Rubius Therapeutics Presents Initial Clinical Results from the Ongoing Phase 1/2 Clinical Trial of RTX-240 in Advanced Solid ...
April 09 2021 - 8:00AM
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 reprised initial clinical results
from its ongoing Phase 1/2 study of RTX-240 in advanced solid
tumors at the American Association for Cancer Research (AACR)
Virtual Annual Meeting. Posters will be available online tomorrow
on the AACR website and Publications page of the Rubius
Therapeutics website at 8:30 a.m. EDT. The data included in the
poster are based on a data cutoff date of February 28, 2021.
“The clinical data shared to date demonstrate that RTX-240 has
the ability to activate and expand a patient’s own immune system to
fight cancer, leading to clinical responses in certain patients
with advanced solid tumors,” said Omid Hamid, M.D., Chief of
Translational Research and Immunotherapy, Director of the Phase 1
Immuno-Oncology Program of The Angeles Clinic and Research
Institute, a Cedars-Sinai Affiliate, and RTX-240 investigator.
“Given the promising emerging safety profile, together with initial
indication of clinical activity, RTX-240 represents a potentially
novel therapeutic that may benefit patients with advanced-stage
solid tumors, including those who have been previously treated with
checkpoint inhibition.”
“Based on these initial promising results, we are continuing to
enroll patients and plan to present additional clinical results
from the RTX-240 Phase 1 solid tumor clinical trial by year end,”
said Christina Coughlin, M.D., Ph.D., Chief Medical Officer of
Rubius Therapeutics. “Additionally, by year end, we expect to
select the specific solid tumor types that we plan to pursue in the
Phase 2 expansion cohorts of RTX-240. We also intend to initiate a
new Phase 1 arm to evaluate RTX-240 in combination with anti-PD-1
therapy in advanced solid tumors during the second half of 2021.”
Poster Title: A Phase 1 Trial of RTX-240, an
Allogeneic Engineered Red Blood Cell with Cell-Surface Expression
of 4-1BBL and Trans-Presented IL-15, in Patients with Advanced
Solid TumorsSession Category: Clinical Trials
(Poster Session)Session Title: Phase I Clinical
TrialsAbstract Number: CT141
About RTX-240
RTX-240, Rubius Therapeutics' lead oncology program, is an
allogeneic, off-the-shelf cellular therapy product candidate that
is engineered to simultaneously present hundreds of thousands of
copies of the costimulatory molecule 4-1BB ligand (4-1BBL) and
IL-15TP (trans-presentation of IL-15 on IL-15Rα) in their native
forms. RTX-240 is designed to broadly stimulate the immune system
by activating and expanding both NK and memory T cells to generate
a potent anti-tumor response.
About the RTX-240 Clinical Trial
This is a Phase 1/2 open label, multicenter, multidose,
first-in-human dose-escalation and expansion study designed to
determine the safety and tolerability, pharmacokinetics, maximum
tolerated dose and a recommended Phase 2 dose and dosing regimen of
RTX-240 in adult patients with relapsed/refractory or locally
advanced solid tumors or with relapsed/refractory acute myeloid
leukemia. The trial will also assess the pharmacodynamics of
RTX-240 measured by changes in T and NK cell number and function
relative to baseline and anti-tumor activity. The study will
include a monotherapy dose escalation phase followed by an
expansion phase in specified tumor types during the Phase 2 portion
of the trial. The extent to which the COVID-19 pandemic may impact
Rubius’ ability to enroll patients in the trial will depend on
future developments.
About Rubius Therapeutics
Rubius 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
recently named among the Top Places to Work in Massachusetts by the
Boston Globe, and its manufacturing site was recently named 2020
Top 5 Best Places to Work in Rhode Island among medium-sized
companies 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 with respect to the therapeutic
potential of our pipeline of Red Cell Therapeutics, including
RTX-240, our expectations regarding the timing, enrollment, data
from and success of the future cohorts and phases of the clinical
trial of RTX-240, including the Phase 1/2 clinical trial of
RTX-240, our plans to initiate a RTX-240 Phase 2 expansion cohort,
an RTX-240 Phase 1 clinical trial in combination with an anti-PD-1
therapy in advanced solid tumors, our expectations regarding the
biological effects of RTX-240 on innate and adaptive immunity and
the related therapeutic benefits, our expectations regarding the
initial preliminary data from RTX-240 and the related therapeutic
benefits and validation of our RED PLATFORM 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
Annual Report on Form 10-K for the year ended December 31,
2020, and subsequent filings with the SEC and risks and
uncertainties related to the severity and duration of the impact of
COVID-19 on our clinical trials, 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
Rubius Therapeutics (NASDAQ:RUBY)
Historical Stock Chart
From Jun 2024 to Jul 2024
Rubius Therapeutics (NASDAQ:RUBY)
Historical Stock Chart
From Jul 2023 to Jul 2024