Nanobiotix SA (NASDAQ:NBTX) announced new results focused on patients with primary cutaneous melanoma from an ongoing Phase 1 Study.
1100 evaluating JNJ-1900 (NBTXR3) in combination with immune checkpoint inhibitors (pembrolizumab or nivolumab) for advanced cancer patients.
All 21 patients with primary cutaneous melanoma had shown prior resistance to anti-PD-1, and treatment with RT-activated JNJ-1900 (NBTXR3), followed by anti-PD-1, showed a favorable safety profile:
Nanobiotix confirmed injection feasibility at the recommended Phase 2 dose (33% gross tumor volume or GTV).
In total, 16 patients experienced grade 1, grade 2, or grade 3+ TEAEs related to the overall therapeutic regimen.
Early Signs of Efficacy
- JNJ-1900 (NBTXR3) demonstrated preliminary signals of efficacy in 19 patients who were evaluable for tumor response:
- A best observed objective response rate (ORR) in all lesions of 47.4% (9/19), including four complete responses and five partial responses
- A best observed disease control rate (DCR) in all lesions of 78.9% (15/19).
- In JNJ-1900-injected & irradiated tumors, a DCR of 100% (19/19) was observed.
- A median Overall Survival (mOS) of 14.6 months in all patients treated (n=21).
A relationship was observed between the depth of local response and systemic tumor regression, suggesting a possible priming or reactivation of the immune response.
In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson (NYSE:JNJ) company.
Price Action: NBTX stock is up 22.03% at $12.45 at the last check on Thursday.
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