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Immix Biopharma Announces Dosing of First 2 Patients in its IMX-110 + BeiGene/Novartis anti-PD-1 Tislelizumab Phase 1b/2a Combination Clinical Trial in Patients with Advanced Cancer

Key Takeaway: Immix Biopharma has announced the dosing of the first two patients in its Phase 1b/2a clinical trial of IMX-110 in combination with BeiGene/Novartis' anti-PD-1 Tislelizumab. This trial aims to enhance responses in patients with advanced solid tumors by converting immunologically 'cold' tumors into 'hot' tumors. Initial clinical data from the trial is expected in the first half of 2023. The FDA has granted orphan drug and rare pediatric disease designations for IMX-110, further accelerating its potential approval pathway.

Market Sentiment Analysis

POSITIVE FACTORS

  • Immix Biopharma has commenced dosing for its promising IMX-110 trial.
  • The combination therapy may significantly improve treatment outcomes for advanced solid tumors.
  • FDA grants orphan drug and rare pediatric disease designations to IMX-110, facilitating faster development.

Full Press Release Details

IMX-110 + Beigene/Novartis anti-PD-1 Tislelizumab combination designed to enhance response to solid tumors by turning immunologically “cold” tumors “hot”
Initial data anticipated in 1H 2023
LOS ANGELES, Feb. 07, 2023 (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 dosing of the first 2 patients in its IMX-110 + Beigene/Novartis anti-PD-1 Tislelizumab Combination Phase 1b/2a Clinical Trial in patients with advanced solid tumors. Initial clinical data from this combination trial is anticipated to be released on a rolling basis beginning in 1H 2023. IMX-110 + Beigene/Novartis anti-PD-1 tislelizumab combination treatment is designed to enhance response to solid tumors by turning immunologically “cold” tumors “hot”. In ImmixBio prior IMX-110 + anti-PD-1 preclinical experiments, a 50% improvement (63-day median survival) was produced by IMX-110 + anti-PD-1 in a genetic (KPC) pancreatic cancer mouse model in which mice develop their own pancreatic cancer and have an intact immune system, compared to a 4-drug combination of 2 chemotherapies and 2 immunotherapies (anti-PD-1/anti-CD40/nab-paclitaxel/gemcitabine) in the same genetic pancreatic cancer mouse model (42-day median survival) according to Winograd et al., 2015.
“We are thrilled to kick-off this important milestone working with our partner BeiGene,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “We believe the combination of IMX-110 + Beigene/Novartis anti-PD-1 Tislelizumab will have a synergistic effect that could bolster responses and expand the population of cancer patients benefiting from these therapies.”
The U.S. Food and Drug Administration (“FDA”) approved orphan drug designation (“ODD”) for IMX-110 in soft tissue sarcoma. The FDA also approved Rare Pediatric Disease Designation (“RPDD”) for IMX-110 for the treatment of rhabdomyosarcoma, a life-threatening form of cancer in children.  RPDD qualifies Immix Biopharma to receive fast track review, and a priority review voucher (“PRV”) at the time of marketing approval of IMX-110. PRV holders can benefit from an expedited six-month review of a new drug application for any disease by the FDA.  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.
Immix Biopharma, Inc.
Chief Financial Officer

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Frequently Asked Questions

What is IMX-110 combined with Tislelizumab designed for?

This combination aims to convert immunologically 'cold' tumors to 'hot' tumors.

When is initial data expected from the IMX-110 trial?

Initial data from the trial is anticipated to be released in the first half of 2023.

What designations has the FDA granted to IMX-110?

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

What is the aim of ImmixBio's TME Normalization technology?

It aims to disrupt the connection between tumors and their metabolic support.

What improvement was noted in preclinical experiments with IMX-110?

A 50% median survival improvement was observed in a pancreatic cancer mouse model.

Last updated: Feb 7, 2023