Market Alert: Nuvectis Pharma reports promising data for NXP800 in Phase 1b; Advancing Towards Higher Dose Cohort

November 14, 2024 at 08:00 AM EST

TL;DR: Nuvectis Pharma’s interim data on NXP800 shows stable disease and some tumor shrinkage in platinum-resistant ovarian cancer, even at a reduced dose. An intermittent dosing schedule adopted effectively managed thrombocytopenia, enabling safe study progress, a key milestone. A higher dose cohort is underway, with data expected by Q2 2025. Nuvectis’s NXP900 also shows promise in targeting resistance in NSCLC. (NASDAQ: NVCT)

Nuvectis Pharma (NASDAQ: NVCT) has shared promising interim data from its Phase 1b study of NXP800, a drug candidate for treating platinum-resistant, ARID1a-mutated ovarian cancer. This patient population faces limited treatment options, and any indication of tumor stability or reduction is significant. The latest results reveal that NXP800, as a single-agent therapy, has led to stable disease in six patients and an unconfirmed partial response in one patient, which includes some cases of tumor shrinkage. These findings indicate that NXP800's effect even at a reduced dose, pointing to its potential as a potential therapeutic option in this challenging cancer subtype.

Managing safety has been a key focus for Nuvectis as it advances NXP800. Early in the trial, Nuvectis reported that some patients experienced severe thrombocytopenia, a condition marked by low platelet counts that can lead to bleeding risks. To address this, the company introduced an intermittent dosing schedule of 50 mg per day with a “five days on, two days off” regimen, which has proven effective at reducing the severity of thrombocytopenia from Grade 4 to Grade 2. This approach to dosing has enabled Nuvectis to advance the study confidently, balancing efficacy and safety while maintaining anti-tumor activity.

Building on this progress, Nuvectis is now enrolling patients in a new cohort with an increased dose of 75 mg per day, following the same intermittent dosing strategy. This step is likely intended to enhance efficacy by providing greater exposure to NXP800 while preserving tolerability. Data from this expanded cohort are expected by the second quarter of 2025 and could confirm NXP800's potential as a breakthrough therapy for patients with platinum-resistant, ARID1a-mutated ovarian cancer.

In addition to NXP800, Nuvectis’s pipeline includes NXP900, a drug candidate currently in Phase 1a trials that targets SRC/YES1 kinases. NXP900 has shown synergy with ALK inhibitors in preclinical studies of non-small cell lung cancer (NSCLC) cell lines that have developed resistance to standard ALK therapies such as alectinib and lorlatinib. By targeting SRC and YES1 pathways, NXP900 tackles a mechanism that cancer cells often use to evade treatment, providing a potential solution for patients with few remaining options. This mechanism positions NXP900 as a potential combination therapy with ALK inhibitors, extending their effectiveness and potentially improving outcomes for patients who have exhausted standard treatment options.

Nuvectis’s strategy with both NXP800 and NXP900 focuses on high-need cancer indications where resistance mechanisms present significant challenges. The company’s approach of targeting specific molecular pathways aligns with an industry shift toward precision oncology, where treatments are designed to address complex resistance patterns. If further data confirm NXP800’s anti-tumor activity and NXP900’s potential in overcoming drug resistance, Nuvectis could see a substantial impact on its market valuation, with both candidates offering hope for patients facing difficult-to-treat cancers.

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Market Alert: Nuvectis Pharma reports promising data for NXP800 in Phase 1b; Advancing Towards Higher Dose Cohort

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