Nuvectis Pharma, Inc. is a preclinical stage biopharmaceutical company. It focuses on the development of novel targeted small molecule therapeutics for the treatment of cancer in genetically defined patient populations. Its product pipeline includes NXP800 and NXP900. The company was founded by Ron Bentsur, Enrique Poradosu and Shay Shemesh on July 27, 2020 and is headquartered in Fort Lee, NJ.
Clinical Trials
4
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2020
Recruiting
3
75.0%
Terminated
1
25.0%
No approval data available
- China's Center for Drug Evaluation granted Breakthrough Therapy Designation to Nuvectis and Haisco's oral, brain-penetrant BRAF inhibitor NXP200 for BRAF V600-mutant recurrent or progressive high-grade glioma. - The designation follows a completed dose-escalation study in which single-agent NXP200 produced responses in more than 40% of heavily pretreated adult low- and high-grade glioma patients, including one complete response. - NXP200 is designed as a paradox-breaker that shuts down the BRAF pathway without the paradoxical reactivation that limits first-generation BRAF inhibitors and drives resistance to them. - The FDA granted Breakthrough Therapy Designation in April to FORE Biotherapeutics' plixorafenib, another brain-penetrant paradox-breaking BRAF inhibitor, for adults with BRAF V600E-mutated high-grade glioma.
- Nuvectis Pharma secured exclusive ex-China rights from Haisco Pharmaceutical Group for NXP100, a once-daily oral Complement Factor B inhibitor, and NXP200, a paradox-breaker BRAF inhibitor. - Two Marketing Authorization Applications for NXP100 in paroxysmal nocturnal hemoglobinuria are under NMPA review, with Phase 3 data showing superiority over eculizumab (59.5% vs 8.3% response rate, p<0.001). - NXP200 demonstrated single-agent durable responses across multiple BRAF-mutated solid tumors including a >40% response rate in glioma, positioning it as a potential best-in-class next-generation BRAF inhibitor. - The deal includes up to $40 million in upfront and near-term payments, with up to $1.421 billion in total milestone payments plus tiered royalties on future net sales.
- Nuvectis Pharma has initiated a Phase 1b study evaluating NXP900 in combination with osimertinib for patients with EGFR-mutated non-small cell lung cancer who developed resistance to osimertinib treatment. - NXP900 is an oral small molecule inhibitor targeting SRC and YES1 kinases, pathways known to drive resistance to EGFR inhibitor therapy in EGFR-mutated NSCLC patients. - The combination study targets patients with unresectable, metastatic or locally advanced EGFR-mutated NSCLC who previously responded to osimertinib but subsequently acquired resistance. - The company expects multiple data readouts from both single agent and combination studies throughout 2026, marking a significant milestone in their clinical development program.
- Nuvectis Pharma will showcase five presentations on their novel SRC/YES1 inhibitor NXP900 at the 2025 AACR Meeting in Chicago from April 25-30, highlighting its potential in multiple cancer types. - The presentations will feature first-in-human Phase 1 trial data and preclinical evidence of NXP900's efficacy in overcoming resistance in NSCLC, blocking YAP1 signaling, and treating endocrine-resistant breast cancer. - NXP900's unique mechanism inhibits both catalytic and scaffolding functions of SRC kinase, providing complete shutdown of the signaling pathway in a Phase 1a dose escalation study.
- Nuvectis Pharma's NXP800 demonstrates antitumor activity in a Phase 1b study for ARID1a-mutated ovarian cancer resistant to platinum-based chemotherapy. - The FDA granted Fast Track and Orphan Drug Designations to NXP800 for ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers. - Nuvectis Pharma is also advancing NXP900, targeting the SRC Family of Kinases, with clinical data expected in the second quarter of 2025.
- Nuvectis Pharma reported a net loss of $4.2 million for the quarter ended September 30, 2024, a decrease of $1.7 million compared to the same period in 2023. - The Phase 1b expansion phase of NXP800, targeting ARID1a-mutated ovarian carcinoma, is evaluating safety and preliminary anti-tumor activity. - NXP900, a SRC/YES1 kinase inhibitor, is currently in a Phase 1 study for advanced solid tumors after its IND was cleared by the FDA in May 2023. - The company's cash and cash equivalents totaled $17.2 million as of September 30, 2024, expected to fund operations for at least 12 months.
