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Rubius Therapeutics Presents Initial Clinical Results from the Ongoing Phase 1/2 Clinical Trial of RTX-240

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April 9, 2021

Rubius Therapeutics, Inc. is 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™, today reprised initial clinical results from its ongoing Phase 1/2 study of RTX-240 in advanced solid tumors at the American Association for Cancer Research (AACR) Virtual Annual Meeting.

Posters will be available online tomorrow on the AACR website and Publications page of the Rubius Therapeutics website at 8:30 a.m. EDT. The data included in the poster are based on a data cutoff date of February 28, 2021.

“The clinical data shared to date demonstrate 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 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. “Given the promising emerging safety profile, together with initial indication of clinical activity, RTX-240 represents a potentially novel therapeutic that may benefit patients with advanced-stage solid tumors, including those who have been previously treated with checkpoint inhibition.”

“Based on these initial promising results, we are continuing to enroll patients and plan to present additional clinical results from the RTX-240 Phase 1 solid tumor clinical trial by year end,” said Christina Coughlin, M.D., Ph.D., Chief Medical Officer of Rubius Therapeutics. “Additionally, by year end, we expect to select the specific solid tumor types that we plan to pursue in the Phase 2 expansion cohorts of RTX-240. We also intend to initiate a new Phase 1 arm to evaluate RTX-240 in combination with anti-PD-1 therapy in advanced solid tumors during the second half of 2021.”

Poster Title: A Phase 1 Trial of RTX-240, an Allogeneic Engineered Red Blood Cell with Cell-Surface Expression of 4-1BBL and Trans-Presented IL-15, in Patients with Advanced Solid Tumors
Session Category: Clinical Trials (Poster Session)
Session Title: Phase I Clinical Trials
Abstract Number: CT141

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 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 in adult patients with relapsed/refractory or locally advanced solid tumors or with relapsed/refractory acute myeloid leukemia. 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 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. The extent to which the COVID-19 pandemic may impact Rubius’ ability to enroll patients in the trial will depend on future developments.

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