Immix Biopharma Doses Additional Patients in Ongoing Phase 1b/2a IMX-110 Monotherapy Clinical Trial
Immix Biopharma (Nasdaq: IMMX) has successfully dosed its 17th patient in the ongoing Phase 1b/2a clinical trial of IMX-110. Positive safety data has allowed for the continued dosing of previously enrolled patients. Clinical data is expected to be released on a rolling basis starting in Q1 2023, with patients undergoing CT scans every 8 weeks to monitor tumor response. IMX-110 has received FDA orphan drug designation for soft tissue sarcoma and rare pediatric disease designation for rhabdomyosarcoma, enabling potential fast-track review and a priority review voucher upon marketing approval.
- Successful dosing of the 17th patient in Phase 1b/2a trial of IMX-110.
- Positive safety data supports ongoing dosing for previously enrolled patients.
- FDA granted orphan drug designation for IMX-110 in soft tissue sarcoma.
- FDA approved rare pediatric disease designation for IMX-110 in rhabdomyosarcoma, providing potential for fast track review.
- None.
- In January 2023, the 17th new patient was dosed with IMX-110 to date
- Positive safety data enabled continued dosing of previously enrolled patients
- Patients undergo CT scans every 8 weeks after dosing to assess tumor response to IMX-110; clinical data expected to be released on a rolling basis beginning in Q1 2023
LOS ANGELES, Jan. 13, 2023 (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 dosing of an additional patient in its ongoing Phase 1b/2a IMX-110 monotherapy clinical trial. Positive safety data enabled continued dosing of previously enrolled patients. In January 2023, the seventeenth patient was 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. “We are delighted with continued robust IMX-110 clinical trial enrollment,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “We continue to accumulate valuable clinical data for first-in-class IMX-110 therapy. In Q1 2023 we plan to share clinical data from our IMX-110 monotherapy and IMX-110 combination trial 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
This press release contains “forward-looking statements” Forward-looking statements reflect our current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this press release relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; and other factors relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Immix Biopharma’s Annual Report on Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Immix Biopharma, Inc. specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. 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
FAQ
What are the latest developments in Immix Biopharma's IMX-110 clinical trial?
When will clinical data for IMX-110 be released?
What designations has IMX-110 received from the FDA?
How frequently are patients monitored in the IMX-110 trial?
What is the significance of the FDA's designations for IMX-110?
