ImmixBio Ships Tislelizumab for Patient Dosing in its Combination Clinical Trial with IMX-110 in Advanced Solid Tumors

Rhea-AI Summary

Immix Biopharma (Nasdaq: IMMX) has shipped GMP-manufactured Tislelizumab to commence a clinical trial evaluating the combination with IMX-110 in advanced solid tumors. This follows the release of IMX-110 on December 12, 2022. Clinical data is expected to be reported beginning in Q1 2023, with patients undergoing CT scans every 8 weeks. The FDA has granted orphan drug designation for IMX-110 for soft tissue sarcoma and rare pediatric disease designation for rhabdomyosarcoma, potentially facilitating fast-track and priority review processes.

Positive

• Successful shipment of Tislelizumab and IMX-110, completing drug supply preparations.
• Clinical trial expected to start reporting data in Q1 2023.
• FDA granted orphan drug and rare pediatric disease designations for IMX-110, facilitating potential expedited review.

Negative

• None.

• Tislelizumab supplied by BeiGene as part of ImmixBio’s Clinical Trial and Supply Agreement with BeiGene to Evaluate Combination of IMX-110 and Tislelizumab in Solid Tumors
• IMX-110 + Tislelizumab 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 + Tislelizumab

LOS ANGELES, CA, Dec. 19, 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 shipped Good Manufacturing Practice (“GMP”) manufactured batches of Tislelizumab for clinical trial patient dosing. 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.

“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

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. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

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 and Tislelizumab clinical trial?

The clinical trial aims to evaluate the efficacy of IMX-110 in combination with Tislelizumab in patients with advanced solid tumors.

When will the clinical trial data for IMX-110 and Tislelizumab be released?

Clinical trial data is expected to be released on a rolling basis beginning in Q1 2023.

What designations has the FDA granted to IMX-110?

The FDA has granted orphan drug designation for soft tissue sarcoma and rare pediatric disease designation for rhabdomyosarcoma.

How will patients be monitored during the IMX-110 and Tislelizumab clinical trial?

Patients will undergo CT scans every 8 weeks to assess tumor response during the trial.

What is Tislelizumab and its role in the trial?

Tislelizumab is an anti-PD-1 antibody that will be combined with IMX-110 in the clinical trial to evaluate its effectiveness in treating solid tumors.