Immix Biopharma Inc (IMMX)

[Alice-N-Wonderland]

FORM 8-K

https://www.immixbio.com/sec-filings/

Item 8.01 Other Events.


On January 3, 2022, Immix Biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for IMX-110 for the treatment of a life-threatening form of pediatric cancer in children, rhabdomyosarcoma. IMX-110, an investigational product, is currently being evaluated in a Phase 1b/2a clinical trial. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.


Item 9.01 Financial Statements and Exhibits.


(d) Exhibits.


Exhibit No. Description99.1 Press release dated January 3, 2022
 
Exhibit 99.1


U.S. Food and Drug Administration Approves Immix Biopharma Rare Pediatric Disease Designation for IMX-110 as a Treatment for Life-Threatening Pediatric Cancer in Children


Rare Pediatric Disease Designation (“RPDD”) qualifies Immix Biopharma to receive fast track review, and a priority review voucher (“PRV”) at the time of marketing approval of IMX-110.


PRV holders can benefit from an expedited six-month 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 $67 to $350 million according to a January 2020 report on drug development by the Government Accountability Office.


LOS ANGELES, January 3, 2021 (GLOBE NEWSWIRE) — Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the “Company”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for IMX-110 for the treatment of a life-threatening 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 diseases that primarily affect children aged 18 years or younger and impact fewer than 200,000 people in the United States.


If a New Drug Application in the United States for IMX-110 is approved, ImmixBio may be eligible to receive a Priority Review Voucher (PRV) from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application, or may 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,” stated ImmixBio’s Chief Executive Officer Ilya Rachman, M.D., PhD. “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.”


Rhabdomyosarcoma (“RMS”) is a high-grade, malignant neoplasm, the most common soft tissue sarcoma in pediatric and adolescent populations and which rarely occurs 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 cancer spreads widely in the body.


IMX-110 is the first clinical-stage product of ImmixBio’s SMARxT Tissue-Specific™ Platform, which produces Tissue-Specific Therapeutics that accumulate at intended therapeutic sites at 3 to 5 times the rate of conventional medicines. The FDA has already granted orphan drug designation (ODD) to IMX-110 for the treatment of soft tissue sarcoma.


ImmixBio recently shared clinical data across multiple soft tissue sarcoma subtypes in several heavily pretreated patients demonstrating median progression-free survival (PFS) of 4 months with zero drug-related severe adverse events and zero dose interruptions due to toxicity. The data can be viewed in the Immix Biopharma Corporate Presentation at http://www.immixbio.com/pres