Friday, August 27, 2021
Immix Biopharma, Inc. announced a clinical trial and supply agreement with BeiGene, Ltd. to evaluate the safety, tolerability and efficacy of combining IMX-110, a Tissue Specific Therapeutic™ with TME Normalization™ Technology, with BeiGene’s anti-PD-1 antibody tislelizumab, for the treatment of various solid tumors, in the U.S. and internationally.
Under the terms of the agreement, ImmixBio will evaluate the combination of IMX-110 with tislelizumab in a Phase 1/2a trial in patients with advanced solid tumors.
“ImmixBio is proud to showcase our Tissue Specific Therapeutics (TSTx)™ platform to the world. Promising data from our ongoing IMX-110 clinical trial, from pre-clinical studies in a genetic mouse model of pancreatic cancer showing IMX-110 turning “cold” tumors “hot,” and IMX-110 in combination with murine anti-PD-1 demonstrating extended survival in a genetic mouse model of pancreatic cancer versus multi-drug combinations in the literature, have demonstrated substantial rationale to combine IMX-110 and tislelizumab,” said Ilya Rachman, MD, PhD – ImmixBio CEO. “We have high hopes that IMX-110 in combination with tislelizumab could expand the population of cancer patients experiencing extended remissions.”
IMX-110 is a Tissue-Specific Therapeutic™ built on ImmixBio’s TME Normalization™ Technology encapsulating a poly-kinase inhibitor and apoptosis inducer delivered deep into the tumor micro-environment, or TME. ImmixBio’s TME Normalization Technology enables IMX-110 to circulate in the bloodstream, then exit through porous tumor blood vessels, and accumulate in the TME. IMX-110 then simultaneously attacks all 3 components of the TME (cancer associated fibroblasts, or CAFs; tumor-associated macrophages/immune cells, or TAMs, and cancer itself), severing the critical lifelines between the tumor and its metabolic and structural support. IMX-110’s TME Normalization Technology causes tumor apoptosis, a non-inflammatory tumor-cell death (vs. necroptosis, which results in repeat reignition of the inflammatory cascade leading to tumor progression).
IMX-110 is currently being evaluated in a phase 1b/2a open-label, dose-escalation/dose-expansion safety, tolerability and pharmacokinetic study in patients with advanced solid tumors in the United States and Australia.
Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
The China National Medical Products Administration (NMPA) has granted tislelizumab market authorization in four indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab is not approved for use outside of China.
In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.
ImmixBio™ is a clinical-stage biopharmaceutical company pioneering a novel class of Tissue-Specific Therapeutics (TSTx)™ in oncology and inflammation. Our lead asset, IMX-110, is currently in phase 1b/2a clinical trials for solid tumors in the United States and Australia. Our proprietary System Multi-Action RegulaTors SMARxT Tissue-Specific™ Platform produces drugs that accumulate at intended therapeutic sites at 3-5 times the rate of conventional medicines. Our TME Normalization™ Technology allows our drug candidates to circulate in the bloodstream, exit through tumor blood vessels and simultaneously attack all components of the tumor micro-environment, or TME. We have uncovered fundamental biological systems that link oncology and inflammation. In addition to oncology, our pipeline includes Tissue-Specific Biologic™ candidates to treat inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. Learn more at www.immixbio.com
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the clinical development of IMX-110 in combination with tislelizumab, ImmixBio’s and BeiGene’s roles and responsibilities in the collaboration, the opportunity and potential benefits of their product candidates both as monotherapies and in combination, and other information that is not historical information. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the ability of ImmixBio and BeiGene to develop and receive regulatory approvals for the combination therapies in the collaboration; the risk that the potential benefits of the collaboration do not materialize or do not outweigh the costs; the ability of ImmixBio and BeiGene to demonstrate the efficacy and safety of their respective drug candidates as monotherapies or in combination; the clinical results for such drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; ImmixBio’s and BeiGene’s ability to achieve commercial success for their marketed products and drug candidates, if approved; ImmixBio’s and BeiGene’s ability to obtain and maintain protection of intellectual property for their respective technology and drugs; BeiGene’s and ImmixBio’s reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene’s and ImmixBio’s ability to obtain additional funding for operations and to complete the development and commercialization of their drug candidates; and the impact of the COVID-19 pandemic on BeiGene’s and ImmixBio’s clinical development, commercial and other operations. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see ImmixBio’s or BeiGene’s filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and neither ImmixBio nor BeiGene undertakes a duty to update such information unless required by law.
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