Inhibrx has received the orphan drug designation from the European Commission (EC) for its INBRX-109 to treat chondrosarcoma.
The latest move follows a positive opinion issued by the European Medicines Agency (EMA).
A precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody, INBRX-109 has been designed for exploiting the tumour-biased cell death induction by DR5 activation in several cancer types.
DR5 is a receptor for the tumour necrosis factor-related apoptosis-inducing ligand (TRAIL) and its activation naturally removes the damaged and/or neoplastic cells and normal cells are less sensitive to DR5-mediated cell death.
Inhibrx CEO Mark Lappe said: “We are highly optimistic about the potential of INBRX-109 in chondrosarcoma to address a high unmet medical need.
“The positive opinion issued by the EMA is excellent news and acknowledges the potential of INBRX-109 as a treatment for patients throughout Europe who suffer from this debilitating, rare condition.”
Last year, INBRX-109 received Fast Track designation from the US Food and Drug Administration (FDA) to treat unresectable or metastatic conventional chondrosarcoma patients.
It also received orphan-drug designation for the treatment of chondrosarcoma in the US.
Every year around 2,800 new patients are diagnosed with chondrosarcoma, an orphan bone cancer, in the US and the EU.
Inhibrx commenced a placebo-controlled, randomised, blinded, potential registration-enabling Phase II trial of INBRX-109 in patients with unresectable or metastatic conventional chondrosarcoma, in June last year.
Last November, the company provided updated data from its ongoing Phase I clinical trial of INBRX-109.
The Phase I study was designed to assess INBRX-109’s efficacy and safety to treat conventional chondrosarcoma.
According to the findings, initial disease control was observed in 16 of the 18 evaluable patients (89%) and the remaining two achieved partial responses (11%).