Benzinga | May 12, 2021 08:06AM EDT

Rubius Therapeutics Highlights Publication Of RTX-321 Preclinical Data In Nature Communications

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(tm), today announced the publication of preclinical data in the peer-reviewed journal Nature Communications, for its lead artificial antigen-presenting (aAPC) cell program, RTX-321, for the potential treatment of human papillomavirus (HPV) 16-positive cancers. RTX-321 is an allogeneic, off-the-shelf Red Cell Therapeutic product candidate that is engineered as an aAPC with a dual mechanism of action: to boost HPV 16-specific CD8+ T cell responses and promote broad stimulation of both innate and adaptive immune responses. Rubius Therapeutics is currently enrolling patients with persistent, recurrent, or metastatic, unresectable, HPV 16-positive cancers, including cervical cancer, head and neck squamous cell carcinoma (HNSCC) and anal cancer, in a Phase 1 clinical trial.



The paper entitled "Engineered red blood cells as an off-the-shelf allogeneic anti-tumor therapeutic" highlights preclinical findings demonstrating that the surrogate model of RTX-321 induced a target antigen-specific immune response, epitope spreading, memory formation as well as broad immune stimulation. This suggests that in patients, an effective immune response could be generated against multiple HPV antigens, and potentially enable the patient's own immune system to remember a cancer's identity, which could lead to long-term protection from tumor recurrence. The paper is available here: https://rdcu.be/ckodl.

"These preclinical findings support the potential of RTX-321 as an effective antigen-specific therapy for advanced HPV 16-positive cancers, where few treatment options exist in the metastatic setting for this group of patients. Our publication describes an elegant mechanism of action for RTX-321, combining antigen-specific responses with the addition of broad immune stimulation," said Laurence Turka, M.D., chief scientific officer of Rubius Therapeutics. "We are very excited about the potential of this investigational therapy and plan to share initial clinical results from our Phase 1 clinical trial in the first quarter of 2022."

For additional background on the paper, see accompanying article on Rubius Therapeutics' RED PLATFORM(r) from the authors in Nature's Behind the Paper Channel, here.

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).