On December 12, 2022 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, reported that it has completed release testing and shipped Good Manufacturing Practice ("GMP") process manufactured batches of IMX-110 for clinical trial patient dosing (Press release, Immix Biopharma, DEC 12, 2022, View Source [SID1234625121]). 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.
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"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