FDA grants rare pediatric disease designation to IMX-110 for rhabdomyosarcoma
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The FDA granted rare pediatric disease designation to IMX-110 for treatment of children with rhabdomyosarcoma.
IMX-110 (Immix Biopharma) encapsulates a poly-kinase inhibitor and apoptosis inducer delivered deep into the tumor microenvironment, according to its manufacturer.
The FDA grants rare pediatric disease designation to therapies intended to treat serious or life-threatening diseases that primarily occur among children and affect fewer than 200,000 people in the United States.
Rhabdomyosarcoma is the most common soft tissue sarcoma among children and adolescents. Five-year survival rates are approximately 20% to 30% for children with high-risk disease, meaning cancer has spread widely throughout the body.
If the FDA approves a new drug application for IMX-110, ImmixBio may be eligible to receive a priority review voucher. The company can redeem the voucher to obtain priority review for a subsequent marketing application. The voucher also can be sold or transferred.
“We are pleased by FDA’s acknowledgment of the urgent need for a safe and effective treatment for children with this devastating disease,” Ilya Rachman, MD, PhD, CEO of ImmixBio, said in a company-issued press release. “We are encouraged by our phase 1b/2a clinical data in soft tissue sarcoma. IMX-110 is a tissue-specific therapeutic that simultaneously attacks all three components of the tumor microenvironment, severing the critical lifelines between the tumor and its metabolic and structural support.”
The FDA previously granted orphan drug designation to IMX-110 for the treatment of soft tissue sarcoma.
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