Rubius Therapeutics Announces Publication of RTX-240 Preclinical Data in Cancer Immunology, Immunotherapy
July 15 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 announced the publication of
preclinical data in the peer-reviewed journal Cancer Immunology,
Immunotherapy, for its lead clinical oncology program, RTX-240, for
the treatment of adults with advanced solid tumors and
relapsed/refractory acute myeloid leukemia.
The paper entitled “Anti-Tumor Effects of RTX-240: an Engineered
Red Blood Cell Expressing 4-1BB Ligand and Interleukin-15”
highlights preclinical findings, which demonstrate that RTX-240
activates and expands CD8+ T cells and NK cells in vitro and in
vivo generating potent anti-tumor activity in both a colorectal and
melanoma model. The paper is available here:
https://doi.org/10.1007/s00262-021-03001-7.
“These preclinical data demonstrate RTX-240’s mechanism of
action, which we’ve also seen translated to the clinic thus far.
Namely, in these preclinical models, RTX-240 activated and expanded
both NK and T cells capable of trafficking to the tumor and killing
tumor cells, while showing only minimal toxicity due to the
biodistribution of RTX-240 to the vasculature and spleen,” said
Laurence Turka, M.D., chief scientific officer of Rubius
Therapeutics. “Compared to a 4-1BB agonist antibody, RTX-240 was
better tolerated and demonstrated a wider therapeutic window in
preclinical studies, suggesting that RTX-240 could provide a more
efficacious and safer option for the treatment of patients with
advanced solid tumors and acute myeloid leukemia.”
“These preclinical data supported advancing RTX-240 into the
clinic, where the initial clinical results have shown 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 Christina Coughlin,
M.D., Ph.D., chief medical officer of Rubius Therapeutics. “We are
continuing to enroll patients in our ongoing Phase 1/2 clinical
trial of RTX-240 in three Phase 1 arms: a monotherapy dose
escalation arm in adults with relapsed/refractory or locally
advanced solid tumors, a monotherapy dose escalation arm in adults
with relapsed/refractory acute myeloid leukemia, and a combination
therapy dose escalation arm with pembrolizumab in adults with
relapsed/refractory or locally advanced solid tumors.”
About RTX-240RTX-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 Phase 1/2 Clinical TrialThis
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,
a recommended Phase 2 dose and dosing regimen of RTX-240. 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 trial has three separate Phase 1 arms:
an ongoing monotherapy dose escalation arm in adults with
relapsed/refractory or locally advanced solid tumors, an ongoing
monotherapy dose escalation arm in adults with relapsed/refractory
acute myeloid leukemia, and a combination therapy dose escalation
arm with pembrolizumab in adults with relapsed/refractory or
locally advanced solid tumors. The monotherapy arm of the trial in
advanced solid tumors includes a Phase 2 expansion in specified
tumor types.
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
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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
expectations regarding the biological effects of RTX-240 on innate
and adaptive immunity and the related therapeutic benefits,
including the therapeutic window, and beliefs about the safety and
efficacy profile of RTX-240 and its potential role in the treatment
of cancer, 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,
including RTX-240, and their therapeutic potential and other risks
identified in our filings with the U.S. Securities and Exchange
Commission (SEC), including our Quarterly Report on Form 10-Q for
the quarter ended March 31, 2021, and subsequent filings with the
SEC. 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 our 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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