LOS ANGELES, Sept. 30, 2021 /PRNewswire/ — Immix Biopharma, Inc. ("ImmixBio"), a biotechnology company pioneering Tissue Specific Therapeutics (TSTx)TM for oncology and inflammation, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to IMX-110 for the treatment of soft tissue sarcoma.
The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to 7 years of market exclusivity in the U.S. upon regulatory approval.
"We are pleased to receive FDA’s orphan drug designation in soft tissue sarcoma for IMX-110, the first clinical-stage product of our SMARxT Tissue-Specific Platform," said Ilya Rachman MD PhD, ImmixBio Founder & CEO. "We are thrilled to potentially contribute to expanding therapeutic options for oncology patients, beginning with soft tissue sarcoma."
Gabriel Morris, ImmixBio Chief Financial Officer, added: "Orphan drug designation for IMX-110 represents a substantial value creating step along our path of building a strong, independent biopharmaceutical organization."
IMX-110 is a Tissue-Specific TherapeuticTM built on ImmixBio’s TME NormalizationTM Technology encapsulating a poly-kinase inhibitor and apoptosis inducer delivered deep into the tumor micro-environment, or TME. ImmixBio’s TME Normalization Technology enables IMX-110 to circulate in the bloodstream, then exit through porous tumor blood vessels, and accumulate in the TME. IMX-110 then simultaneously attacks all 3 components of the TME (cancer associated fibroblasts, or CAFs; tumor-associated macrophages/immune cells, or TAMs, and cancer itself), severing the critical lifelines between the tumor and its metabolic and structural support. IMX-110’s TME Normalization Technology causes tumor apoptosis, a non-inflammatory tumor-cell death (vs. necroptosis, which results in repeat reignition of the inflammatory cascade leading to tumor progression).
IMX-110 is currently being evaluated in a phase 1b/2a open-label, dose-escalation/dose-expansion safety, tolerability and pharmacokinetic study in patients with advanced solid tumors in the United States and Australia.
ImmixBioTM is a clinical-stage biopharmaceutical company pioneering a novel class of Tissue-Specific Therapeutics (TSTx)TM in oncology and inflammation. Our proprietary System Multi-Action RegulaTors SMARxT Tissue-SpecificTM Platform produces drugs that accumulate at intended therapeutic sites at 3-5 times the rate of conventional medicines. Our TME Normalization™ Technology allows our drug candidates to circulate in the bloodstream, exit through tumor blood vessels and simultaneously attack all components of the tumor micro-environment, or TME. We have uncovered fundamental biological systems that link oncology and inflammation. In addition to oncology, our pipeline includes Tissue-Specific BiologicTM candidates to treat inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. Learn more at www.immixbio.com
This press release contains forward-looking statements. These forward-looking statements may include, but may not be limited to, express or implied statements regarding the ability of Immix Biopharma, Inc. ("ImmixBio") to develop potential therapies for patients; the design and potential efficacy of our therapeutic approaches; the predictive capability of our SMARxT Tissue-Specific™ Platform in the development of Tissue-Specific Therapeutics (TSTx)™; the potential timing, design and advancement of our pre-clinical studies and clinical trials, including the potential timing for regulatory authorization related to clinical trials; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials; our ability to replicate results achieved in our pre-clinical studies or clinical trials in any future studies or trials; the impact of COVID-19 on our operations, clinical trials and supply chain; our current resources and cash runway; and regulatory developments in the United States and foreign countries. Any forward-looking statements in this press release are based on management’s existing operating plan, current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing, advancement and conduct of pre-clinical and clinical studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will cost more to develop or may not be successfully developed and commercialized; and the risk that the results of pre-clinical studies and/or clinical trials will or will not be predictive of results in connection with future studies or trials. All information in this press release is as of the date of the release, and ImmixBio undertakes no duty to update this information unless required by law.
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