On September 7, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported that it has completed Good Manufacturing Practice ("GMP") manufacturing of a scaled-up batch of IMX-110 for clinical trials. IMX-110 was produced using our proprietary, scaled-up manufacturing process that will provide drug supply for 2 ImmixBio clinical trials planned to start in 2022: first, planned monotherapy IMX-110 clinical trial in soft tissue sarcoma ("STS"); second, planned combination IMX-110 + BeiGene anti-PD-1 tislelizumab clinical trial in advanced solid tumors (Press release, Immix Biopharma, SEP 7, 2022, View Source [SID1234619143]).
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"Completing the first batch of GMP IMX-110 using our proprietary, scaled-up GMP manufacturing process just 7 months after our manufacturing kick-off is a testament to the efficiency and dedication of our stellar team," said Ilya Rachman, MD PhD, CEO of ImmixBio. "Building on promising clinical and animal data for IMX-110 as a monotherapy and in combination with PD-1, we are excited to kick off 2 clinical trials soon in 2022 – IMX-110 monotherapy, and IMX-110 combined with BeiGene anti-PD-1 tislelizumab."
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.