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

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.
Posted In: BriefsPhase 1 TrialPhase 2 TrialBiotechNewsHealth CareSmall CapFDAGeneral