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Nuvectis Pharma, Inc. reports developments as a clinical-stage biopharmaceutical company focused on precision medicines for serious oncology indications. Company news centers on NXP900, an oral small-molecule inhibitor of the SRC Family of Kinases, including SRC and YES1, and on clinical and preclinical work in genetically or molecularly defined cancer settings.
Recurring updates include financial results, business highlights, clinical program progress, AACR and other oncology conference presentations, pharmacokinetic and pharmacodynamic findings, drug-drug interaction data, and combination-therapy research in non-small cell lung cancer and other advanced solid tumors. News also covers capital resources and financing activity tied to development operations.
Nuvectis Pharma (NASDAQ: NVCT) announced promising results for NXP800, demonstrating significant antitumor activity in cholangiocarcinoma through two patient-derived xenograft (PDX) models, as presented at the AACR Annual Meeting 2023.
Cholangiocarcinoma, with about 10,000 new cases annually in the U.S., has limited treatment options, with only 30% of patients eligible for surgical resection. Ron Bentsur, CEO, emphasized the urgent need for new therapies in this area, stating that NXP800's data offers hope for improved outcomes.
The research, led by Mayo Clinic's Dr. Rory L. Smoot, indicates potential clinical benefits from NXP800 for this challenging condition, which typically results in poor patient prognosis.
Nuvectis Pharma has initiated a Phase 1b clinical trial for NXP800, targeting patients with platinum-resistant, ARID1a-mutated ovarian carcinoma. This trial, building on promising preclinical and Phase 1a results, will study the drug's safety and efficacy in this specific cancer population. The trial aims to enroll around 50 patients across multiple sites in the U.S., UK, and Europe. NXP800 is an oral small molecule that has shown strong anti-tumor activity in preclinical models and received Fast Track Designation by the FDA. Results from the previous Phase 1a study indicated acceptable safety with the most common side effects being manageable. The company anticipates sharing detailed results from Phase 1a at a future scientific conference.
Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical-stage biopharmaceutical company, announced upcoming presentations for its drug candidates NXP800 and NXP900 at the 2023 American Association for Cancer Research Meeting, scheduled from April 14-19 in Orlando, Florida. NXP800, currently in a Phase 1a study, targets advanced solid tumors and has received Fast Track Designation from the FDA for ARID1a-mutated ovarian carcinoma. NXP900 is a novel SRC/YES1 kinase inhibitor with an IND pending submission. Presentations will include significant findings on therapeutic efficacy in various cancer models.
FORT LEE, NJ, March 10, 2023 (GLOBE NEWSWIRE) -- Nuvectis Pharma, a biopharmaceutical firm specializing in precision oncology medicines, announced that CEO Ron Bentsur will join a fireside chat at the 35th Annual Roth Conference on March 14, 2023, at 12:00 PM PT (3:00 PM ET). Nuvectis is developing innovative treatments, including NXP800, currently in a Phase 1a trial for advanced solid tumors and has received Fast Track Designation from the FDA for treating platinum-resistant ovarian carcinoma. Another candidate, NXP900, is pending IND submission.
For more details, visit www.nuvectis.com.
Nuvectis Pharma, Inc. (NASDAQ: NVCT) reported significant advancements in 2022, highlighted by FDA's Fast Track Designation for NXP800 aimed at treating ARID1A-mutated ovarian carcinoma. The ENOT and GOG Foundation will spearhead the Phase 1b clinical trial for NXP800. Additionally, the IND submission and Phase 1 study for NXP900 are anticipated in the first half of 2023. Financially, the company ended 2022 with $20 million in cash and an increased net loss of $19.1 million, reflecting rising R&D costs at $13.2 million. Nuvectis remains optimistic about its programs, emphasizing the year as potentially transformational for its drug candidates.
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.
Nuvectis Pharma, Inc. (NASDAQ: NVCT) announced a publication in the Journal of Experimental Medicine regarding NXP900's efficacy in treating metastatic castration resistant prostate cancer (mCRPC) resistant to enzalutamide (XTANDI®). The publication suggests that NXP900, also known as eCF506, may reverse resistance to XTANDI® when combined with it. The CEO, Ron Bentsur, emphasized the drug's potential as a leading SRC/YES1 kinase inhibitor, with expectations for clinical advancement. Nuvectis Pharma is focused on addressing unmet medical needs in oncology and is also developing NXP800, which targets ARID1a mutations.
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.
Nuvectis Pharma (NASDAQ: NVCT) announced on December 1, 2022, that the FDA granted Fast Track Designation to its drug candidate NXP800, aimed at treating platinum-resistant, ARID1A-mutated ovarian carcinoma. This designation highlights the drug's potential to meet urgent medical needs in oncology. CEO Ron Bentsur expressed confidence in NXP800's ability to improve patient outcomes. Nuvectis is also developing NXP900, a SRC/YES1 kinase inhibitor, currently in preclinical studies. Fast Track allows for expedited drug development and review for serious conditions.
Nuvectis Pharma (NASDAQ: NVCT) announced its Q3 2022 financial results and progress in drug development. The Phase 1a trial for NXP800 is ongoing, with Phase 1b set to start in Q1 2023. Positive preclinical data for NXP800 was reported, highlighting its potential for treating ARID1a-mutated gastric cancer. NXP900 is advancing towards IND submission expected in Q1 2023, with new insights on its activity profile. Cash reserves grew to $23.6 million, but net losses increased to $5.9 million from $4.7 million year-on-year, primarily due to R&D costs.