ImmixBio IMX-110 Produced 50% Positive Response Rate in First-Line-Therapy-Resistant Cancer, Surpassing the Standard of Care in Mice Study

Rhea-AI Summary

Immix Biopharma reported promising results for its lead candidate IMX-110, demonstrating a 50% response rate in a study involving first-line-therapy-resistant soft tissue sarcoma (STS) mice, outperforming the standard treatment doxorubicin’s 0% response rate. This candidate is positioned in a lucrative market projected to grow from $2.9 billion in 2019 to $6.5 billion by 2030. Additionally, IMX-110 has received orphan drug and rare pediatric disease designations from the FDA, which could expedite its development and approval process.

Positive

• IMX-110 achieved a 50% response rate in preclinical testing, significantly higher than doxorubicin's 0% rate.
• Potential market growth for STS therapeutics is projected from $2.9 billion in 2019 to $6.5 billion by 2030.
• FDA orphan drug designation received for IMX-110, enhancing its market access and development speed.
• Zero severe drug-related adverse events reported in recent clinical data.

Negative

• None.

• IMX-110 produced a 50% response rate after 1 cycle of treatment as a monotherapy in first-line-therapy-resistant cancer - soft tissue sarcoma (STS) mice study
• IMX-110 response rate surpassed standard of care doxorubicin’s response rate of 0% after 1 cycle of treatment in the same study
• IMX-110 is in clinical development for STS, a $3 billion market expected to grow to $6.5 billion by 2030
  

A graph accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/14a74b9a-30ad-4410-a0d6-9a084753dd4c

LOS ANGELES, Jan. 12, 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 study data showing that ImmixBio’s lead candidate IMX-110 produced a 50% response rate in a first-line-therapy-resistant cancer - soft tissue sarcoma (STS) mouse study, surpassing the STS standard of care doxorubicin’s 0% response rate in the same mouse study.   The responses were assessed by RECIST 1.1 criteria applied to mice, with progression assessed after one cycle of treatment in a study funded by ImmixBio and conducted by a major STS oncology treatment center.

“We strive to test our drug candidates in the most realistic, challenging animal models available,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “We are thrilled to see that in this first-line-therapy resistant STS model that IMX-110 showed significant activity. We believe this study is a preview of what our SMARxT Platform generating Tissue-Specific Therapeutics can do, a distinct alternative to the traditional ‘single target, single mutation’ development model.”

The U.S. Food and Drug Administration (“FDA”) has approved orphan drug designation (“ODD”) for IMX-110 for the treatment of soft tissue sarcoma. The FDA has already approved rare pediatric disease (“RPD”) designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma.

ImmixBio recently shared IMX-110 clinical data across multiple STS subtypes in several heavily pretreated patients demonstrating median progression-free survival (PFS) of 4 months with zero drug-related severe adverse events and zero dose interruptions due to toxicity. The data can be viewed in the Immix Biopharma Corporate Presentation at http://www.immixbio.com/pres

Soft tissue sarcoma is a cancer that begins in the tissues that connect, support, and surround body structures. The global STS market is estimated to reach approximately $6.5 billion by 2030 from the estimated $2.9 billion in 2019. Globally, there are roughly 116,000 new cases of STSs each year, of which 21,500 are in the European Union and 40,500 are in China. According to the American Cancer Society, there were roughly 13,000 new cases of STS in the United States during 2020. Approximately 160,000 people live with soft tissue cancers in the United States.

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 lead asset IMX-110, currently in Phase 1b/2a clinical trials, holds orphan drug designation (ODD) by the FDA for soft tissue sarcoma, and has received Rare Pediatric Disease Designation (RPDD) for the treatment of rhabdomyosarcoma, a life-threatening form of cancer in children. RPPD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. 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 ImmixBio’s TME Normalization^TM 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 is the response rate of IMX-110 in the recent study?

IMX-110 achieved a 50% response rate in a study involving first-line-therapy-resistant soft tissue sarcoma mice.

How does IMX-110 compare to doxorubicin in the study?

IMX-110 surpassed doxorubicin, which showed a 0% response rate after one cycle of treatment.

What market size does the STS therapeutic field aim for by 2030?

The global soft tissue sarcoma therapeutic market is expected to grow to $6.5 billion by 2030.

What designations has IMX-110 received from the FDA?

IMX-110 has received orphan drug designation and rare pediatric disease designation from the FDA.

What are the key safety outcomes from the latest IMX-110 clinical data?

Recent clinical data showed zero severe drug-related adverse events and no dose interruptions due to toxicity.