Inhibrx Precision Cancer Antibody Receives FDA Orphan Drug Tag For Rare Bone Cancer

The FDA has granted Orphan Drug designation to Inhibrx Inc's INBX INBRX-109 for chondrosarcoma. Chondrosarcoma is an orphan bone cancer with approximately 2,800 new patients diagnosed annually in the U.S. and the European Union. 

• Currently, there are no therapeutics approved for the treatment of chondrosarcoma.
• INBRX-109 is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody that exploits the tumor-biased cell death induced by DR5 activation.
• In November, updated results from Inhibrx Phase 1 showed preliminary disease control in 16 of the 18 evaluable patients (89%), with two of the 18 achieving partial responses (11%). 
• Based on preliminary results of the ongoing Phase 1 trial, the median progression-free survival (PFS) is 7.4 months, and the median overall survival has not been reached. 
• Three patients have exceeded 61 weeks on treatment with INBRX-109, with 77 weeks.
• In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, potential registration-enabling Phase 2 trial of INBRX-109 in conventional chondrosarcoma.
• See here Benzinga's Full FDA Calendar.
• Price Action: INBX shares closed at $40.25 on Wednesday.