Rubius Therapeutics Announces Dosing of First Patient in Phase 1/2 Trial of RTX-224, a Broad Immune Agonist, for the Treatment of Certain Solid Tumors
14 January 2022 - 12:00AM
Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage
biopharmaceutical company that is biologically engineering red
blood cells to create an entirely new class of cellular medicines
called Red Cell Therapeutics™ for the treatment of cancer and
autoimmune disease, today announced that the first patient has been
dosed in its Phase 1/2 clinical trial of RTX-224 for the treatment
of patients with certain relapsed/refractory or locally advanced
solid tumors, including non-small cell lung cancer, cutaneous
melanoma, head and neck squamous cell carcinoma, urothelial
(bladder) carcinoma and triple-negative breast cancer.
“While our lead oncology product candidate, RTX-240, is designed
to broadly stimulate the immune system by activating and expanding
NK and CD8+ memory T cells, we expect RTX-224 to produce a broad
and potent anti-tumor T cell response, an innate immune response
and have anti-tumor activity in those tumor types with known
sensitivity to T cell killing, including tumor types with high
mutational burden, PD-L1 expression and known responsiveness to
checkpoint inhibitors,” said Larry Turka, M.D., chief scientific
officer and head of research and translational medicine of Rubius
Therapeutics. “Given the mechanism of action of RTX-224 and
totality of our preclinical data generated to date, we believe
RTX-224 will be an effective treatment for select advanced solid
tumors.”
RTX-224 is an allogeneic, off-the-shelf cellular therapy product
candidate that is engineered to express hundreds of thousands of
copies of 4-1BB ligand (4-1BBL) and interleukin-12 (IL-12) on the
cell surface.
About the RTX-224 Phase 1/2 Clinical TrialThis
is a Phase 1/2 open label, multicenter, multidose, first-in-human
dose-escalation and expansion study to determine the safety and
tolerability, pharmacokinetics, maximum tolerated dose and a
recommended Phase 2 dose and dosing regimen of RTX-224 in adult
patients with certain relapsed/refractory or locally advanced solid
tumors including non-small cell lung cancer, cutaneous melanoma,
head and neck squamous cell carcinoma, urothelial (bladder)
carcinoma and triple-negative breast cancer. The trial will also
assess pharmacodynamic changes in immune cell populations 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.
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 biologically 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 2021 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 with respect to the therapeutic potential of our
pipeline of Red Cell Therapeutics™, including RTX-224, analyses of
expectations based on our preclinical data, including the impact of
RTX-224 on certain immune cells and anti-tumor effects, beliefs
that RTX-224 could be an effective treatment for advanced solid
tumors, expectations regarding dosing, expectations for the
potential for IL-12 and 4-1BB ligand to broadly induce an immune
response in patients and act as a bridge between the innate and
adaptive immune systems and the belief that the combined
enhancement of both adaptive and innate immune responses leads to a
productive antitumor response. 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-224, 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 September
30, 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
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