Nuvectis Pharma, Inc. Announces a Collaboration with Mayo Clinic to Evaluate NXP800 in an Investigator-Sponsored Clinical Trial in Cholangiocarcinoma

Rhea-AI Summary

Nuvectis Pharma, a clinical-stage biopharmaceutical company (NASDAQ: NVCT), collaborates with Mayo Clinic to evaluate NXP800 in an Investigator-sponsored clinical trial for cholangiocarcinoma. Mitesh Borad, M.D., will serve as the Principal Investigator. NXP800 was granted orphan drug designation by the FDA for the treatment of cholangiocarcinoma in August 2023.

• Mitesh Borad, M.D., will serve as the Principal Investigator for the clinical trial
• The Investigator-sponsored clinical trial follows the robust preclinical proof of concept data generated by investigators from Mayo Clinic in PDX models of cholangiocarcinoma (presented at the 2023 American Association for Cancer Research ("AACR"))
• NXP800 was granted orphan drug designation by the FDA for the treatment of cholangiocarcinoma in August 2023

Fort Lee, NJ, Dec. 18, 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 a collaboration with Mayo Clinic to evaluate NXP800 in an Investigator-sponsored clinical trial in cholangiocarcinoma. Mitesh Borad, M.D., an oncologist at Mayo Clinic Comprehensive Cancer Center in Arizona, will serve as the principal investigator for the trial.

"We are honored to announce this collaboration with Mayo Clinic," said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. "Similar to platinum resistant, ARID1a-mutated ovarian cancer, this clinical development program in cholangiocarcinoma represents another opportunity for NXP800 in a serious condition of unmet medical need and we are very hopeful that the robust activity seen in the cholangiocarcinoma PDX models will be translated into clinical activity in humans."

About Cholangiocarcinoma

Cholangiocarcinoma is a cancer of the biliary tract originating in the epithelium of the biliary tree accounting for approximately 3% of all gastrointestinal malignancies, with an annual incidence of approximately 8,000 – 10,000 in the United States. Surgical resection is the only potentially curative treatment for cholangiocarcinoma, but the disease is often diagnosed as unresectable because of local extension and/or metastases. While several targeted therapies have been approved in recent years for subsets of patients with cholangiocarcinoma based on specific tumor genetics, the overall prognosis remains poor with 5-year survival rates of 20-50% after resection and almost 0% in unresectable tumors.

About Nuvectis Pharma, Inc.

Nuvectis Pharma, Inc. is 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. The Company is currently developing two drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule currently in a Phase 1b clinical trial investigating its potential to treat platinum resistant, ARID1a-mutated ovarian carcinoma. The FDA 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 an oral small molecule SRC/YES1 kinase family (SFK) inhibitor currently in a Phase 1a dose escalation clinical trial.

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," "set to," 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 and timing of operations, including clinical trials, 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, and the safety and tolerability data from the NXP800 Phase 1a study and the clinical expectations for NXP800 and NXP900, including the safety, tolerability and efficacy from and timing of the NXP800 Phase 1b study in platinum-resistant ARID1a-Mutated Ovarian Cancer and the investigator-sponsored clinical study of NXP800 in cholangiocarcinoma, as well as the NXP900 Phase 1 dose-escalation studies. 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 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
201-614-3151
rbentsur@nuvectis.com

Media Relations Contact

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

FAQ

What is the collaboration between Nuvectis Pharma and Mayo Clinic for?

The collaboration is for the evaluation of NXP800 in an Investigator-sponsored clinical trial for cholangiocarcinoma.

Who will serve as the Principal Investigator for the clinical trial?

Mitesh Borad, M.D., an oncologist at Mayo Clinic Comprehensive Cancer Center in Arizona, will serve as the Principal Investigator.

What is the orphan drug designation granted by the FDA for NXP800?

NXP800 was granted orphan drug designation by the FDA for the treatment of cholangiocarcinoma in August 2023.

What is NXP800?

NXP800 is an innovative precision medicine developed by Nuvectis Pharma for the treatment of serious conditions of unmet medical need in oncology, with a focus on cholangiocarcinoma.