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ImmixBio Initiates GMP Manufacturing of IMX-120, a Biologic for Inflammatory Bowel Disease

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Immix Biopharma (Nasdaq: IMMX) has initiated Good Manufacturing Practice (GMP) manufacturing for IMX-120, a biologic targeting inflammatory bowel disease (IBD). The company plans to file an Investigational New Drug (IND) application for IMX-120 in 2023, marking an important milestone for future clinical trials. The IBD market is projected to grow from $18.4 billion in 2019 to $21.4 billion by 2024, underscoring the potential market opportunity for IMX-120. This development highlights ImmixBio's commitment to advancing treatment options in the biopharmaceutical sector.

Positive
  • Initiation of GMP manufacturing for IMX-120 marks a significant development phase.
  • Anticipated IND filing for IMX-120 in 2023, paving the way for clinical trials.
  • The IBD market is projected to reach $21.4 billion by 2024, indicating potential revenue growth.
Negative
  • None.
  • IMX-120 utilizes proprietary, humanized antibody fragment to selectively silence disease-causing, overactive inflammatory bowel immune cells

  • ImmixBio anticipates filing an IND for IMX-120 in 2023

  • The inflammatory bowel disease market is expected to reach $21.4 billion by 2024 from the existing $18.4 billion in 2019

A graphic accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4733027e-ec5e-4598-9b6e-d5a9c4031c56

LOS ANGELES, Feb. 22, 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 initiated Good Manufacturing Practice (“GMP”) manufacturing of IMX-120, a biologic for inflammatory bowel disease (“IBD”). ImmixBio anticipates filing an IND for IMX-120 in 2023, representing a significant milestone on ImmixBio’s path to clinical trials for IMX-120 in inflammatory bowel disease. The IBD market is expected to reach $21.4 billion by 2024 from the existing $18.4 billion in 2019.

IMX-120 is a Tissue-Specific Biologic™ built on ImmixBio’s Immune Normalization Technology™ for IBD with proprietary GLUT1 antibody and other proprietary targeting coupled with polyphenol poly-kinase inhibitors. IMX-120 takes advantage of the fact that overexpression and activation of GLUT1 on overactive immune cells has been shown to be widely present in patients with inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease. IMX-120 is the latest drug candidate to initiate GMP manufacturing produced by ImmixBio’s SMARxT Tissue-Specific Platform.

“Initiating GMP manufacturing of IMX-120 represents a wholly new phase of development for ImmixBio as a biologics innovator,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “We believe this step is the beginning of a path toward a Biologics License Application (“BLA”) for IMX-120 in inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.”

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 lead asset IMX-110, currently in Phase 1b/2a clinical trials, holds orphan drug designation (ODD) by the FDA for soft tissue sarcoma, and has received Rare Pediatric Disease Designation (RPDD) for the treatment of rhabdomyosarcoma, a life-threatening form of cancer in children. RPDD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. 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.

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. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

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

 


FAQ

What is IMX-120 and its significance for ImmixBio?

IMX-120 is a biologic targeting inflammatory bowel disease (IBD), and its GMP manufacturing initiation represents a critical step towards clinical trials.

When does ImmixBio plan to file an IND for IMX-120?

ImmixBio anticipates filing an Investigational New Drug (IND) application for IMX-120 in 2023.

What is the projected market size for inflammatory bowel disease?

The IBD market is expected to grow from $18.4 billion in 2019 to $21.4 billion by 2024.

What technology underlies IMX-120?

IMX-120 is based on ImmixBio's Tissue-Specific Therapeutics (TSTx) and utilizes proprietary GLUT1 antibody targeting.

How does IMX-120 aim to address inflammatory bowel diseases?

IMX-120 aims to selectively silence overactive immune cells that contribute to inflammatory bowel diseases.

Immix Biopharma, Inc.

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