Immix Biopharma Gets FDA Rare-Pediatric Designation for IMX-110

By Colin Kellaher

Immix Biopharma Inc. on Monday said the U.S. Food and Drug Administration granted rare-pediatric-disease designation to IMX-110 for the treatment of rhabdomyosarcoma, a life-threatening form of pediatric cancer.

The Los Angeles clinical-stage biopharmaceutical company said it is currently studying IMX-110 in a Phase 1b/2a clinical trial.

The FDA's rare-pediatric-disease designation covers diseases with serious or life-threatening manifestations that mainly affect fewer than 200,000 people in the U.S. under the age of 18. The agency awards priority-review vouchers to drugmakers upon approval of drugs that are granted the designation, and those vouchers can be used to obtain priority review for another drug or sold to other companies.

Rhabdomyosarcoma affects about 20,000 children in the U.S., Immix said.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

01-03-22 0830ET