FDA Grants RPD to Immix Biopharma

Jan 3, 2022 By MarketDepth

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FDA Approved

Immix Biopharma, Inc. (Nasdaq: IMMX) announced earlier today the U.S. Food and Drug Administration’s decision to grant a Rare Pediatric Disease (RPD) designation for the company’s IMX-110 as a treatment for life-threatening pediatric cancer in children.

Urgent Application

IMX-110 is currently being evaluated in a Phase 1b/2a clinical trial and should the company’s New Drug Application in the United States for IMX-110 be approved, ImmixBio may be eligible to receive a Priority Review Voucher, granting it the ability to obtain priority review for any subsequent marketing application.

“We are pleased by FDA’s acknowledgment of the urgent need for a safe and effective treatment for children with this devastating disease.”

ImmixBio’s Chief Executive Officer Ilya Rachman, M.D., PhD

Additionally, IMX-110 has already been granted an Orphan Drug Designation (ODD) by the FDA for the treatment of soft tissue sarcoma, and is the first clinical-stage product of ImmixBio’s SMARxT Tissue-Specific™ Platform. 

“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 3 components of the tumor micro-environment, severing the critical lifelines between the tumor and its metabolic and structural support. We believe our SMARxT platform generating Tissue-Specific Therapeutics represents a distinct alternative to the traditional ‘single target, single mutation’ development model.”

ImmixBio’s Chief Executive Officer Ilya Rachman, M.D., PhD