Immix Biopharma Announces Patient Dosing in Ongoing Phase 1b/2a IMX-110 Monotherapy Clinical Trial
Immix Biopharma, Inc. recently announced patient dosing in its ongoing Phase 1b/2a IMX-110 monotherapy clinical trial. This is the 15 patient dosed with IMX-110 to-date. IMX-110 clinical trial data is expected to be released on a rolling basis beginning in Q1 2023; once dosing begins, patients undergo CT scans every 8 weeks to assess tumor response to IMX-110. IMX-110 monotherapy and IMX-110 combination clinical trial with Beigene/Novartis anti-PD-1 tislelizumab are enabled by newly manufactured, scaled-up IMX-110 GMP batches produced using our proprietary process.
“We are thrilled to accelerate our efforts to bring IMX-110 to patients after scaling-up manufacturing of IMX-110,” said Ilya Rachman, MD, PhD, CEO of ImmixBio. “Key opinion leaders at our 5 clinical trial sites are excited to bring IMX-110 to their adult and pediatric cancer patients as a monotherapy and as a combination with Beigene/Novartis anti-PD-1 tislelizumab.”
The US FDA approved orphan drug designation (ODD) for IMX-110 in soft tissue sarcoma. The FDA also approved Rare Pediatric Disease Designation (RPDD) for IMX-110 for the treatment of rhabdomyosarcoma, a life-threatening form of cancer in children. RPDD qualifies Immix Biopharma to receive fast track review, and a priority review voucher (PRV) at the time of marketing approval of IMX-110. PRV holders can benefit from an expedited 6-month review of a new drug application for any disease by the FDA. IMX-110 is currently being evaluated in a phase 1b/2a clinical trial in patients with advanced solid tumors. For more information, visit www.immixbio.com/iMX-110.
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. For more information, visit www.immixbio.com.
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