ImmixBio Completes GMP Manufacturing of Scaled-Up Batch of IMX-110 for Clinical Trials

Rhea-AI Summary

Immix Biopharma (Nasdaq: IMMX) has successfully completed Good Manufacturing Practice (GMP) manufacturing of IMX-110, a drug candidate for clinical trials. This scaled-up process will support two upcoming clinical trials: one for monotherapy in soft tissue sarcoma and another combining IMX-110 with BeiGene's anti-PD-1 tislelizumab for advanced solid tumors. The FDA has granted orphan drug and rare pediatric disease designations for IMX-110, enabling it to benefit from expedited review processes. The company aims to initiate these trials in 2022.

Positive

• Successful completion of GMP manufacturing for IMX-110.
• FDA grants orphan drug and rare pediatric disease designations for IMX-110.
• Upcoming clinical trials planned for 2022 reinforce potential market advancements.

Negative

• None.

• Scaled-up, proprietary GMP manufacturing process to be utilized in 2 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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/49d68ad5-624b-46b9-8f15-cc07b6717d92

LOS ANGELES, Sept. 07, 2022 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases, today announced that it has completed Good Manufacturing Practice (“GMP”) manufacturing of a scaled-up batch of IMX-110 for clinical trials. IMX-110 was produced using our proprietary, scaled-up manufacturing process that will provide drug supply for 2 ImmixBio clinical trials planned to start in 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.

“Completing the first batch of GMP IMX-110 using our proprietary, scaled-up GMP manufacturing process just 7 months after our manufacturing kick-off is a testament to the efficiency and dedication of our stellar team,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “Building on promising clinical and animal data for IMX-110 as a monotherapy and in combination with PD-1, we are excited to kick off 2 clinical trials soon in 2022 – IMX-110 monotherapy, and IMX-110 combined with BeiGene 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.

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 upcoming trials for IMMX (Immix Biopharma)?

Immix Biopharma plans to initiate a monotherapy trial for IMX-110 in soft tissue sarcoma and a combination trial with BeiGene's tislelizumab in advanced solid tumors in 2022.

What designations has the FDA granted to IMX-110?

IMX-110 has received orphan drug designation and rare pediatric disease designation from the FDA, allowing for expedited review.

What is the significance of the GMP manufacturing completion for IMMX?

The completion of GMP manufacturing is critical as it provides the necessary drug supply for upcoming clinical trials, indicating progress in product development.

When did Immix Biopharma announce the GMP manufacturing completion for IMX-110?

Immix Biopharma announced the completion of GMP manufacturing for IMX-110 on September 7, 2022.