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” tumours “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.”

About IMX-110

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 tumour micro-environment, or TME. ImmixBio’s TME Normalization Technology enables IMX-110 to circulate in the bloodstream, then exit through porous tumour blood vessels, and accumulate in the TME. IMX-110 then simultaneously attacks all 3 components of the TME (cancer associated fibroblasts, or CAFs; tumour-associated macrophages/immune cells, or TAMs, and cancer itself), severing the critical lifelines between the tumour and its metabolic and structural support. IMX-110’s TME Normalization Technology causes tumour apoptosis, a non-inflammatory tumour-cell death (vs. necroptosis, which results in repeat reignition of the inflammatory cascade leading to tumour 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.

About Tislelizumab

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 the 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 tumour 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.