On May 19, 2021 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, reported that the Company will present a Trials in Progress poster presentation for its lead artificial antigen-presenting (aAPC) cell program, RTX-321, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually from June 4-8, 2021 (Press release, Rubius Therapeutics, MAY 19, 2021, View Source [SID1234584706]).
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The Trials in Progress poster presentation will summarize the proposed mechanism of action of RTX-321, preclinical observations to date and the clinical trial design, including translational medicine methodology, for the Company’s ongoing Phase 1 clinical trial of RTX-321 for the treatment of HPV 16-positive cancers, including cervical cancer, anal cancer, and head and neck cancer.
Poster Title: A Phase 1 Study of RTX-321, an Engineered Red Blood Cell as an Artificial Antigen-Presenting Cell Expressing HLA-A*02 with the HPV-16 E7 Peptide and 4-1BB Ligand with Membrane-Bound IL-12 for the Treatment of HPV 16-Positive Cancers
Session Title: Poster Session: Developmental Therapeutics—Immunotherapy
Abstract Number: TPS2664
Date and Time: Friday, June 4, 2021 at 9:00 AM ET on the ASCO (Free ASCO Whitepaper) website, View Source
About HPV 16-Positive Cancers
Human papillomavirus (HPV) 16 is associated with approximately 70 percent of cervical cancers, approximately 40 percent of head and neck squamous cell carcinoma (HNSCC) arising in the oropharynx, approximately 25-40 percent of HNSCC arising in other locations and approximately 80-85 percent of anal cancers. A critical need remains for better treatment options for advanced HPV 16-associated cancers. The prognosis remains poor for patients with metastatic disease with few treatment options beyond the first-line setting.
About the RTX-321 Clinical Trial
Rubius Therapeutics is enrolling patients in a Phase 1 open-label, multicenter, monotherapy dose escalation, first-in-human study of RTX-321 for the treatment of patients that are HLA-A*02:01-positive with persistent, recurrent, or metastatic, unresectable, HPV 16-positive cancers, including unresectable cervical cancer (squamous, adeno, or adenosquamous histology), head and neck squamous cell carcinoma (including of the nasal and oral cavities, larynx, hypopharynx, nasopharynx, and oropharynx) and squamous cell cancer of the anal canal that is not amenable to curative therapy. The purpose of the trial is to determine the safety and tolerability, recommended Phase 2 dose and pharmacology, and antitumor activity of RTX-321. For more information about the Phase 1 clinical trial of RTX-321, please visit clinicaltrials.gov (NCT04672980).
About RTX-321
RTX-321 is an allogeneic, off-the-shelf aAPC therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses hundreds of thousands of copies of an HPV peptide antigen bound to major histocompatibility complex class I proteins, the costimulatory molecule 4-1BBL and the cytokine IL-12 on the cell surface to mimic human T cell-APC interactions.