Recursion announces first patient dosed in Phase 1/2 clinical study of REC-1245, a potential first-in-class, RBM39 degrader for Biomarker-Enriched Solid Tumors and Lymphoma
03 Dicembre 2024 - 2:30PM
Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company
decoding biology to radically improve lives, today announced that
the first patient has been dosed in its Phase 1/2 clinical trial of
REC-1245, a new chemical entity for the treatment of
biomarker-enriched solid tumors and lymphoma.
Recursion identified the novel regulatory role of RBM39 on CDK12
function using its AI-powered maps of biology. Recursion believes
the modulation of RBM39 may be associated with a therapeutic effect
in certain biomarker-enriched solid tumors and lymphoma.
Preclinical data support that RBM39 degradation induces splicing
defects which downregulate DNA Damage Response (DDR) networks and
cell cycle checkpoints.
Dr. McKean, a Clinical Investigator at START Mountain Region in
Salt Lake City, Utah shared “The evolution of precision and
personalized treatment options for oncology patients provides
promising alternatives. We are so pleased to be working with
Recursion as a participating site in the DAHLIA trial, and look
forward to advancing the science of cancer treatment.”
“Dosing the first patient in the DAHLIA trial marks a pivotal
moment for Recursion as we combine the power of our AI-enabled
platform with cutting-edge science to pioneer a new class of
targeted therapies,” added Najat Khan, PhD, Chief R&D Officer
and Chief Commercial Officer of Recursion “REC-1245 represents not
only a potential breakthrough for patients with biomarker-enriched
cancers but also a testament to our ability to rapidly translate
novel insights into clinical programs. This milestone exemplifies
our commitment to transforming the future of oncology with
precision and speed.”
The DAHLIA clinical trial is an open-label Ph1/2 study to
characterize the safety, tolerability, PK, PD, and preliminary
activity (ORR) of REC-1245 and to identify the maximum tolerated
dose (MTD) and / or recommended phase 2 dose (RP2D). REC-1245 is a
potential single agent or for use in combination with other agents
(DDR inhibitors, checkpoint inhibitors, chemotherapy).
About the potential patient population Based on
an as of yet undisclosed specific set of biomarkers, Recursion
estimates that the initially addressable population for this
potential therapeutic to be >100,000 patients in the US and
EU5.
About REC-1245REC-1245 is a novel molecular
glue that leads to the degradation of RBM39 via E3 ligase adaptor
DCAF15, which disrupts RNA splicing to downregulate cell cycle
checkpoints and DDR networks, including CDK12. REC-1245 was
characterized to selectively mimic the phenotype associated with
CDK12 loss of function, and is an alternative target for modulating
DNA damage response (DDR) pathways. It was developed with
Recursion’s AI-enabled drug discovery platform.
About the Trial The DAHLIA trial is a
multi-center, open-label Ph1/2 study to characterize the safety,
tolerability, PK, PD, and preliminary activity (ORR) of REC-1245
and to identify the maximum tolerated dose (MTD) and the
recommended phase 2 dose (RP2D).
In the DAHLIA trial REC-1245 will be administered orally on a
once daily (QD) schedule in participants with unresectable, locally
advanced, or metastatic cancer and refractory to, had a relapse, or
were intolerant of established standard of care treatments.
Following the completion of Part 1A (monotherapy dose-finding), up
to two previously examined dose levels will be randomized 1:1 in
the monotherapy dose confirmation (Part 1B) portion of the study to
determine the RP2D. The Phase 2 portion of this study will
independently enroll one or more cohorts in parallel at the chosen
RP2D dose.
About RecursionRecursion (NASDAQ: RXRX) is a
leading, clinical-stage TechBio company decoding biology to
industrialize drug discovery. Central to its mission is the
Recursion Operating System (OS), a platform built across diverse
technologies that continuously expands one of the world’s largest
proprietary biological, chemical and patient-centric datasets.
Recursion leverages sophisticated machine-learning algorithms to
distill from its dataset a collection of trillions of searchable
relationships across biology and chemistry unconstrained by human
bias. By commanding massive experimental scale—up to millions of
wet lab experiments weekly—and massive computational scale—owning
and operating one of the most powerful supercomputers in the
world—Recursion is uniting technology, biology, chemistry and
patient-centric data to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a
founding member of BioHive, the Utah life sciences industry
collective. Recursion also has other primary offices in Toronto,
Montreal, the San Francisco Bay Area, New York, the Oxford area,
and London.
Media ContactMedia@Recursion.com
Investor ContactInvestor@Recursion.com
Forward-Looking Statements
This document contains information that includes or is based
upon “forward-looking statements” within the meaning of the
Securities Litigation Reform Act of 1995, including, without
limitation, those regarding the potential efficacy of REC-1245;
timing of the Phase 1/2 clinical trial of REC-1245; early and late
stage discovery, preclinical, and clinical programs; prospective
products and their potential future indications and market
opportunities; Recursion OS and the ability achieve results of
REC-1245 on other targets and/or compounds, and other technologies;
business and financial plans and performance; and all other
statements that are not historical facts. Forward-looking
statements may or may not include identifying words such as “plan,”
“will,” “expect,” “anticipate,” “intend,” “believe,” “potential,”
“continue,” and similar terms. These statements are subject to
known or unknown risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in
such statements, including but not limited to: challenges inherent
in pharmaceutical research and development, including the timing
and results of preclinical and clinical programs, where the risk of
failure is high and failure can occur at any stage prior to or
after regulatory approval due to lack of sufficient efficacy,
safety considerations, or other factors; our ability to leverage
and enhance our drug discovery platform; our ability to obtain
financing for development activities and other corporate purposes;
the success of our collaboration activities; our ability to obtain
regulatory approval of, and ultimately commercialize, drug
candidates; our ability to obtain, maintain, and enforce
intellectual property protections; cyberattacks or other
disruptions to our technology systems; our ability to attract,
motivate, and retain key employees and manage our growth; inflation
and other macroeconomic issues; and other risks and uncertainties
such as those described under the heading “Risk Factors” in our
filings with the U.S. Securities and Exchange Commission, including
our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
other filings. All forward-looking statements are based on
management’s current estimates, projections, and assumptions, and
Recursion undertakes no obligation to correct or update any such
statements, whether as a result of new information, future
developments, or otherwise, except to the extent required by
applicable law.
Grafico Azioni Recursion Pharmaceuticals (NASDAQ:RXRX)
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Grafico Azioni Recursion Pharmaceuticals (NASDAQ:RXRX)
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Da Gen 2024 a Gen 2025