NovaBridge Announces Presentation of Ragistomig Expanded Phase 1 Data at ESMO-IO
Rhea-AI Summary
NovaBridge (Nasdaq: NBP) announced that expanded Phase 1 dosing data for ragistomig (4-1BB x PD-L1 bispecific) will be presented in a poster at ESMO-IO on December 10, 2025. The company said the Q6W extended dosing interval met the study objective by delivering strong anti-tumor efficacy in PD-L1 non-responders while improving tolerability, including hepatic safety. Interim immunologic readouts showing CD8+ cell proliferation and memory T-cell activation will be included. The poster (Abstract #688) will be presented by Gerald Falchook, MD, at 5:30 PM GMT and supports planned progression to combination studies with partner ABL Bio.
Positive
- Q6W dosing produced strong anti-tumor efficacy in PD-L1 non-responders
- Expanded schedule showed improved hepatic safety with extended dosing
- Interim immunologic data: CD8+ proliferation and memory T-cell activation
- Poster presentation scheduled for Dec 10, 2025 at ESMO-IO (Abstract #688)
Negative
- Data described as interim, not final or confirmatory
- Results support progression to combination studies but no combination efficacy data yet
News Market Reaction
On the day this news was published, NBP gained 4.94%, reflecting a moderate positive market reaction. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $21M to the company's valuation, bringing the market cap to $449M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
No peer stocks or sector momentum data were flagged, indicating the reaction around this clinical update appears stock-specific rather than part of a broader sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 03 | Clinical data update | Positive | +4.9% | Expanded Phase 1 ragistomig data with Q6W dosing and improved safety. |
| Nov 20 | Management appointments | Positive | -7.5% | Key clinical leadership hires for VIS-101 despite subsequent share price decline. |
Recent news shows mixed alignment: a positive clinical trial update saw a positive price move, while seemingly positive management news coincided with a notable selloff.
This announcement adds to NovaBridge’s recent clinically focused trajectory. On Nov 20, 2025, the company highlighted senior ophthalmology hires at its Visara subsidiary to advance VIS-101 toward being Phase-3-ready in 2026, but shares fell 7.51%. By Dec 3, 2025, the ragistomig expanded Phase 1 data, emphasizing Q6W dosing with favorable efficacy and hepatic safety, coincided with a 4.94% gain, reinforcing investor sensitivity to core oncology progress.
Market Pulse Summary
This announcement highlights expanded Phase 1 data for ragistomig, a 4-1BB × PD-L1 bispecific antibody, with a Q6W dosing schedule aimed at balancing safety and sustained efficacy in checkpoint-resistant patients. The upcoming December 10, 2025 ESMO-IO poster and immunologic readouts build on prior ASCO 2024 results. Investors may watch for durability of response, safety details, and how these findings support progression into combination studies.
Key Terms
bispecific antibody medical
checkpoint inhibitors medical
CD8+ T cells medical
dose escalation medical
immuno-oncology medical
AI-generated analysis. Not financial advice.
- Ragistomig is a 4-1BB X PD-L1 bispecific antibody, designed to treat patients who are relapsed or refractory to checkpoint inhibitors, a multi-billion dollar drug class hampered by widespread resistance
- The Phase 1 ragistomig study achieved its objective, as the new Q6W extended dosing interval produced strong anti-tumor efficacy in PD-L1-non-responders, with an improved safety profile
- The interim results, including immunological data on CD8+ cell proliferation and memory T-cell activation, are expected to be presented in a poster session at ESMO-IO on December 10, 2025
ROCKVILLE, Md., Dec. 03, 2025 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, today announced that new data from the expanded Phase 1 dosing study for ragistomig, a 4-1BB X PD-L1 bispecific antibody, will be presented in a poster at the European Society for Medical Oncology – Immuno-Oncology Congress 2025 (ESMO-IO 2025) by co-developer ABL Bio. The poster (Abstract #688) will be presented by Gerald Falchook, MD, Director of the Sarah Cannon Research Institute (SCRI) at HealthONE Denver, on Wednesday, December 10th at 5:30 PM GMT.
“The expanded Phase 1 dosing study achieved its objective of extending the therapeutic window for ragistomig by defining a new dosing schedule that could provide strong anti-tumor efficacy and a more manageable tolerability profile, including improved hepatic safety. The data build on promising Phase 1 data presented at ASCO 2024 and support progression to combination studies which could significantly advance patient care,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge.
“Ragistomig was designed to deliver new therapeutic options for patients who have developed resistance or relapsed after treatment with checkpoint inhibitors, a multi-billion dollar drug class that serves as the cornerstone of care for many cancers. We are encouraged by the promising ragistomig advancements and data that will be presented at ESMO-IO and look forward to continuing the program in collaboration with our partner, ABL Bio,” said Sean Fu, PhD, Chief Executive Officer of NovaBridge.
ESMO-IO Meeting information:
- Title: 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
- Abstract #688
- Date and Time: Wednesday, December 10th at 5:30 PM GMT
A copy of the poster will be available here after the session. To review an overview of the Phase 1 dose escalation data, click here.
About Ragistomig
Ragistomig (also known as ABL503) is a differentiated novel bispecific that integrates a single-chain, Fc-silent PD-L1 segment as a tumor engager and 4-1BB segment as a conditional T cell activator. It was developed using ABL Bio’s “Grabody-T” bispecific antibody platform technology to overcome resistance to PD-(L)1 inhibition and stimulate 4-1BB activation only in the presence of PD-L1 expressing tumor cells, to minimize the risk of off-tumor toxicity. Preclinical studies demonstrated that the bispecific antibody showed better anti-tumor activity than its single-agent components. A Phase 1 dose expansion study (NCT04762641) is currently being conducted in the U.S. and South Korea. The study was designed with a primary endpoint of defining the dose-limiting toxicity and adverse event profile of ragistomig, as well as to observe the objective response rate, pharmacokinetic and immunogenicity profiles and other secondary endpoints.
Ragistomig (also known as ABL503) is being jointly developed with ABL Bio
ASCO 2024: the 2024 American Society for Clinical Oncology Annual Meeting; Q6W: every six weeks
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.
For more information, please visit https://www.novabridge.com and follow us on LinkedIn.
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”, “designed to”, “anticipates”, “future”, “intends”, “plans”, “potential”, “estimates”, “confident”, and similar terms or the negative thereof. NovaBridge may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its 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, without limitation, statements regarding: the strategy, clinical development, plans, results, safety and efficacy of givastomig and VIS-101 and its other drug candidates, including ragistomg; the strategic and clinical development of NovaBridge’s drug candidates, including givastomig, ragistomig and VIS-101; anticipated clinical milestones and results, and related timing, and the impact of new leadership appointments. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: the Company’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of 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 protection of intellectual property for its technology and drugs; the Company’s reliance on third parties to conduct drug development, manufacturing and other services; the Company’s limited operating history and the Company’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and those risks more fully discussed in the “Risk Factors” section in the Company’s annual report on Form 20-F filed with the SEC on April 3, 2025 as well as the discussions of potential risks, uncertainties, and other important factors 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 may be required by law.
NovaBridge Investor & Media Contacts
PJ Kelleher
LifeSci Advisors
+1-617-430-7579
pkelleher@lifesciadvisors.com
NovaBridge Biosciences
+1-240-745-6330
IR@novabridge.com
FAQ
What did NovaBridge (NBP) announce about ragistomig for December 10, 2025?
What efficacy and safety findings will NBP present for ragistomig at ESMO-IO?
What immunologic data for ragistomig will NovaBridge show at ESMO-IO?
Who will present NovaBridge's ragistomig poster and when is it scheduled?
Does the ESMO-IO presentation mean ragistomig is ready for combination trials?
