Nuvectis Pharma Recaps Poster Presentation Highlights for NXP800 at the 2023 ESMO Gynecological Cancers Congress

Rhea-AI Summary

Nuvectis Pharma (NASDAQ: NVCT) announced promising results for its drug candidate NXP800 at the ESMO Gynecological Cancers Congress. In two in vivo xenograft models of ARID1a-mutated ovarian carcinoma, NXP800 demonstrated significant tumor growth inhibition (TGI) of 70% and 82%, outperforming cisplatin's TGI of 42% and 20%, respectively.

Dr. Susana Banerjee highlighted the urgent need for new therapies for ovarian cancer patients, particularly those with ARID1a mutations, which are linked to poor outcomes. NXP800 is set to enter a Phase 1b clinical trial, following its Fast Track Designation from the FDA for treating platinum-resistant ovarian carcinoma.

Positive

• NXP800 showed 70% and 82% tumor growth inhibition in two in vivo models, surpassing cisplatin's performance.
• The drug candidate is entering Phase 1b clinical trials, indicating progress in development.
• NXP800 received Fast Track Designation from the FDA for platinum-resistant, ARID1a-mutated ovarian carcinoma.

Negative

• None.

Treatment with NXP800 resulted in substantial tumor growth inhibition in two in vivo xenograft models of ARID1a-mutated ovarian carcinoma, superior to treatment with cisplatin

Fort Lee, N.J., Feb. 23, 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 provided highlights from the poster presentation that took place earlier today at the European Society for Medical Oncology (“ESMO”) Gynecological Cancers Congress. Two in vivo experiments in models of ARID1a-mutated ovarian carcinoma resulted in robust tumor growth inhibition (“TGI”) by NXP800 (70% in one model and 82% in the second model, including tumor regression in both models, versus 42% and 20% TGI with cisplatin with no tumor regression).

Susana Banerjee, MBBA MA PhD, the Global Lead for the NXP800/ENGOTGYN5/GOG-3087 Phase 1b clinical trial in platinum resistant, ARID1a-mutated ovarian carcinoma and last author on the poster, commented: “There is a great need for new treatment options for women with ovarian cancer. We have known for a long time that ovarian cancer is a general term encompassing several diseases with different histologic and genetic characteristics that impact our patients’ likelihood to respond to standard of care chemotherapy and their overall prognosis. Our poster today showed the activity of NXP800 in two xenograft models of ARID1a-mutated ovarian carcinoma, a genetically defined subset of ovarian cancer. In patients with ovarian cancer, mutated ARID1a is mostly found in clear cell and endometrioid carcinomas, two diseases that are associated with poor outcomes in the platinum-resistant setting. I am excited about the Phase 1b clinical trial that is about to commence, given the clear need for new therapies for our patients and the potential of NXP800 in these disease settings.”

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 currently in a Phase 1 study in patients with advanced solid tumors. NXP800 was granted Fast Track Designation by the United States Food and Drug Administration for the treatment of platinum-resistant, ARID1a-mutated, ovarian carcinoma. NXP900 is a novel, small molecule SRC/YES1 kinase inhibitor with an IND submission 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, and other factors that are difficult to predict and include any statements regarding preclinical and clinical data,  and clinical expectations for NXP800, including the timing for the completion of the Phase 1a study and commencement of the Phase 1b study, as well as statements regarding NXP800's potential ability to become a therapeutic option for the treatment of ARID1a-mutated ovarian carcinoma. 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 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 and CEO
Nuvectis Pharma, Inc.
rbentsur@nuvectis.com

IR Contact

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

FAQ

What were the results of Nuvectis Pharma's NXP800 in recent trials?

NXP800 achieved 70% and 82% tumor growth inhibition in two in vivo xenograft models of ARID1a-mutated ovarian carcinoma.

When is the Phase 1b clinical trial for NXP800 expected to commence?

The Phase 1b clinical trial for NXP800 is set to commence soon, following promising preclinical results.

What designation did NXP800 receive from the FDA?

NXP800 was granted Fast Track Designation by the FDA for treating platinum-resistant, ARID1a-mutated ovarian carcinoma.

How does NXP800 compare to cisplatin in effectiveness?

NXP800 outperformed cisplatin, achieving significantly higher tumor growth inhibition in clinical models.