Highly Versatile and Programmable RED PLATFORM Enables Multiple Modalities to Target Different Immune Pathways Across a Range of Diseases
Demonstrated Tolerance Induction with Bystander Suppression in Type 1 Diabetes Preclinical Program with Findings Translatable to Multiple T Cell-Mediated Autoimmune Diseases
Advancing Next-Gen Artificial-Antigen Presenting Cells (aAPCs) with Loadable MHC Class 1 Platform, Enabling Presentation of Multiple Antigens on a Single Red Cell Therapeutic
Continuing Dose Escalation in Single-Agent Phase 1 RTX-240 Clinical Trial in Advanced Solid Tumors with No Dose-Limiting Toxicities Observed to Date and an NK Cell Dose Response with Clinical Results Expected in Q1’22
Scaling Manufacturing to Support a Potential Pivotal Trial and Eventual Commercialization
Live Webcast Today at 11:00 a.m. ET with Rubius Management Team and Dr. Gerald T. Nepom, M.D., Ph.D., Expert in Autoimmunity and Type 1 Diabetes
CAMBRIDGE, Mass., Dec. 16, 2021 (GLOBE NEWSWIRE) — Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is biologically 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 significant advances from its RED PLATFORM and across its pipeline of Red Cell Therapeutics (RCTs) at the Company’s first Pipeline and Platform Day.
“Over the course of our presentations, we will highlight the incredible scope and versatility of the programmable RED PLATFORM, enabling targeting of multiple immune pathways via several different modalities, as well as the progress Rubius Therapeutics is making in advancing our clinical-stage cancer therapies, autoimmune programs and manufacturing capabilities,” said Pablo J. Cagnoni, M.D., “Today, for the first time, we will be unveiling preclinical proof of concept data demonstrating tolerance induction with bystander suppression of type 1 diabetes, a T cell-mediated disease. We expect next year to be data rich with several important clinical milestones from our oncology pipeline, including additional clinical results from the single-agent RTX-240 Phase 1 clinical trial in advanced solid tumors and acute myeloid leukemia and initial clinical results from our RTX-321 Phase 1 clinical trial in advanced HPV 16-positive cancers, which we anticipate occurring during the first quarter of 2022.”
Highlights and Progress
RED PLATFORM
Oncology
Broad Immune Stimulation Approach
RTX-240
RTX-224
Antigen-Specific Immune Stimulation Approach
RTX-321
Autoimmune Diseases and Type 1 Diabetes
Manufacturing
Video Webcast Information
A live video webcast is scheduled for today from 11:00 a.m. to 2:00 p.m. ET and can be accessed via the Events and Presentations page within the Investor and Media section of the Rubius Therapeutics website. The Rubius management team and Dr. Nepom will host a Q&A session following the presentations.
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 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 beliefs about Rubius’ execution across preclinical and clinical development, Rubius’ plans and expected timing to present clinical results for RTX-240 and RTX-321, beliefs that findings from preclinical models will be translatable to multiple T cell-mediated autoimmune diseases, plans to advance and expectations for aAPCs, plans and timing to scale manufacturing, beliefs about the scope and versatility of the programmable RED PLATFORM and the generation of therapeutic candidates, expectations regarding the timing for initiating the RTX-224 trial, expectations regarding the therapeutic potential and safety profile of our pipeline of Red Cell Therapeutics, our interpretations of data, including as to the efficacy of our product candidates with respect to autoimmune diseases and Type 1 diabetes, as well as beliefs about our manufacturing accomplishments and goals and expectations for further manufacturing activities. 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, 2020 and our subsequent filings with the SEC, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, 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.
Contacts:
Investors
Elhan Webb, CFA, VP Investor Relations
elhan.webb@rubiustx.com
Media
Marissa Hanify, Director, Corporate Communications
marissa.hanify@rubiustx.com
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