Rubius Therapeutics to Present Trials in Progress Poster on the Phase 1 Clinical Trial of RTX-321 for HPV 16-Positive Cancers...
May 19 2021 - 5:02PM
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 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) Annual Meeting being
held virtually from June 4-8, 2021.
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—ImmunotherapyAbstract Number:
TPS2664Date and Time: Friday, June 4, 2021 at 9:00
AM ET on the ASCO website, https://meetings.asco.org/
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 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 and expectations 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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