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ImmixBio Releases and Ships Scaled-Up GMP Batches of IMX-110 for Clinical Trial Patient Dosing
ソース: Nasdaq GlobeNewswire / 12 12 2022 08:00:01 America/New_York
LOS ANGELES, CA, Dec. 12, 2022 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, today announced that it has completed release testing and shipped Good Manufacturing Practice (“GMP”) process manufactured batches of IMX-110 for clinical trial patient dosing. IMX-110 was produced using our proprietary, scaled-up manufacturing process that will provide drug supply for 2 clinical trials: IMX-110 monotherapy and combination IMX-110 + BeiGene/Novartis anti-PD-1 tislelizumab clinical trial in advanced solid tumors.
“Completing release testing and shipping GMP IMX-110 manufactured with our new scaled-up, proprietary process for patient dosing is a pivotal milestone,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “We are looking forward to releasing clinical data in our IMX-110 monotherapy and IMX-110 plus BeiGene/Novartis anti-PD-1 tislelizumab combination clinical trial.”
About IMX-110
The U.S. Food and Drug Administration (“FDA”) has approved orphan drug designation (“ODD”) for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease designation (“RPDD”) for IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma. RPDD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. IMX-110 is currently being evaluated in a phase 1b/2a clinical trial in patients with advanced solid tumors. Learn more at www.immixbio.com/iMX-110
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
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Contacts
Immix Biopharma, Inc.
Gabriel Morris
Chief Financial Officer
ir@immixbio.com
+1 (888) 958-1084