On June 23, 2021 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics, reported that the first patient has been dosed in a new Phase 1 arm of the ongoing Phase 1/2 clinical trial of RTX-240 in combination with KEYTRUDA (pembrolizumab)1 for the treatment of patients with relapsed/refractory or locally advanced solid tumors (Press release, Rubius Therapeutics, JUN 23, 2021, View Source [SID1234584708]). To be eligible for the trial, patients must have disease that is relapsed or refractory to an anti-PD-1 or PD-L1 therapy.
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"RTX-240 is designed to activate and expand a patient’s own immune cells to mount a broad and potent anti-tumor response. Combining an immune agonist with a PD-1 checkpoint inhibitor has the potential to prevent the cancer from evading the immune response. The RTX-240 and pembrolizumab combination is anticipated to drive activated T cells and NK cells into the tumor microenvironment with the potential to overcome resistance to PD-1 inhibition," said Christina Coughlin, M.D., Ph.D., chief medical officer at Rubius Therapeutics. "Given the favorable emerging safety profile and promising initial clinical activity reported as part of our initial clinical results from the ongoing Phase 1 monotherapy trial of RTX-240 in advanced solid tumors, we believe that the combination with pembrolizumab has the potential to provide significant benefit to patients with disease that is relapsed or refractory to prior anti-PD-1 or PD-L1 therapy."
"Despite recent advances in cancer immunotherapy, there remains a need for new combination approaches that broaden the benefits of immunotherapy in patients with solid tumors following treatment with checkpoint inhibition," said Omid Hamid, M.D., Chief of Translational Research and Immunotherapy, Director of the Phase 1 Immuno-Oncology Program of The Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, and RTX-240 investigator. "The exciting initial safety and efficacy data from the ongoing monotherapy Phase 1 clinical trial make RTX-240 a potentially promising candidate for the treatment of cancer, and we are excited to work with Rubius to evaluate RTX-240 in combination with pembrolizumab."
RTX-240 is engineered to express a co-stimulatory molecule, 4-1BB ligand, and a cytokine, IL-15TP, on the cell’s surface, and is designed to broadly stimulate the immune system by activating and expanding both natural killer (NK) cells and T cells to generate a potent anti-tumor response. Pembrolizumab is a humanized monoclonal immunoglobulin G4 antibody (IgG4 mAb) with high specificity of binding to the programmed cell death protein-1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Based on in vitro data, pembrolizumab has high affinity and potent receptor blocking activity for PD-1. Pembrolizumab is indicated for the treatment of patients across several indications as monotherapy and in combination with numerous therapies.
About the RTX-240 Phase 1/2 Clinical Trial
This is a Phase 1/2 open label, multicenter, multidose, first-in-human dose-escalation and expansion study designed to determine the safety and tolerability, pharmacokinetics, maximum tolerated dose and a recommended Phase 2 dose and dosing regimen of RTX-240. The trial will also assess the pharmacodynamics of RTX-240 measured by changes in T and NK cell number and function relative to baseline and anti-tumor activity. The trial has three separate Phase 1 arms: an ongoing monotherapy dose escalation arm in adults with relapsed/refractory or locally advanced solid tumors, an ongoing monotherapy dose escalation arm in adults with relapsed/refractory acute myeloid leukemia, and a combination therapy dose escalation arm with pembrolizumab in adults with relapsed/refractory or locally advanced solid tumors. The monotherapy arm of the trial in advanced solid tumors includes a Phase 2 expansion in specified tumor types.