Rubius Therapeutics to Present Trials in Progress Poster for the Phase 1/2 Clinical Trial of RTX-224 in Select Advanced Solid Tumors at the 2022 American Society of Clinical Oncology Annual Meeting

Cambridge, Massachusetts, UNITED STATES

CAMBRIDGE, Mass., May 26, 2022 (GLOBE NEWSWIRE) -- 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, today announced 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) Annual Meeting being held virtually from June 3-7, 2022.

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.

About Rubius Therapeutics

Rubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics™. The Company’s proprietary RED PLATFORM® was designed to biologically engineer and culture Red Cell Therapeutics™ that are selective, potent and off-the-shelf allogeneic cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Rubius’ initial focus is to advance RCT™ product candidates for the treatment of cancer and autoimmune diseases by leveraging two distinct therapeutic modalities — potent cell-cell interaction and tolerance induction. Rubius Therapeutics was recently named among the 2021 Top Places to Work in Massachusetts by the Boston Globe, and its manufacturing site was recently named 2022 Best Places to Work in Rhode Island by Providence Business News. For more information, visit, follow us on Twitter or LinkedIn or like us on Facebook.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, plans and expectations, and the potential, for RTX-224, including the RTX-224 Phase 1/2 clinical trial.  The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the development of our Red Cell Therapeutic product candidates and their therapeutic potential, our ability to execute on our plans and expectations, our analyses of clinical and preclinical data and other risks identified in our filings with the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent filings with the SEC, including our Quarterly Report on Form 10-Q for the quarter-ended March 31, 2022, and risks and uncertainties related to the severity and duration of the impact of COVID-19 on our business and operations. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Lori Murray, Chief Corporate Affairs Officer

Marissa Hanify, Director, Corporate Communications