The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Nuvectis Pharma’s NXP800, targeting AT-rich interactive domain-containing protein 1a (ARID1a)-deficient ovarian, fallopian tube and primary peritoneal cancers.
ODD status is granted by the US regulator for treatments of rare diseases affecting fewer than 200,000 people in the US, and offers development incentives.
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The designation could lead to seven years of marketing exclusivity in the US for NXP800 if it is approved for these specific cancers.
An oral GCN2 activator, NXP800 is also part of an investigator-sponsored trial for cholangiocarcinoma treatment.
The FDA previously awarded fast track designation to NXP800 for platinum-resistant ovarian carcinoma and ODD for cholangiocarcinoma.
Nuvectis Pharma is also developing NXP900, an inhibitor targeting the SRC family of kinases.
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By GlobalDataNXP900’s dual inhibition mechanism offers a comprehensive approach to shutting down the SRC signalling pathway.
The asset is currently in a Phase 1a dose escalation study.
Nuvectis chairman and CEO Ron Bentsur stated: “We are very pleased to have received this designation from the FDA for NXP800. The prevalence of ovarian cancer, which is comprised of ovarian, fallopian tube and primary peritoneal cancers, exceeds the 200,000 patient threshold below which drugs may be eligible to receive orphan drug designation in the United States, and in ovarian cancer it has been uncommon to receive this designation for the treatment of a subset of the disease.
“We therefore believe that this orphan drug designation granted by the FDA for NXP800 for the treatment of a subset of ovarian cancer, specifically for patients with an ARID1a deficiency, provides further validation for NXP800’s mechanism of action and the target patient population in our ongoing Phase Ib clinical trial in patients with platinum-resistant, ARID1a-mutated ovarian cancer.”
