On December 19, 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 shipped Good Manufacturing Practice ("GMP") manufactured batches of Tislelizumab for clinical trial patient dosing (Press release, Immix Biopharma, DEC 19, 2022, View Source [SID1234625404]). Tislelizumab, Beigene/Novartis anti-PD-1 antibody, will be combined with IMX-110 in a clinical trial for patients with advanced solid tumors. GMP manufactured IMX-110 was already released and shipped on December 12, 2022.
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"Having shipped both IMX-110 and Tislelizumab to sites completes drug supply preparations and puts us on a launching pad for this exciting combination clinical trial," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We expect to begin reporting clinical data from this trial beginning in Q1 2023."
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