Fort Lee, New Jersey — Nuvectis Pharma, Inc. (NASDAQ:NVCT) (“Nuvectis” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, today provided highlights from the oral presentation of positive, expanded data from the Phase 1b study for NXP200, a second-generation, paradox-breaker BRAF inhibitor, in patients with recurrent or progressive BRAF V600-mutated gliomas at the 2026 European Society for Medical Oncology (ESMO) Congress taking place in Madrid, Spain.
Oral Presentation Highlights
- As of the May 4, 2026 cutoff, 27 efficacy-evaluable patients with recurrent or progressive BRAF V600 glioma were treated with NXP200 monotherapy, including 20 patients with high-grade glioma and 7 with low-grade glioma.
- Treatment with NXP200 resulted in an ORR of 40.0% in the high-grade glioma cohort, including 3 CRs (one preliminary CR) and 42.9%, including one confirmed CR, in the low-grade glioma cohort; responses were assessed based on RANO 2.0 criteria.
- Deep responses (>80% tumor burden reduction) were achieved in 87.5% (7/8) of responders with high-grade glioma and 66.7% (2/3) of responders with low-grade glioma. Notably, among the three patients previously treated with a BRAF inhibitor, two achieved a partial response and one had stable disease. 81.5% (22/27) of patients achieved tumor reduction and the Disease Control Rate (ORR plus SD) was 85.2% (23/27).
- In patients with high-grade glioma, the median duration of response was 6.97 months, and the median overall survival was 17.15 months; in patients with low-grade glioma, the median duration of response and overall survival had not been reached. 12-month survival was 95% and 100% in the high-grade and low-grade glioma cohorts, respectively.
- Among 28 safety-evaluable patients, 14.3% experienced a Grade 3 or higher treatment-related adverse event. One serious adverse event (SAE) was reported (intracranial pressure increased), which was not related to treatment. No treatment-related adverse event resulted in treatment discontinuation or death.
- The Phase 1b study is being conducted by Haisco Pharmaceutical Group in China. In June 2026, Nuvectis in-licensed exclusive worldwide, ex-Greater China rights to NXP200 from Haisco.
- In September 2026, NXP200 was granted Breakthrough Therapy Designation for the treatment of patients with BRAF V600-mutated, recurrent or progressive high-grade glioma by China’s Center for Drug Evaluation (CDE). In April 2026, the project was officially selected as a pilot project under the “Pediatric Anti-tumor Drug R&D Encouragement Pilot Scheme (Starlight Program)” for the indication of pediatric BRAF V600-mutated recurrent or progressive glioma by CDE.
- The presentation is available on Nuvectis’ website at www.nuvectis.com.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “We congratulate our partner Haisco on these robust results with NXP200. The rate and durability of the responses reported with single-agent NXP200 in patients with recurrent or progressive gliomas are very encouraging, given the depth of the observed responses, which include CRs and PRs with >80% tumor burden reduction, together with the ability to induce responses in patients previously treated with a BRAF inhibitor while maintaining a manageable safety profile. We are excited about the emerging clinical profile of NXP200, which demonstrates the potential of NXP200 to become a differentiated, best-in-class, second-generation, paradox-breaker BRAF inhibitor. We look forward to further updates from the ongoing Phase 1b program, including in additional tumor types, and we remain on track to submit a U.S. IND for NXP200 by the end of this year.”
About NXP200
NXP200 is an oral paradox-breaking (second generation) BRAF inhibitor designed to block the BRAF pathway without triggering paradoxical activation that is seen with first-generation BRAF inhibitors. To date, NXP200 has demonstrated single-agent clinical activity, including in heavily pre-treated patients as well as in patients previously treated with BRAF inhibitors, against progressive gliomas and other tumor types including non-small cell lung, colorectal and papillary thyroid cancers.
About Nuvectis Pharma, Inc.
Nuvectis Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology. The Company’s pipeline includes ciprocopan (NXP100), a complement Factor B inhibitor in development for the treatment of complement-mediated diseases, and the oncology drug candidates NXP200 and NXP900, in development for the treatment of advanced cancers.
The company’s lead drug candidate is NXP100 (ciprocopan), a once-a-day Factor B inhibitor, with best-in-class potential, recently approved in China for the treatment of PNH patients previously untreated with complement inhibitors.
NXP200 is an oral, brain-penetrant, paradox-breaker BRAF inhibitor for the treatment of BRAF V600X-mutated and Class II/III non-V600-mutated solid tumor malignancies, with best-in-class potential.
NXP900 is an oral small molecule inhibitor of the SRC family kinases, including SRC and YES1.
For more information visit https://nuvectis.com/.
Company Contact
Ron Bentsur
Chairman, Chief Executive Officer and President
Media Relations Contact
Kevin Gardner
LifeSci Advisors