On May 26, 2022 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 for the treatment of cancer and autoimmune diseases, reported that the Company will present a Trials in Progress poster presentation for its second broad immune stimulation program, RTX-224, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually from June 3-7, 2022 (Press release, Rubius Therapeutics, MAY 26, 2022, View Source [SID1234615100]).
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The Trials in Progress poster presentation will summarize the proposed mechanism of action of RTX-224, preclinical observations to date and the clinical trial design, including the translational medicine approach, for the ongoing Phase 1/2 clinical trial of RTX-224 for the treatment of patients with select advanced solid tumors, including cutaneous melanoma, head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer and urothelial cancer.
Poster Title: A Phase 1/2 Study of RTX-224, an Engineered Red Blood Cell Expressing 4-1BB Ligand and Membrane-Bound IL-12, for the Treatment of Patients with Select Advanced Solid Tumors
Session Title: Developmental Therapeutics—Immunotherapy
Abstract Number: TPS2680
Date and Time: Sunday, June 5, 2022, 8:00-11:00 a.m. CDT
About the RTX-224 Phase 1/2 Clinical Trial
This is a Phase 1/2 open label, multicenter, multidose, first-in-human dose-escalation and expansion study to determine the safety and tolerability, pharmacokinetics, maximum tolerated dose and a recommended Phase 2 dose and dosing regimen of RTX-224 in adult patients with certain relapsed/refractory or locally advanced solid tumors including non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma, urothelial (bladder) carcinoma and triple-negative breast cancer. The trial will also assess pharmacodynamic changes in immune cell populations relative to baseline and anti-tumor activity. The study will include a monotherapy dose escalation phase followed by an expansion phase in specified tumor types during the Phase 2 portion of the trial.
About RTX-224
RTX-224 is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to express hundreds of thousands of copies of 4-1BB ligand (4-1BBL) and interleukin-12 (IL-12) on the cell surface. RTX-224 is designed to broadly stimulate the immune system by activating and expanding NK and CD8+ memory T cells and is expected to produce a broad and potent anti-tumor T cell response, an innate immune response and generate anti-tumor activity in those tumor types with known sensitivity to T cell killing, including tumor types with high mutational burden, PD-L1 expression and/or known responsiveness to checkpoint inhibitors.