ImmixBio Approves 4 Additional Clinical Trial Sites for IMX-110 Clinical Trials, Complementing Existing Soft Tissue Sarcoma Lead Site

Rhea-AI Summary

Immix Biopharma (Nasdaq: IMMX) has expanded its clinical trial consortium by adding four additional oncology sites to enhance the testing of its drug IMX-110 for soft tissue sarcoma. The lead site in California has historically enrolled 2-3 patients monthly. As part of the trial, patients will receive CT scans every eight weeks to monitor tumor response, with data release commencing in Q1 2023. The FDA has granted orphan drug designation and rare pediatric disease designation for IMX-110, enabling potential fast track and priority review upon marketing approval.

Positive

• Approval of 4 additional clinical trial sites for IMX-110, enhancing patient enrollment.
• Historical data shows lead site enrolling 2-3 patients per month.
• FDA granted orphan drug and rare pediatric disease designations for IMX-110, enabling potential fast track review.

Negative

• None.

• California Soft Tissue Sarcoma Site to lead expanded clinical site consortium
• Historically, high-enrolling lead site has enrolled 2-3 patients per month
• 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
  

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/400e1702-f2a3-4d75-bc8a-3554ee8fa7af

LOS ANGELES, Oct. 18, 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 that it has approved 4 additional clinical trial sites for IMX-110 clinical trials, complementing existing soft tissue sarcoma lead clinical trial site in California. Historically, the lead high-enrolling site has enrolled 2-3 patients per month. Once dosing begins, patients will undergo CT scans every 8 weeks to assess tumor response to IMX-110; results are expected to be released on a rolling basis beginning in Q1 2023.

“We are excited to select these 4 preeminent oncology sites to join our clinical site consortium from a larger group of interested centers. We are humbled by the enthusiasm from these key opinion leaders to bring IMX-110 to their patients,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “These KOLs are excited about both IMX-110 as a monotherapy, and in combination with BeiGene and Novartis’ 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

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 is the purpose of the IMX-110 clinical trial?

The IMX-110 clinical trial aims to evaluate the efficacy and safety of the drug for treating soft tissue sarcoma.

When will the results of the IMX-110 trial be released?

The trial results are expected to be released on a rolling basis starting in Q1 2023.

How often will patients be monitored during the IMX-110 trial?

Patients will undergo CT scans every eight weeks to assess their tumor response.

What designations has the FDA granted for IMX-110?

The FDA has granted orphan drug designation and rare pediatric disease designation for IMX-110.

How does the addition of four new clinical sites impact IMMX?

The addition is expected to increase patient enrollment and expedite the clinical trial process for IMX-110.