Nuvectis' NXP800 Receives FDA ODD for Cancer

The United States Food and Drug Administration (FDA) has recently awarded orphan drug designation (ODD) to Nuvectis Pharma's NXP800. This designation specifically targets AT-rich interactive domain-containing protein 1a (ARID1a)-deficient ovarian, fallopian tube, and primary peritoneal cancers.

Orphan drug designation is granted by the FDA to treatments addressing rare diseases that affect fewer than 200,000 people in the United States. The designation aims to encourage the development of drugs for these conditions by offering various incentives. If NXP800 is approved for these specific cancers, the designation could provide up to seven years of marketing exclusivity in the U.S.

NXP800 is an oral GCN2 activator. In addition to targeting ARID1a-deficient cancers, it is also part of an investigator-sponsored trial for the treatment of cholangiocarcinoma. The FDA has previously granted fast track designation to NXP800 for treating platinum-resistant ovarian carcinoma and orphan drug designation for cholangiocarcinoma.

Nuvectis Pharma is not limited to NXP800; the company is also developing another promising drug, NXP900. This drug is an inhibitor targeting the SRC family of kinases and employs a dual inhibition mechanism to comprehensively shut down the SRC signaling pathway. NXP900 is currently undergoing a Phase 1a dose escalation study.

Ron Bentsur, the chairman and CEO of Nuvectis Pharma, expressed his satisfaction with the FDA’s decision. He noted that ovarian cancer, which includes ovarian, fallopian tube, and primary peritoneal cancers, affects a patient population that exceeds the 200,000 threshold. Therefore, receiving orphan drug designation for a subset of this disease is uncommon. Bentsur believes that the FDA's decision to grant ODD for NXP800 for treating ARID1a-deficient ovarian cancer validates both the drug's mechanism of action and its target patient population in their ongoing Phase Ib clinical trial. This trial is focused on patients with platinum-resistant, ARID1a-mutated ovarian cancer.

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