Nuvectis Pharma Announces Encouraging Preliminary Data from the NXP800 Phase 1b Clinical Trial in Platinum-Resistant ARID1a-Mutated Ovarian Cancer

By: Nuvectis Pharma, Inc. via GlobeNewswire

March 14, 2024 at 09:00 AM EDT

33% Response Rate and 100% Disease Control Rate Observed in Patients Evaluated for Efficacy
Complete Response of Non-Target Tumor Also Observed
Platinum-Resistant Ovarian Cancer is a Devastating Serious Condition of Unmet Medical Need with a Median Life Expectancy of Approximately One Year

Fort Lee, NJ, March 14, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) today announced preliminary data from the ongoing Phase 1b clinical trial of NXP800 in patients with platinum resistant ARID1a-mutated ovarian cancer, a deadly disease of unmet medical need. The NXP800 development program in this disease was granted Fast Track Designation by the U.S. Food and Drug Administration (“FDA”). The Phase 1b clinical trial is being conducted in top clinical centers in the United States and the United Kingdom.

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “We are pleased to share the preliminary results from the NXP800 Phase 1b study in the target patient population of platinum resistant, ARID1a-mutated ovarian cancer patients. The clinical activity observed thus far includes a 33% response rate and 100% disease control rate, defined as partial response (“PR”) plus stable disease (“SD”), in patients evaluated for efficacy. While the data presented today is early, we are encouraged by the achievement of a PR as well as a complete response (“CR”) of the non-target lymph node disease in a patient with a progressive malignancy after a surgical resection and two prior lines of systemic combination chemotherapy, and stable disease in patients with similar stage disease. We believe that this provides an important initial signal that NXP800 can potentially be effective in this devastating and difficult to treat cancer.”

Mr. Bentsur continued, “After a cautious start to the study, we are now seeing a ramp up in the number of participating clinical sites, which is already translating into increased rates of patient identification and enrollment. Moreover, similar to what has been done with other classes of potent drugs, dosing management procedures have recently been implemented to better manage the key side effects associated with treatment with NXP800. We believe that we can now make significant progress with this clinical trial and unlock the full potential of NXP800 in this disease setting.”

Preliminary Clinical Data Summary

Encouraging preliminary efficacy data was observed and includes data from the first four patients enrolled in the study, two treated with 75 mg/day and two treated with 50 mg/day. All patients failed at least two prior lines of systemic chemotherapy, including at least one prior platinum-based chemotherapy regimen. Three of the patients also failed prior treatment with bevacizumab (Avastin). Efficacy was evaluated in three of the four patients.

One patient treated with 75 mg/day achieved a PR, unconfirmed, that also included a CR of her non-target lymph node disease. Both patients treated with 50 mg/day achieved SD and the fourth patient was not evaluated for efficacy.

Three of these four patients experienced an adverse event of thrombocytopenia that was Grade 4 in intensity, these events were transient in nature with no concurrent bleeding events reported. Following these events, as mentioned above, a management procedure for the monitoring of platelets and dose adjustments, as necessary, has been implemented with the goal of minimizing dosing interruptions and increasing patient retention. No other ≥ Grade 3 hematological toxicities were reported. In addition, gastrointestinal adverse events were reported in all four patients, all Grade 1-2.

About the Phase 1b Study

The Phase 1b study is a multicenter, single arm, open-label clinical trial of NXP800 in patients with platinum-resistant, ARID1a-mutated ovarian cancer. The study is examining the safety and preliminary efficacy of NXP800 in this target patient population.

The study is being conducted in the US and UK in collaboration with the European Network of Gynecological Oncological Trial Groups and the GOG Foundation, Inc., recognized as the world's leading gynecology oncology clinical trials consortia.

About NXP800

NXP800 is an oral, small molecule, potentially first-in-class GCN2 kinase activator. NXP800 is also being evaluated in an investigator-initiated study conducted in collaboration with the Mayo Clinic for the treatment of cholangiocarcinoma, an indication for which the FDA granted NXP800 Orphan Drug Designation. The NXP800 development program in platinum-resistant, ARID1a-mutated ovarian cancer was granted Fast Track Designation by the FDA. NXP800 completed a Phase 1a dose-escalation study in the first half of 2023.

Nuvectis licensed exclusive world-wide rights to NXP800 from the Institute of Cancer Research in London, UK.

About Platinum-Resistant, ARID1a-Mutated Ovarian Carcinoma

ARID1a-mutated ovarian carcinoma is comprised almost exclusively of two histologies, ovarian clear cell carcinoma (“OCCC”) and ovarian endometrioid carcinoma (“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, with median life expectancy estimated to be approximately one year. It is estimated that approximately 66% of patients with OCCC and 40% of patients with OEC have the ARID1a mutation.

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 an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. The U.S. Food and Drug Administration granted Fast Track Designation to the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma, and Orphan Drug Designation for the treatment of cholangiocarcinoma. NXP900 is a novel, small molecule SRC/YES1 kinase inhibitor currently undergoing a Phase 1a dose escalation study.

Forward Looking Statements

Certain statements in this press release constitute "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 conclusions and interpretation of the Phase 1a data generated for NXP800 and the timing and clinical expectations for 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 cholangiocarcinoma; whether the preliminary safety and efficacy data reported today from the Phase 1b study will translate into data that can lead to the successful completion of the Phase 1b study, whether the dosing management algorithms that include dose modifications to better manage the key side effects associated with treatment with NXP800 that have been implemented will lead to longer treatment periods and better patient retention and whether patient enrollment into the study will be satisfactory and lead to a timely completion of the study. 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 our 2023 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
201-614-3151
rbentsur@nuvectis.com

Media Relations Contact

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