Rubius Therapeutics, Inc. (Nasdaq: RUBY), a biopharmaceutical
company that is developing an entirely new class of cellular
medicines called Red Cell Therapeutics™ for the treatment of cancer
and autoimmune diseases, today announced plans to restructure the
Company and align resources to advance its next generation red
blood cell-based cell conjugation platform.
“With more than 80 patients dosed across three clinical trials
to date, Rubius Therapeutics has demonstrated that engineered red
blood cells can be manufactured at scale, safely administered and
activate a patient’s immune system, resulting in clinical benefit
in certain cancer patients, including evidence of tumor shrinkage
and prolonged stable disease in PD-(L)-1 refractory solid tumors,”
said Pablo J. Cagnoni, M.D., president and chief executive officer
of Rubius Therapeutics. “Based on these early findings, we firmly
believe in the potential of Red Cell Therapeutics for the treatment
of cancer and autoimmunity. Following careful review of recent
technical progress in an alternative format for making Red Cell
Therapeutics, we believe that this process has the potential for
substantive improvements over our existing platform, and,
therefore, continued investment in our two current clinical
candidates is no longer justified. Instead, we plan to focus on
advancing a next generation red blood cell platform that utilizes
cell conjugation to potentially improve upon the existing benefits
of the RED PLATFORM, with the potential for greater efficacy and
enhanced versatility, while maintaining our favorable tolerability
profile. As a result, we have decided to discontinue our ongoing
clinical trials of RTX-240 and RTX-224 for the treatment of
advanced solid tumors and restructure the organization to support
advancing drug candidates based on the next generation platform. I
would like to express my sincere gratitude to the patients who
participated in our clinical trials, the investigators who
partnered with us in this endeavor and our employees for their
immense dedication and contributions that have brought us to where
we are today.”
Next Generation Red Blood Cell-Based Conjugation
Platform Overview
The new platform is expected to improve upon the existing
benefits of the RED PLATFORM, with the potential for greater
efficacy and enhanced versatility, while maintaining a favorable
tolerability profile, and reduce the complexity and cost of
generating cells by leveraging chemical conjugation to produce Red
Cell Therapeutics. Cell conjugation creates a covalent link between
the cell surface and the molecule of interest. This approach is
intended to:
- deliver a higher effective dose by enabling a longer
circulation time and/or administering a higher cell dose;
- be more versatile, enabling the conjugation of different
payloads, immunomodulatory agents, small molecules and proteins on
the cell for enhanced potency; and
- reduce the cost of goods manufacturing by utilizing
blood-banked RBCs versus biologically engineering and
differentiating early progenitor cells into reticulocytes that
express proteins
These attributes are expected to result in greater efficacy, a
similar safety profile given the restricted biodistribution of RBCs
to the spleen and vasculature and a significant reduction in
overall cost structure.
Business & Strategy Update
To enable continued investment in the new platform, the Company
is restructuring its business and implementing a series of
cost-saving measures, which extends the Company’s cash runway until
the end of 2023. These measures include:
- Implementing a 75% reduction in force, primarily focused on
clinical development, manufacturing and general and
administrative;
- Discontinuing its ongoing Phase 1 clinical trials of RTX-240
and RTX-224 for the treatment of advanced solid tumors; and
- Exploring the sale of its manufacturing facility in Smithfield,
Rhode Island
- Patients still on trial will continue to be dosed until disease
progression or discontinuation (n=6)
The Company will maintain its robust technical development and
preclinical oncology and autoimmunity research capabilities to
advance the new platform and related preclinical programs.
Overview of Current Clinical Programs
Phase 1 Clinical Trial of Monotherapy
RTX-240
As of September 12, 2022, 36 patients have been dosed in the
monotherapy arm of the Phase 1/2 clinical trial of RTX-240 in
advanced solid tumors. One patient with renal cell carcinoma
remains on study with stable disease for more than one year after
developing progressive disease on prior treatment with nivolumab.
This ongoing patient was dose-escalated from the 3e10 x 3 + 1e10
Q3W dose level (n=6) to the 5e10 Q3W dose level after Cycle 12.
Seven patients were dosed at 5e10 Q3W with one anal cancer patient
experiencing stable disease for 5 months before disease
progression. RTX-240 continued to be well tolerated with no
treatment-related Grade 3/4 adverse events (AEs) and no
dose-limiting toxicities.
Phase 1 Clinical Trial of RTX-240 + Pembrolizumab in
Advanced Solid Tumors
Fourteen patients were dosed in the “all comers” dose-escalation
portion of the Phase 1 clinical trial evaluating RTX-240 in
combination with pembrolizumab in advanced solid tumors. Four
patients had stable disease of greater than 12 weeks with one
colorectal cancer patient remaining on study with stable disease of
greater than 4 months. Two additional patients have been dosed in
the non-clear cell RCC (nccRCC) and non-small cell lung cancer
(NSCLC) expansion cohorts. Both patients remain on treatment with
one nccRCC patient with stable disease greater than 12 weeks and
one NSCLC patient who is not yet evaluable for response. The
combination of RTX-240 with pembrolizumab continued to be well
tolerated with no treatment or investigator-identified
immune-related Grade 3/4 AEs and no dose-limiting toxicities.
Phase 1 Clinical Trial of RTX-224 in Select Advanced
Solid Tumors
Seven patients have been dosed across two dose cohorts in the
Phase 1 clinical trial evaluating RTX-224 in select 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. One patient dosed at
the 5e8 Q3W dose level with melanoma remains on study and is not
yet evaluable for response. There have been no treatment-related
Grade 3/4 AEs and no dose-limiting toxicities.
Investor Teleconference & Webcast
An audio webcast will be available on the Events and
Presentations page within the Investors and Media section of the
Rubius Therapeutics website and can be directly accessed here. An
archived webcast will be accessible for 90 days after the
event.
About Rubius Therapeutics
Rubius Therapeutics is a biopharmaceutical company that is
developing an entirely new class of cellular medicines called Red
Cell Therapeutics™ for the treatment of cancer and autoimmune
diseases. The Company was named among the 2021 Top Places to Work
in Massachusetts by the Boston Globe, and its manufacturing site
was recently named 2022 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 release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including, without limitation, statements regarding
beliefs about and expectation for the restructuring plan described
in this release, including associated costs, cost savings and
timing, as well as our beliefs about the next generation red blood
cell platform, including that it will potentially improve upon the
existing benefits of the RED PLATFORM, and its potential for
greater efficacy and enhanced versatility. 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 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
release, including, without limitation, risks related to the
substantial doubt about our ability to continue as a going concern
given that we currently do not have adequate financial resources to
fund our forecasted operating costs for at least 12 months; our
ability to execute on and realize the expected benefits of the
restructuring plan described in this release; the amount of debt we
have outstanding and the lender’s rights under our loan facility,
including the lender’s ability to accelerate amounts outstanding
under the loan facility, or exert control over our cash accounts in
connection with certain events of default, including a material
adverse change in our business; our ability to pursue and secure
financing to fund our operations; our ability to maintain our
listing on the Nasdaq Stock Market, particularly in light of our
recently disclosed deficiencies; those risks and uncertainties
related to the development of the our Red Cell Therapeutic product
candidates and their therapeutic potential; risks related to our
ability to execute on our plans and expectations and our analyses
of clinical and preclinical data; 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
June 30, 2022 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 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.
Investor and Media ContactLori Murray, Chief
Corporate Affairs Officer lori.murray@rubiustx.com
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