Nuvectis Pharma Announces Initiation of the Phase 1b Study for NXP800 in Platinum-Resistant, ARID1a-Mutated Ovarian Carcinoma

Fort Lee, NJ, April 10, 2023 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced the initiation of the Phase 1b study for NXP800 in platinum-resistant, ARID1a-mutated ovarian carcinoma.

The Phase 1b study is a multicenter, single-agent, open-label clinical trial of NXP800 in patients with platinum-resistant, ARID1a-mutated ovarian cancer, a tumor type that is comprised almost exclusively of ovarian clear-cell carcinoma (“OCCC”) and ovarian endometrioid carcinoma (“OEC”). The study will examine the safety, tolerability and preliminary efficacy of NXP800 in this target patient population. The study will enroll two cohorts of up to approximately 25 patients each and will evaluate two dosing regimens, 50 mg and 75 mg, administered once daily, selected based on data from the Phase 1a dose escalation study in patients with various types of advanced solid tumors.

The study will be conducted in 25-30 sites in the United States (“U.S.”), United Kingdom (“UK”) and Europe in collaboration with the European Network of Gynaecological Oncological Trial Groups and the GOG Foundation, Inc., recognized as the world's premier gynecology oncology clinical trials consortia. The NXP800 development program in platinum-resistant, ARID1a-mutated ovarian cancer was granted Fast Track Designation by the U.S. Food and Drug Administration (“FDA”).

“We are excited to announce the initiation of the Phase 1b study in which NXP800 will be tested, for the first time, in patients with a target disease,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. “The robust preclinical anti-tumor activity of NXP800, coupled with the data from the Phase 1a dose escalation study, led to the design of the Phase 1b study, including the definition of the patient population and selection of doses and dosing schedules.” Mr. Bentsur concluded, “Based on the totality of the data generated to date, we believe that NXP800 has the potential to become an effective treatment for patients with platinum-resistant, ARID1a-mutated ovarian carcinoma, as well as additional target tumor types, which we plan to also investigate in the near term."

About NXP800

NXP800 is an oral, small molecule inhibitor of the HSF1 pathway. NXP800 has demonstrated robust anti-tumor activity in xenograft models of ARID1a-mutated ovarian carcinoma and other disease models.

The NXP800 development program in platinum-resistant, ARID1a-mutated ovarian carcinoma was granted Fast Track Designation by the U.S. FDA. Nuvectis licensed exclusive world-wide rights to NXP800 from the Institute of Cancer Research in London, UK.

Phase 1a Data Highlights

• The NXP800 Phase 1a study is the first-in-human clinical trial with NXP800, in patients with various types of non-target, advanced solid tumors. As of April 2023, 18 patients have received at least one dose of NXP800, and the longest treatment duration is 10 months (treatment ongoing).
• The clinical profile of NXP800 that emerged from the Phase 1a study is consistent with the expectations from the preclinical experiments. The study evaluated two different dosing schedules: once per day (using total daily doses of 50 mg to 150 mg) and twice per day (using total daily doses of 100 mg and 150 mg).
• The most common treatment emergent adverse events were vomiting, nausea, diarrhea, fatigue, decreased appetite and weight decrease; guidelines for the management of vomiting, nausea, and diarrhea based on standard medicines have been developed and implemented. Common lab abnormalities included transient changes in platelets, liver enzymes and red blood cells, which had no clinical consequences. No drug-related Grade 4 or Grade 5 events have been reported.
• The doses for the Phase 1b study, 50 and 75 mg per day, were chosen based on preliminary population pharmacokinetics and pharmacodynamic analyses indicating that once daily oral administration of NXP800 at these doses achieved exposure levels considered biologically active while providing for an acceptable safety and tolerability profile.
• Nuvectis plans to share the detailed results from the Phase 1a study at a future scientific conference.

About Platinum-Resistant, ARID1a-Mutated Ovarian Carcinoma

ARID1a-mutated ovarian carcinoma is comprised almost exclusively of two histologies, OCCC and OEC, each representing about 10% of the overall ovarian cancer cases in the U.S. with an annual incidence of approximately 2,200 patients per histology. Platinum resistant ovarian carcinoma is recognized as a serious condition of unmet medical need, given the lack of effective treatments and the poor patient prognosis in this setting. It is estimated that approximately 66% of patients with OCCC and 40% of patients with OEC have the ARID1a mutation, supporting the potential opportunity for the use of NXP800 as a new therapeutic option.

About Nuvectis Pharma, Inc.

Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two drug candidates, NXP800 and NXP900. NXP800 is a clinical-stage, oral small molecule under development for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma and additional solid tumor types. The FDA granted Fast Track Designation to NXP800 for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma. NXP900 is a novel, small molecule SRC/YES1 kinase inhibitor with an Investigational New Drug (“IND”) application pending.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict and include statements regarding the preclinical data generated to date for NXP800 and NXP900, the Phase 1a data generated and the Phase 1b clinical expectations for NXP800, including the safety, tolerability and other observations from the NXP800 Phase 1a study and timing, and safety and efficacy data from the NXP800 Phase 1b study, including statements regarding NXP800's potential ability to become a therapeutic option for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma and potentially other cancer indications, and timing for the IND submission and commencement of the Phase 1 program for NXP900. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are subject to market and other conditions and described more fully in the section titled "Risk Factors" in the 2022 Form 10-K filed with the Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Company Contact

Ron Bentsur
Chairman, Chief Executive Officer and President
Tel: 201-614-3151
rbentsur@nuvectis.com

Media Relations Contact

Christopher M. Calabrese
LifeSci Advisors
Tel: 917-680-5608
ccalabrese@lifesciadvisors.com