On July 15, 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 the publication of preclinical data in the peer-reviewed journal Cancer Immunology, Immunotherapy, for its lead clinical oncology program, RTX-240, for the treatment of adults with advanced solid tumors and relapsed/refractory acute myeloid leukemia (Press release, Rubius Therapeutics, JUL 15, 2021, View Source [SID1234584880]).

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The paper entitled "Anti-Tumor Effects of RTX-240: an Engineered Red Blood Cell Expressing 4-1BB Ligand and Interleukin-15" highlights preclinical findings, which demonstrate that RTX-240 activates and expands CD8+ T cells and NK cells in vitro and in vivo generating potent anti-tumor activity in both a colorectal and melanoma model. The paper is available here: View Source

"These preclinical data demonstrate RTX-240’s mechanism of action, which we’ve also seen translated to the clinic thus far. Namely, in these preclinical models, RTX-240 activated and expanded both NK and T cells capable of trafficking to the tumor and killing tumor cells, while showing only minimal toxicity due to the biodistribution of RTX-240 to the vasculature and spleen," said Laurence Turka, M.D., chief scientific officer of Rubius Therapeutics. "Compared to a 4-1BB agonist antibody, RTX-240 was better tolerated and demonstrated a wider therapeutic window in preclinical studies, suggesting that RTX-240 could provide a more efficacious and safer option for the treatment of patients with advanced solid tumors and acute myeloid leukemia."

"These preclinical data supported advancing RTX-240 into the clinic, where the initial clinical results have shown that RTX-240 has the ability to activate and expand a patient’s own immune system to fight cancer, leading to clinical responses in certain patients with advanced solid tumors," said Christina Coughlin, M.D., Ph.D., chief medical officer of Rubius Therapeutics. "We are continuing to enroll patients in our ongoing Phase 1/2 clinical trial of RTX-240 in three Phase 1 arms: a monotherapy dose escalation arm in adults with relapsed/refractory or locally advanced solid tumors, a 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."

About RTX-240
RTX-240, Rubius Therapeutics’ lead oncology program, is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BB ligand (4-1BBL) and IL-15TP (trans-presentation of IL-15 on IL-15Rα) in their native forms. RTX-240 is designed to broadly stimulate the immune system by activating and expanding both NK and memory T cells to generate a potent anti-tumor response.

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, 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.