Nuvectis Pharma Announces the Initiation of the Phase 1b Program for NXP900
Rhea-AI Summary
Nuvectis Pharma (NASDAQ: NVCT) has announced the initiation of its Phase 1b program for NXP900, following successful completion of dose escalation and drug-drug interaction studies. The program consists of two components: a single-agent study evaluating NXP900 in patients with specific genetic alterations, and a combination study with EGFR and ALK inhibitors in NSCLC patients who developed treatment resistance.
The single-agent component targets patients with YES1 amplification, FAT1 mutations in NSCLC, NF2 mutations in mesothelioma and renal cancer, and other solid tumors with relevant Hippo Pathway alterations. The combination study, expected to start later in 2025, will focus on NSCLC patients who developed resistance to existing treatments.
Positive
- Successful completion of Phase 1a dose escalation and drug-drug interaction studies
- Company is well-funded to execute NXP900 development plans
- Recent share acquisition by healthcare-specialized institutional investor shows confidence in the program
- NXP900 represents potential 'pipeline in a pill' opportunity addressing multiple cancer types
Negative
- Phase 1b combination study component has not yet started
- Clinical efficacy data still pending from Phase 1b program
News Market Reaction
On the day this news was published, NVCT gained 11.26%, reflecting a significant positive market reaction. Argus tracked a peak move of +6.2% during that session. Our momentum scanner triggered 14 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $18M to the company's valuation, bringing the market cap to $173M at that time.
Data tracked by StockTitan Argus on the day of publication.
- The Phase 1b program is designed to evaluate the clinical activity of NXP900 as a single agent in patients with advanced solid tumors whose cancers harbor specific genetic alterations, and in combination with EGFR and ALK inhibitors in patients with NSCLC whose cancers developed resistance to these treatments
- Nuvectis will hold a conference call tomorrow, Tuesday, August 12 at 8:30 AM ET to discuss the elements of the Phase 1b program and the overall market opportunity for NXP900
Fort Lee, NJ, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), 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 program for NXP900.
NXP900 Phase 1b clinical program
The Phase 1b program was initiated following the successful completion of a dose escalation study in patients with advanced solid tumors and a clinical drug-drug interaction study in healthy volunteer, and is intended to include a single agent component, which is now underway, and a combination component that is expected to commence later this year.
Single agent: We will evaluate patients with specific genetic alterations selected based on their characteristics as either direct (YES1 amplification), or dependent (Hippo Pathway alterations) targets of NXP900, and the tumor types were selected based on the prevalence of the relevant genetic alterations and supporting scientific data. These include:
- YES1 amplified or FAT1 mutated non-small cell lung cancer (NSCLC)
- NF2 mutated mesothelioma and renal cancer
- Other advanced solid tumors with any of the genetic alterations mentioned above or other relevant Hippo Pathway alterations
Combination: We plan to evaluate NXP900 in combination with market-leading epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors for the treatment of non-small cell lung cancer, in patients who have initially responded to treatment and subsequently developed acquired resistance and experienced disease progression.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis commented, "We are very excited to announce the initiation of the NXP900 Phase 1b program, starting with the single agent segment. We believe that NXP900 represents a unique ‘pipeline in a pill’ opportunity with the potential to address several substantial areas of unmet medical need in oncology. The Phase 1b protocol was designed to showcase the potential of NXP900 as an important treatment option for various types of cancer and increase the likelihood of observing a therapeutic effect, building on an extensive scientific program to understand the underlying biology of specific cancers that may confer sensitivity to treatment with NXP900. We have high expectations for the Phase 1b program for NXP900 based on a robust dataset comprised of early mechanistic studies, preclinical proof of concept results and the emerging clinical profile from the completed Phase 1a and drug-drug interaction clinical studies,” added Mr. Bentsur. “Additionally, we believe that the recent acquisition of shares by a highly regarded healthcare-specialized institutional investor is a vote of confidence in this Phase 1b program, and that we are well funded to execute on our ambitious plans for NXP900.”
Conference Call and Webcast Information
- Date: Tuesday, August 12, 2025, at 8:30 AM ET
- Participant Dial-in (U.S.): 1-877-407-0784
- Participant Dial-in (International): 1-201-689-8560
- Webcast Access: Click Here
A replay of the webcast will be available on the Investors section of the Nuvectis website at https://nuvectis.com/investors/.
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’s assets include two clinical-stage drug candidates, NXP900 and NXP800. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. Its unique mechanism of action enables inhibition of both the catalytic and scaffolding functions of the SRC kinase, providing comprehensive shutdown of the signaling pathway. NXP900 has completed a Phase 1a dose escalation study and the Phase 1b program has been initiated. NXP800 is an oral small molecule GCN2 activator that has demonstrated anti-cancer activity in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer, and may be explored in the future in other cancer types. For additional information about Nuvectis Pharma please visit: https://nuvectis.com.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws, which 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 and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for NXP900 and the timing and data expectations for the NXP900 Phase 1b study and estimates and projections regarding our financial condition. The outcomes 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. 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 may also be subject to market and other conditions and described more fully in the section titled "Risk Factors" in our Q2 2025 Form 10-Q and our other public filings with the U.S. 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
rbentsur@nuvectis.com
Media Relations Contact
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
FAQ
What is the purpose of Nuvectis Pharma's Phase 1b program for NXP900?
Which types of cancer patients will be included in NXP900's single-agent study?
When will Nuvectis (NVCT) begin the combination therapy component of the NXP900 Phase 1b program?
What previous studies has Nuvectis completed for NXP900?
How is Nuvectis Pharma's NXP900 development program funded?
