ROCKVILLE, Md., Oct. 08, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (NASDAQ: NBP) today announced that updated results from the Phase 1b combination study of givastomig, a Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy (mFOLFOX6) in participants with previously untreated, HER2-negative, CLDN18.2-positive, and PD-L1-positive locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (GEA), will be presented at the European Society for Medical Oncology (ESMO) Congress 2026. ESMO Congress 2026 is scheduled to take place October 23-27, 2026, in Madrid, Spain.
“Patients with metastatic gastroesophageal adenocarcinoma continue to need more effective treatment options, particularly those whose tumors express lower levels of CLDN18.2,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. “Givastomig is designed to amplify T-cell activity where CLDN18.2 is expressed. The data we plan to share at ESMO will provide a more mature view of the safety, efficacy and durability observed to date in combination with nivolumab and chemotherapy. These findings further strengthen our confidence in the program as we advance toward registrational development in first-line metastatic gastroesophageal adenocarcinoma.”
Presentation Details
Title: Expanded Safety and Efficacy of Givastomig, a Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in 1L Metastatic Gastroesophageal Carcinoma (mGEC)
Presentation Number: 2945P
Presenter: Samuel J. Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital
Date: Sunday, October 25, 2026
Time: 12:00 p.m. - 12:45 p.m. CET
Location: Poster Area, Hall 5
About Givastomig
Givastomig (TJ033721 / ABL111), a potential first-in-class Conditional T-cell Engager and Immune Amplifier (CTIA), is a Claudin 18.2 × 4-1BB bispecific antibody. 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 for potential treatment of gastroesophageal adenocarcinoma, its current lead indication. Givastomig also has potential applicability across other Claudin 18.2+ gastrointestinal malignancies including biliary tract cancer and pancreatic ductal adenocarcinoma.
Givastomig is being evaluated in a global, randomized Phase 2 study (NCT07432295), following positive topline results from a Phase 1b multicenter, open-label study in first-line metastatic gastroesophageal adenocarcinoma. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to givastomig for the treatment of previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinoma in combination with nivolumab and chemotherapy.
About NovaBridge
NovaBridge Biosciences (NASDAQ: NBP) is a global biotechnology company advancing a portfolio of therapeutic programs in oncology and ophthalmology. The Company identifies differentiated therapeutic opportunities, generates value-defining clinical evidence, and applies the development, financing, and partnering strategy best suited to each program.
NovaBridge's portfolio is led by givastomig, a Claudin 18.2 × 4-1BB bispecific antibody being developed for the potential treatment of gastrointestinal malignancies, and VIS-101, a tetravalent VEGF-A × ANG-2 peptibody being developed for the potential treatment of neovascular retinal diseases.
The Company's objective is to build a sustainable biotechnology company by repeatedly identifying differentiated innovation, advancing it efficiently, and bringing novel therapies to patients through the development, partnering, or commercialization path best suited to each opportunity.
For more information, please visit 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,” “look forward to,” 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, regulatory strategy and designations, including Fast Track Designation, plans, results, safety and efficacy for givastomig, VIS-101 and its other drug candidates; the strategic and clinical development of NovaBridge’s drug candidates, including givastomig, VIS-101, ragistomig, and uliledlimab; anticipated clinical milestones and results, and related timing. 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 or eligibility for accelerated approval pathway or receipt of accelerated approval; the content and timing of decisions made by the relevant regulatory authorities, including the FDA, 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; the impact of macroeconomic conditions, including inflation, tariffs, volatile interest rates, regulatory uncertainty, potential government shutdowns, volatility in the capital markets, and regional and other global events, including ongoing armed conflicts in different regions of the world; 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 7, 2026, and amended on June 16, 2026, 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
Investors:
Bill Begien, SVP, Investor Relations
+1-240-745-6330
[email protected]
[email protected]
Media Inquiries:
Eric Van Zanten, VP, Communications
+1-610-529-6219
[email protected]