Nuvectis Pharma Announces FDA Clearance of IND for NXP800
Nuvectis Pharma announced FDA clearance for its Investigational New Drug Application for NXP800, a new approach for treating ARID1a-mutated ovarian clear cell carcinoma. The Phase 1 trial, comprising dose escalation and expansion stages, will now include U.S. sites, expanding its reach beyond the U.K. The company anticipates initiating the Phase 1b in early 2023, aiming to address significant unmet medical needs. NXP800 could become a first-in-class treatment targeting the HSF1 pathway, which is crucial in cancer progression.
- FDA clearance for NXP800 IND facilitates U.S. clinical trial expansion.
- NXP800 has potential as a first-in-class HSF1 pathway inhibitor.
- Ongoing Phase 1 trial targets significant unmet medical needs in oncology.
- None.
FORT LEE, NJ,, June 21, 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 that the U.S. Food and Drug Administration (“FDA”) cleared the Company's Investigational New Drug Application (“IND”) for NXP800, which includes the Phase 1 clinical trial protocol. The NXP800 Phase 1 clinical trial is comprised of two parts, a dose escalation study (“Phase 1a”) to be followed by an expansion study (“Phase 1b”). The Phase 1a is currently ongoing in the United Kingdom (“U.K.”) and, with the IND in effect, U.S. clinical sites will now be included. The Company expects to initiate the Phase 1b study in early 2023.
“The FDA approval of the IND for NXP800 marks an important milestone towards our mission of developing novel treatments for unmet medical needs in oncology” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. “We continue to effectively execute our clinical development strategy for NXP800, with the hope of it becoming the first drug approved for ARID1a-mutated ovarian clear cell carcinoma and endometrioid ovarian carcinoma, and potentially for additional cancers of unmet medical need.” Mr. Bentsur added, “We look forward to building on the substantial interest that NXP800 has garnered in the medical community and to working with leading clinical centers in the U.S. and the U.K. on this important project.”
Mr. Bentsur concluded, "With the progress that we continue to make with NXP800 and NXP900, our novel, oral and highly-specific SRC/YES1 kinase inhibitor, which is expected to enter the clinic in early 2023, we believe that we are emerging as an exciting precision medicine company."
About NXP800
Nuvectis licensed exclusive world-wide rights to NXP800, a novel, oral Heat Shock Factor 1 (“HSF1”) pathway inhibitor, which was discovered at the Institute of Cancer Research in London, England. The HSF1 pathway is implicated in cancer cell growth, metastasis, and survival across several types of cancer. In preclinical studies, NXP800 demonstrated potent anti-proliferative activity against a variety of cancer cell lines, and inhibited tumor growth in ARID1A-mutated ovarian clear cell carcinoma and ovarian endometrioid carcinoma human xenograft models. Nuvectis is conducting further in vivo studies to evaluate the potential use of NXP800 in additional tumor types, including gastric, liver and esophageal cancers, with and without mutations in ARID1a and other biomarkers.
NXP800 is currently in a Phase 1 clinical trial that is comprised of two parts: dose-escalation Phase 1a, to be followed by an expansion Phase 1b. In the Phase 1a, the safety and tolerability of NXP800 is being evaluated in patients with advanced solid tumors to identify a dose and dosing schedule for the Phase 1b. In the Phase 1b study, the safety and preliminary anti-tumor activity of NXP800 will be evaluated, initially in Arid1a-mutated ovarian clear cell carcinoma and ovarian endometrioid carcinoma, Nuvectis expects to include additional arms in the Phase 1b study based on the results of the ongoing in-vivo studies in other tumor types. The Company plans to initiate the Phase 1b in early 2023.
NXP800 has the potential to become a first-in-class inhibitor of the HSF1 pathway.
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 need 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, and the clinical expectations for NXP800 and NXP900 including NXP800's potential ability to become a therapeutic option for the treatment of ovarian clear cell carcinoma, ovarian endometrioid carcinoma and potentially other cancer indications. 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
Media Relations Contact:
Christopher M. Calabrese
LifeSci Advisors
Tel: 917-680-5608
ccalabrese@lifesciadvisors.com
FAQ
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