Shares of NovaBridge Biosciences (NASDAQ: NBP) experienced volatility Tuesday after the company unveiled updated outcomes from its ongoing Phase 1b clinical study. Initially advancing during the trading session, the stock ultimately retreated to trade below previous levels by market close.
The trial centers on evaluating the safety and efficacy of givastomig combined with nivolumab and chemotherapy regimen mFOLFOX6 for individuals diagnosed with HER2-negative metastatic gastric cancer as a first-line treatment.
Clinical Findings Provide Optimistic Signals
NovaBridge reported a notable overall response rate (ORR) of 77% in patients receiving an 8 mg/kg dose of givastomig. Meanwhile, participants administered 12 mg/kg achieved an ORR of 73%. These response metrics were consistently observed across diverse expression levels of the molecular markers CLDN18.2 and PD-L1, which play roles in tumor biology and immune interactions.
In terms of progression-free survival (PFS), the median duration for the 8 mg/kg cohort was 16.9 months. Data on PFS for the higher 12 mg/kg dose remains immature due to shorter patient follow-up times, reflecting ongoing nature of the study.
Additionally, landmark analysis of PFS at six months demonstrated rates of 73% for the lower dose and 91% for the higher dose group. The combination therapy was generally well tolerated, with a safety profile comparable to current standard-of-care treatments. Notably, immune-related gastritis was reported in some patients and appeared to correlate with more favorable clinical outcomes.
Future Trial Plans and Upcoming Data Presentations
Building on these findings, NovaBridge intends to initiate a global, randomized Phase 2 trial comparing both the 8 mg/kg and 12 mg/kg givastomig doses against standard treatment options. This study is slated to commence in the first quarter of 2026.
Moreover, detailed results from the Phase 1b dose expansion cohort are expected to be shared at a forthcoming medical conference later in 2026, potentially providing deeper insights into efficacy and safety parameters.
Market Response and Stock Performance
Despite the encouraging clinical update, investor enthusiasm appeared mixed. After an initial uptick, NovaBridge shares reversed course and ended Tuesday's trading session down by 8.01%, settling at $4.02 per share, as per Benzinga Pro data.
Key Points
- NovaBridge unveiled positive efficacy and safety data from a Phase 1b trial of givastomig combined with nivolumab and chemotherapy in HER2-negative metastatic gastric cancer.
- Response rates were 77% at 8 mg/kg and 73% at 12 mg/kg doses, with progression-free survival reaching a median of 16.9 months in the lower dose cohort.
- The combination therapy was generally tolerated well, with immune-related gastritis linked to improved outcomes.
- The company plans a global randomized Phase 2 study expected to start in early 2026 and aims to present comprehensive Phase 1b expansion data later that year.
Risks and Uncertainties
- Progression-free survival data for the 12 mg/kg group remains immature, limiting full assessment of longer-term efficacy at this higher dose.
- The trial's Phase 2 study initiation is planned but not yet commenced, subject to regulatory and operational factors.
- Market reaction indicates potential caution among investors despite promising clinical data, which may impact near-term stock volatility.
- Immune-related gastritis, while possibly correlated with better outcomes, represents a notable adverse event that requires ongoing monitoring for safety implications.