The Phase 1 Study Will be Comprised of Two Parts: Phase 1a Dose-escalation that will Evaluate the Safety and Tolerability of NXP800 in Patients with Advanced Solid Tumors, Followed by a Phase 1b to Evaluate Preliminary Efficacy in Specific Populations

Fort Lee, NJ, USA I December 31, 2021 I Nuvectis Pharma, Inc. (“Nuvectis”, “Company”), a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical needs in oncology, today announced the initiation of a Phase 1 clinical trial of NXP800, a novel Heat Shock Factor 1 (HSF1)-pathway inhibitor.

The HSF1 pathway is implicated in cancer cell growth, metastasis, and survival across several types of cancer. In preclinical studies, NXP800 demonstrated potent anti-proliferative activity against a variety of cancer cell lines, and inhibited tumor growth in ARID1a-mutated ovarian clear cell carcinoma and endometrioid carcinoma human xenograft models. NXP800 will be further evaluated in-vivo in additional tumor types, including in additional ARID1a-mutated tumors. NXP800 has the potential to become a first-in-class inhibitor of the HSF1 pathway.

The Phase 1 clinical trial will have two parts: dose-escalation (Phase 1a) and expansion (Phase 1b). In the Phase 1a, the safety and tolerability of NXP800 will be evaluated in patients with advanced solid tumors to identify a dose and dosing schedule for the Phase 1b. In the Phase 1b, the safety and preliminary anti-tumor activity of NXP800 will be evaluated in biomarker-selected patients, initially in ovarian clear cell carcinoma and endometrioid carcinoma. The Phase 1a will be conducted in the U.K. and the Phase 1b is expected to be conducted in the U.S. and the U.K.

Professor Udai Banerji, Chief Investigator of the trial and Deputy Director of Drug Development at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, said: “We have been following the pre-clinical development of NXP800, a first-in-class drug candidate discovered at the Institute of Cancer Research and now being developed by Nuvectis. We look forward to gaining an understanding on the safety, dose and schedule of administration of NXP800 to unlock its therapeutic potential in specific hard-to-treat cancers where new treatments are needed.”

“We are pleased to have achieved this important milestone in the NXP800 development program” said Ron Bentsur, Co-Founder, Chairman and Chief Executive Officer of Nuvectis. “NXP800 has demonstrated great promise in preclinical studies, and we’re excited to advance it into clinical trials.”

Nuvectis licensed exclusive worldwide rights to develop and commercialize the drug candidate NXP800, a novel, oral small-molecule inhibitor of the HSF1 pathway, from the CRT Pioneer Fund LP – a specialist oncology investment fund managed by U.K.-based fund manager Sixth Element Capital. The drug candidate was discovered in the Cancer Research UK Cancer Therapeutics Unit at The Institute for Cancer Research, London, U.K.

About Nuvectis Pharma

Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical needs in oncology. The Company’s pipeline includes NXP800, a clinical-stage HSF1-pathway inhibitor, and NXP900, a SRC/YES1 kinase inhibitor in IND-enabling pre-clinical testing.

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SOURCE: Nuvectis Pharma