Nuvectis Pharma Announces Collaboration with ENGOT and GOG Foundation to Conduct the NXP800 Phase 1b Clinical Trial in ARID1A-Mutated Ovarian Carcinoma in Europe and in the United States
Nuvectis Pharma, Inc. (NASDAQ: NVCT) announced a collaboration with ENGOT and GOG Foundation to conduct the NXP800 Phase 1b clinical trial targeting ARID1A-mutated ovarian clear cell and endometrioid carcinomas. Dr. Susana Banerjee leads the trial, with co-leads Dr. Shannon Westin and Dr. Ramez Eskander. The ongoing Phase 1a trial demonstrates promising results, supporting the safety and effectiveness of NXP800. The FDA has granted Fast Track Designation for the drug, highlighting its potential in addressing significant unmet medical needs in oncology.
- Collaboration with renowned organizations ENGOT and GOG Foundation for NXP800 Phase 1b trial.
- Promising results from ongoing Phase 1a trial, indicating potential efficacy of NXP800.
- NXP800 received Fast Track Designation from the FDA, facilitating its development process.
- None.
Dr. Susana Banerjee (The Royal Marsden NHS Foundation Trust, UK), will be the ENGOT and Global Clinical Trial Lead
Dr. Shannon Westin (MD Anderson Cancer Center, Houston, TX) and Dr. Ramez Eskander (University of California San Diego, San Diego, CA) will be the co-GOG Foundation Trial Leads in the US
Fort Lee, N.J., Jan. 04, 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 the European Network of Gynecological Oncology Trial Groups (“ENGOT”) and the GOG Foundation, Inc. (“GOG-F”) to conduct the NXP800 Phase 1b clinical trial in ARID1A-mutated, ovarian clear cell and endometroid carcinomas in Europe and the United States.
“We are honored to collaborate with the ENGOT and GOG-F on this very important clinical trial. ENGOT and GOG-F are the world's premier gynecology oncology clinical trials consortia, representing some of the leading medical centers and having spear-headed several drug approvals in the field, including the 2 PARP inhibitors for the treatment of BRCA-mutated ovarian cancers, Olaparib (Astra Zeneca) and Niraparib (GSK), as well as the antibody-drug conjugate Tivdak (Seattle Genetics), which is approved for cervical cancer,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur continued, “As our Phase 1a dose-escalation study in patients with advanced solid tumors is nearing completion, we have begun preparing for the start of the Phase 1b trial alongside the consortia's world renowned experts who provide guidance into key design elements of the study protocol and access to top clinical centers.”
Mr. Bentsur added: “We believe that the high-quality discovery and lead optimization program at the Institute of Cancer Research, the robust preclinical proof of concept, the recent Fast Track Designation by the U.S. FDA, and now the collaboration with ENGOT and GOG-F, bode well for the future of NXP800. Clinical data from the ongoing Phase 1a trial to date suggest that the emerging clinical profile of NXP800 can provide a good balance between systemic exposure, pharmacodynamic activity and tolerability, and we look forward to the initiation of the Phase 1b trial in the next few months.”
About ENGOT
ENGOT is a research network of the European Society of Gynecological Oncology (ESGO) and was founded in Berlin in October 2007. Currently, ENGOT consists of 21 trial groups from several European countries that perform cooperative clinical trials. The ultimate goal of ENGOT is to bring the best treatment to gynecological cancer patients through the best science, and enabling every patient in every European country to access a clinical trial.
The ENGOT reference number for the Phase 1b clinical trial of NXP800 is ENGOT-GYN5/NCRI/NXP800-101.
About The GOG Foundation, Inc. (www.gog.org)
The GOG Foundation is a not for profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis, and distribution of results. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, vagina, and vulva. The GOG Foundation is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatistitions (including those with Expertise in bioinformatics), basic scientists quality of life experts, data managers, and administrative personnel.
About GOG Partners
Supported by industry, GOG Partners is structured to work directly with pharmaceutical organizations and operate clinical trials outside the National Cancer Institute (NCI) framework. The GOG Partners shares the same mission of the GOG Foundation dedicated to transforming the care in Gynecologic Oncology. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network.
The GOG reference number for the Phase 1b clinical trial of NXP800 is GOG-3087.
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 an oral small molecule that has demonstrated robust preclinical anti-tumor activity in ARID1A-mutated xenograft models of ovarian and gastric carcinomas. NXP800 is currently in a dose-escalation Phase 1a study in patients with advanced solid tunors and was granted Fast Track Designation by the United States Food and Drug Administration (“FDA”) for the treatment of platinum-resistant, ARID1A-mutated, ovarian carcinoma. NXP900 is a novel, small molecule SRC/YES1 kinase inhibitor currently in Investigational New Drug (“IND”)-enabling studies.
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, the pharmacodynamic, pharmacokinetic and safety data generated to date for NXP800 in the ongoing Phase 1a study 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.
Company Contact:
Ron Bentsur, Chairman and CEO
Nuvectis Pharma, Inc.
IR Contact:
Christopher M. Calabrese
LifeSci Advisors
Tel: 917-680-5608
ccalabrese@lifesciadvisors.com
