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PARIS and CAMBRIDGE, Mass. - Nanobiotix (NBTX), a late-stage clinical biotechnology company with a market capitalization of approximately $169 million, has announced preliminary results from a Phase 1 study of its product NBTXR3, also known as JNJ-1900, for the treatment of non-small cell lung cancer (NSCLC). According to InvestingPro data, the company maintains a strong balance sheet, holding more cash than debt, which provides financial flexibility for its clinical development programs. The study, sponsored by The University of Texas MD Anderson Cancer Center, showed favorable safety and efficacy in patients with locally advanced NSCLC amenable to re-irradiation.
The completed dose escalation part of the study involved 12 patients whose previous therapies had failed. The results indicated no dose-limiting toxicities and no serious adverse events related to NBTXR3 at grade 3 or higher. The recommended phase 2 dose was established at 33% of gross tumor volume. While the clinical results are promising, InvestingPro analysis indicates analysts anticipate a sales decline in the current year, though the company maintains a "GOOD" overall financial health score.
A preliminary review of survival data revealed a 12-month local progression-free survival (LPFS) rate of 64% and a 12-month overall survival (OS) rate of 83%. These findings suggest that NBTXR3 could potentially offer a new therapeutic option for NSCLC patients who have exhausted other treatments.
Dr. Saumil Gandhi from MD Anderson noted the importance of innovative therapies for patients with limited options, highlighting the potential of NBTXR3 to improve patient outcomes. The expansion phase of the study is currently in progress, with 5 out of 12 patients already receiving injections.
NBTXR3, composed of functionalized hafnium oxide nanoparticles, is administered via a one-time intratumoral injection and activated by radiotherapy. This approach is designed to cause significant tumor cell death when activated, potentially triggering an adaptive immune response.
The product has already received a European CE mark for soft tissue sarcomas and is being evaluated across various solid tumor indications. In 2020, the U.S. Food and Drug Administration granted NBTXR3 a Fast Track designation for the treatment of certain head and neck cancers.
This announcement is based on a press release statement by Nanobiotix, which has entered into a clinical research collaboration with MD Anderson and a license agreement with Janssen Pharmaceutica NV for the co-development and commercialization of NBTXR3. The stock, currently trading at $3.56, is considered undervalued according to InvestingPro’s Fair Value analysis. Investors seeking deeper insights can access the comprehensive Pro Research Report, which provides detailed analysis of Nanobiotix’s financial health, market position, and growth prospects among 1,400+ top stocks covered by InvestingPro’s expert analysts.
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