ImmixBio Initiates IMX-110 GMP Manufacturing Scale-Up, Potentially Accelerating Clinical Trial Data

Rhea-AI Summary

Immix Biopharma, Inc. (Nasdaq: IMMX) announced the initiation of Good Manufacturing Practice (GMP) scale-up for IMX-110, marking a significant step toward accelerating two clinical trials planned for 2022. The first trial focuses on IMX-110 monotherapy for soft tissue sarcoma, while the second tests the combination of IMX-110 with BeiGene's anti-PD-1 tislelizumab for advanced solid tumors. IMX-110 has received orphan drug and rare pediatric disease designations from the FDA, enabling fast-track review for its marketing approval.

Positive

• Initiation of GMP scale-up manufacturing for IMX-110, potentially expediting clinical trials.
• FDA granted orphan drug and rare pediatric disease designations for IMX-110, facilitating marketing approval process.

Negative

• None.

• Manufactured IMX-110 to be utilized in both clinical trials:
• 2022 planned monotherapy IMX-110 Clinical Trial in soft tissue sarcoma (“STS”)
• 2022 planned combination IMX-110 + BeiGene anti-PD-1 tislelizumab Clinical Trial in advanced solid tumors

An image of IMX-110 is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/870f17c2-db33-4a8b-bccd-b09dc60f1e7d. 

LOS ANGELES, Jan. 31, 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 initiated IMX-110 Good Manufacturing Practice (“GMP”) scale-up manufacturing, potentially accelerating the timeline to clinical data from two ImmixBio clinical trials planned for 2022: first, planned monotherapy IMX-110 clinical trial in soft tissue sarcoma (“STS”); second, planned combination IMX-110 + BeiGene anti-PD-1 tislelizumab clinical trial in advanced solid tumors.

“Initiating GMP manufacturing 36 days after the closing of our IPO puts us on a path of potentially accelerating our clinical trials,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “We believe this step paves the way to execute our planned milestones at an accelerated pace.”

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 (“RPD”) designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma. RPD 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^TM) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering a novel class of Tissue-Specific Therapeutics (TSTx)^TM targeting oncology and immuno-dysregulated diseases.   Our proprietary SMARxT Tissue-Specific^TM 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 our TME Normalization^TM technology allows our drug candidates to sever the lifelines between the tumor and its metabolic and structural support. We have uncovered fundamental biological systems that link oncology and immuno-dysregulated diseases. In addition to oncology, our pipeline includes Tissue-Specific Biologic^TM candidates to treat inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. 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.

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 are the clinical trials planned for IMX-110 in 2022?

The planned clinical trials for IMX-110 in 2022 include a monotherapy trial for soft tissue sarcoma and a combination trial with BeiGene's anti-PD-1 tislelizumab for advanced solid tumors.

What designations has IMX-110 received from the FDA?

IMX-110 has received orphan drug designation for soft tissue sarcoma and rare pediatric disease designation for rhabdomyosarcoma, a pediatric cancer.

How does GMP scale-up impact IMX-110's clinical development?

The initiation of GMP scale-up manufacturing for IMX-110 is expected to accelerate the timeline to clinical data from the planned trials.

What is the significance of the orphan drug designation for IMX-110?

The orphan drug designation allows IMX-110 to qualify for certain benefits, such as fast-track review and a priority review voucher upon marketing approval.

When can we expect results from the IMX-110 clinical trials?

While specific timelines for results are not mentioned, the GMP scale-up suggests a potential acceleration in the trials scheduled for 2022.