Nuvectis Pharma Announces Positive Data for NXP800 in a Preclinical Model of ARID1a-Mutated Gastric Carcinoma

Rhea-AI Summary

Nuvectis Pharma announced promising preclinical results for NXP800, targeting ARID1a-mutated gastric carcinoma. Following successful outcomes in ovarian carcinoma models, the company is optimistic about expanding NXP800's development to gastric cancer, which affects 20-25% of the 26,000 annual U.S. diagnoses. The current prognosis for gastric cancer is poor, with a 5-year survival rate of just 32%. Nuvectis is on track with the Phase 1a study and anticipates beginning Phase 1b in Q1 2023.

Positive

• Promising preclinical results for NXP800 in ARID1a-mutated gastric carcinoma.
• Potential expansion of NXP800's development into a new therapeutic area.
• Progressing Phase 1a study with expectations to start Phase 1b in Q1 2023.

Negative

• Gastric cancer has a poor prognosis with a 5-year survival rate of only 32%.
• Limited treatment options exist for patients with advanced gastric cancer.

FORT LEE, N.J., Sept. 13, 2022 (GLOBE NEWSWIRE) -- 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 need in oncology, today announced positive data for NXP800 in a preclinical xenograft model of ARID1a-mutated gastric carcinoma.

“Following the strong preclinical proof of concept in ARID1a-mutated ovarian carcinoma models, we are very pleased with this new preclinical data for NXP800 in ARID1a-mutated gastric cancer, potentially expanding the development opportunity for NXP800 to an additional therapeutic area with a clear unmet need,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur continued, “Out of approximately 26,000 people that receive a diagnosis of gastric cancer annually in the United States, it is estimated that about 20-25% have ARID1a-mutated tumors. Gastric cancer has a very poor prognosis with a 5-year survival rate limited to 32%. The NXP800 Phase 1a dose escalation study is progressing as planned and we expect to begin the Phase 1b portion of the study in Q1 2023.”

Key Results

• The study was conducted in a mouse model of ARID1a-mutated gastric cancer (SNU-1).
• Mice in each group were treated with either vehicle or NXP800 and tumor volumes were measured over 28 days.
• Treatment with NX800 resulted in tumor regression and substantial tumor growth inhibition versus the control.
  

About Gastric Cancer

Gastric cancer is the second most common cause of cancer death worldwide. The American Cancer Society estimates that there will be 26,380 new cases in the U.S. in 2022, with most patients having advanced, non-resectable disease at the time of presentation. There is no universal standard therapy for patients with metastatic and unresectable disease, and treatments aimed at controlling tumor growth, symptom palliation and prolongation of survival include chemotherapy and chemotherapy-based regimens with immunotherapy or with radiation therapy. For patients whose cancers are HER2-positive, a HER2-targeted agent can be added to the treatment regimen. ARID1a mutation is detected in approximately 20-25% of cases of gastric cancer.

About Nuvectis

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 studies.

For more information, please visit www.nuvectis.com.

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, and other factors that are difficult to predict and include statements regarding the preclinical data generated to date, including the preclinical data in gastric carcinoma discussed in this press release, and the preclinical and clinical expectations for NXP800 and NXP900 including NXP800's potential ability to become a therapeutic option for the treatment of ovarian and gastric carcinomas for patients with the ARID1a mutation. 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 2021 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 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.

Nuvectis Pharma Contact:
Ron Bentsur
Chairman, Chief Executive Officer and President
rbentsur@nuvectis.com

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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ccaf8a60-071e-4da1-b3c8-446d1ea3855f

FAQ

What are the recent developments for Nuvectis Pharma (NVCT) regarding NXP800?

Nuvectis announced positive preclinical data for NXP800, showing potential efficacy in treating ARID1a-mutated gastric carcinoma.

When does Nuvectis expect to start the Phase 1b study for NXP800?

Nuvectis anticipates beginning the Phase 1b portion of the NXP800 study in Q1 2023.

What is the survival rate for gastric cancer patients according to Nuvectis's press release?

The 5-year survival rate for gastric cancer patients is reported to be only 32%.

How many people are diagnosed with gastric cancer annually in the U.S.?

Approximately 26,000 people are diagnosed with gastric cancer each year in the United States.

What is the significance of ARID1a mutations in gastric cancer?

ARID1a mutations are present in about 20-25% of gastric cancer cases, representing a target for NXP800.