medical conference in the second half of 2026
ShanghaiJune 16, 2026 /PRNewswire/ — On June 16, global biotechnology platform company NovaBridge Biosciences (NASDAQ: NBP, “NovaBridge” or the “Company”) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation, FTD for its core pipeline asset Givastomig, based on the treatment regimen combining Givastomig with nivolumab and chemotherapy, for the treatment of previously untreated patients with HER2-negative advanced or metastatic gastroesophageal adenocarcinoma (GEA) whose tumors are both Claudin 18.2 (CLDN18.2) and PD-L1 positive.
As a novel bispecific antibody targeting CLDN18.2 and 4-1BB, Givastomig has demonstrated compelling efficacy and tolerability in Phase Ib data in combination with immunotherapy and chemotherapy, showing potential as a leading CLDN18.2 therapy in gastric cancer. The FDA Fast Track Designation is designed to accelerate the development and review of therapies for serious conditions with unmet medical needs.
Dr. Phillip Dennis, Chief Medical Officer of NovaBridge, stated, “Receiving Fast Track Designation is a significant step forward for Givastomig and for patients with first-line HER2-negative metastatic gastric cancer. Phase Ib results showed robust efficacy and a favorable overall tolerability profile for Givastomig in combination with immunotherapy and chemotherapy. In a broad patient population, responses were deep and durable, representing a meaningful improvement over standard of care. The Fast Track Designation, combined with the FDA’s previously confirmed eligibility for the Accelerated Approval Pathway, provides a more efficient path for the pivotal Phase III trial of Givastomig and highlights its potential as a first-in-class and best-in-class CLDN18.2 therapy in gastric cancer. We look forward to continued communication with the FDA to bring Givastomig to more patients as soon as possible.”
About Fast Track Designation
Fast Track Designation is a special process designed by the U.S. FDA to facilitate the development and expedite the review of new therapies intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Drugs receiving Fast Track Designation may benefit from more frequent interactions with the FDA during development. If relevant criteria are met, programs with Fast Track Designation may also be eligible for rolling review of regulatory submissions, Priority Review, and Accelerated Approval.
About Givastomig
Givastomig (TJ033721/ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells, designed to conditionally activate T cells via the 4-1BB signaling pathway within the CLDN18.2-expressing tumor microenvironment. Givastomig is currently under development and is expected to be used for the treatment of gastric cancer and other CLDN18.2-positive gastrointestinal malignancies. In Phase I clinical trials, Givastomig has shown encouraging anti-tumor activity, with a mechanism of action potentially arising from the synergistic effect of the proximity interaction between CLDN18.2 on tumor cell surfaces and 4-1BB on T cells within the tumor microenvironment, while significantly reducing the toxicity risks commonly associated with other 4-1BB agonists. Based on positive Phase I clinical data for Givastomig, the U.S. Food and Drug Administration (FDA) has confirmed its eligibility for Accelerated Approval. A pivotal Phase III combination trial is expected to commence as early as the fourth quarter of 2026, with the objective response rate (ORR) as the primary endpoint for seeking Accelerated Approval. Givastomig has the potential to be a global first-in-class and best-in-class CLDN18.2-targeted therapy.
Givastomig is being co-developed by NovaBridge and ABL Bio through a global collaboration. Under the collaboration agreement, NovaBridge, as the lead party, shares the rights to the product equally with ABL Bio globally (excluding Greater China and South Korea).
About NovaBridge Biosciences
NovaBridge Biosciences is a global biotechnology platform company dedicated to accelerating access to innovative medicines. We combine specialized business development capabilities with agile translational clinical development to discover, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to move rapidly from discovery to patients in need. The Company’s differentiated pipeline is primarily led by Givastomig and VIS-101. Givastomig is a potential global first-in-class and best-in-class CLDN18.2-targeted therapy; VIS-101 is a potential best-in-class bifunctional biologic targeting VEGF-A/ANG2. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the Claudin 18.2-expressing tumor microenvironment. Givastomig is being developed for the treatment of Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies and has received confirmation from the U.S. Food and Drug Administration (FDA) of its eligibility for Accelerated Approval. A pivotal Phase III combination trial is expected to commence as early as the fourth quarter of 2026, with the objective response rate (ORR) as the primary endpoint for seeking Accelerated Approval. NovaBridge is also developing Ragistomig in collaboration with partner ABL Bio, a bispecific antibody that uses PD-L1 as a tumor-binding target and 4-1BB as a conditional T cell activator in solid tumors. Additionally, NovaBridge holds global rights to Uliledlimab outside of China. Uliledlimab is an anti-CD73 antibody targeting adenosine-mediated immunosuppression in tumors. VIS-101 targets VEGF-A/ANG-2 and is designed to provide more potent and durable efficacy for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). VIS-101 is currently being evaluated in a large, randomized, dose-ranging Phase IIa study for wet AMD, with a Phase IIb dose-finding study expected to commence in the second half of 2026. NovaBridge is the controlling shareholder of Visara, which holds an exclusive license to global rights for VIS-101 outside of Greater China and certain Asian countries. For more information, please visit: https://www.novabridge.com
Forward-Looking Statements
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “believes,” “aims,” “anticipates,” “future,” “intends,” “plans,” “potential,” “estimates,” “confident,” “look forward to,” and similar expressions (or their negative equivalents). NovaBridge may also make written or oral forward-looking statements in its periodic reports filed with the U.S. Securities and Exchange Commission (SEC), annual reports to shareholders, press releases, and other written materials, as well as in oral statements made by the Company’s officers, directors, or employees to third parties. Statements that are not historical facts (including statements about the Company’s beliefs and expectations) are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, expectations regarding the Company’s strategy, and the strategy, clinical development, plans, results, safety, and efficacy of Givastomig, VIS-101, and other drug candidates; the strategy and clinical development of NovaBridge’s drug candidates (including Givastomig, Ragistomig, VIS-101, and Uliledlimab); anticipated clinical milestones and results and related timing; and the impact of new leadership appointments. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contained in these forward-looking statements, including, but not limited to, the following factors: the Company’s ability to demonstrate the safety and efficacy of its drug candidates; clinical results for drug candidates, which may or may not support further development or approval of New Drug Applications/Biologic License Applications (NDA/BLA); the content and timing of decisions by relevant regulatory authorities regarding regulatory approvals for the Company’s drug candidates; the Company’s ability to achieve commercial success for its drug candidates if approved; the Company’s ability to obtain and maintain intellectual property protection for its technologies and drugs; the Company’s reliance on third parties for drug development, manufacturing, and other services; the Company’s limited operating history and its ability to obtain additional operating capital and complete the development and commercialization of its drug candidates; and the risks more fully discussed in the “Risk Factors” section of the Company’s Annual Report on Form 20-F filed with the U.S. SEC on April 7, 2026, as well as potential risks, uncertainties, and other important factors discussed in the Company’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to the Company. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.