- The Rare Pediatric Disease (âRPDDâ) designation qualifies Immix Biopharma to receive an Expedited Review and Priority Review Voucher (âPRVâ) upon approval for marketing of IMX-110.
- PRV holders may benefit from a six-month expedited review of a new drug application for any disease by the FDA.
- While their future value is uncertain, PRVs are transferable to other companies and have historically sold for between $ 67 million and $ 350 million, according to a January 2020 report on drug development from the Government Accountability Office.
LOS ANGELES, January 03, 2022 (GLOBE NEWSWIRE) – Immix Biopharma, Inc, (Nasdaq: IMMX) (âImmixBioâ or the âCompanyâ), a pioneering biopharmaceutical company in the field of tissue-specific therapies (TSTx)MT targeting oncology and immuno-regulated diseases, today announced that the United States Food and Drug Administration (FDA) has granted rare pediatric disease (RPD) designation to IMX-110 for the treatment of ‘a potentially fatal form of pediatric cancer in children, rhabdomyosarcoma. IMX-110, an investigational product, is currently being evaluated in a Phase 1b / 2a clinical trial.
The FDA grants rare pediatric disease designation for serious and life-threatening conditions that primarily affect children 18 years of age or younger and affect fewer than 200,000 people in the United States.
If a US New Drug Application for IMX-110 is approved, ImmixBio may be eligible to receive a Priority Review Voucher (PRV) from the FDA, which can be used to obtain priority review for any market submission. later, or may be sold or transferred.
âWe are delighted that the FDA recognizes the urgent need for a safe and effective treatment for children with this devastating disease,â said ImmixBio General Manager Ilya Rachman, MD, PhD. âWe are encouraged by our phase 1b / 2a clinical data in soft tissue sarcoma. IMX-110 is a tissue-specific therapeutic product that simultaneously attacks all 3 components of the tumor microenvironment, cutting critical lifelines between the tumor and its metabolic and structural support. We believe that our SMARxT platform generating tissue-specific therapies represents a distinct alternative to the traditional âsingle target, single mutationâ development model.
Rhabdomyosarcoma (âRMSâ) is a high-grade malignant tumor, the most common soft tissue sarcoma in pediatric and adolescent populations and rarely seen in adults. The prevalence of RMS in the United States is approximately 20,000 children of all ages. The five-year survival rate ranges from 20 to 30% for children in the high-risk group where the cancer spreads widely in the body.
IMX-110 is the first clinical stage product in ImmixBio’s SMARxT Tissue-Specific â¢ platform, which produces tissue-specific therapeutics that accumulate at intended therapy sites at a rate 3 to 5 times higher. to that of conventional drugs. The FDA has previously granted orphan drug designation (ODD) to IMX-110 for the treatment of soft tissue sarcoma.
ImmixBio recently shared clinical data on several subtypes of soft tissue sarcoma in several heavily pretreated patients demonstrating a median progression-free survival (PFS) of 4 months with zero serious drug-related adverse events and zero dose interruptions due to toxicity. The data can be viewed in Immix Biopharma’s corporate presentation at http://www.immixbio.com/pres
ImmixBioMT is a clinical-stage biopharmaceutical company pioneering a new class of tissue-specific therapies (TSTx)MT targeting oncology and immune-deregulated diseases. Our exclusive system SMARxT Tissue-Specific multi-action regulatorsMT The platform produces drugs that accumulate at intended therapeutic sites at a rate 3-5 times that of conventional drugs. Our TME Normalization â¢ technology allows our drug candidates to flow through the bloodstream, exit through tumor blood vessels, and simultaneously attack all components of the tumor microenvironment, or TME. We have discovered fundamental biological systems that link oncology and immune-deregulated diseases. In addition to oncology, our pipeline includes tissue-specific biologicsMT candidates for treating inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. Learn more about www.immixbio.com.
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Contacts Immix Biopharma, Inc. Gabriel Morris Chief Financial Officer [email protected] +1 (888) 958-1084