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Rubius Therapeutics Announces Preclinical Data for RTX-224, a Broad Immune Costimulatory Agonist, to be Presented at the Society for Immunotherapy of Cancer’s Annual Meeting

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Rubius Therapeutics (Nasdaq: RUBY) announced it will present preclinical data on RTX-224 at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting from November 10-14, 2021. RTX-224 aims to enhance immune responses against tumors by utilizing 4-1BB ligand and interleukin-12. The data suggests RTX-224 activates immune cells in the spleen and blood, potentially increasing their presence in tumor areas. The company plans to submit an Investigational New Drug application to the FDA by year-end, indicating progress in their development pipeline.

Positive
  • Presentation of preclinical data for RTX-224, indicating it activates immune cells and promotes anti-tumor effects.
  • Plans to submit an Investigational New Drug application to the FDA by year-end, signaling further advancement in drug development.
Negative
  • None.

CAMBRIDGE Mass., Oct. 01, 2021 (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 it will present preclinical data for RTX-224, a broad immune costimulatory agonist for the treatment of cancer, at the upcoming Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting which is being held from November 10-14, 2021, in Washington, D.C., and virtually.

RTX-224 is an allogeneic cellular therapy 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.

“At SITC, we plan to present preclinical data indicating that RTX-224 activates immune cells in the spleen and blood, leading to their trafficking into the tumor microenvironment to deliver an anti-tumor effect in our preclinical models,” said Laurence Turka, M.D., chief scientific officer of Rubius Therapeutics. “The combination of IL-12 and 4-1BB ligand has the potential to broadly induce an immune response in patients with solid tumors and may serve as the bridge between the innate and adaptive immune systems. These preclinical data are encouraging, and we plan to submit an Investigational New Drug application to the FDA by year end.”

Details of the poster are as follows:

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
Abstract Number: 208 (ePoster)
Date, Time and Location: Friday, November 12, 2021, at 7 a.m. EST through Sunday, November 14, 2021, at 5 p.m. EST on the SITC website: www.sitcancer.org/2021

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 genetically 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 named among the 2020 Top Places to Work in Massachusetts by the Boston Globe, and its manufacturing site was recently named 2021 Best Places to Work in Rhode Island by Providence Business News. For more information, visit www.rubiustx.com, 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, statements regarding our expectations with respect to the therapeutic potential of our pipeline of Red Cell Therapeutics™, including RTX-224, analyses of our preclinical data, including the impact of RTX-224 on certain immune cells and anti-tumor effects, expectations for the potential for IL-12 and 4-1BB ligand to broadly induce an immune response in patients and act as a bridge between the innate and adaptive immune systems and plans to submit an IND by year end. 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, including RTX-224, and their therapeutic potential and other risks identified in our filings with the U.S. Securities and Exchange Commission (SEC), including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, and subsequent filings with the SEC. 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 our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

Contacts:

Investors
Elhan Webb, CFA, Vice President of Investor Relations
elhan.webb@rubiustx.com

Media
Marissa Hanify, Director, Corporate Communications
Marissa.hanify@rubiustx.com

Dan Budwick, 1AB
+1 (973) 271-6085
dan@1abmedia.com


FAQ

What is RTX-224 and its significance for Rubius Therapeutics (RUBY)?

RTX-224 is an engineered allogeneic cellular therapy aimed at enhancing immune responses in cancer treatment, which Rubius is presenting at the SITC meeting.

When will Rubius Therapeutics present data for RTX-224?

Rubius Therapeutics will present preclinical data for RTX-224 at the SITC Annual Meeting from November 10-14, 2021.

What are the expected outcomes of RTX-224 based on preclinical data?

The preclinical data suggest RTX-224 activates immune cells, potentially leading to increased anti-tumor activity.

What are the next steps for Rubius Therapeutics after the SITC meeting?

Rubius Therapeutics plans to submit an Investigational New Drug application to the FDA for RTX-224 by the end of 2021.

Rubius Therapeutics, Inc.

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