Immix Biopharma Announces Patient Dosing in Ongoing Phase 1b/2a IMX-110 Monotherapy Clinical Trial
Immix Biopharma has successfully dosed its 15th patient in the ongoing Phase 1b/2a clinical trial of IMX-110, targeting advanced solid tumors. Clinical trial data is expected to be released rolling basis starting Q1 2023, with patient assessments every 8 weeks through CT scans. The trial includes both IMX-110 monotherapy and a combination treatment with Beigene/Novartis's anti-PD-1 tislelizumab. The FDA has granted orphan drug designation and rare pediatric disease designation for IMX-110, boosting its potential for expedited review upon market approval.
- 15th patient dosed in Phase 1b/2a trial, indicating progress.
- FDA orphan drug designation and rare pediatric disease designation for IMX-110.
- Clinical data expected to be released starting Q1 2023.
- Enhanced manufacturing capabilities with scaled-up GMP batches.
- None.
- In December 2022, the 15th patient was dosed with IMX-110
- IMX-110 clinical trial data 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 enabled by newly manufactured, scaled-up IMX-110 GMP batches
LOS ANGELES, CA, Dec. 13, 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 patient dosing in its ongoing Phase 1b/2a IMX-110 monotherapy clinical trial. This is the fifteenth 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.”
About IMX-110
The U.S. Food and Drug Administration (“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 six-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. 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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Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements.
Contacts
Immix Biopharma, Inc.
Gabriel Morris
Chief Financial Officer
ir@immixbio.com
+1 (888) 958-1084
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