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™, 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® from the authors in Nature’s
Behind the Paper Channel, here.
About HPV 16-Positive CancersHuman
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 TrialRubius
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-321RTX-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 (MHC) class I proteins, the
costimulatory molecule 4-1BBL and the cytokine IL-12 on the cell
surface to mimic human T cell-APC interactions.
About Rubius TherapeuticsRubius 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 regarding the therapeutic potential of our pipeline of
Red Cell Therapeutics, including the dual mechanism of RTX-321 for
the treatment of HPV 16-positive cancers, the potential therapeutic
benefits of RTX-321, timelines related to the Phase 1 clinical
trial of RTX-321, and our expectations regarding our strategy,
business plans and focus. 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 and
other risks identified in our SEC filings, including our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2021, and
subsequent filings with the SEC 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. We
explicitly disclaim any obligation to update any forward-looking
statements.
Contacts:
InvestorsElhan Webb, CFA, Vice President of
Investor Relationselhan.webb@rubiustx.com
Media Marissa Hanify, Director, Corporate
CommunicationsMarissa.hanify@rubiustx.com
Dan Budwick, 1AB+1 (973) 271-6085dan@1abmedia.com
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