FDA Grants Orphan Drug Status to Nuvectis Pharma's NXP800 for ARID1a-deficient Cancers

Nuvectis Pharma, Inc., a biopharmaceutical company focusing on precision medicines for oncology, announced that the FDA has granted Orphan Drug Designation to its drug candidate NXP800 for the treatment of ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers. This designation is given to drugs aimed at treating rare diseases affecting fewer than 200,000 people in the United States, providing certain incentives like financial support for clinical development and up to seven years of market exclusivity upon approval.

Ron Bentsur, Chairman and CEO of Nuvectis, expressed satisfaction with the designation. He noted the significant prevalence of ovarian cancers, which include ovarian, fallopian tube, and primary peritoneal cancers, and highlighted the rarity of receiving such a designation for a subset of this disease. The designation is seen as validation for NXP800's mechanism of action and its target patient group in their ongoing Phase 1b clinical trial for patients with platinum-resistant, ARID1a-mutated ovarian cancer. Bentsur mentioned that they plan to provide a data update from this study in the upcoming fall.

Nuvectis Pharma is currently developing two clinical-stage drug candidates: NXP800 and NXP900. NXP800, an oral small molecule GCN2 activator, is in a Phase 1b clinical trial for treating platinum-resistant, ARID1a-mutated ovarian carcinoma and is also being tested in an Investigator-sponsored trial for cholangiocarcinoma. The FDA has granted Fast Track Designation for NXP800 in platinum-resistant, ARID1a-mutated ovarian carcinoma, and Orphan Drug Designations for treating cholangiocarcinoma and ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.

The second candidate, NXP900, is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900 has a unique mechanism of action, inhibiting both the catalytic and scaffolding functions of the SRC kinase, thereby effectively shutting down the signaling pathway. This drug is currently in a Phase 1a dose escalation study.

Nuvectis Pharma, Inc. continues to advance its development pipeline to address serious conditions of unmet medical need in oncology, contributing to the field with their innovative precision medicines.

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