On November 12, 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 for the treatment of cancer and autoimmune diseases, reported the poster presentation of preclinical data for RTX-224, a broad immune costimulatory agonist for the treatment of cancer, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting which is being held from November 10-14, 2021, in Washington, D.C., and virtually (Press release, Rubius Therapeutics, NOV 12, 2021, View Source [SID1234595408]).
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"The preclinical data presented at SITC (Free SITC Whitepaper) indicate that RTX-224 stimulates both adaptive and innate immune responses, leading to an antitumor effect in our surrogate models," said Laurence Turka, M.D., chief scientific officer and head of research & translational medicine of Rubius Therapeutics. "Our preclinical model of RTX-224 demonstrated significant activation of CD4+ T cells, CD8+ T cells, antigen-presenting cells and NK cells as well as potent anti-tumor activity in a melanoma model, giving us confidence that RTX-224 may be an effective treatment for advanced solid tumors. The U.S. FDA recently cleared our Investigational New Drug application for RTX-224, and we expect to begin dosing patients during the first quarter of 2022."
Poster Title: RTX-224, An Engineered Allogeneic Red Cell Therapeutic Expressing 4-1BBL and IL-12, Activates Immune Cells in Blood and Spleen to Promote Tumor Growth Inhibition in Mice
RTX-224 is an allogeneic 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 as a broad immune agonist of both adaptive and innate responses, activating CD8+ and CD4+ T cells, promoting antigen presentation and activating and expanding NK cells. It is expected to produce a broad and potent anti-tumor T cell response, an innate immune response and have 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 prior responsiveness to checkpoint inhibitors.
Data Summary
The mouse surrogate of RTX-224, mRBC-224, demonstrated potent anti-tumor activity in B16F10 melanoma models, intravenously and subcutaneously, that was associated with pharmacodynamic changes in the tumors, including activated CD8+ T cells, NK cells and macrophages.
mRBC-224 distributed mainly in the spleen of tumor-bearing mice 24 hours after one dose.
mRBC-224 treatment in mice promoted activation of NK cells, CD8+ T cells and monocytes/macrophages in the blood and spleen of naïve and tumor-bearing mice.
RTX‑224 (in vitro) and mRBC‑224 (in vivo) stimulate adaptive (CD8+ T cells and CD4+ T cells) and innate (NK cells and macrophages) immune responses.
The combined enhancement of both adaptive and innate immune responses leads to a productive antitumor response as demonstrated in preclinical studies.