Immix Biopharma Receives Institutional Review Board Approval to Enroll Pediatric Patients in Upcoming IMX-110 Clinical Trial, Key Requirement for U.S. Food and Drug Administration Approval of Rare Pediatric Disease Priority Review Voucher

Rhea-AI Summary

Immix Biopharma (Nasdaq: IMMX) has received IRB approval for enrolling pediatric patients in its IMX-110 clinical trial, crucial for FDA's Priority Review Voucher (PRV) approval. The PRV enables expedited review for new drug applications. Historically, these vouchers sell for $67 to $350 million. The company is focusing on treating pediatric rhabdomyosarcoma, a severe childhood cancer, and soft tissue sarcoma in adults. IMX-110 is part of ImmixBio's innovative Tissue-Specific Therapeutics platform, enhancing treatment efficacy by targeting tumor sites more effectively.

Positive

• IRB approval obtained for enrolling pediatric patients in IMX-110 trial, a step towards FDA PRV approval.
• Pediatric rhabdomyosarcoma has a significant unmet need, creating market potential for IMX-110.
• PRVs offer a financial incentive as they can sell for up to $350 million.

Negative

• Uncertainty about the future value of the PRV could affect strategic planning and investment.
• High competition in oncology could impact the market success of IMX-110.

• Enrolling pediatric patients in a clinical trial is a key requirement for FDA approval of a Priority Review Voucher (“PRV”)
  
• 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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/be19ab99-a0c8-4850-a0a4-1592fdc18600

LOS ANGELES, Nov. 11, 2022 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases, today announced that it has received Institutional Review Board (“IRB”) approval to enroll pediatric patients in its upcoming IMX-110 clinical trial. Enrolling pediatric patients in a clinical trial is a key requirement for FDA approval of a Priority Review Voucher (“PRV”). 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.

“We are pursuing FDA approval of IMX-110 in pediatric rhabdomyosarcoma, a life-threatening cancer in children and the subject of our rare pediatric disease designation from FDA, as well as approval of IMX-110 to treat soft tissue sarcoma in adults,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “Our key opinion leaders at our 5 clinical trial sites are excited to bring IMX-110 to their adult and pediatric cancer patients.”

Rhabdomyosarcoma (“RMS”) is a high-grade, malignant cancer in children, the most common soft tissue sarcoma in pediatric and adolescent populations. 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.

About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio™) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering a novel class of Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases. Our proprietary SMARxT Tissue-Specific™ Platform produces drug candidates that circulate in the bloodstream, exit through tumor blood vessels and simultaneously attack all 3 components of the tumor micro-environment (TME). We believe ImmixBio’s TME Normalization™ technology severs the lifelines between the tumor and its metabolic and structural support. Learn more at www.immixbio.com

Forward Looking Statements
This press release contains “forward-looking statements” Forward-looking statements reflect our current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this press release relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; and other factors relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Immix Biopharma’s Annual Report on Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Immix Biopharma, Inc. specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements.

Contacts
Immix Biopharma, Inc.
Gabriel Morris
Chief Financial Officer
ir@immixbio.com
+1 (888) 958-1084

FAQ

What is the significance of IRB approval for Immix Biopharma's clinical trial of IMX-110?

IRB approval allows Immix Biopharma to enroll pediatric patients, which is essential for FDA's Priority Review Voucher (PRV) eligibility.

What is IMX-110 being developed to treat?

IMX-110 is being developed for pediatric rhabdomyosarcoma and soft tissue sarcoma in adults.

How does the Priority Review Voucher (PRV) work?

The PRV allows for an expedited six-month review of drug applications for any disease by the FDA, potentially reducing the time to market.

What are the potential financial benefits of the PRV for Immix Biopharma?

Historically, PRVs have sold for $67 to $350 million, providing a significant financial opportunity.

What are the survival rates for pediatric rhabdomyosarcoma?

The five-year survival rate for high-risk pediatric rhabdomyosarcoma patients ranges from 20% to 30%.