Rubius Therapeutics to Highlight the Power of its RED PLATFORM®, Significant Advances Across Red Cell Therapeutic Oncology Pipeline and New Type 1 Diabetes Program at Platform and Pipeline Day

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

Excerpt from the Press Release:

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

• Achieved clinical validation of the RED PLATFORM with initial clinical results from the single-agent RTX-240 Phase 1 clinical trial in advanced solid tumors, reported in March 2021
  • RCTs are well tolerated, induce the desired biological effect and generate clinical benefit in certain patients with advanced solid tumors
• Advancing next generation aAPCs with loadable MHC Class I, enabling the presentation of multiple antigens on a single RCT and broadening the potential patient population with a library of HLA types
• Enabling rapid and repeatable parallel generation of therapeutic candidates with the programmable RED PLATFORM
  • The platform creates multiple modalities for the treatment of cancer and autoimmune disease and the ability to express hundreds of thousands of copies of therapeutic proteins on or within the cell to access numerous immune pathways

Oncology

Broad Immune Stimulation Approach

RTX-240

• Established clinical proof of concept of RTX-240 in advanced solid tumors, based on initial results reported in March 2021, potentially increasing the likelihood of clinical success across the oncology pipeline
• Escalating the dose of single-agent RTX-240 in the Phase 1 solid tumor clinical trial to three doses of 5e10 followed by one dose 1e10 until disease progression or unacceptable toxicity, based on no dose-limiting toxicities observed to date, a clear dose response in the increase of NK cells and other pharmacodynamic effects
  • Additional clinical results are expected from this trial and the Phase 1 arm in relapsed/refractory AML during the first quarter of 2022.
  • The Company plans to initiate single-agent RTX-240 Phase 2 expansion cohorts in select solid tumor types during the first quarter of 2022.
• Continuing dose escalation in the RTX-240 Phase 1 combination study with pembrolizumab in patients with advanced solid tumors.

RTX-224

• Planning to initiate the Phase 1 clinical trial of RTX-224 in patients with certain advanced solid tumors during the first quarter of 2022
  • Investigational New Drug application cleared

Antigen-Specific Immune Stimulation Approach

RTX-321

• Continuing enrollment in Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers
• Planning to report initial clinical results during the first quarter of 2022

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